Cefotaxime
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Side Effects & Adverse Reactions
BEFORE THERAPY WITH CEFOTAXIME IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOTAXIME SODIUM, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PATIENTS WITH TYPE I HYPERSENSITIVITY REACTIONS TO PENICILLIN. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO CEFOTAXIME OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.
During post-marketing surveillance, a potentially life-threatening arrhythmia was reported in each of six patients who received a rapid (less than 60 seconds) bolus injection of cefotaxime through a central venous catheter. Therefore, cefotaxime should only be administered as instructed in the
DOSAGE AND ADMINISTRATION section.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefotaxim, 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.
Legal Issues
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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
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime for injection and other antibacterial drugs, cefotaxime for injection 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.
- Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa).
- Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae , including penicillinase producing sjtrains.
- Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. Nucleatum*). Cefotaxime, like other cephalosporins, has no activity against Chlamydia trachomatis.
Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. - Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus andStreptococcus species (including S. pneumonia).
- Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing),Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species).
- Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*.
- Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*.
- Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*.
Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, Cefotaxime has been used successfully in treating patients with infections caused by susceptible organisms.
Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to Cefotaxime. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.
In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, Cefotaxime may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if Cefotaxime is used concomitantly with an aminoglycoside.
(*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections.
In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of Cefotaxime may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section.
Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, Cefotaxime should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section.
For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended.
If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime and other antibacterial drugs, cefotaxime 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.
- Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa).
- Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae , including penicillinase producing sjtrains.
- Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. Nucleatum*). Cefotaxime, like other cephalosporins, has no activity against Chlamydia trachomatis.
Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. - Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus andStreptococcus species (including S. pneumonia).
- Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing),Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species).
- Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*.
- Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*.
- Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*.
Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, Cefotaxime has been used successfully in treating patients with infections caused by susceptible organisms.
Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to Cefotaxime. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.
In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, Cefotaxime may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if Cefotaxime is used concomitantly with an aminoglycoside.
(*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. PreventionThe administration of Cefotaxime preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated.
In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of Cefotaxime may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section.
Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, Cefotaxime should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section.
For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a non-absorbable antibiotic (e.g., neomycin) is recommended.
If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefotaxime and other antibacterial drugs, cefotaxime 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
Cefotaxime for injection is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 7
2 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of Cefotaxime for injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5.
The molecular formula is C 16H 16N 5NaO 7S 2 and the molecular weight is 477.45
Cefotaxime for injection, USP is supplied as a dry powder in conventional vials.
Sources
Cefotaxime Manufacturers
-
Wockhardt Usa Llc.
![Cefotaxime Injection, Powder, For Solution [Wockhardt Usa Llc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cefotaxime | Wockhardt Usa Llc.
AdultsDosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime for injection may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.
GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION Type of Infection
Daily Dose grams)
Frequency and Route Gonococcal urethritis/cervicitis in males and females
Rectal gonorrhea in females
Rectal gonorrhea in males
Uncomplicated infections
Moderate to severe infections
Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
Life-threatening infections 0.5
0.5
1
2
3-6
6-8
up to 12
0.5 gram IM (single dose)
0.5 gram IM (single dose)
1 gram IM (single dose)
1 gram every 12 hours IM or IV
1-2 grams every 8 hours IM or IV
2 grams every 6-8 hours IV
2 grams every 4 hours IV
If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism.
To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery. Cesarean Section PatientsThe first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose. Neonates, Infants, and ChildrenThe following dosage schedule is recommended:
Neonates (birth to 1 month):
0-1 week of age 50 mg/kg per dose every 12 hours IV
1-4 weeks of age 50 mg/kg per dose every 8 hours IV
It is not necessary to differentiate between premature and normal-gestational age infants.
Infants and Children (1 month to 12 years):
For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams. Geriatric UseThis drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See P RECAUTIONS, General and PRECAUTIONS, Geriatric Use.) Impaired Renal Functionsee PRECAUTIONS, General.
