Ciprofloxacin
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Questions & Answers
Side Effects & Adverse Reactions
Fluoroquinolones, including Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.
THE SAFETY AND EFFECTIVENESS OF CIPROFLOXACIN IN PREGNANT AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.
(See
PRECAUTIONS: Pregnancy,
and
Nursing Mothers
subsections.)
Ciprofloxacin should be used in pediatric patients (less than 18 years of age) only for infections listed in the
INDICATIONS AND USAGE
section. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See
ADVERSE REACTIONS
.)
In pre-clinical studies, oral administration of ciprofloxacin caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. (See
ANIMAL PHARMACOLOGY
.)
Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway. Coadministration of ciprofloxacin and other drugs primarily metabolized by CYP1A2 (e.g. theophylline, methylxanthines, tizanidine) results in increased plasma concentrations of the coadministered drug and could lead to clinically significant pharmacodynamic side effects of the coadministered drug.
Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving quinolones, including ciprofloxacin. Ciprofloxacin may also cause central nervous system (CNS) events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving ciprofloxacin, the drug should be discontinued and appropriate measures instituted. As with all quinolones, ciprofloxacin should be used with caution in patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (e.g. severe cerebral arteriosclerosis, epilepsy), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g. certain drug therapy, renal dysfunction). (See
PRECAUTIONS: General, Information for Patients, Drug Interactions
and
ADVERSE REACTIONS
.)
SERIOUS AND FATAL REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AND THEOPHYLLINE.
These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure. Although similar serious adverse effects have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by ciprofloxacin cannot be eliminated. If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should be administered as indicated.
Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:
- fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome);
- vasculitis; arthralgia; myalgia; serum sickness;
- allergic pneumonitis;
- interstitial nephritis; acute renal insufficiency or failure;
- hepatitis; jaundice; acute hepatic necrosis or failure;
- anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted (See PRECAUTIONS: Information for Patients and ADVERSE REACTIONS).
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including ciprofloxacin. Ciprofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.
Ciprofloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with ciprofloxacin should have a follow-up serologic test for syphilis after three months.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see
DOSAGE AND ADMINISTRATION
for specific recommendations.
Urinary Tract Infections
caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa,
methicillin-susceptible
Staphylococcus epidermidis, Staphylococcus saprophyticus,
or
Enterococcus faecalis.
Acute Uncomplicated Cystitis in females
caused by
Escherichia coli
or
Staphylococcus saprophyticus.
Chronic Bacterial Prostatitis
caused by
Escherichia coli
or
Proteus mirabilis.
Lower Respiratory Tract Infections
caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae,
or penicillin-susceptible
Streptococcus pneumoniae.
Also,
Moraxella catarrhalis
for the treatment of acute exacerbations of chronic bronchitis.
NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to
Streptococcus pneumoniae.
Acute Sinusitis
caused by
Haemophilus influenzae,
penicillin-susceptible
Streptococcus pneumoniae,
or
Moraxella catarrhalis.
Skin and Skin Structure Infections
caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa,
methicillin-susceptible
Staphylococcus aureus,
methicillin-susceptible
Staphylococcus epidermidis,
or
Streptococcus pyogenes.
Bone and Joint Infections
caused by
Enterobacter cloacae, Serratia marcescens,
or
Pseudomonas aeruginosa.
Complicated Intra-Abdominal Infections
(used in combination with metronidazole) caused by
Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae,
or
Bacteroides fragilis.
Infectious Diarrhea
caused by
Escherichia coli
(enterotoxigenic strains),
Campylobacter jejuni, Shigella boydii
†
,
Shigella dysenteriae, Shigella flexneri
or
Shigella sonnei
†
when antibacterial therapy is indicated.
Typhoid Fever (Enteric Fever)
caused by
Salmonella typhi.
NOTE: The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.
Uncomplicated cervical and urethral gonorrhea
due to
Neisseria gonorrhoeae.
Complicated Urinary Tract Infections and Pyelonephritis
due to
Escherichia coli.
NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. (See
WARNINGS, PRECAUTIONS, Pediatric Use, ADVERSE REACTIONS
and
CLINICAL STUDIES
.)
Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals. (See
ANIMAL PHARMACOLOGY
.)
Inhalational anthrax
(post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized
Bacillus anthracis.
Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.
5
Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001. (See also,
INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION
).
†
Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some strains of
Pseudomonas aeruginosa
may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg and other antibacterial drugs, Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
History
There is currently no drug history available for this drug.
Other Information
Ciprofloxacin Hydrochloride Tablets USP, 250 mg, 500 mg and 750 mg are synthetic broad spectrum antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C
17
H
18
FN
3
O
3
•HCl•H
2
O and its chemical structure is as follows:
Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C
17
H
18
FN
3
O
3
and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:
Ciprofloxacin Tablets USP are film-coated tablets and are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets are white to slightly yellowish. The inactive ingredients are pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and purified water.
Sources
Ciprofloxacin Manufacturers
-
Remedyrepack Inc.
![Ciprofloxacin Tablet [Remedyrepack Inc. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ciprofloxacin | Remedyrepack Inc.
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See
CLINICAL PHARMACOLOGY
and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See
ADVERSE REACTIONS
and
CLINICAL STUDIES
.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m
2
).
-
Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Ciprofloxacin | Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Adults
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * Used in conjunction with metronidazole
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 days
Mild/Moderate
250 mg
q 12 h
7 to 14 days
Severe/Complicated
500 mg
q 12 h
7 to 14 days
Chronic Bacterial
ProstatitisMild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and
Skin StructureMild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical
Gonococcal InfectionsUncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**500 mg
q 12 h
60 days
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:> 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = ---------------------------------------
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
PEDIATRIC DOSAGE GUIDELINES Infection Route
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax in Adults and Pediatrics, Additional Information.
Complicated Urinary Tract or
PyelonephritisIntravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)Every 8 hours
10-21 days*(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)Every 12 hours
Inhalational Anthrax
(Post-Exposure)**Intravenous
10 mg/kg
(maximum 400 mg per
dose)Every 12 hours
60 daysOral
15 mg/kg
(maximum 500 mg per dose)Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Henry Schein Inc.
Ciprofloxacin | Akorn Animal Health, Inc.
Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.
-
Proficient Rx Lp
Ciprofloxacin | Proficient Rx Lp
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
How Supplied: As a sterile ophthalmic solution, in a plastic dispenser:
5 mL NDC 63187-150
STORAGE: Store at 25°C (77°F); excursions permitted to15 - 30°C (59 - 86°F) [See USP controlled room temperature]. Protect from light. Retain in carton until contents are used.
-
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See
CLINICAL PHARMACOLOGY
and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See
ADVERSE REACTIONS
and
CLINICAL STUDIES
.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m
2
).
-
Lake Erie Medical Dba Quality Care Products Llc
Ciprofloxacin | Lake Erie Medical Dba Quality Care Products Llc
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
How Supplied: As a sterile ophthalmic solution, in a plastic dispenser:
2.5 mL NDC16571-120-25
5 mL NDC16571-120-50
STORAGE: Store at 25°C (77°F); excursions permitted to15 - 30°C (59 - 86°F) [See USP controlled room temperature]. Protect from light. Retain in carton until contents are used.
-
Blenheim Pharmacal, Inc.
Ciprofloxacin | Bayer Healthcare, Llc Animal Health Division
Droncit® Feline Cestocide Tablets may be administered directly per os or crumbled and mixed with the feed. The recommended dosage of praziquantel varies according to body weight. Smaller animals require a relatively larger dosage because of their higher metabolic rate. The optimum dose for each individual animal will be achieved by utilizing the following dosage schedule:
* Not intended for use in kittens less than 6 weeks of age.Cats and Kittens*
4 pounds and under
½ tablet
5-11 pounds
1 tablet
Over 11 pounds
1 ½ tablets
-
Cardinal Health
Ciprofloxacin | Cardinal Health
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Golden State Medical Supply, Inc
Ciprofloxacin | Golden State Medical Supply, Inc
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate ) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal InfectionsUncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days
* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose> 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis250 – 500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Pediatrics
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of Administration
Dose
(mg/kg)
Frequency
Total Duration
Complicated Urinary Tract or
Pyelonephritis(patients from 1 to 17 years of age)
Intravenous
6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients
weighing > 51 kg)
Every 8 hours
10-21 days*Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients
weighing > 51 kg)
Every 12 hours
Inhalational Anthrax
(Post- Exposure)**Intravenous
10 mg/kg
(maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
State Of Florida Doh Central Pharmacy
Ciprofloxacin | State Of Florida Doh Central Pharmacy
DOSAGE AND ADMINISTRATION - ADULTS
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
DOSAGE AND ADMINISTRATION - PEDIATRICS
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2). -
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See
CLINICAL PHARMACOLOGY
and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See
ADVERSE REACTIONS
and
CLINICAL STUDIES
.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m
2
).
-
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See
CLINICAL PHARMACOLOGY
and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See
ADVERSE REACTIONS
and
CLINICAL STUDIES
.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m
2
).
-
Proficient Rx Lp
Ciprofloxacin | Proficient Rx Lp
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES
Infection
Severity
Dose
Frequency
Usual Durations†
Urinary Tract
Acute Uncomplicated Mild/Moderate Severe/Complicated
250 mg250 mg500 mg
q 12 hq 12 hq 12 h
3 days7 to 14 days7 to 14 days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/ModerateSevere/Complicated
500 mg750 mg
q 12 hq 12 h
7 to 14 days7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/ModerateSevere/Complicated
500 mg750 mg
q 12 hq 12 h
7 to 14 days7 to 14 days
Bone and Joint
Mild/ModerateSevere/Complicated
500 mg750 mg
q 12 hq 12 h
³ 4 to 6 weeks ³ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and CervicalGonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 days
* Used in conjunction with metronidazole
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit6. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX- ADDITIONAL INFORMATION.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with Ciprofloxacin IV may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens
Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage
250 mg Tablet q 12 h 200 mg IV q 12 h
500 mg Tablet q 12 h 400 mg IV q 12 h
750 mg Tablet q 12 h 400 mg IV q 8 h
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSESFOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min) Dose
> 50 See Usual Dosage
30 – 50 250 – 500 mg q 12 h
5 – 29 250 – 500 mg q 18 h
Patients on hemodialysis 250 – 500 mg q 24 h (after dialysis)
or Peritoneal dialysis
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
______________________
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES .)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatricpatients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours andallowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of Administration
Dose(mg/kg)
Frequency
Total Duration
Complicated Urinary Tract or Pyelonephritis (patients from1 to 17 years of age)
Intravenous
6 to 10 mg/kg(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 8 hours
10-21 days*
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing> 51 kg)
Every 12 hours
Inhalational Anthrax (Post-Exposure)**
Intravenous
10 mg/kg(maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit6. For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics — Additional Information .
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Preferred Pharmaceuticals, Inc.
Ciprofloxacin | Preferred Pharmaceuticals, Inc.
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES
Infection
Severity
Dose
Frequency
Usual Durations†
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 days
Mild/Moderate
250 mg
q 12 h
7 to 14 days
Severe/Complicated
500 mg
q 12 h
7 to 14 days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and
Skin StructureMild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**500 mg
q h 12
60 days
* Used in conjunction with metronidazole
† Generally ciprofloxacin tablets should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens
Ciprofloxacin Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES
FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 to 50
250 to 500 mg q 12 h
5 to 29
250 to 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250 to 500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) =
Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of Administration
Dose (mg/kg)
Frequency
Total Duration
Complicated
Urinary Tract
or
Pyelonephritis
(patients from
1 to 17 years of
age)Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)Every 12 hours
10 to 21 days*
Inhalational Anthrax (Post-Exposure)**
Oral
15 mg/kg
(maximum 500 mg per dose)Every 12 hours
60 days
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Taro Pharmaceuticals U.s.a., Inc.
Ciprofloxacin | Taro Pharmaceuticals U.s.a., Inc.
Ciprofloxacin Tablets, USP should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations* * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 Days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax (post-exposure)‡ 500 mg q 12 h 60 DaysThis indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX—ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment.
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30-50 250-500 mg q 12 h 5-29 250-500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250-500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL) Women: 0.85 × the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table.
Information related to dosing ciprofloxacin in pediatric patients for the treatment of complicated urinary tract infections and pyelonephritis is approved for Bayer Pharmaceutical Corporation's ciprofloxacin drug products. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS.) Due to Bayer's marketing exclusivity rights, this drug product, produced by Taro Pharmaceutical Industries Ltd., is not labeled for pediatric use, except for inhalational anthrax (post-exposure).
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration * Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Inhalational Anthrax (Post-Exposure)* Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 Hours 60 Days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 Hours -
Pfizer Labs, Division Of Pfizer Inc
Ciprofloxacin | Pfizer Labs, Division Of Pfizer Inc
DOSAGE AND ADMINISTRATION – ADULTSCiprofloxacin Injection, USP should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation.. (See Preparation of Ciprofloxacin Injection, USP for Administration section.)
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
ADULT DOSAGE GUIDELINES * DUE TO THE DESIGNATED PATHOGENS (See INDICATIONS AND USAGE.) † used in conjunction with metronidazole. (See product labeling for prescribing information.) ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Total duration of ciprofloxacin administration (IV or oral) for inhalational anthrax (post-exposure) is 60 days. Infection* Severity Dose Frequency Usual Duration Urinary Tract Mild/Moderate
Severe/Complicated 200 mg
400 mg q12h
q12h 7-14 Days
7-14 Days Lower
Respiratory Tract Mild/Moderate
Severe/Complicated 400 mg
400 mg q12h
q8h 7-14 Days
7-14 Days Nosocomial
Pneumonia Mild/Moderate/Severe 400 mg q8h 10-14 Days Skin and Skin
Structure Mild/Moderate
Severe/Complicated 400 mg
400 mg q12h
q8h 7-14 Days
7-14 Days Bone and Joint Mild/Moderate
Severe/Complicated 400 mg
400 mg q12h
q8h ≥ 4-6 Weeks
≥ 4-6 Weeks Intra-Abdominal †
Acute Sinusitis Complicated
Mild/Moderate 400 mg
400 mg q12h
q12h 7-14 Days
10 Days Chronic
Bacterial Prostatitis Mild/Moderate 400 mg q12h 28 Days Empirical
Therapy in
Febrile
Neutropenic
Patients Severe
Ciprofloxacin
+
Piperacillin 400 mg
50 mg/kg
Not to exceed
24 g/day q8h
q4h
7-14 Days Inhalational
anthrax (post-
exposure)‡ 400 mg q12h 60 DaysCiprofloxacin Injection, USP should be administered by intravenous infusion over a period of 60 minutes.
