Besivance

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• Physicians Total Care, Inc.
  

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  Besivance | Physicians Total Care, Inc.

  

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  Invert closed bottle and shake once before use.

  Instill one drop in the affected eye(s) 3 times a day, four to twelve hours apart for 7 days.

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• Bausch & Lomb Incorporated
  

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  Besivance | Bayer Healthcare Pharmaceuticals Inc.

  

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  CIPRO IV should be administered intravenously at dosages described in the appropriate Dosage Guidelines tables.

  2.1 Dosage in Adults

  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 Guidelines * Due to the designated pathogens (see Indications and Usage.) † Used in conjunction with metronidazole. ‡ Begin administration as soon as possible after suspected or confirmed exposure.

  Infection*

  Dose

  Frequency

  Usual Duration

  Urinary Tract

  200 mg to 400 mg

  every 12 to every 8 hours

  7–14 days

  Lower Respiratory Tract

  400 mg

  every 12 to every 8 hours

  7–14 days

  Nosocomial Pneumonia

  400 mg

  every 8 hours

  10–14 days

  Skin and Skin Structure

  400 mg

  every 12 to every 8 hours

  7–14 days

  Bone and Joint

  400 mg

  every 12 to every 8 hours

  4 to 8 weeks

  Complicated Intra-Abdominal†

  400 mg

  every 12 hours

  7–14 days

  Acute Sinusitis

  400 mg

  every 12 hours

  10 days

  Chronic Bacterial prostatitis

  400 mg

  every 12 hours

  28 days

  Empirical Therapy In Febrile Neutropenic Patients

  CIPRO IV

  400 mg

  and

  every 8 hours

  7–14 days

  Piperacillin

  50 mg/kg

  every 4 hours

  Inhalational anthrax(post-exposure)‡

  400 mg

  every 12 hours

  60 days

  Plague‡

  400 mg

  every 12 to 8 hours

  14 days

  Conversion of Intravenous to Oral Dosing in Adults

  Patients whose therapy is started with CIPRO IV may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].

  Table 2:

  CIPRO Oral DEquivalent AUC Dosing Regimensosage

  Equivalent CIPRO IV Dosage

  250 mg Tablet every 12 hours

  200 mg intravenous every 12 hours

  500 mg Tablet every 12 h

  400 mg intravenous every 12 hours

  750 mg Tablet every 12 hours

  400 mg intravenous every 8 hours

  2.2 Dosage in Pediatric Patients

  Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection.

  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

  (mg/kg)

  Frequency

  Total Duration

  Complicated Urinary Tract or Pyelonephritis

  (patients from 1 to 17 years of age)*

  6 mg/kg to 10 mg/kg

  (maximum 400 mg per dose; not to be exceeded even in patients weighing more than 51 kg)

  Every 8 hours

  10–21 days

  Inhalational Anthrax

  (Post-Exposure)†

  10 mg/kg

  (maximum 400 mg per dose)

  Every 12 hours

  60 days

  Plague†, ‡

  10 mg/kg
  (maximum 400 mg per dose)

  Every 12 to 8 hours

  10–21 days

  2.3 Dosage Modifications in Patients with Renal Impairment

  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 Function

  Creatinine Clearance (mL/min)

  Dose

  >30

  See Usual Dosage.

  5–29

  200–400 mg every 18–24 hours

  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 and hepatic insufficiency, careful monitoring is suggested.

  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).

  2.3 Preparation of CIPRO IV for Administration Flexible Containers

  CIPRO IV is available as a 0.2% premixed solution in 5% dextrose in flexible containers of 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described above.

  2.4 Important Administration Instructions Intravenous Infusion

  CIPRO IV should be administered to by intravenous infusion over a period of 60 minutes. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation.

  Hydration of Patients Receiving CIPRO IV

  Adequate hydration of patients receiving CIPRO IV 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), Nonclinical Toxicology (13.2) and Patient Counseling Information (17)].

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