NOTE: As with antibiotic therapy in general, administration of Cefotaxime for injection should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used. Preparation of Cefotaxime for injection SterileCefotaxime for injection for IM or IV administration should be reconstituted as follows:
Strength Diluent
(mL)
Withdrawable Volume
(mL) Approximate Concentration
(mg/mL) 500 mg vial (IM)
1 g vial (IM)
2 g vial (IM)
500 mg vial (IV)
1 g vial (IV)
2 g vial (IV) 2
3
5
10
10
10
2.2
3.4
6
10.2
10.4
11
230
300
330
50
95
180
Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of Cefotaxime for injection range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
For intramuscular use: Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.
For intravenous use: Reconstitute VIALS with at least 10 mL of Sterile Water for Injection.
NOTE: Solutions of Cefotaxime for injection must not be admixed with aminoglycoside solutions. If Cefotaxime for injection and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.
A SOLUTION OF 1 G CEFOTAXIME FOR INJECTION IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.
IM Administration: As with all IM preparations, Cefotaxime for injection should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.
IV Administration: The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Cefotaxime for injection, it is advisable to discontinue temporarily the administration of other solutions at the same site.
For the administration of higher doses by continuous IV infusion, a solution cefotaxime may be added to IV bottles containing the solutions discussed below.
Compatibility and StabilitySolutions of Cefotaxime for injection reconstituted as described above (Preparation of Cefotaxime for injection) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:
Strength
Reconstituted Concentration mg/mL
Stability at or below 220C
Stability under Refrigeration (at or below 50C)
Original Containers
Plastic Syringes
500 mg vial IM
1 g vial IM
2 g vial IM
500 mg vial IV
1 g vial IV
2 g vial IV 230
300
330
50
95
180
12 hours
12 hours
12 hours
24 hours
24 hours
12 hours
7 days
7 days
7 days
7 days
7 days
7 days
5 days
5 days
5 days
5 days
5 days
5 days
Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.
Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22 0C, and at least 5 days under refrigeration (at or below 5 0C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL ® (Amino Acid) Injection without Electrolytes.
NOTE: Cefotaxime for injection solutions exhibit maximum stability in the pH 5-7 range. Solutions of Cefotaxime for injection should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. AdultsDosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime for injection may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.
GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION Type of Infection
Daily Dose grams)
Frequency and Route Gonococcal urethritis/cervicitis in males and females
Rectal gonorrhea in females
Rectal gonorrhea in males
Uncomplicated infections
Moderate to severe infections
Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
Life-threatening infections 0.5
0.5
1
2
3-6
6-8
up to 12
0.5 gram IM (single dose)
0.5 gram IM (single dose)
1 gram IM (single dose)
1 gram every 12 hours IM or IV
1-2 grams every 8 hours IM or IV
2 grams every 6-8 hours IV
2 grams every 4 hours IV
If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism.
To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery. Cesarean Section PatientsThe first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose. Neonates, Infants, and ChildrenThe following dosage schedule is recommended:
Neonates (birth to 1 month):
0-1 week of age 50 mg/kg per dose every 12 hours IV
1-4 weeks of age 50 mg/kg per dose every 8 hours IV
It is not necessary to differentiate between premature and normal-gestational age infants.
Infants and Children (1 month to 12 years):
For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams. Geriatric UseThis drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See P RECAUTIONS, General and PRECAUTIONS, Geriatric Use.) Impaired Renal Functionsee PRECAUTIONS, General.
NOTE: As with antibiotic therapy in general, administration of Cefotaxime for injection should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used. Preparation of Cefotaxime for injection SterileCefotaxime for injection for IM or IV administration should be reconstituted as follows:
Strength Diluent
(mL)
Withdrawable Volume
(mL) Approximate Concentration
(mg/mL) 500 mg vial (IM)
1 g vial (IM)
2 g vial (IM)
500 mg vial (IV)
1 g vial (IV)
2 g vial (IV) 2
3
5
10
10
10
2.2
3.4
6
10.2
10.4
11
230
300
330
50
95
180
Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of Cefotaxime for injection range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
For intramuscular use: Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.