Conversion of I.V. to Oral Dosing in Adults: Ciprofloxacin tablets and oral suspension for oral administration are available. Parenteral therapy may be switched to oral ciprofloxacin when the condition warrants, at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin Injection, USP Dosage 250 mg Tablet q 12 h 200mg I.V.q 12 h 500 mg Tablet q 12 h 400mg I.V.q 12 h 750 mg Tablet q 12 h 400mg I.V.q 8hParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dosage >30 See usual dosage. 5-29 200-400 mg q 18-24 hrWhen only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance:
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function. For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.
DOSAGE AND ADMINISTRATION – PEDIATRICSCiprofloxacin injection should be administered by intravenous infusion as described in the Dosage Guidelines table.
An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Infection Route of Administration Dose
>(mg/kg) Frequency Total
Duration Complicated
Urinary
Tract
or
Pyelonephritis
(patients from1
to 17 years of age) Intravenous 6 to 10 mg/kg
(maximum 400mg per
dose; not to be
exceeded even in patients
weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be
exceeded even in
patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-Exposure)† Intravenous 10 mg/kg
(maximum 400mg per
dose) Every 12 hours 60 days Oral 15 mg/kg
(maximum 500 mg per
dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of 50 mL/min/1.73m2).
Preparation of Ciprofloxacin Injection, USP for AdministrationVials (Injection Concentrate): THIS PREPARATION MUST BE DILUTED BEFORE USE. The intravenous dose should be prepared by aseptically withdrawing the concentrate from the vial of Ciprofloxacin Injection, USP. This should be diluted with a suitable intravenous solution to a final concentration of l-2mg/mL. (See COMPATIBILITY AND STABILITY .) The resulting solution should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.
If the Y-type or “piggyback” method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of ciprofloxacin injection. If the concomitant use of ciprofloxacin injection and another drug is necessary each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.
Flexible Containers:Ciprofloxacin Injection, USP is also available as a 0.2% premixed solution in 5% dextrose in flexible containers of 100 mL or 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described above.
COMPATIBILITY AND STABILITYCiprofloxacin injection 1% (10 mg/mL), when diluted with the following intravenous solutions to concentrations of 0.5 to 2.0 mg/mL, is stable for up to 14 days at refrigerated or room temperature storage.
0.9% Sodium Chloride Injection 5% Dextrose Injection Sterile Water for Injection 10% Dextrose for Injection 5% Dextrose and 0.225% Sodium Chloride for Injection 5% Dextrose and 0.45% Sodium Chloride for Injection Lactated Ringer’s for Injection -
Rebel Distributors Corp.
Ciprofloxacin | Rebel Distributors Corp.
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Urinary Tract Acute Uncomplicated 100 mg or 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure)** Conversion of I.V. to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose
(mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age)
10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-
Exposure)**
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Testpak Holding Company
Ciprofloxacin | Testpak Holding Company
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx®4 (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs,or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES *Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
†used in conjunction with metronidazole
‡Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX: Additional Information.
Infection Severity Dose Frequency Usual Durations* Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 Days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 Weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 Weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg Single Dose Single Dose Inhalational Anthrax (post-exposure)‡ 500 mg q 12 h 60 Days 4Videx® (didanosine) is a registered trademark of Bristol Myers Squibb.
Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 to 50 250 to 500 mg q 12 h 5 to 29 250 to 500 mg q 18 h Patients on hemodialysis or
Peritoneal dialysis 250 to 500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES *The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
†Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX: Additional Information.
Infection Route of Administration Dose (mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10 to 21 days* (patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post-Exposure)† Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Kaiser Foundation Hospitals
Ciprofloxacin | Kaiser Foundation Hospitals
Ciprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 Days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 Days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 Days (post-exposure)** Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table.
An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose
(mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours
10 to 21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-
Exposure)** Intravenous 10 mg/kg
(maximum 400 mg per dose) Every 12 hours
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Stat Rx Usa Llc
Ciprofloxacin | Stat Rx Usa Llc
DOSAGE AND ADMINISTRATION - ADULTS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
State Of Florida Doh Central Pharmacy
Ciprofloxacin | State Of Florida Doh Central Pharmacy
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Urinary Tract Acute Uncomplicated 100 mg or 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure)** Conversion of I.V. to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose
(mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age)
10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-
Exposure)**
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Blenheim Pharmacal, Inc.
Ciprofloxacin | Blenheim Pharmacal, Inc.
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations* * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † Used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)‡ 500 mg q 12 h 60 Days Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL) Women: 0.85 × the value calculated for men.The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION – PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-Exposure)† Intravenous 10 mg/kg
(maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Blenheim Pharmacal, Inc.
Ciprofloxacin | Blenheim Pharmacal, Inc.
DOSAGE AND ADMINISTRATION - ADULTS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Blenheim Pharmacal, Inc.
Ciprofloxacin | Blenheim Pharmacal, Inc.
DOSAGE AND ADMINISTRATION - ADULTS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Blenheim Pharmacal, Inc.
Ciprofloxacin | Blenheim Pharmacal, Inc.
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs,or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 Days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 Weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 Weeks Intra-Abdominal Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg Single Dose Single Dose Inhalational Anthrax (post-exposure) 500 mg q 12 h 60 Days Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 to 50 250 to 500 mg q 12 h 5 to 29 250 to 500 mg q 18 h Patients on hemodialysis or
Peritoneal dialysis 250 to 500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10 to 21 days (patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post-Exposure) Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Blenheim Pharmacal, Inc.
Ciprofloxacin | Blenheim Pharmacal, Inc.
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations* * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † Used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)‡ 500 mg q 12 h 60 Days Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL) Women: 0.85 × the value calculated for men.The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION – PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-Exposure)† Intravenous 10 mg/kg
(maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Rebel Distributors Corp
Ciprofloxacin | Rebel Distributors Corp
Ciprofloxacin injection should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation. (See Preparation of Ciprofloxacin Injection for Administration section.)
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient's host-defense mechanisms, and the status of renal and hepatic function.
ADULT DOSAGE GUIDELINES Infection* Severity Dose Frequency Usual Duration * DUE TO THE DESIGNATED PATHOGENS (See INDICATIONS AND USAGE.) † used in conjunction with metronidazole. (See product labeling for prescribing information.) ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Total duration of ciprofloxacin administration (I.V. or oral) for inhalational anthrax (post-exposure) is 60 days. Urinary Tract Mild/Moderate 200 mg q12h 7 - 14 Days Severe/Complicated 400 mg q12h 7 - 14 Days Lower Mild/Moderate 400 mg q12h 7 - 14 Days Respiratory Tract Severe/Complicated 400 mg q8h 7 - 14 Days Nosocomial Pneumonia Mild/Moderate/Severe 400 mg q8h 10 - 14 Days Skin and Mild/Moderate 400 mg q12h 7 - 14 Days Skin Structure Severe/Complicated 400 mg q8h 7 - 14 Days Bone and Joint Mild/Moderate 400 mg q12h ≥ 4 - 6 Weeks Severe/Complicated 400 mg q8h ≥ 4 - 6 Weeks Intra-Abdominal† Complicated 400 mg q12h 7 - 14 Days Acute Sinusitis Mild/Moderate 400 mg q12h 10 Days Chronic Bacterial Prostatitis Mild/Moderate 400 mg q12h 28 Days Empirical Therapy in Febrile Neutropenic Patients Severe
Ciprofloxacin
+
Piperacillin
400 mg
50 mg/kg
Not to exceed 24 g/day
q8h
q4h 7 - 14 Days Inhalational anthrax
(post-exposure)‡ 400 mg q12h 60 DaysCiprofloxacin injection should be administered by intravenous infusion over a period of 60 minutes.
Conversion of I.V. to Oral Dosing in AdultsCiprofloxacin tablets and ciprofloxacin oral suspension for oral administration are available. Parenteral therapy may be switched to oral ciprofloxacin when the condition warrants, at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin Injection Dosage 250 mg Tablet q 12 h 200 mg IV q 12 h 500 mg Tablet q 12 h 400 mg IV q 12 h 750 mg Tablet q 12 h 400 mg IV q 8 hParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dosage >30 See usual dosage. 5–29 200–400 mg q 18–24 hrWhen only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance:
Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL)Women: 0.85 × the value calculated for men.
The serum creatinine should represent a steady-state of renal function.
For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.
Ciprofloxacin injection should be administered as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALAIONAL ANTHRAX-ADDITIONAL INFORMATION. Complicated Urinary Tract or Pyelonephritis Intravenous 6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 8 hours 10-21 days* (patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing 51 kg) Every 12 hours Inhalational Anthrax
(Post-Exposure)† Intravenous 10 mg/kg
(maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73 m2).
Preparation of Ciprofloxacin Injection for Administration Vials (Injection Concentrate)THIS PREPARATION MUST BE DILUTED BEFORE USE. The intravenous dose should be prepared by aseptically withdrawing the concentrate from the vial of ciprofloxacin injection. This should be diluted with a suitable intravenous solution to a final concentration of 1 - 2 mg/mL. (See COMPATIBILITY AND STABILITY.) The resulting solution should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.
If the Y-type or "piggyback" method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of ciprofloxacin injection. If the concomitant use of ciprofloxacin injection and another drug is necessary each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.
-
Pack Pharmaceuticals, Llc
Ciprofloxacin | Rising Pharmaceuticals, Inc.
Ciprofloxacin should be administered orally as described in the appropriate Dosage Guidelines tables.
2.1 Dosage in AdultsThe determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Table 1: Adult Dosage Guidelines * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † Used in conjunction with metronidazole. ‡ Begin drug administration as soon as possible after suspected or confirmed exposure.Infection
Dose
Frequency
Usual Durations*
Urinary Tract
250 mg- 500 mg
every 12 hours
7 to 14 days
Acute Uncomplicated Cystitis
250 mg
every 12 hours
3 days
Chronic Bacterial Prostatitis
500 mg
every 12 hours
28 days
Lower Respiratory Tract
500 mg -750 mg
every 12 hours
7 to 14 days
Acute Sinusitis
500 mg
every 12 hours
10 days
Skin and Skin Structure
500 mg -750 mg
every 12 hours
7 to 14 days
Bone and Joint
500 mg -750 mg
every 12 hours
4 to 8 weeks
Complicated Intra–Abdominal†
500 mg
every 12 hours
7 to 14 days
Infectious Diarrhea
500 mg
every 12 hours
5 to 7 days
Typhoid Fever
500 mg
every 12 hours
10 days
Uncomplicated Urethral and Cervical Gonococcal Infections
250 mg
single dose
single dose
Inhalational Anthrax (Post-Exposure)‡
500 mg
every 12 hours
60 days
Plague‡
500 mg - 750 mg
every 12 hours
14 days
Conversion of IV to Oral Dosing in AdultsPatients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets or Oral Suspension when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
Table 2: Equivalent AUC Dosing RegimensCiprofloxacin Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet every 12 hours
200 mg intravenous every 12 hours
500 mg Tablet every 12 hours
400 mg intravenous every 12 hours
750 mg Tablet every 12 hours
400 mg intravenous every 8 hours
2.2 Dosage in Pediatric PatientsDosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin should be administered as described in Table 3.
Table 3: Pediatric Dosage Guidelines * The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Begin drug administration as soon as possible after suspected or confirmed exposure. ‡ Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.Infection
Dose
Frequency
Total Duration
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg)
Every 12 hours
10 to 21 days *
Inhalational Anthrax (Post-Exposure) †
15 mg/kg (maximum 500 mg per dose)
Every 12 hours
60 days
Plague † , ‡
15 mg/kg (maximum 500 mg per dose)
Every 12 to 8 hours
10 -21 days
2.3 Dosage Modifications in Patients with Renal ImpairmentCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal FunctionCreatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 - 50
250 mg - 500 mg every 12 hours
5 - 29
250 mg - 500 mg every 18 hours
Patients on hemodialysis or Peritoneal dialysis
250 mg - 500 mg every 24 hours (after dialysis)
When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
Men -Creatinine clearance (mL/min)= Weight (kg) x (140-age)
72 x serum creatinine (mg/dL)Women -0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
2.4 Important Administration InstructionsWith Multivalent Cations
Administer ciprofloxacin at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
With Dairy Products
Concomitant administration of ciprofloxacin with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin
Assure adequate hydration of patients receiving ciprofloxacin to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Instruct the patient of the appropriate ciprofloxacin administration [see Patient Counseling Information (17)].
-
Stat Rx Usa Llc
Ciprofloxacin | Stat Rx Usa Llc
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx ® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection: Complicated Urinary Tract or Pyleonephritis (Patients from 1 to 17 years of age)
Route of Administration: Oral
Frequency: Every 12 Hours
Total Duration: 10 - 21 days*
Infection: Inhalational Anthrax (Post-Exposure)**
Route of Administration: Oral
Dose: 15 mg/ kg (maximum 500 mg per dose)
Frequency: Every 12 Hours
Total Duration: 60 Days
PEDIATRIC DOSAGE GUIDELINES
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION).
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Redpharm Drug Inc.
Ciprofloxacin | Redpharm Drug Inc.
DOSAGE AND ADMINISTRATION - ADULTS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Redpharm Drug Inc.
Ciprofloxacin | Redpharm Drug Inc.
ADULT DOSAGE GUIDELINES Infection
Severity
Dose
Frequency
Usual Durations† Urinary Tract
Acute Uncomplicated
Mild/Moderate
Severe/Complicated
100 mg or 250 mg
250 mg
500 mg
q 12 h
q 12 h
q 12 h
3 days
7 to 14 days
7 to 14 days
Chronic Bacterial
Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory
Tract
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
10 days
Skin and
Skin Structure
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Bone and Joint
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
Intra-Abdominal*
Complicated
500 mg
q 12 h 7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h 5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h 10 days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**
500 mg
q 12 h
60 days
* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
Conversion of I.V. to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Adults with Impaired Renal Function: Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 hCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection
Route of Administration
Dose
(mg/kg)
Frequency
Total Duration
Complicated Urinary Tract
or Pyelonephritis
(patients from 1 to 17 years
of age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be
exceeded even in patients weighing > 51 kg)
Every 12 hours
10-21 days*
Inhalational Anthrax
(Post-
Exposure)**
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
60 days
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of less than 50 mL/min/1.73m2).
-
Redpharm Drug Inc.
Ciprofloxacin | Redpharm Drug Inc.
ADULTS
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Urinary Tract
Acute Uncomplicated
Mild/Moderate
Severe/Complicated
250 mg
250 mg
500 mg
q 12 h
q 12 h
q 12 h
3 Days
7 to 14 Days
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 Days
7 to 14 Days
Bone and Joint
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
≥ 4 to 6 weeks
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens). Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
500 mg Tablet q 12 h
750 mg Tablet q 12 h
200 mg I.V. q 12 h
400 mg I.V. q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment: RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
30 – 50
5 – 29
Patients on hemodialysis or
Peritoneal dialysis
See Usual Dosage.
250 – 500 mg q 12 h
250 – 500 mg q 18 h
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of
Administration
Dose
(mg/kg)
Frequency
Total
Duration
Complicated
Urinary Tract
or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg per
dose; not to be exceeded
even in patients weighing > 51 kg)
Every 8
hours
10-21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-
Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12
hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Bausch & Lomb Incorporated
Ciprofloxacin | Bausch & Lomb Incorporated
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
-
Rebel Distributors Corp
Ciprofloxacin | Rebel Distributors Corp
Ciprofloxacin Injection, USP should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation. (See Preparation of Ciprofloxacin Injection, USP for Administration.)
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
ADULT DOSAGE GUIDELINES Infection†
Severity
Dose
Frequency
Usual Duration
Urinary Tract
Mild/Moderate
Severe/Complicated
200 mg
400 mg
q12h
q12h
7 to 14 Days
7 to 14 Days
Lower
Respiratory Tract
Mild/Moderate
Severe/Complicated
400 mg
400 mg
q12h
q8h
7 to 14 Days
7 to 14 Days
Nosocomial Pneumonia
Mild/Moderate/Severe
400 mg
q8h
10 to 14 Days
Skin and
Skin Structure
Mild/Moderate
Severe/Complicated
400 mg
400 mg
q12h
q8h
7 to 14 Days
7 to 14 Days
Bone and Joint
Mild/Moderate
Severe/Complicated
400 mg
400 mg
q12h
q8h
≥ 4 to 6 Weeks
≥ 4 to 6 Weeks
Intra-Abdominal*
Complicated
400 mg
q12h
7 to 14 Days
Acute Sinusitis
Mild/Moderate
400 mg
q12h
10 Days
Chronic Bacterial Prostatitis
Mild/Moderate
400 mg
q12h
28 Days
Empirical Therapyin
Febrile Neutropenic
PatientsSevere
Ciprofloxacin
+
Piperacillin
400 mg q8h7 to 14 Days
50 mg/kgNot to exceed
24 g/day q4hInhalational anthrax
(post-exposure) **
400 mg
q12h
60 Days
* used in conjunction with metronidazole. (See product labeling for prescribing information.)
† DUE TO THE DESIGNATED PATHOGENS. (See INDICATIONS AND USAGE.)
** Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Total duration of ciprofloxacin administration (I.V. or oral) for inhalational anthrax (post-exposure) is 60 days.
Ciproxoflaxin Injection, USP should be administered by intravenous infusion over a period of 60 minutes.
Conversion of I.V. to Oral Dosing in Adults: Parenteral therapy may be switched to oral ciprofloxacin when the condition warrants, at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing RegimensCiprofloxacin Oral
Dosage
Equivalent
Ciprofloxacin Injection, USP
Dosage
250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTIONCreatinine Clearance (mL/min)
Dosage
>30
See usual dosage.
5 to 29
200 to 400 mg q 18 to 24 hr
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance:
Men:
Creatinine clearance
(mL/min)
=
Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women:
0.85 x the value calculated for men.
The serum creatinine should represent a steady-state of renal function.
For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.
-
Redpharm Drug Inc.
Ciprofloxacin | Redpharm Drug Inc.
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations* * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † Used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)‡ 500 mg q 12 h 60 Days Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL) Women: 0.85 × the value calculated for men.The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION – PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-Exposure)† Intravenous 10 mg/kg
(maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Redpharm Drug Inc.
Ciprofloxacin | Redpharm Drug Inc.
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Urinary Tract Acute Uncomplicated 100 mg or 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure)** Conversion of I.V. to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose
(mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age)
10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-
Exposure)**
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Legacy Pharmaceutical Packaging
Ciprofloxacin | Legacy Pharmaceutical Packaging
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx®4 (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs,or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX: Additional Information. Infection Severity Dose Frequency Usual Durations* Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 Days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 Weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 Weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg Single Dose Single Dose Inhalational Anthrax (post-exposure)‡ 500 mg q 12 h 60 Days 4Videx® (didanosine) is a registered trademark of Bristol Myers Squibb.
Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 to 50 250 to 500 mg q 12 h 5 to 29 250 to 500 mg q 18 h Patients on hemodialysis or
Peritoneal dialysis 250 to 500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX: Additional Information. Infection Route of Administration Dose (mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10 to 21 days* (patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post-Exposure)† Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Pd-rx Pharmaceuticals, Inc.
Ciprofloxacin | Pd-rx Pharmaceuticals, Inc.
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx ® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Pd-rx Pharmaceuticals, Inc.
Ciprofloxacin | Pd-rx Pharmaceuticals, Inc.
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx ® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Akorn Inc.
Ciprofloxacin | Akorn Inc.
Corneal UlcersThe recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial ConjunctivitisThe recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
-
H.j. Harkins Company, Inc.
Ciprofloxacin | H.j. Harkins Company, Inc.
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Urinary Tract Acute Uncomplicated 100 mg or 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure)** Conversion of I.V. to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose
(mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age)
10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-
Exposure)**
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Rebel Distributors Corp
Ciprofloxacin | Rebel Distributors Corp
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection
Severity
Dose
Frequency
Usual Durations† Urinary Tract
Acute Uncomplicated
Mild/Moderate
Severe/Complicated
100 mg or 250 mg
250 mg
500 mg
q 12 h
q 12 h
q 12 h
3 days
7 to 14 days
7 to 14 days
Chronic Bacterial
Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory
Tract
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
10 days
Skin and
Skin Structure
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Bone and Joint
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
Intra-Abdominal*
Complicated
500 mg
q 12 h 7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h 5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h 10 days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**
500 mg
q 12 h
60 days
* used in conjunction with metronidazole
†
Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 hAdults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES .)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose
(mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age)
10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-
Exposure)**
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Lake Erie Medical Dba Quality Care Products Llc
Ciprofloxacin | Lake Erie Medical Dba Quality Care Products Llc
DOSAGE AND ADMINISTRATION DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx ® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairmentWhen only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician -
Pd-rx Pharmaceuticals, Inc.
Ciprofloxacin | Pd-rx Pharmaceuticals, Inc.
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx ® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Life Line Home Care Services, Inc.
Ciprofloxacin | Life Line Home Care Services, Inc.
DOSAGE AND ADMINISTRATION - ADULTS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Pack Pharmaceuticals, Llc
Ciprofloxacin | Pack Pharmaceuticals, Llc
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
How Supplied: As a sterile ophthalmic solution, in a plastic dispenser:
2.5 mL NDC16571-120-25
5 mL NDC16571-120-50
STORAGE: Store at 25°C (77°F); excursions permitted to15 - 30°C (59 - 86°F) [See USP controlled room temperature]. Protect from light. Retain in carton until contents are used.
-
Dr. Reddy’s Laboratories Limited
Ciprofloxacin | Dr. Reddy's Laboratories Limited
Ciprofloxacin extended-release tablets and ciprofloxacin immediate-release tablets are not interchangeable. Ciprofloxacin extended-release tablets should be administered orally once daily as described in the following Dosage Guidelines table:
DOSAGE GUIDELINES Indication Unit Dose Frequency Usual Duration Uncomplicated Urinary Tract Infection
(Acute Cystitis) 500 mg Q24h 3 Days Complicated Urinary Tract Infection 1000 mg Q24h 7-14 Days Acute Uncomplicated Pyelonephritis 1000 mg Q24h 7-14 DaysPatients whose therapy is started with ciprofloxacin I.V. for urinary tract infections may be switched to ciprofloxacin extended-release tablets when clinically indicated at the discretion of the physician.
Ciprofloxacin extended-release tablets should be administered at least 2 hours before or 6 hours after antacids containing magnesium or aluminum, as well as sucralfate, VIDEX® (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, metal cations such as iron, and multivitamin preparations with zinc. Although ciprofloxacin extended-release tablets may be taken with meals that include milk, concomitant administration with dairy products alone, or with calcium-fortified products should be avoided, since decreased absorption is possible. A 2-hour window between substantial calcium intake (> 800 mg) and dosing with ciprofloxacin extended-release tablets are recommended. Ciprofloxacin extended-release tablets should be swallowed whole. DO NOT SPLIT, CRUSH, OR CHEW THE TABLET. (See CLINICAL PHARMACOLOGY, Drug-drug Interactions, PRECAUTIONS, Drug Interactions and Information for Patients.)
Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternate pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. No dosage adjustment is required for patients with uncomplicated urinary tract infections receiving 500 mg ciprofloxacin extended-release tablets. In patients with complicated urinary tract infections and acute uncomplicated pyelonephritis, who have a creatinine clearance of < 30 mL/min, the dose of ciprofloxacin extended-release tablets should be reduced from 1000 mg to 500 mg daily. For patients on hemodialysis or peritoneal dialysis, administer ciprofloxacin extended-release tablets after the dialysis procedure is completed. (See CLINICAL PHARMACOLOGY, Special Populations, and PRECAUTIONS, Geriatric Use.)
Impaired Hepatic FunctionNo dosage adjustment is required with ciprofloxacin extended-release tablets in patients with stable chronic cirrhosis. The kinetics of ciprofloxacin in patients with acute hepatic insufficiency, however, have not been fully elucidated. (See CLINICAL PHARMACOLOGY, Special Populations.)
-
Hhs/program Support Center/supply Service Center
Ciprofloxacin | Hhs/program Support Center/supply Service Center
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Urinary Tract Acute Uncomplicated 100 mg or 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure)** Conversion of I.V. to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose
(mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age)
10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-
Exposure)**
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
West-ward Pharmaceutical Corp
Ciprofloxacin | West-ward Pharmaceutical Corp
ADULTSCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(Patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Hhs/program Support Center/supply Service Center
Ciprofloxacin | Hhs/program Support Center/supply Service Center
ADULTSCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(Patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Pd-rx Pharmaceuticals, Inc.
Ciprofloxacin | Pd-rx Pharmaceuticals, Inc.
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate ) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Hhs/program Support Center/supply Service Center
Ciprofloxacin | Hhs/program Support Center/supply Service Center
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* Used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure)** Conversion of IV to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h 200 mg IV q 12 h 500 mg Tablet q 12 h 400 mg IV q 12 h 750 mg Tablet q 12 h 400 mg IV q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose
(mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age)
10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-
Exposure)**
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Hhs/program Support Center/supply Service Center
Ciprofloxacin | Hhs/program Support Center/supply Service Center
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (e.g., sevelamer, lanthanum carbonate ) or sucralfate, Videx®†† (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX: Additional Information. Infection Severity Dose Frequency Usual Durations* Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 Days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 Weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 Weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg Single Dose Single Dose Inhalational Anthrax (post-exposure)‡ 500 mg q 12 h 60 Days Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 to 50 250 mg to 500 mg q 12 h 5 to 29 250 mg to 500 mg q 18 h Patients on hemodialysis or
Peritoneal dialysis 250 mg to 500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX: Additional Information. Infection Route of Administration Dose (mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10 to 21 days* (patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post-Exposure)† Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Unit Dose Services
Ciprofloxacin | Unit Dose Services
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the . Dosage Guidelines table
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc. ®
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* Used in conjunction with metronidazole
Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). †
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. For a discussion of ciprofloxacin serum concentrations in various human populations, see 4). INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION
Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure) ** Conversion of IV to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See and table below for the equivalent dosing regimens). CLINICAL PHARMACOLOGY
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h 200 mg IV q 12 h 500 mg Tablet q 12 h 400 mg IV q 12 h 750 mg Tablet q 12 h 400 mg IV q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the . An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See and .) Dosage Guidelines tableADVERSE REACTIONSCLINICAL STUDIES
Dosing and initial route of therapy (i.e., IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
Drug administration should begin as soon as possible after suspected or confirmed exposure to spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. For a discussion of ciprofloxacin serum concentrations in various human populations, see **Bacillus anthracis4). INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION
Infection Route of Administration Dose (mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)
10-21 days*
Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 12 hours Inhalational Anthrax (Post- Exposure)**
60 days
Oral 15 mg/kg (maximum 500 mg per dose)
Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m ). 2
-
Watson Pharma, Inc.
Ciprofloxacin | Watson Pharma, Inc.
Ciprofloxacin extended-release tablets and ciprofloxacin immediate-release tablets are not interchangeable. Ciprofloxacin extended-release tablets should be administered orally once daily as described in the following Dosage Guidelines table:
-
Aurolife Pharma Llc
Ciprofloxacin | Aurolife Pharma Llc
ADULTS
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate)or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
Mild/Moderate
Severe/Complicated
250 mg
250 mg
500 mg
q 12 h
q 12 h
q 12 h
3 Days
7 to 14 Days
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 Days
7 to 14 Days
Bone and Joint
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
≥ 4 to 6 weeks
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**
500 mg
q 12 h
60 Days
* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
500 mg Tablet q 12 h
750 mg Tablet q 12 h
200 mg I.V. q 12 h
400 mg I.V. q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
30 – 50
5 – 29
Patients on hemodialysis or
Peritoneal dialysis
See Usual Dosage.
250 – 500 mg q 12 h
250 – 500 mg q 18 h
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. PEDIATRICS
Ciprofloxacin tablets should be administered orally as described in the
Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of
Administration
Dose
(mg/kg)
Frequency
Total
Duration
Complicated
Urinary Tract
or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg per
dose; not to be exceeded
even in patients weighing > 51 kg)
Every 8
hours
10-21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-
Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12
hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Carlsbad Technology, Inc.
Ciprofloxacin | Walgreen Co.
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 gelcaps every 4 hours do not take more than 10 gelcaps in 24 hours swallow whole; do not crush, chew or dissolve children under 12 years: ask a doctor -
Lake Erie Medical Dba Quality Care Products Llc
Ciprofloxacin | Lake Erie Medical Dba Quality Care Products Llc
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Urinary Tract Acute Uncomplicated 100 mg or 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure)** Conversion of I.V. to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose
(mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age)
10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-
Exposure)**
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Physicians Total Care, Inc.
Ciprofloxacin | Physicians Total Care, Inc.
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* Used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure)** Conversion of IV to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h 200 mg IV q 12 h 500 mg Tablet q 12 h 400 mg IV q 12 h 750 mg Tablet q 12 h 400 mg IV q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose
(mg/kg)
Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age)
10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-
Exposure)**
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Bryant Ranch Prepack
Ciprofloxacin | Bryant Ranch Prepack
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations* * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † Used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)‡ 500 mg q 12 h 60 Days Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL) Women: 0.85 × the value calculated for men.The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION – PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-Exposure)† Intravenous 10 mg/kg
(maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Ciprofloxacin | Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * Used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax – Additional Information.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 days
Mild/Moderate
250 mg
q 12 h
7 to 14 days
Severe/Complicated
500 mg
q 12 h
7 to 14 days
Chronic Bacterial
Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and
Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**
500 mg
q 12 h
60 days
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax – Additional Information.