For intravenous use: Reconstitute VIALS with at least 10 mL of Sterile Water for Injection.
NOTE: Solutions of Cefotaxime for injection must not be admixed with aminoglycoside solutions. If Cefotaxime for injection and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.
A SOLUTION OF 1 G CEFOTAXIME FOR INJECTION IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.
IM Administration: As with all IM preparations, Cefotaxime for injection should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.
IV Administration: The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Cefotaxime for injection, it is advisable to discontinue temporarily the administration of other solutions at the same site.
For the administration of higher doses by continuous IV infusion, a solution cefotaxime may be added to IV bottles containing the solutions discussed below.
Compatibility and StabilitySolutions of Cefotaxime for injection reconstituted as described above (Preparation of Cefotaxime for injection) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:
Strength
Reconstituted Concentration mg/mL
Stability at or below 220C
Stability under Refrigeration (at or below 50C)
Original Containers
Plastic Syringes
500 mg vial IM
1 g vial IM
2 g vial IM
500 mg vial IV
1 g vial IV
2 g vial IV 230
300
330
50
95
180
12 hours
12 hours
12 hours
24 hours
24 hours
12 hours
7 days
7 days
7 days
7 days
7 days
7 days
5 days
5 days
5 days
5 days
5 days
5 days
Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.
Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22 0C, and at least 5 days under refrigeration (at or below 5 0C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL ® (Amino Acid) Injection without Electrolytes.
NOTE: Cefotaxime for injection solutions exhibit maximum stability in the pH 5-7 range. Solutions of Cefotaxime for injection should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. -
Wockhardt Limited
Cefotaxime | Wockhardt Limited
AdultsDosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime for injection may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.
GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION Type of Infection
Daily Dose grams)
Frequency and Route Gonococcal urethritis/cervicitis in males and females
Rectal gonorrhea in females
Rectal gonorrhea in males
Uncomplicated infections
Moderate to severe infections
Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
Life-threatening infections 0.5
0.5
1
2
3-6
6-8
up to 12
0.5 gram IM (single dose)
0.5 gram IM (single dose)
1 gram IM (single dose)
1 gram every 12 hours IM or IV
1-2 grams every 8 hours IM or IV
2 grams every 6-8 hours IV
2 grams every 4 hours IV
If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism.
To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery. Cesarean Section PatientsThe first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose. Neonates, Infants, and ChildrenThe following dosage schedule is recommended:
Neonates (birth to 1 month):
0-1 week of age 50 mg/kg per dose every 12 hours IV
1-4 weeks of age 50 mg/kg per dose every 8 hours IV
It is not necessary to differentiate between premature and normal-gestational age infants.
Infants and Children (1 month to 12 years):
For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams. Geriatric UseThis drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See P RECAUTIONS, General and PRECAUTIONS, Geriatric Use.) Impaired Renal Functionsee PRECAUTIONS, General.
NOTE: As with antibiotic therapy in general, administration of Cefotaxime for injection should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used. Preparation of Cefotaxime for injection SterileCefotaxime for injection for IM or IV administration should be reconstituted as follows:
Strength Diluent
(mL)
Withdrawable Volume
(mL) Approximate Concentration
(mg/mL) 500 mg vial (IM)
1 g vial (IM)
2 g vial (IM)
500 mg vial (IV)
1 g vial (IV)
2 g vial (IV) 2
3
5
10
10
10
2.2
3.4
6
10.2
10.4
11
230
300
330
50
95
180
Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of Cefotaxime for injection range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
For intramuscular use: Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.
For intravenous use: Reconstitute VIALS with at least 10 mL of Sterile Water for Injection.
NOTE: Solutions of Cefotaxime for injection must not be admixed with aminoglycoside solutions. If Cefotaxime for injection and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.
A SOLUTION OF 1 G CEFOTAXIME FOR INJECTION IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.
IM Administration: As with all IM preparations, Cefotaxime for injection should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.
IV Administration: The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Cefotaxime for injection, it is advisable to discontinue temporarily the administration of other solutions at the same site.