Complicated Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Lake Erie Medical Dba Quality Care Products Llc
Ciprofloxacin | Lake Erie Medical Dba Quality Care Products Llc
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection
Severity
Dose
Frequency
Usual Durations† Urinary Tract
Acute Uncomplicated
Mild/Moderate
Severe/Complicated
100 mg or 250 mg
250 mg
500 mg
q 12 h
q 12 h
q 12 h
3 days
7 to 14 days
7 to 14 days
Chronic Bacterial
Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory
Tract
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
10 days
Skin and
Skin Structure
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Bone and Joint
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
Intra-Abdominal*
Complicated
500 mg
q 12 h 7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h 5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h 10 days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**
500 mg
q 12 h
60 days
* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Conversion of I.V. to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection
Route of Administration
Dose
(mg/kg)
Frequency
Total Duration
Complicated Urinary Tract
or Pyelonephritis
(patients from 1 to 17 years
of age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be
exceeded even in patients weighing > 51 kg)
Every 12 hours
10-21 days*
Inhalational Anthrax
(Post-
Exposure)**
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
60 days
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of less than 50 mL/min/1.73m 2). -
Pd-rx Pharmaceuticals, Inc.
Ciprofloxacin | Pd-rx Pharmaceuticals, Inc.
DOSAGE AND ADMINISTRATION - ADULTS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Unit Dose Services
Ciprofloxacin | Unit Dose Services
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table. The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function. The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc. Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See and table below for the equivalent dosing regimens). Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment: When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance. Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL) Women: 0.85 x the value calculated for men. The serum creatinine should represent a steady state of renal function. In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations † used in conjunction with metronidazole Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. For a discussion of ciprofloxacin serum concentrations in various human populations, see . *
†
**
4
INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal *
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure) **
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
CLINICAL PHARMACOLOGY
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250-500 mg q 24 h (after dialysis)
Weight (kg) x (140 - age)
DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See and .) Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician. Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m ).
ADVERSE REACTIONS CLINICAL STUDIES
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration
Dose (mg/kg)
Frequency Total Duration
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). ** Drug administration should begin as soon as possible after suspected or confirmed exposure to spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. For a discussion of ciprofloxacin serum concentrations in various human populations, see .
Bacillus anthracis
5
INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION
Complicated Urinary Tract or Pyelonephritis
Intravenous
6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 8 hours
10-21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 12 hours
Inhalational Anthrax (Post-Exposure)**
Intravenous
10 mg/kg (maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg (maximum 500 mg per dose)
Every 12 hours
2 -
Bryant Ranch Prepack
Ciprofloxacin | Bryant Ranch Prepack
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx ® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Lake Erie Medical Dba Quality Care Products Llc
Ciprofloxacin | Lake Erie Medical Dba Quality Care Products Llc
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate ) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)**
500 mg
q 12 h
60 Days* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(Patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m 2). -
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
How Supplied: As a sterile ophthalmic solution, in a plastic dispenser:
2.5 mL NDC16571-120-25
5 mL NDC16571-120-50
STORAGE: Store at 25°C (77°F); excursions permitted to15 - 30°C (59 - 86°F) [See USP controlled room temperature]. Protect from light. Retain in carton until contents are used.
-
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Blenheim Pharmacal, Inc.
Ciprofloxacin | Blenheim Pharmacal, Inc.
DOSAGE AND ADMINISTRATION - ADULTS
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatits Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical
Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)** 500 mg q 12 h 60 Days
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30-50 250-500 mg q 12 h 5-29 250-500 mg q 18 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
DOSAGE AND ADMINISTRATION - PEDIATRICS
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Complicated
Urinary Tract or
Pyelonephritis Intravenous 6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg) Every 8 hours 10-21 days* (patients from
1 to 17 years of
age) Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg) Every 12 hours Inhalational
Anthrax
(Post-Exposure)** Intravenous 10 mg/kg
(maximum 400 mg per
dose) Every 12 hours
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2). -
Sandoz Inc
Ciprofloxacin | Sandoz Inc
AdultsCIPROFLOXACIN INJECTION, USP should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation. (See Preparation of CIPROFLOXACIN INJECTION, USP for Administration section.)
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient's host-defense mechanisms, and the status of renal and hepatic function.
* DUE TO THE DESIGNATED PATHOGENS (See INDICATIONS AND USAGE.) † Used in conjunction with metronidazole. (See product labeling for prescribing information.) ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION. Total duration of ciprofloxacin administration (IV or oral) for inhalational anthrax (post-exposure) is 60 days.ADULT DOSAGE GUIDELINES
Infection*
Severity
Dose
Frequency
Usual Duration
Urinary Tract
Mild/Moderate
200 mg
q12h
7-14 Days
Severe/Complicated
400 mg
q12h (or q 8h)
7-14 Days
Lower
Respiratory TractMild/Moderate
Severe/Complicated400 mg
400 mgq12h
q8h7-14 Days
7-14 DaysNosocomial Pneumonia
Mild/Moderate/Severe
400 mg
q8h
10-14 Days
Skin and
Skin StructureMild/Moderate
Severe/Complicated400 mg
400 mgq12h
q8h7-14 Days
7-14 DaysBone and Joint
Mild/Moderate
Severe/Complicated400 mg
400 mgq12h
q8h≥4-6 Weeks
≥4-6 WeeksIntra-Abdominal†
Complicated
400 mg
q12h
7-14 Days
Acute Sinusitis
Mild/Moderate
400 mg
q12h
10 Days
Chronic Bacterial Prostatitis
Mild/Moderate
400 mg
q12h
28 Days
Empirical Therapy in
Severe
Febrile Neutropenic
Ciprofloxacin
400 mg
q8h
Patients
+
7-14 Days
Piperacillin
50 mg/kg
Not to exceed
24 g/dayq4h
Inhalational anthrax
(post-exposure)‡400 mg
q12h
60 Days
CIPROFLOXACIN INJECTION, USP should be administered by intravenous infusion over a period of 60 minutes.
Conversion of IV to Oral Dosing in AdultsCIPROFLOXACIN is also available for oral administration. Parenteral therapy may be switched to oral therapy when the condition warrants, at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing Regimens
CIPROFLOXACIN Oral Dosage
Equivalent CIPROFLOXACIN INJECTION Dosage
250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min)
Dosage
> 30
See usual dosage.
5-29
200-400 mg q 18-24 hr
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance:
Men: Creatinine clearance (mL/min) =
Weight (kg) × (140 - age)
72 × serum creatinine (mg/dL)
Women: 0.85 × the value calculated for men.
The serum creatinine should represent a steady state of renal function.
For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.
PediatricsCIPROFLOXACIN INJECTION, USP should be administered as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 6 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION.PEDIATRIC DOSAGE GUIDELINES
Infection
Route of
AdministrationDose
(mg/kg)Frequency
Total Duration
Complicated
Urinary Tract
or
PyelonephritisIntravenous
6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing
> 51 kg)Every
8 hours10-21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing
> 51 kg)Every
12 hoursInhalational Anthrax
(Post-exposure)†Intravenous
10 mg/kg
(maximum 400 mg per dose)Every
12 hours60 days
Oral
15 mg/kg
(maximum 500 mg per dose)Every
12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
Preparation of CIPROFLOXACIN INJECTION, USP for Administration Flexible ContainersCiprofloxacin injection is available as a 0.2% premixed solution in 5% dextrose in flexible containers of 100 mL or 200 mL. The solutions in flexible containers do not need to be diluted and should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.
If the Y-type or “piggyback” method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of ciprofloxacin injection. If the concomitant use of ciprofloxacin injection and another drug is necessary, each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.
-
American Health Packaging
Ciprofloxacin | American Health Packaging
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
* Used in conjunction with metronidazole
† Generally ciprofloxacin tablets should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.ADULT DOSAGE GUIDELINES
Infection
Severity
Dose
Frequency
Usual Durations†
Urinary Tract
Acute Uncomplicated
Mild/Moderate
Severe/Complicated
250 mg
250 mg
500 mg
q 12 h
q 12 h
q 12 h
3 days
7 to 14 days
7 to 14 days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and
Skin StructureMild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Bone and Joint
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
≥ 4 to 6 weeks
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**500 mg
q h 12
60 days
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens
Ciprofloxacin Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES
FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 to 50
250 to 500 mg q 12 h
5 to 29
250 to 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250 to 500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) =
Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.PEDIATRIC DOSAGE GUIDELINES
Infection
Route of Administration
Dose (mg/kg)
Frequency
Total Duration
Complicated
Urinary Tract
or
Pyelonephritis
(patients from
1 to 17 years of
age)Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)Every 12 hours
10 to 21 days*
Inhalational Anthrax (Post-Exposure)**
Oral
15 mg/kg
(maximum 500 mg per dose)Every 12 hours
60 days
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Lake Erie Medical Dba Quality Care Products Llc
Ciprofloxacin | Lake Erie Medical Dba Quality Care Products Llc
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Lake Erie Medical Dba Quality Care Products Llc
Ciprofloxacin | Lake Erie Medical Dba Quality Care Products Llc
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatits Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical
Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)** 500 mg q 12 h 60 Days
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30-50 250-500 mg q 12 h 5-29 250-500 mg q 18 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
DOSAGE AND ADMINISTRATION - PEDIATRICS
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Complicated
Urinary Tract or
Pyelonephritis Intravenous 6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg) Every 8 hours 10-21 days* (patients from
1 to 17 years of
age) Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg) Every 12 hours Inhalational
Anthrax
(Post-Exposure)** Intravenous 10 mg/kg
(maximum 400 mg per
dose) Every 12 hours
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2). -
Clinical Solutions Wholesale
Ciprofloxacin | Clinical Solutions Wholesale
DOSAGE AND ADMINISTRATION - ADULTS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatits Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical
Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)** 500 mg q 12 h 60 Days
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30-50 250-500 mg q 12 h 5-29 250-500 mg q 18 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
DOSAGE AND ADMINISTRATION - PEDIATRICS
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Complicated
Urinary Tract or
Pyelonephritis Intravenous 6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg) Every 8 hours 10-21 days* (patients from
1 to 17 years of
age) Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg) Every 12 hours Inhalational
Anthrax
(Post-Exposure)** Intravenous 10 mg/kg
(maximum 400 mg per
dose) Every 12 hours
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2). -
Medvantx, Inc.
Ciprofloxacin | Medvantx, Inc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * Used in conjunction with metronidazole
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 days
Mild/Moderate
250 mg
q 12 h
7 to 14 days
Severe/Complicated
500 mg
q 12 h
7 to 14 days
Chronic Bacterial
ProstatitisMild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and
Skin StructureMild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical
Gonococcal InfectionsUncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**500 mg
q 12 h
60 days
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:> 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)
PEDIATRIC DOSAGE GUIDELINES Infection Route
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax in Adults and Pediatrics, Additional Information.
Complicated Urinary Tract or
PyelonephritisIntravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)Every 8 hours
10-21 days*(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)Every 12 hours
Inhalational Anthrax
(Post-Exposure)**Intravenous
10 mg/kg
(maximum 400 mg per
dose)Every 12 hours
60 daysOral
15 mg/kg
(maximum 500 mg per dose)Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
How Supplied: As a sterile ophthalmic solution, in a plastic dispenser:
2.5 mL NDC16571-120-25
5 mL NDC16571-120-50
STORAGE: Store at 25°C (77°F); excursions permitted to15 - 30°C (59 - 86°F) [See USP controlled room temperature]. Protect from light. Retain in carton until contents are used.
-
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
West-ward Pharmaceutical Corp
Ciprofloxacin | West-ward Pharmaceuticals Corp
Ciprofloxacin Tablets, USP, should be administered orally to adults as described in the appropriate Dosage Guidelines table.
2.1 Dosage in AdultsThe determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Table 1: Adult Dosage Guidelines Infection Dose Frequency Usual Durations1 Urinary Tract 250–500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500–750 mg every 12 hours 7 to 14 days Acute Sinusitis 500 mg every 12 hours 10 days Skin and Skin Structure 500–750 mg every 12 hours 7 to 14 days Bone and Joint 500–750 mg every 12 hours 4 to 8 weeks Complicated Intra–Abdominal2 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Urethral and Cervical Gonococcal Infections 250 mg single dose single dose Inhalational anthrax (postexposure)3 500 mg every 12 hours 60 days Plague 3 500–750 mg every 12 hours 14 days Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
Used in conjunction with metronidazole.
Begin drug administration as soon as possible after suspected or confirmed exposure.Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to Ciprofloxacin tablets, USP when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
Table 2: Equivalent AUC Dosing Regimens Ciprofloxacin Tablets, USP Oral Dosage Equivalent ciprofloxacin IV Dosage 250 mg Tablet every 12 hours 200 mg intravenous every 12 hours 500 mg Tablet every 12 hours 400 mg intravenous every 12 hours 750 mg Tablet every 12 hours 400 mg intravenous every 8 hours 2.2 Dosage in Pediatric PatientsDosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets, USP should be administered as described in Table 3.
Table 3 : Pediatric Dosage Guidelines Guidelines Infection Dose Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from
1 to 17 years of age) 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 12 hours 10–21 days1 Inhalational Anthrax
(PostExposure)2 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague2,3 15 mg/kg (maximum 500 mg per dose) Every 12 to 8 hours 10–21 days The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
Begin drug administration as soon as possible after suspected or confirmed exposure.
Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis. 2.3 Dosage Modifications in Patients with Renal ImpairmentCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30–50 250–500 mg every12 hours 5–29 250–500 mg every 18 hours Patients on hemodialysis or Peritoneal dialysis 250–500 mg every 24 hours
(after dialysis)When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
Men -Creatinine clearance (mL/min) = Weight (kg) x (140–age)
72 x serum creatinine (mg/dL)
Women -0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
2.4 Important Administration InstructionsWith Multivalent Cations
Administer Ciprofloxacin Tablets, USP at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
With Dairy Products
Concomitant administration of Ciprofloxacin Tablets, USP with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, Ciprofloxacin Tablets, USP may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin Tablets, USP
Assure adequate hydration of patients receiving Ciprofloxacin Tablets, USP to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Instruct the patient of the appropriate Ciprofloxacin Tablets, USP administration [see Patient Counseling Information (17)].
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Dr Reddy’s Laboratories
Ciprofloxacin | Dr Reddy's Laboratories
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Ranbaxy Pharmaceuticals Inc.
Ciprofloxacin | Ranbaxy Pharmaceuticals Inc.
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES* Used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
Infection Severity Dose Frequency Usual Durations† Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)** 500 mg q h 12 60 daysThis indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Conversion of IV to Oral Dosing in Adults:
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h 200 mg IV q 12 h 500 mg Tablet q 12 h 400 mg IV q 12 h 750 mg Tablet q 12 h 400 mg IV q 8 hAdults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES
FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 to 50 250 to 500 mg q 12 h 5 to 29 250 to 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 to 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (See ADVERSE REACTIONS and CLINICAL STUDIES).
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10 to 21 days* Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post-Exposure)** Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hours -
Clinical Solutions Wholesale
Ciprofloxacin | Clinical Solutions Wholesale
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Golden State Medical Supply, Inc.
Ciprofloxacin | Golden State Medical Supply, Inc.
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Urinary Tract Acute Uncomplicated 100 mg or 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure)** Conversion of I.V. to Oral Dosing in Adults:Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function:Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).
Infection Route of Administration Dose (mg/kg) Frequency Total Duration omplicated Urinary Tract or Pyelonephritis(patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours 10-21 15 mg/kg (maximum 500 mg per dose)mg per dose)tional Anthrax (Post-Exposure)** Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 daysPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
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Apotex Corp
Ciprofloxacin | Cardinal Health
Major Depressive Disorder Usual Initial DosageParoxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 20 mg dose may benefit from dose increases, in 10 mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least one week.
Maintenance TherapyThere is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.
Systematic evaluation of the efficacy of paroxetine tablets has shown that efficacy is maintained for periods of up to one year with doses that averaged about 30 mg.
Obsessive Compulsive Disorder Usual Initial DosageParoxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of paroxetine tablets in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least one week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.
Maintenance TherapyLong-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients with OCD assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY: Clinical Trials). OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Panic Disorder Usual Initial DosageParoxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The target dose of paroxetine tablets in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least one week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets. The maximum dosage should not exceed 60 mg/day.
Maintenance TherapyLong-term maintenance of efficacy was demonstrated in a 3 month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY: Clinical Trials). Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Social Anxiety Disorder Usual Initial DosageParoxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of paroxetine tablets has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day (see CLINICAL PHARMACOLOGY: Clinical Trials).
Maintenance TherapyThere is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on it. Although the efficacy of paroxetine tablets beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Generalized Anxiety Disorder Usual Initial DosageParoxetine tablets should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least one week.
Maintenance TherapySystematic evaluation of continuing paroxetine tablets for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking paroxetine tablets during an 8 week acute treatment phase has demonstrated a benefit of such maintenance (see CLINICAL PHARMACOLOGY: Clinical Trials). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Special Populations Treatment of Pregnant Women During the Third TrimesterNeonates exposed to paroxetine tablets and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS: Usage in Pregnancy). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic ImpairmentThe recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.
Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with paroxetine tablets. Conversely, at least 14 days should be allowed after stopping paroxetine tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).
Use of Paroxetine Tablets with Other MAOIs Such as Linezolid or Methylene BlueDo not start paroxetine tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving therapy with paroxetine tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, paroxetine tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with paroxetine tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with paroxetine tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
Discontinuation of Treatment with Paroxetine TabletsSymptoms associated with discontinuation of paroxetine tablets have been reported (see PRECAUTIONS: Discontinuation of Treatment with Paroxetine Hydrochloride). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which paroxetine tablets is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
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Northstar Rx Llc
Ciprofloxacin | Northstar Rx Llc
Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables.
2.1 Dosage in AdultsThe determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Table 1: Adult Dosage Guidelines 1. Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
2. Used in conjunction with metronidazole.
3. Begin drug administration as soon as possible after suspected or confirmed exposure.
Infection
Dose
Frequency
Usual Durations1
Urinary Tract
250 to 500 mg
every 12 hours
7 to 14 days
Acute Uncomplicated Cystitis
250 mg
every 12 hours
3 days
Chronic Bacterial Prostatitis
500 mg
every 12 hours
28 days
Lower Respiratory Tract
500 to 750 mg
every 12 hours
7 to 14 days
Acute Sinusitis
500 mg
every 12 hours
10 days
Skin and Skin Structure
500 to 750 mg
every 12 hours
7 to 14 days
Bone and Joint
500 to 750 mg
every 12 hours
4 to 8 weeks
Complicated Intra–Abdominal2
500 mg
every 12 hours
7 to 14 days
Infectious Diarrhea
500 mg
every 12 hours
5 to 7 days
Typhoid Fever
500 mg
every 12 hours
10 days
Uncomplicated Urethral and
Cervical Gonococcal Infections
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)3
500 mg
every 12 hours
60 days
Plague3
500 to 750 mg
every 12 hours
14 days
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
Table 2: Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet every 12 hours
200 mg intravenous every 12 hours
500 mg Tablet every 12 hours
400 mg intravenous every 12 hours
750 mg Tablet every 12 hours
400 mg intravenous every 8 hours
2.2 Dosage in Pediatric PatientsDosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets should be administered as described in Table 3.
Table 3: Pediatric Dosage Guidelines 1. The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
2. Begin drug administration as soon as possible after suspected or confirmed exposure.
3. Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis. Infection
Dose
Frequency
Total Duration
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg)
Every 12 hours
10 to 21 days1
Inhalational Anthrax (Post-Exposure)2
15 mg/kg (maximum 500 mg per dose)
Every 12 hours
60 days
Plague2,3
15 mg/kg (maximum 500 mg per dose)
Every 12 to 8 hours
10 to 21 days
2.3 Dosage Modifications in Patients with Renal ImpairmentCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function Creatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 to 50
250 to 500 mg every12 hours
5 to 29
250 to 500 mg every 18 hours
Patients on hemodialysis or Peritoneal dialysis
250 to 500 mg every 24 hours (after dialysis)
When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
Men - Creatinine clearance (mL/min) = Weight (kg) x (140–age)
72 x serum creatinine (mg/dL)
Women - 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73 m2).
2.4 Important Administration InstructionsWith Multivalent Cations
Administer ciprofloxacin tablets at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
With Dairy Products
Concomitant administration of ciprofloxacin tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin tablets may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin Tablets
Assure adequate hydration of patients receiving ciprofloxacin tablets to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Instruct the patient of the appropriate ciprofloxacin tablets administration [see Patient Counseling Information (17)].
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Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
How Supplied: As a sterile ophthalmic solution, in a plastic dispenser:
2.5 mL NDC16571-120-25
5 mL NDC16571-120-50
STORAGE: Store at 25°C (77°F); excursions permitted to15 - 30°C (59 - 86°F) [See USP controlled room temperature]. Protect from light. Retain in carton until contents are used.
-
Mylan Pharmaceuticals Inc.
Ciprofloxacin | Actavis Pharma, Inc.
The recommended regimen of isosorbide mononitrate tablets is 20 mg twice daily, with the doses seven hours apart. A starting dose of 5 mg (½ tablet of the 10 mg dosing strength) might be appropriate for persons of particularly small stature but should be increased to at least 10 mg by the second or third day of therapy. Dosage adjustments are not necessary for elderly patients or patients with altered hepatic or renal function.
As noted above (CLINICAL PHARMACOLOGY), multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The asymmetric (2 doses, 7 hours apart) dosing regimen for isosorbide mononitrate tablets provides a daily nitrate-free interval to minimize the development of tolerance.
As also noted under CLINICAL PHARMACOLOGY, well-controlled studies have shown that tolerance to isosorbide mononitrate tablets occurs to some extent when using the twice-daily regimen in which the two doses are given seven hours apart. This regimen has been shown to have antianginal efficacy beginning one hour after the first dose and lasting at least seven hours after the second dose. The duration (if any) of antianginal activity beyond fourteen hours has not been studied.
In clinical trials, isosorbide mononitrate has been administered in a variety of regimens and doses. Doses above 20 mg twice-a-day (with the doses seven hours apart) have not been adequately studied. Doses of 5 mg twice-a-day are clearly effective (effectiveness based on exercise tolerance) for only the first day of a twice-a-day (with doses 7 hours apart) regimen.
-
Ivax Pharmaceuticals, Inc.
Ciprofloxacin | Ivax Pharmaceuticals, Inc.
Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables.
2.1 Dosage in AdultsThe determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Table 1: Adult Dosage Guidelines * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † Used in conjunction with metronidazole. ‡ Begin drug administration as soon as possible after suspected or confirmed exposure.Infection
Dose
Frequency
Usual Durations*
Urinary Tract
250 to 500 mg
every 12 hours
7 to 14 days
Acute Uncomplicated Cystitis
250 mg
every 12 hours
3 days
Chronic Bacterial Prostatitis
500 mg
every 12 hours
28 days
Lower Respiratory Tract
500 to 750 mg
every 12 hours
7 to 14 days
Acute Sinusitis
500 mg
every 12 hours
10 days
Skin and Skin Structure
500 to 750 mg
every 12 hours
7 to 14 days
Bone and Joint
500 to 750 mg
every 12 hours
4 to 8 weeks
Complicated Intra-Abdominal†
500 mg
every 12 hours
7 to 14 days
Infectious Diarrhea
500 mg
every 12 hours
5 to 7 days
Typhoid Fever
500 mg
every 12 hours
10 days
Uncomplicated Urethral and
Cervical Gonococcal Infections250 mg
single dose
single dose
Inhalational anthrax (post-exposure)‡
500 mg
every 12 hours
60 days
Plague‡
500 to 750 mg
every 12 hours
14 days
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
Table 2: Equivalent AUC Dosing RegimensCiprofloxacin Tablets Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet every 12 hours
200 mg intravenous every 12 hours
500 mg Tablet every 12 hours
400 mg intravenous every 12 hours
750 mg Tablet every 12 hours
400 mg intravenous every 8 hours
2.2 Dosage in Pediatric PatientsDosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets should be administered as described in Table 3.
Table 3: Pediatric Dosage Guidelines * The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Begin drug administration as soon as possible after suspected or confirmed exposure. ‡ Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.Infection
Dose
Frequency
Total Duration
Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age)10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg)Every 12 hours
10 to 21 days*
Inhalational Anthrax (Post-Exposure)†
15 mg/kg
(maximum 500 mg per dose)Every 12 hours
60 days
Plague†,‡
15 mg/kg
(maximum 500 mg per dose)Every 12 to 8 hours
10 to 21 days
2.3 Dosage Modifications in Patients with Renal ImpairmentCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal FunctionCreatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 to 50
250 to 500 mg every12 hours
5 to 29
250 to 500 mg every 18 hours
Patients on hemodialysis or Peritoneal dialysis
250 to 500 mg every 24 hours (after dialysis)
When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
Men - Creatinine clearance (mL/min) =
Weight (kg) x (140–age)
72 x serum creatinine (mg/dL)
Women - 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
2.4 Important Administration InstructionsWith Multivalent Cations
Administer ciprofloxacin tablets at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
With Dairy Products
Concomitant administration of ciprofloxacin tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin tablets may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin Tablets
Assure adequate hydration of patients receiving ciprofloxacin tablets to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Instruct the patient of the appropriate ciprofloxacin tablets administration [see Patient Counseling Information (17)].
-
Mylan Pharmaceuticals Inc.
Ciprofloxacin | Mylan Pharmaceuticals Inc.
2.1 DosageCiprofloxacin extended-release tablets and ciprofloxacin immediate-release tablets are not interchangeable. Ciprofloxacin extended-release tablets should be administered orally once daily (Table 1).
Table 1: Dosage GuidelinesIndication
Dose
Frequency
Usual Duration
Uncomplicated Urinary Tract Infection (Acute Cystitis)
500 mg
every 24 hours
3 Days
Complicated Urinary Tract Infection and Acute Uncomplicated Pyelonephritis
1000 mg
every 24 hours
7 to 14 Days
Patients whose therapy is started with ciprofloxacin IV for UTIs may be switched to ciprofloxacin extended-release tablets when clinically indicated at the discretion of the physician.
2.2 Administration • Ciprofloxacin extended-release tablets should be taken whole and not split, crushed, or chewed. • Ciprofloxacin extended-release tablets should be administered at least 2 hours before or 6 hours after antacids containing magnesium or aluminum, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate), as well as sucralfate, VIDEX ®‡ (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, metal cations such as iron, and multivitamin preparations with zinc [see Drug Interactions (7)]. • Concomitant administration of ciprofloxacin extended-release tablets with dairy products (like milk or yogurt) or with calcium-fortified products alone should be avoided since decreased absorption is possible. A 2 hour window between substantial calcium intake (greater than 800 mg) and dosing with ciprofloxacin extended-release tablets is recommended [see Patient Counseling Information (17)]. • Adequate hydration of patients receiving ciprofloxacin extended-release tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones [see Warnings and Precautions (5.12), Adverse Reactions (6.1) and Patient Counseling Information (17)]. 2.3 Impaired Renal Function • In patients with cUTI and acute uncomplicated pyelonephritis with a creatinine clearance of ≤ 30 mL/min, the dose of ciprofloxacin extended-release tablets should be reduced from 1000 mg to 500 mg daily. The use of ciprofloxacin 1000 mg extended-release tablets is not recommended in this patient population. • For patients on hemodialysis or peritoneal dialysis, administer ciprofloxacin extended-release tablets after the dialysis procedure is completed (maximum dose should be ciprofloxacin 500 mg extended-release tablets every 24 hours). The use of ciprofloxacin 1000 mg extended-release tablets is not recommended in this patient population [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. • For patients on continuous ambulatory peritoneal dialysis (CAPD), the maximum dose should be 500 mg every 24 hours. -
Aidarex Pharmaceuticals Llc
Ciprofloxacin | Aidarex Pharmaceuticals Llc
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
DOSAGE AND ADMINISTRATION - PEDIATRICS
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
St Marys Medical Park Pharmacy
Ciprofloxacin | St Marys Medical Park Pharmacy
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatits Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical
Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)** 500 mg q 12 h 60 Days
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30-50 250-500 mg q 12 h 5-29 250-500 mg q 18 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)
DOSAGE AND ADMINISTRATION - PEDIATRICS
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2). -
Sagent Pharmaceuticals
Ciprofloxacin | Sagent Pharmaceuticals
AdultsCIPROFLOXACIN INJECTION, USP should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation. (See Preparation of CIPROFLOXACIN INJECTION, USP for Administration section.)
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient's host-defense mechanisms, and the status of renal and hepatic function.
*Used in conjunction with metronidazole. (See product labeling for prescribing information.)
†DUE TO THE DESIGNATED PATHOGENS (See INDICATIONS AND USAGE.)
**Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information. Total duration of ciprofloxacin administration (IV or oral) for inhalational anthrax (post-exposure) is 60 days.
ADULT DOSAGE GUIDELINES Infection†
Severity Dose Frequency Usual Duration Urinary Tract Mild/Moderate 200 mg q12h 7-14 Days Severe/Complicated 400 mg q12h (or q 8h) 7-14 Days Lower
Respiratory Tract Mild/Moderate
Severe/Complicated 400 mg
400 mg q12h
q8h 7-14 Days
7-14 Days Nosocomial Pneumonia Mild/Moderate/Severe 400 mg q8h 10-14 Days Skin and
Skin Structure Mild/Moderate
Severe/Complicated 400 mg
400 mg q12h
q8h 7-14 Days
7-14 Days Bone and Joint Mild/Moderate
Severe/Complicated 400 mg
400 mg q12h
q8h ≥4-6 Weeks
≥4-6 Weeks Intra-Abdominal* Complicated 400 mg q12h 7-14 Days Acute Sinusitis Mild/Moderate 400 mg q12h 10 Days Chronic Bacterial Prostatitis Mild/Moderate 400 mg q12h 28 Days Empirical Therapy in Severe
Febrile Neutropenic Ciprofloxacin 400 mg q8h Patients + 7-14 Days Piperacillin 50 mg/kg
Not to exceed
24 g/day q4h Inhalational anthrax
(post-exposure)** 400 mg q12h 60 DaysCIPROFLOXACIN INJECTION, USP should be administered by intravenous infusion over a period of 60 minutes.
Conversion of IV to Oral Dosing in AdultsCIPROFLOXACIN is also available for oral administration. Parenteral therapy may be switched to oral therapy when the condition warrants, at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing Regimens CIPROFLOXACIN Oral Dosage Equivalent CIPROFLOXACIN INJECTION Dosage 250 mg Tablet q 12 h 200 mg IV q 12 h 500 mg Tablet q 12 h 400 mg IV q 12 h 750 mg Tablet q 12 h 400 mg IV q 8 hParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dosage > 30 See usual dosage. 5-29 200-400 mg q 18-24 hrWhen only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance:
Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age)
72 × serum creatinine (mg/dL) Women: 0.85 × the value calculated for men.The serum creatinine should represent a steady state of renal function.
For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.
PediatricsCIPROFLOXACIN INJECTION, USP should be administered as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
*The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
**Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration
Dose
(mg/kg) Frequency Total Duration Complicated
Urinary Tract
or
Pyelonephritis Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing
> 51 kg) Every
8 hours 10-21 days* (patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing
> 51 kg) Every
12 hours Inhalational Anthrax
(Post-exposure) ** Intravenous 10 mg/kg
(maximum 400 mg per dose) Every
12 hours 60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every
12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
Preparation of CIPROFLOXACIN INJECTION, USP for Administration Flexible ContainersCiprofloxacin injection is available as a 0.2% premixed solution in 5% dextrose in flexible containers of 100 mL or 200 mL. The solutions in flexible containers do not need to be diluted and should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.
If the Y-type or “piggyback” method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of ciprofloxacin injection. If the concomitant use of ciprofloxacin injection and another drug is necessary, each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.
-
Pd-rx Pharmaceuticals, Inc.
Ciprofloxacin | Teva Parenteral Medicines, Inc.
For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection USP (IM or IV). Doses of 10 mg may be administered slowly by the intravenous route over a 1- to 2-minute period.
Administration of metoclopramide injection USP up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted. The physician should make a thorough assessment of the risks and benefits prior to prescribing further metoclopramide treatment.
For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer ChemotherapyIntravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses.
The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate.
For doses in excess of 10 mg, metoclopramide injection USP should be diluted in 50 mL of a parenteral solution.
The preferred parenteral solution is Sodium Chloride Injection (normal saline), which when combined with metoclopramide injection USP, can be stored frozen for up to 4 weeks. Metoclopramide injection USP is degraded when admixed and frozen with Dextrose-5% in Water. Metoclopramide injection USP diluted in Sodium Chloride Injection, Dextrose-5% in Water, Dextrose-5% in 0.45% Sodium Chloride, Ringer’s Injection, or Lactated Ringer’s Injection may be stored up to 48 hours (without freezing) after preparation if protected from light. All dilutions may be stored unprotected from light under normal light conditions up to 24 hours after preparation.
If acute dystonic reactions should occur, inject 50 mg Benadryl® (diphenhydramine hydrochloride) intramuscularly, and the symptoms usually will subside.
For the Prevention of Postoperative Nausea and VomitingMetoclopramide injection USP should be given intramuscularly near the end of surgery. The usual adult dose is 10 mg; however, doses of 20 mg may be used.
To Facilitate Small Bowel IntubationIf the tube has not passed the pylorus with conventional maneuvers in 10 minutes, a single dose (undiluted) may be administered slowly by the intravenous route over a 1- to 2-minute period.
The recommended single dose is: Pediatric patients above 14 years of age and adults — 10 mg metoclopramide base. Pediatric patients (6-14 years of age) — 2.5 to 5 mg metoclopramide base; (under 6 years of age) — 0.1 mg/kg metoclopramide base.
To Aid in Radiological ExaminationsIn patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine, a single dose may be administered slowly by the intravenous route over a 1- to 2-minute period.
For dosage, see intubation above.
Use in Patients With Renal or Hepatic ImpairmentSince metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.
See OVERDOSAGE section for information regarding dialysis.
Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
ADMIXTURES COMPATIBILITIESMetoclopramide injection USP is compatible for mixing and injection with the following dosage forms to the extent indicated below:
Physically and Chemically Compatible Up to 48 HoursCimetidine Hydrochloride (SK&F), Mannitol, USP (Abbott), Potassium Acetate, USP (Invenex), Potassium Phosphate, USP (Invenex).
Physically Compatible Up to 48 HoursAscorbic Acid, USP (Abbott), Benztropine Mesylate, USP (MS&D), Cytarabine, USP (Upjohn), Dexamethasone Sodium Phosphate, USP (ESI, MS&D), Diphenhydramine Hydrochloride, USP (Parke-Davis), Doxorubicin Hydrochloride, USP (Adria), Heparin Sodium, USP (ESI), Hydrocortisone Sodium Phosphate (MS&D), Lidocaine Hydrochloride, USP (ESI), Multi-Vitamin Infusion (must be refrigerated-USV), Vitamin B Complex with Ascorbic Acid (Roche).
Physically Compatible Up to 24 Hours(Do not use if precipitation occurs)
Clindamycin Phosphate, USP (Upjohn), Cyclophosphamide, USP (Mead-Johnson), Insulin, USP (Lilly).
Conditionally Compatible(Use within one hour after mixing or may be infused directly into the same running IV line)
Ampicillin Sodium, USP (Bristol), Cisplatin (Bristol), Erythromycin Lactobionate, USP (Abbott), Methotrexate Sodium, USP (Lederle), Penicillin G Potassium, USP (Squibb), Tetracycline Hydrochloride, USP (Lederle).
Incompatible(Do Not Mix)
Cephalothin Sodium, USP (Lilly), Chloramphenicol Sodium, USP (Parke-Davis), Sodium Bicarbonate, USP (Abbott).
-
Preferred Pharmaceuticals, Inc
Ciprofloxacin | Preferred Pharmaceuticals, Inc.
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, seeINHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal InfectionsUncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose> 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various
human populations, seeINHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Complicated
Urinary Tract or
PyelonephritisIntravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**Intravenous
10 mg/kg
(maximum 400 mg per
dose)Every 12 hours
60 daysOral
15 mg/kg
(maximum 500 mg per dose)Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Mylan Institutional Inc.
Ciprofloxacin | Mylan Institutional Inc.
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (e.g., sevelamer, lanthanum carbonate) or sucralfate, Videx®† (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 6 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX: Additional Information.Infection
Severity
Dose
Frequency
Usual Durations*
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 Days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 Weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 Weeks
Intra-Abdominal†
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical Gonococcal Infections
Uncomplicated
250 mg
Single Dose
Single Dose
Inhalational Anthrax (post-exposure)‡
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens.)
Equivalent AUC Dosing RegimensCiprofloxacin Oral Dosage
Equivalent Ciprofloxacin I.V. Dosage
250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTIONCreatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 to 50
250 mg to 500 mg q 12 h
5 to 29
250 mg to 500 mg q 18 h
Patients on hemodialysis or
Peritoneal dialysis250 mg to 500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 6 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX IN ADULTS AND PEDIATRICS: Additional Information.Infection
Route of Administration
Dose (mg/kg)
Frequency
Total Duration
Complicated Urinary Tract or Pyelonephritis
Intravenous
6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 8 hours
10 to 21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 12 hours
Inhalational Anthrax (Post-Exposure)†
Intravenous
10 mg/kg (maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg (maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Aphena Pharma Solutions – New Jersey, Llc
Ciprofloxacin | Aphena Pharma Solutions - New Jersey, Llc
ADULTS
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate)or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
Mild/Moderate
Severe/Complicated
250 mg
250 mg
500 mg
q 12 h
q 12 h
q 12 h
3 Days
7 to 14 Days
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 Days
7 to 14 Days
Bone and Joint
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
≥ 4 to 6 weeks
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**
500 mg
q 12 h
60 Days
* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
500 mg Tablet q 12 h
750 mg Tablet q 12 h
200 mg I.V. q 12 h
400 mg I.V. q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
30 – 50
5 – 29
Patients on hemodialysis or
Peritoneal dialysis
See Usual Dosage.
250 – 500 mg q 12 h
250 – 500 mg q 18 h
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
PEDIATRICS
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin tablets should be administered orally as described in theDosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of
Administration
Dose
(mg/kg)
Frequency
Total
Duration
Complicated
Urinary Tract
or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg per
dose; not to be exceeded
even in patients weighing > 51 kg)
Every 8
hours
10-21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-
Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12
hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Aphena Pharma Solutions – Tennessee, Llc
Ciprofloxacin | Aphena Pharma Solutions - Tennessee, Llc
ADULTS
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate)or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
Mild/Moderate
Severe/Complicated
250 mg
250 mg
500 mg
q 12 h
q 12 h
q 12 h
3 Days
7 to 14 Days
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 Days
7 to 14 Days
Bone and Joint
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
≥ 4 to 6 weeks
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**
500 mg
q 12 h
60 Days
* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
500 mg Tablet q 12 h
750 mg Tablet q 12 h
200 mg I.V. q 12 h
400 mg I.V. q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
30 – 50
5 – 29
Patients on hemodialysis or
Peritoneal dialysis
See Usual Dosage.
250 – 500 mg q 12 h
250 – 500 mg q 18 h
250 – 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
PEDIATRICS
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin tablets should be administered orally as described in theDosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of
Administration
Dose
(mg/kg)
Frequency
Total
Duration
Complicated
Urinary Tract
or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg per
dose; not to be exceeded
even in patients weighing > 51 kg)
Every 8
hours
10-21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-
Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12
hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Direct Rx
Ciprofloxacin | Direct Rx
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatits Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical
Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)** 500 mg q 12 h 60 DaysConversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 hAdults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30-50 250-500 mg q 12 h 5-29 250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age) Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.DOSAGE AND ADMINISTRATION - PEDIATRICS
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in
the clinical trial was determined by the physician. The mean duration of treatment was
11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed
exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint,
ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict
clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION. Complicated
Urinary Tract or
Pyelonephritis Intravenous 6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg) Every 8 hours 10-21 days* (patients from
1 to 17 years of
age) Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg) Every 12 hours Inhalational
Anthrax
(Post-Exposure)** Intravenous 10 mg/kg
(maximum 400 mg per
dose) Every 12 hours
60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Cardinal Health
Ciprofloxacin | Mylan Pharmaceuticals Inc.
Premenstrual Dysphoric Disorder Initial TreatmentThe recommended dose of fluoxetine capsules for the treatment of PMDD is 20 mg/day given continuously (every day of the menstrual cycle) or intermittently (defined as starting a daily dose 14 days prior to the anticipated onset of menstruation through the first full day of menses and repeating with each new cycle). The dosing regimen should be determined by the physician based on individual patient characteristics. In a study comparing continuous dosing of fluoxetine capsules 20 and 60 mg/day to placebo, both doses were proven to be effective, but there was no statistically significant added benefit for the 60 mg/day compared with the 20 mg/day dose. Fluoxetine capsule doses above 60 mg/day have not been systematically studied in patients with PMDD. The maximum fluoxetine capsule dose should not exceed 80 mg/day.
As with many other medications, a lower or less frequent dosage should be considered in patients with hepatic impairment. A lower or less frequent dosage should also be considered for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary (see CLINICAL PHARMACOLOGY: Liver Disease and Renal Disease, and PRECAUTIONS: Use in Patients with Concomitant Illness).
Maintenance/Continuation TreatmentSystematic evaluation of fluoxetine capsules has shown that its efficacy in PMDD is maintained for periods of up to 6 months at a dose of 20 mg/day given continuously and up to 3 months at a dose of 20 mg/day given intermittently, (see CLINICAL TRIALS). Patients should be periodically reassessed to determine the need for continued treatment.
Special Populations Treatment of Pregnant Women During the Third TrimesterNeonates exposed to fluoxetine and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with fluoxetine capsules during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering fluoxetine capsules in the third trimester.
Discontinuation of Treatment with Fluoxetine CapsulesSymptoms associated with discontinuation of fluoxetine capsules and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Plasma fluoxetine and norfluoxetine concentration decrease gradually at the conclusion of therapy which may minimize the risk of discontinuation symptoms with this drug.
-
Readymeds
Ciprofloxacin | Readymeds
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate ) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)** 500 mg q 12 h 60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Pediatrics
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of Administration
Dose
(mg/kg)
Frequency
Total Duration
Complicated Urinary Tract or
Pyelonephritis(patients from 1 to 17 years of age)
Intravenous
6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients
weighing > 51 kg)
Every 8 hours
10-21 days*Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients
weighing > 51 kg)
Every 12 hours
Inhalational Anthrax
(Post- Exposure)**Intravenous
10 mg/kg
(maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Hospira, Inc.
Ciprofloxacin | Eon Labs, Inc.
Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia.
Attention Deficit Hyperactivity DisorderNot recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.
In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.
NarcolepsyUsual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response.
Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
-
Lupin Pharmaceuticals, Inc.
Ciprofloxacin | Lupin Pharmaceuticals, Inc.