For the administration of higher doses by continuous IV infusion, a solution cefotaxime may be added to IV bottles containing the solutions discussed below.
Compatibility and StabilitySolutions of Cefotaxime for injection reconstituted as described above (Preparation of Cefotaxime for injection) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:
Strength
Reconstituted Concentration mg/mL
Stability at or below 220C
Stability under Refrigeration (at or below 50C)
Original Containers
Plastic Syringes
500 mg vial IM
1 g vial IM
2 g vial IM
500 mg vial IV
1 g vial IV
2 g vial IV 230
300
330
50
95
180
12 hours
12 hours
12 hours
24 hours
24 hours
12 hours
7 days
7 days
7 days
7 days
7 days
7 days
5 days
5 days
5 days
5 days
5 days
5 days
Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.
Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22 0C, and at least 5 days under refrigeration (at or below 5 0C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL ® (Amino Acid) Injection without Electrolytes.
NOTE: Cefotaxime for injection solutions exhibit maximum stability in the pH 5-7 range. Solutions of Cefotaxime for injection should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. AdultsDosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime for injection may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.
GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION Type of Infection
Daily Dose grams)
Frequency and Route Gonococcal urethritis/cervicitis in males and females
Rectal gonorrhea in females
Rectal gonorrhea in males
Uncomplicated infections
Moderate to severe infections
Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
Life-threatening infections 0.5
0.5
1
2
3-6
6-8
up to 12
0.5 gram IM (single dose)
0.5 gram IM (single dose)
1 gram IM (single dose)
1 gram every 12 hours IM or IV
1-2 grams every 8 hours IM or IV
2 grams every 6-8 hours IV
2 grams every 4 hours IV
If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism.
To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery. Cesarean Section PatientsThe first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose. Neonates, Infants, and ChildrenThe following dosage schedule is recommended:
Neonates (birth to 1 month):
0-1 week of age 50 mg/kg per dose every 12 hours IV
1-4 weeks of age 50 mg/kg per dose every 8 hours IV
It is not necessary to differentiate between premature and normal-gestational age infants.
Infants and Children (1 month to 12 years):
For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams. Geriatric UseThis drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See P RECAUTIONS, General and PRECAUTIONS, Geriatric Use.) Impaired Renal Functionsee PRECAUTIONS, General.
NOTE: As with antibiotic therapy in general, administration of Cefotaxime for injection should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used. Preparation of Cefotaxime for injection SterileCefotaxime for injection for IM or IV administration should be reconstituted as follows:
Strength Diluent
(mL)
Withdrawable Volume
(mL) Approximate Concentration
(mg/mL) 500 mg vial (IM)
1 g vial (IM)
2 g vial (IM)
500 mg vial (IV)
1 g vial (IV)
2 g vial (IV) 2
3
5
10
10
10
2.2
3.4
6
10.2
10.4
11
230
300
330
50
95
180
Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of Cefotaxime for injection range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
For intramuscular use: Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.
For intravenous use: Reconstitute VIALS with at least 10 mL of Sterile Water for Injection.
NOTE: Solutions of Cefotaxime for injection must not be admixed with aminoglycoside solutions. If Cefotaxime for injection and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.
A SOLUTION OF 1 G CEFOTAXIME FOR INJECTION IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.
IM Administration: As with all IM preparations, Cefotaxime for injection should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.
IV Administration: The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing Cefotaxime for injection, it is advisable to discontinue temporarily the administration of other solutions at the same site.
For the administration of higher doses by continuous IV infusion, a solution cefotaxime may be added to IV bottles containing the solutions discussed below.
Compatibility and StabilitySolutions of Cefotaxime for injection reconstituted as described above (Preparation of Cefotaxime for injection) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:
Strength
Reconstituted Concentration mg/mL
Stability at or below 220C
Stability under Refrigeration (at or below 50C)
Original Containers
Plastic Syringes
500 mg vial IM
1 g vial IM
2 g vial IM
500 mg vial IV
1 g vial IV
2 g vial IV 230
300
330
50
95
180
12 hours
12 hours
12 hours
24 hours
24 hours
12 hours
7 days
7 days
7 days
7 days
7 days
7 days
5 days
5 days
5 days
5 days
5 days
5 days
Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.
Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22 0C, and at least 5 days under refrigeration (at or below 5 0C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL ® (Amino Acid) Injection without Electrolytes.
NOTE: Cefotaxime for injection solutions exhibit maximum stability in the pH 5-7 range. Solutions of Cefotaxime for injection should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. -
West-ward Pharmaceutical Corp
Cefotaxime | West-ward Pharmaceutical Corp
AdultsDosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.
GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION Type of Infection Daily Dose (grams) Frequency and Route Gonococcal urethritis/cervicitis in males and females 0.5 0.5 gram IM (single dose) Rectal gonorrhea in females 0.5 0.5 gram IM (single dose) Rectal gonorrhea in males 1 1 gram IM (single dose) Uncomplicated infections 2 1 gram every 12 hours IM or IV Moderate to severe infections 3-6 1-2 grams every 8 hours IM or IV Infections commonly needing antibiotics in higher dosage (e.g., septicemia) 6-8 2 grams every 6-8 hours IV Life-threatening infections up to 12 2 grams every 4 hours IVIf C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism.
To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery.
Cesarean Section PatientsThe first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose.
Neonates, Infants, and ChildrenThe following dosage schedule is recommended:
Neonates (birth to 1 month):
0-1 week of age 50 mg/kg per dose every 12 hours IV
1-4 weeks of age 50 mg/kg per dose every 8 hours IVIt is not necessary to differentiate between premature and normal-gestational age infants.
Infants and Children (1 month to 12 years):
Geriatric Use
For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.)
Impaired Renal FunctionSee PRECAUTIONS, General.
NOTE: As with antibiotic therapy in general, administration of cefotaxime should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used.
Preparation of cefotaxime for injection sterileCefotaxime for IM or IV administration should be reconstituted as follows:
StrengthDiluent
(mL)Withdrawable Volume
(mL)Approximate Concentration
500 mg vial* (IM) 2 2.2 230 1 g vial* (IM) 3 3.4 300 2 g vial* (IM) 5 6.0 330 500 mg vial* (IV) 10 10.2 50 1 g vial* (IV) 10 10.4 95 2 g vial* (IV) 10 11.0 180 1 g infusion 50-100 50-100 20-10 2 g infusion 50-100 50-100 40-20
(mg/mL)(*) in conventional vials
Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of cefotaxime range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
For intramuscular use: Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.
For intravenous use: Reconstitute VIALS with at least 10 mL of Sterile Water for Injection. Reconstitute INFUSION BOTTLES with 50 or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection. For other diluents, see COMPATIBILITY AND STABILITY section.
NOTE: Solutions of cefotaxime must not be admixed with aminoglycoside solutions. If cefotaxime and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.
A SOLUTION OF 1 G CEFOTAXIME IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.
IM Administration: As with all IM preparations, cefotaxime should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.
IV Administration: The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing cefotaxime, it is advisable to discontinue temporarily the administration of other solutions at the same site.
For the administration of higher doses by continuous IV infusion, a solution of cefotaxime may be added to IV bottles containing the solutions discussed below.
Compatibility and StabilitySolutions of cefotaxime reconstituted as described above (Preparation of cefotaxime for injection sterile) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:
StrengthReconstituted
Concentration
mg/mLStability at or
below 22ºCStability under
Original Containers Plastic Syringes 500 mg vial IM 230 12 hours 7 days 5 days 1 g vial IM 300 12 hours 7 days 5 days 2 g vial IM 330 12 hours 7 days 5 days 500 mg vial IV 50 24 hours 7 days 5 days 1 g vial IV 95 24 hours 7 days 5 days 2 g vial IV 180 12 hours 7 days 5 days 1 g infusion bottle 10-20 24 hours 10 days — 2 g infusion bottle 20-40 24 hours 10 days —
Refrigeration
(at or below 5ºC)Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.
Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22°C, and at least 5 days under refrigeration (at or below 5°C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL® (Amino Acid) Injection without Electrolytes.
NOTE: Cefotaxime solutions exhibit maximum stability in the pH 5-7 range. Solutions of cefotaxime should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
West-ward Pharmaceutical Corp
Cefotaxime | West-ward Pharmaceutical Corp
The intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only. Dosing references to the intramuscular route of administration are for informational purposes only.
AdultsDosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.
GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION Type of Infection Daily Dose
(grams) Frequency and Route Gonococcal urethritis/cervicitis in males and females 0.5 0.5 gram IM (single dose) Rectal gonorrhea in females 0.5 0.5 gram IM (single dose) Rectal gonorrhea in males 1 1 gram IM (single dose) Uncomplicated infections 2 1 gram every 12 hours IM or IV Moderate to severe infections 3-6 1-2 grams every 8 hours IM or IV Infections commonly needing antibiotics in higher dosage (e.g., septicemia) 6-8 2 grams every 6-8 hours IV Life-threatening infections up to 12 2 grams every 4 hours IVIf C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism.
To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery.
Cesarean Section PatientsThe first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose.
Neonates, Infants, and ChildrenThe following dosage schedule is recommended:
Neonates (birth to 1 month):
0-1 week of age 50 mg/kg per dose every 12 hours IV
1-4 weeks of age 50 mg/kg per dose every 8 hours IV
It is not necessary to differentiate between premature and normal-gestational age infants.
Infants and Children (1 month to 12 years):
For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.
Geriatric UseThis drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.)
Impaired Renal FunctionSee PRECAUTIONS, General.
NOTE: As with antibiotic therapy in general, administration of cefotaxime should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used.
DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE:The 10 gram Pharmacy Bulk Package should be penetrated ONLY ONE TIME utilizing a suitable sterile transfer device or dispensing set and should be reconstituted with 47 mL of diluent for an approximate concentration of 200 mg/mL (withdrawable volume 52 mL) or 97 mL of diluent for an approximate concentration of 100 mg/mL withdrawable volume 102 mL), in a suitable work area such as a laminar flow hood, using aseptic technique. Shake to dissolve; inspect for particulate matter and discoloration prior to use. Stock solutions may be further diluted for IV infusion with diluents as listed in COMPATIBILITY AND STABILITY section. The reconstituted content of the 10 g Pharmacy Bulk Package should be withdrawn immediately, using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. However, if it is not possible, aliquoting operations must be completed within four hours of reconstitution. Discard the reconstituted stock solution 4 hours after initial entry. Solutions of cefotaxime range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
Reconstituted Bulk Solutions Should Not Be Used For Direct Infusion
NOTE: Solutions of cefotaxime must not be admixed with aminoglycoside solutions. If cefotaxime and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.
A SOLUTION OF 1 G CEFOTAXIME IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.
IM Administration: As with all IM preparations, cefotaxime should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.
IV Administration: The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing cefotaxime, it is advisable to discontinue temporarily the administration of other solutions at the same site.
For the administration of higher doses by continuous IV infusion, a solution of cefotaxime may be added to IV bottles containing the solutions discussed below.
COMPATIBILITY AND STABILITYSolutions of cefotaxime reconstituted as described above (DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE) should be discarded 4 hours after initial entry.
Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22°C, and at least 5 days under refrigeration (at or below 5°C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer’s Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL® (Amino Acid) Injection without Electrolytes.
NOTE: Cefotaxime solutions exhibit maximum stability in the pH 5-7 range. Solutions of cefotaxime should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
![Cefotaxime Injection, Powder, For Solution [Wockhardt Limited]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7&name=CefotaximeInjection_2g_10sCarton.jpg)
![Cefotaxime Injection, Powder, For Solution [West-ward Pharmaceutical Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ed23b6bc-32c7-4c50-a53d-313ae78e5623&name=cefotaxime-for-injection-2.jpg)
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