AdultsCiprofloxacin for oral suspension should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
* Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † Used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. ADULT DOSAGE GUIDELINES
Infection
Severity
Dose
Frequency
Usual Durations*
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 days
Mild/Moderate
250 mg
q 12 h
7 to 14 days
Severe/Complicated
500 mg
q 12 h
7 to 14 days
Chronic Bacterial
Mild/Moderate
500 mg
q 12 h
28 days
Prostatitis
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Skin Structure
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 weeks
Intra-Abdominal†
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical
Uncomplicated
250 mg
single dose
single dose
Gonococcal Infections
Inhalational anthrax
(post-exposure)‡
500 mg
q h 12
60 days
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (see CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
250 – 500 mg q 24 h (after dialysis)
or Peritoneal dialysis
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin for oral suspension should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONS and CLINICAL STUDIES).
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.<sup>6</sup><sup> </sup>For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information. Infection
Route of Administration
Dose
(mg/kg)
Frequency
Total Duration
Complicated Urinary Tract
or
Pyelonephritis (patients from
1 to 17 years of age)
Intravenous
6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 8 hours
10-21 days*
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 12 hours
Inhalational Anthrax (Post-Exposure)†
Intravenous
10 mg/kg
(maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Avkare, Inc.
Ciprofloxacin | Avkare, Inc.
AdultsCiprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient'shost-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate ) or sucralfate, Videx® (didanosine) chewable/ buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 week Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days
Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days
Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days
Urethral and Cervical Uncomplicated 250 mg single dose single dose
Gonococcal Infections
Inhalational anthrax 500 mg q 12 h 60 days
(post-exposure)**Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES
Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose
(mg/kg)
Frequency Total
Duration Complicated Urinary Tract
or
Pyelonephritis
(patients from
1 to 17 years of age) Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post- Exposure)** Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12
hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12
hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Northwind Pharmaceuticals
Ciprofloxacin | Northwind Pharmaceuticals
Please see the manufacturer's recommendations on the FDA DAILY MED SITE:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ef468722-68cd-440b-afd7-2285029db41f
-
Aurobindo Pharma Limited
Ciprofloxacin | Aurobindo Pharma Limited
Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables.
2.1 Dosage in AdultsThe determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Table 1: Adult Dosage Guidelines 1. Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
2. Used in conjunction with metronidazole.
3. Begin drug administration as soon as possible after suspected or confirmed exposure.
Infection
Dose
Frequency
Usual Durations1
Urinary Tract
250 to 500 mg
every 12 hours
7 to 14 days
Acute Uncomplicated Cystitis
250 mg
every 12 hours
3 days
Chronic Bacterial Prostatitis
500 mg
every 12 hours
28 days
Lower Respiratory Tract
500 to 750 mg
every 12 hours
7 to 14 days
Acute Sinusitis
500 mg
every 12 hours
10 days
Skin and Skin Structure
500 to 750 mg
every 12 hours
7 to 14 days
Bone and Joint
500 to 750 mg
every 12 hours
4 to 8 weeks
Complicated Intra–Abdominal2
500 mg
every 12 hours
7 to 14 days
Infectious Diarrhea
500 mg
every 12 hours
5 to 7 days
Typhoid Fever
500 mg
every 12 hours
10 days
Uncomplicated Urethral and
Cervical Gonococcal Infections
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)3
500 mg
every 12 hours
60 days
Plague3
500 to 750 mg
every 12 hours
14 days
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
Table 2: Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet every 12 hours
200 mg intravenous every 12 hours
500 mg Tablet every 12 hours
400 mg intravenous every 12 hours
750 mg Tablet every 12 hours
400 mg intravenous every 8 hours
2.2 Dosage in Pediatric PatientsDosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets should be administered as described in Table 3.
Table 3: Pediatric Dosage Guidelines 1. The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
2. Begin drug administration as soon as possible after suspected or confirmed exposure.
3. Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis. Infection
Dose
Frequency
Total Duration
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg)
Every 12 hours
10 to 21 days1
Inhalational Anthrax (Post-Exposure)2
15 mg/kg (maximum 500 mg per dose)
Every 12 hours
60 days
Plague2,3
15 mg/kg (maximum 500 mg per dose)
Every 12 to 8 hours
10 to 21 days
2.3 Dosage Modifications in Patients with Renal ImpairmentCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function Creatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 to 50
250 to 500 mg every12 hours
5 to 29
250 to 500 mg every 18 hours
Patients on hemodialysis or Peritoneal dialysis
250 to 500 mg every 24 hours (after dialysis)
When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
Men - Creatinine clearance (mL/min) = Weight (kg) x (140–age)
72 x serum creatinine (mg/dL)
Women - 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73 m2).
2.4 Important Administration InstructionsWith Multivalent Cations
Administer ciprofloxacin tablets at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
With Dairy Products
Concomitant administration of ciprofloxacin tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin tablets may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin Tablets
Assure adequate hydration of patients receiving ciprofloxacin tablets to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Instruct the patient of the appropriate ciprofloxacin tablets administration [see Patient Counseling Information (17)].
-
Blu Pharmaceuticals, Llc
Ciprofloxacin | Blu Pharmaceuticals, Llc
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract Acute Uncomplicated Mild/Moderate Severe/Complicated 250 mg250 mg500 mg q 12 hq 12 hq 12 h 3 days7 to 14 days7 to 14 days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 days Lower Respiratory Tract Mild/ModerateSevere/Complicated 500 mg750 mg q 12 hq 12 h 7 to 14 days7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/ModerateSevere/Complicated 500 mg750 mg q 12 hq 12 h 7 to 14 days7 to 14 days Bone and Joint Mild/ModerateSevere/Complicated 500 mg750 mg q 12 hq 12 h ³ 4 to 6 weeks ³ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and CervicalGonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax(post-exposure)** 500 mg q 12 h 60 days* Used in conjunction with metronidazole
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit6. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX- ADDITIONAL INFORMATION.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with Ciprofloxacin IV may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens
Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage
250 mg Tablet q 12 h 200 mg IV q 12 h
500 mg Tablet q 12 h 400 mg IV q 12 h
750 mg Tablet q 12 h 400 mg IV q 8 h
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSESFOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min) Dose
> 50 See Usual Dosage
30 – 50 250 – 500 mg q 12 h
5 – 29 250 – 500 mg q 18 h
Patients on hemodialysis 250 – 500 mg q 24 h (after dialysis)
or Peritoneal dialysis
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
______________________
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES .)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatricpatients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours andallowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose(mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from1 to 17 years of age) Intravenous 6 to 10 mg/kg(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing> 51 kg) Every 12 hours Inhalational Anthrax (Post-Exposure)** Intravenous 10 mg/kg(maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg(maximum 500 mg per dose) Every 12 hours* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit6. For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics — Additional Information .
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
A-s Medication Solutions Llc
Ciprofloxacin | A-s Medication Solutions Llc
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate ) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)** 500 mg q 12 h 60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Pediatrics
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of Administration
Dose
(mg/kg)
Frequency
Total Duration
Complicated Urinary Tract or
Pyelonephritis(patients from 1 to 17 years of age)
Intravenous
6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients
weighing > 51 kg)
Every 8 hours
10-21 days*Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients
weighing > 51 kg)
Every 12 hours
Inhalational Anthrax
(Post- Exposure)**Intravenous
10 mg/kg
(maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Preferred Pharmaceuticals, Inc.
Ciprofloxacin | Preferred Pharmaceuticals, Inc.
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
How Supplied: As a sterile ophthalmic solution, in a plastic dispenser:
5 mL - 68788-9391-5
STORAGE: Store at 25°C (77°F); excursions permitted to15 - 30°C (59 - 86°F) [See USP controlled room temperature]. Protect from light. Retain in carton until contents are used.
-
A-s Medication Solutions Llc
Ciprofloxacin | A-s Medication Solutions Llc
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate ) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax(post-exposure)** 500 mg q 12 h 60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Pediatrics
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
Infection
Route of Administration
Dose
(mg/kg)
Frequency
Total Duration
Complicated Urinary Tract or
Pyelonephritis(patients from 1 to 17 years of age)
Intravenous
6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients
weighing > 51 kg)
Every 8 hours
10-21 days*Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients
weighing > 51 kg)
Every 12 hours
Inhalational Anthrax
(Post- Exposure)**Intravenous
10 mg/kg
(maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Bryant Ranch Prepack
Ciprofloxacin | Bryant Ranch Prepack
DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations* * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † Used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)‡ 500 mg q 12 h 60 Days Conversion of I.V. to Oral Dosing in AdultsPatients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal FunctionCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL) Women: 0.85 × the value calculated for men.The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATION – PEDIATRICSCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
(Post-Exposure)† Intravenous 10 mg/kg
(maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
-
Claris Lifesciences Inc.
Ciprofloxacin | Heritage Pharmaceuticals Inc.
2.1 Important Administration InstructionsZoledronic acid injection must be administered as an intravenous infusion over no less than 15 minutes.
Patients must be appropriately hydrated prior to administration of zoledronic acid injection [see Warnings and Precautions (5.3) ]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Intravenous infusion should be followed by a 10 mL normal saline flush of the intravenous line. Administration of acetaminophen following zoledronic acid injection administration may reduce the incidence of acute-phase reaction symptoms. 2.6 Treatment of Paget's Disease of BoneThe recommended dose is a 5 mg infusion. The infusion time must not be less than 15 minutes given over a constant infusion rate.
Re-treatment of Paget's Disease
After a single treatment with zoledronic acid injection in Paget's disease an extended remission period is observed. Specific re-treatment data are not available. However, re-treatment with zoledronic acid injection may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.
2.7 Laboratory Testing and Oral Examination Prior to Administration Prior to administration of each dose of zoledronic acid injection, obtain a serum creatinine and creatinine clearance should be calculated based on actual body weight using Cockcroft-Gault formula before each zoledronic acid injection dose. Zoledronic acid injection is contraindicated in patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment. A 5 mg dose of zoledronic acid injection administered intravenously is recommended for patients with creatinine clearance greater than or equal to 35 mL/min. There are no safety or efficacy data to support the adjustment of the zoledronic acid injection dose based on baseline renal function. Therefore, no dose adjustment is required in patients with CrCl greater than or equal to 35 mL/min [see Contraindications (4), Warnings and Precautions (5.3) ]. A routine oral examination should be performed by the prescriber prior to initiation of zoledronic acid injection treatment [see Warnings and Precautions (5.4) ]. 2.8 Calcium and Vitamin D Supplementation Instruct patients being treated for Paget's disease of bone on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels, and on the symptoms of hypocalcemia. All patients should take 1500 mg elemental calcium daily in divided doses (750 mg two times a day, or 500 mg three times a day) and 800 international units vitamin D daily, particularly in the 2 weeks following zoledronic acid injection administration [see Warnings and Precautions (5.2) ]. 2.9 Method of AdministrationThe zoledronic acid injection infusion time must not be less than 15 minutes given over a constant infusion rate.
The i.v. infusion should be followed by a 10 mL normal saline flush of the intravenous line.
Zoledronic acid injection solution for infusion must not be allowed to come in contact with any calcium or other divalent cation-containing solutions, and should be administered as a single intravenous solution through a separate vented infusion line.
If refrigerated, allow the refrigerated solution to reach room temperature before administration. After opening, the solution is stable for 24 hours at 2°C to 8°C (36°F to 46°F) [see How Supplied/Storage and Handling (16)].
-
Cardinal Health
Ciprofloxacin | Cardinal Health
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
* Used in conjunction with metronidazole
† Generally ciprofloxacin tablets should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.ADULT DOSAGE GUIDELINES
Infection
Severity
Dose
Frequency
Usual Durations†
Urinary Tract
Acute Uncomplicated
Mild/Moderate
Severe/Complicated
250 mg
250 mg
500 mg
q 12 h
q 12 h
q 12 h
3 days
7 to 14 days
7 to 14 days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and
Skin StructureMild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
7 to 14 days
7 to 14 days
Bone and Joint
Mild/Moderate
Severe/Complicated
500 mg
750 mg
q 12 h
q 12 h
≥ 4 to 6 weeks
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**500 mg
q h 12
60 days
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens
Ciprofloxacin Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES
FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 to 50
250 to 500 mg q 12 h
5 to 29
250 to 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250 to 500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) =
Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.PEDIATRIC DOSAGE GUIDELINES
Infection
Route of Administration
Dose (mg/kg)
Frequency
Total Duration
Complicated
Urinary Tract
or
Pyelonephritis
(patients from
1 to 17 years of
age)Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)Every 12 hours
10 to 21 days*
Inhalational Anthrax (Post-Exposure)**
Oral
15 mg/kg
(maximum 500 mg per dose)Every 12 hours
60 days
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Preferred Pharmaceuticals, Inc.
Ciprofloxacin | Preferred Pharmaceuticals, Inc.
Adults
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * Used in conjunction with metronidazole
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 days
Mild/Moderate
250 mg
q 12 h
7 to 14 days
Severe/Complicated
500 mg
q 12 h
7 to 14 days
Chronic Bacterial
ProstatitisMild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and
Skin StructureMild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical
Gonococcal InfectionsUncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**500 mg
q 12 h
60 days
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:> 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = ---------------------------------------
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
PEDIATRIC DOSAGE GUIDELINES Infection Route
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax in Adults and Pediatrics, Additional Information.
Complicated Urinary Tract or
PyelonephritisIntravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)Every 8 hours
10-21 days*(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)Every 12 hours
Inhalational Anthrax
(Post-Exposure)**Intravenous
10 mg/kg
(maximum 400 mg per
dose)Every 12 hours
60 daysOral
15 mg/kg
(maximum 500 mg per dose)Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Preferred Pharmaceuticals, Inc.
Ciprofloxacin | Preferred Pharmaceuticals, Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Gen-source Rx
Ciprofloxacin | Gen-source Rx
Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† * Used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 days
Mild/Moderate
250 mg
q 12 h
7 to 14 days
Severe/Complicated
500 mg
q 12 h
7 to 14 days
Chronic Bacterial
Prostatitis
Mild/Moderate
500 mg
q 12 h
28 days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and
Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax
(post-exposure)**
500 mg
q 12 h
60 days
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h
200 mg IV q 12 h
500 mg Tablet q 12 h
400 mg IV q 12 h
750 mg Tablet q 12 h
400 mg IV q 8 h
Adults with Impaired Renal Function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30 – 50
250 – 500 mg q 12 h
5 – 29
250 – 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis
250 – 500 mg q 24 h (after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = ---------------------------------------
72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route
of
Administration Dose
(mg/kg) Frequency Total
Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax in Adults and Pediatrics, Additional Information.
Complicated Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Hikma Pharmaceutical
Ciprofloxacin | Hikma Pharmaceutical
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate ) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg q 12 h
3 Days
Mild/Moderate
250 mg q 12 h
7 to 14 Days
Severe/Complicated
500 mg q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg q 12 h
7 to 14 days
Severe/Complicated
750 mg q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg q 12 h
7 to 14 Days
Severe/Complicated
750 mg q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated 250 mg single dose
single dose
Inhalational anthrax
(post-exposure)** 500 mg q 12 h 60 Days* used in conjunction with metronidazole
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h
†Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection
have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various
human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).Adults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Pediatrics
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose
(mg/kg) Frequency Total Duration Complicated Urinary Tract or
Pyelonephritis(patients from 1 to 17 years of age)
Intravenous 6 to 10 mg/kg(maximum 400 mg per dose; not to be exceeded even in patients
weighing > 51 kg)
Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patientsweighing > 51 kg)
Every 12 hours Inhalational Anthrax
(Post- Exposure)** Intravenous 10 mg/kg(maximum 400 mg per dose)
Every 12 hours 60 days Oral 15 mg/kg(maximum 500 mg per dose)
Every 12 hours* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Actavis Pharma, Inc.
Ciprofloxacin | Actavis Pharma, Inc.
AdultsCiprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and
Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax
(post-exposure)** 500 mg
q h 12
60 days
* Used in conjunction with metronidazole † Generally ciprofloxacin tablets should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). ** Drug administration should begin as soon as possible after suspected or confirmed exposure.This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h 200 mg IV q 12 h 500 mg Tablet q 12 h 400 mg IV q 12 h 750 mg Tablet q 12 h 400 mg IV q 8 hAdults with Impaired Renal Function: Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 to 50 250 to 500 mg q 12 h 5 to 29 250 to 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 to 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age) 72 x serum creatinine (mg/dL) Women: 0.85 x the value calculated for men.The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
PediatricsCiprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration Complicated
Urinary Tract
or
Pyelonephritis
(patients from
1 to 17 years of
age) Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours 10 to 21 days* Inhalational Anthrax (Post-Exposure)** Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hours 60 days * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
-
Proficient Rx Lp
Ciprofloxacin | Pd-rx Pharmaceuticals, Inc.
2.1 General InstructionsCarefully consider the potential benefits and risks of meloxicam tablets USP and other treatment options before deciding to use meloxicam tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.4)].
After observing the response to initial therapy with meloxicam tablets USP, adjust the dose to suit an individual patient's needs.
In adults, the maximum recommended daily oral dose of meloxicam tablets USP is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Warnings and Precautions (5.6), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Meloxicam tablets USP may be taken without regard to timing of meals.
2.2 OsteoarthritisFor the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam tablets USP is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
2.3 Rheumatoid ArthritisFor the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam tablets USP is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
-
Pd-rx Pharmaceuticals, Inc.
Ciprofloxacin | Pd-rx Pharmaceuticals, Inc.
ADULTS
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES
InfectionSeverityDoseFrequencyUsual Durations** Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).Used in conjunction with metronidazoleDrug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit4. For a discussion of ciprofloxacin serum concentrations in various human populations, seeINHALATIONAL ANTHRAX - ADDITIONAL INFORMATION.Urinary TractAcute Uncomplicated250 mgq 12 h3 DaysMild/Moderate250 mgq 12 h7 to 14 DaysSevere/Complicated500 mgq 12 h7 to 14 DaysChronic Bacterial ProstatitisMild/Moderate500 mgq 12 h28 DaysLower Respiratory TractMild/Moderate500 mgq 12 h7 to 14 daysSevere/Complicated750 mgq 12 h7 to 14 daysAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin and Skin StructureMild/Moderate500 mgq 12 h7 to 14 DaysSevere/Complicated750 mgq 12 h7 to 14 DaysBone and JointMild/Moderate500 mgq 12 h4 to 6 weeksSevere/Complicated750 mgq 12 h4 to 6 weeksIntra-AbdominalComplicated500 mgq 12 h7 to 14 DaysInfectious DiarrheaMild/Moderate/Severe500 mgq 12 h5 to 7 DaysTyphoid FeverMild/Moderate500 mgq 12 h10 daysUrethral and Cervical Gonococcal InfectionsUncomplicated250 mgsingle dosesingle doseInhalational anthrax (post-exposure)500 mgq 12 h60 Days
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (SeeCLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens
Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
Adults with Impaired Renal Function
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min)Dose> 50See Usual Dosage3050250500 mg q 12 h529250500 mg q 18 hPatients on hemodialysis or Peritoneal dialysis250500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine clearance (mL/min) =Weight (kg)(140 - age)72serum creatinine (mg/dL)Women: 0.85the value calculated for men.The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
DOSAGE AND ADMINISTRATIONPEDIATRICS
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (SeeADVERSE REACTIONSandCLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
InfectionRoute of AdministrationDose (mg/kg)FrequencyTotal Duration* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit5. For a discussion of ciprofloxacin serum concentrations in various human populations, seeINHALATIONAL ANTHRAXADDITIONAL INFORMATION.Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)IntravenousEvery 8 hours10-21 days*OralEvery 12 hoursInhalational Anthrax (Post-Exposure)Intravenous10 mg/kg (maximum 400 mg per dose)Every 12 hours60 daysOral15 mg/kg (maximum 500 mg per dose)Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2). -
Medsource Pharmaceuticals
Ciprofloxacin | Medsource Pharmaceuticals
Ciprofloxacin should be administered orally as described in the appropriate Dosage Guidelines tables.
2.1 Dosage in AdultsThe determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Table 1: Adult Dosage Guidelines * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † Used in conjunction with metronidazole. ‡ Begin drug administration as soon as possible after suspected or confirmed exposure.Infection
Dose
Frequency
Usual Durations*
Urinary Tract
250 mg- 500 mg
every 12 hours
7 to 14 days
Acute Uncomplicated Cystitis
250 mg
every 12 hours
3 days
Chronic Bacterial Prostatitis
500 mg
every 12 hours
28 days
Lower Respiratory Tract
500 mg -750 mg
every 12 hours
7 to 14 days
Acute Sinusitis
500 mg
every 12 hours
10 days
Skin and Skin Structure
500 mg -750 mg
every 12 hours
7 to 14 days
Bone and Joint
500 mg -750 mg
every 12 hours
4 to 8 weeks
Complicated Intra–Abdominal †
500 mg
every 12 hours
7 to 14 days
Infectious Diarrhea
500 mg
every 12 hours
5 to 7 days
Typhoid Fever
500 mg
every 12 hours
10 days
Uncomplicated Urethral and Cervical Gonococcal Infections
250 mg
single dose
single dose
Inhalational Anthrax (Post-Exposure) ‡
500 mg
every 12 hours
60 days
Plague ‡
500 mg - 750 mg
every 12 hours
14 days
Conversion of IV to Oral Dosing in AdultsPatients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets or Oral Suspension when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
Table 2: Equivalent AUC Dosing RegimensCiprofloxacin Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet every 12 hours
200 mg intravenous every 12 hours
500 mg Tablet every 12 hours
400 mg intravenous every 12 hours
750 mg Tablet every 12 hours
400 mg intravenous every 8 hours
2.2 Dosage in Pediatric PatientsDosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin should be administered as described in Table 3.
Table 3: Pediatric Dosage Guidelines * The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Begin drug administration as soon as possible after suspected or confirmed exposure. ‡ Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.Infection
Dose
Frequency
Total Duration
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg)
Every 12 hours
10 to 21 days *
Inhalational Anthrax (Post-Exposure) †
15 mg/kg (maximum 500 mg per dose)
Every 12 hours
60 days
Plague † , ‡
15 mg/kg (maximum 500 mg per dose)
Every 12 to 8 hours
10 -21 days
2.3 Dosage Modifications in Patients with Renal ImpairmentCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal FunctionCreatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 - 50
250 mg - 500 mg every 12 hours
5 - 29
250 mg - 500 mg every 18 hours
Patients on hemodialysis or Peritoneal dialysis
250 mg - 500 mg every 24 hours (after dialysis)
When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
Men -Creatinine clearance (mL/min)= Weight (kg) x (140-age)
72 x serum creatinine (mg/dL)Women -0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m 2).
2.4 Important Administration InstructionsWith Multivalent Cations
Administer ciprofloxacin at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx ® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
With Dairy Products
Concomitant administration of ciprofloxacin with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin
Assure adequate hydration of patients receiving ciprofloxacin to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Instruct the patient of the appropriate ciprofloxacin administration [see Patient Counseling Information (17)].
-
Medsource Pharmaceuticals
Ciprofloxacin | Medsource Pharmaceuticals
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
How Supplied: As a sterile ophthalmic solution, in a plastic dispenser:
2.5 mL NDC16571-120-25
5 mL NDC16571-120-50
STORAGE: Store at 25°C (77°F); excursions permitted to15 - 30°C (59 - 86°F) [See USP controlled room temperature]. Protect from light. Retain in carton until contents are used.
-
Remedyrepack Inc.
Ciprofloxacin | Remedyrepack Inc.
Ciprofloxacin should be administered orally as described in the appropriate Dosage Guidelines tables.
The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Table 1: Adult Dosage GuidelinesInfection
Dose
Frequency
Usual Durations*
Urinary Tract
250 mg- 500 mg
every 12 hours
7 to 14 days
Acute Uncomplicated Cystitis
250 mg
every 12 hours
3 days
Chronic Bacterial Prostatitis
500 mg
every 12 hours
28 days
Lower Respiratory Tract
500 mg -750 mg
every 12 hours
7 to 14 days
Acute Sinusitis
500 mg
every 12 hours
10 days
Skin and Skin Structure
500 mg -750 mg
every 12 hours
7 to 14 days
Bone and Joint
500 mg -750 mg
every 12 hours
4 to 8 weeks
Complicated Intra–Abdominal†
500 mg
every 12 hours
7 to 14 days
Infectious Diarrhea
500 mg
every 12 hours
5 to 7 days
Typhoid Fever
500 mg
every 12 hours
10 days
Uncomplicated Urethral and Cervical Gonococcal Infections
250 mg
single dose
single dose
Inhalational Anthrax (Post-Exposure)‡
500 mg
every 12 hours
60 days
Plague3
500 mg - 750 mg
every 12 hours
14 days
1
2
3
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets or Oral Suspension when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
Table 2: Equivalent AUC Dosing RegimensCiprofloxacin Oral Dosage
Equivalent Ciprofloxacin IV Dosage
250 mg Tablet every 12 hours
200 mg intravenous every 12 hours
500 mg Tablet every 12 hours
400 mg intravenous every 12 hours
750 mg Tablet every 12 hours
400 mg intravenous every 8 hours
Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin should be administered as described in Table 3.
Table 3: Pediatric Dosage GuidelinesInfection
Dose
Frequency
Total Duration
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg)
Every 12 hours
10 to 21 days *
Inhalational Anthrax (Post-Exposure) †
15 mg/kg (maximum 500 mg per dose)
Every 12 hours
60 days
Plague 5 , ‡
15 mg/kg (maximum 500 mg per dose)
Every 12 to 8 hours
10 -21 days
4
5
6
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal FunctionCreatinine Clearance (mL/min)
Dose
> 50
See Usual Dosage.
30 - 50
250 mg - 500 mg every 12 hours
5 - 29
250 mg - 500 mg every 18 hours
Patients on hemodialysis or Peritoneal dialysis
250 mg - 500 mg every 24 hours (after dialysis)
When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
Men -Creatinine clearance (mL/min)= Weight (kg) x (140-age)
72 x serum creatinine (mg/dL)Women -0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
With Multivalent Cations
Administer ciprofloxacin at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
With Dairy Products
Concomitant administration of ciprofloxacin with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin
Assure adequate hydration of patients receiving ciprofloxacin to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Instruct the patient of the appropriate ciprofloxacin administration [see Patient Counseling Information (17)].
1 Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). 2 Used in conjunction with metronidazole. 3 Begin drug administration as soon as possible after suspected or confirmed exposure. 4 The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). 5 Begin drug administration as soon as possible after suspected or confirmed exposure. 6 Begin drug administration as soon as possible after suspected or confirmed exposure to -
Kaiser Foundation Hospitals
Ciprofloxacin | Kaiser Foundation Hospitals
Ciprofloxacin Tablets, USP, should be administered orally to adults as described in the appropriate Dosage Guidelines table.
2.1 Dosage in AdultsThe determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Table 1: Adult Dosage Guidelines Infection Dose Frequency Usual Durations1 Urinary Tract 250–500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500–750 mg every 12 hours 7 to 14 days Acute Sinusitis 500 mg every 12 hours 10 days Skin and Skin Structure 500–750 mg every 12 hours 7 to 14 days Bone and Joint 500–750 mg every 12 hours 4 to 8 weeks Complicated Intra–Abdominal2 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Urethral and Cervical Gonococcal Infections 250 mg single dose single dose Inhalational anthrax (postexposure)3 500 mg every 12 hours 60 days Plague 3 500–750 mg every 12 hours 14 days Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
Used in conjunction with metronidazole.
Begin drug administration as soon as possible after suspected or confirmed exposure.Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to Ciprofloxacin tablets, USP when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
Table 2: Equivalent AUC Dosing Regimens Ciprofloxacin Tablets, USP Oral Dosage Equivalent ciprofloxacin IV Dosage 250 mg Tablet every 12 hours 200 mg intravenous every 12 hours 500 mg Tablet every 12 hours 400 mg intravenous every 12 hours 750 mg Tablet every 12 hours 400 mg intravenous every 8 hours 2.2 Dosage in Pediatric PatientsDosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets, USP should be administered as described in Table 3.
Table 3 : Pediatric Dosage Guidelines Guidelines Infection Dose Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from
1 to 17 years of age) 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 12 hours 10–21 days1 Inhalational Anthrax
(PostExposure)2 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague2,3 15 mg/kg (maximum 500 mg per dose) Every 12 to 8 hours 10–21 days The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
Begin drug administration as soon as possible after suspected or confirmed exposure.
Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis. 2.3 Dosage Modifications in Patients with Renal ImpairmentCiprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30–50 250–500 mg every12 hours 5–29 250–500 mg every 18 hours Patients on hemodialysis or Peritoneal dialysis 250–500 mg every 24 hours
(after dialysis)When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
Men -Creatinine clearance (mL/min) = Weight (kg) x (140–age)
72 x serum creatinine (mg/dL)
Women -0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
2.4 Important Administration InstructionsWith Multivalent Cations
Administer Ciprofloxacin Tablets, USP at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
With Dairy Products
Concomitant administration of Ciprofloxacin Tablets, USP with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, Ciprofloxacin Tablets, USP may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin Tablets, USP
Assure adequate hydration of patients receiving Ciprofloxacin Tablets, USP to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Instruct the patient of the appropriate Ciprofloxacin Tablets, USP administration [see Patient Counseling Information (17)].
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