Prescribing information Cefotaxime for Injection, USP Rx only 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 bacteria.
DESCRIPTION
CLINICAL PHARMACOLOGY
Microbiology
Susceptibility Tests
| ≤816-32≥64 | Susceptible (S)Intermediate (I)Resistant (R) |
| ≤2 | Susceptible (S) |
| ≤0.51≥2 | Susceptible (S) Intermediate (I) Resistant (R) |
| ≤0.5 | Susceptible (S) |
| Escherichia coli ATCC 25922Staphylococcus aureus ATCC 29213Pseudomonas aeruginosa ATCC 27853Haemophilus influenzaea ATCC 49247Streptococcus pneumoniaeb ATCC 49619 Neisseria gonorrhoeaec ATCC 49226 | 0.06-0.25 1-4 4-16 0.12-0.5 0.06-0.25 0.015-0.06 |
| ≥23 15-22 ≤14 | Susceptible (S) Intermediate (I) Resistant (R) |
| ≥26 | Susceptible (S) |
| ≥2826-27≤25 | Susceptible (S) Intermediate (I) Resistant (R) |
| ≥31 | Susceptible (S) |
| Escherichia coli ATCC 25922 Staphylococcus aureus ATCC 25923 Pseudomonas aeruginosa ATCC 27853 Haemophilus influenzaea ATCC 49247 Neisseria gonorrhoeaeb ATCC 49226 | 29-3525-3118-2231-2938-48 |
| ≤16 32≥64 | Susceptible (S) Intermediate (I) Resistant (R) |
| Bacteroides fragilisaATCC 25285 Bacteroides thetaiotaomicron ATCC 29741 Eubacterium lantem ATCC 43055 | 8-3216-6464-256 |
INDICATIONS AND USAGE
Treatment
- 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*.
Prevention
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
General
Information for Patients
Drug Interactions
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis
Pregnancy Teratogenic Effects Pregnancy Category B:
Nonteratogenic Effects
Nursing Mothers
Pediatric Use
Geriatric Use
ADVERSE REACTIONS
OVERDOSAGE
DOSAGE AND ADMINISTRATION
Adults
| Gonococcal urethritis/cervicitis in males and femalesRectal gonorrhea in femalesRectal gonorrhea in malesUncomplicated infectionsModerate to severe infectionsInfections commonly needing antibiotics in higher dosage (e.g., septicemia)Life-threatening infections | 0.50.5123-66-8up 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 IV2 grams every 6-8 hours IV2 grams every 4 hours IV |
Cesarean Section Patients
Neonates, Infants, and Children
Geriatric Use
Impaired Renal Function
Preparation of Cefotaxime for injection Sterile
| 500 mg vial (IM)1 g vial (IM)2 g vial (IM)500 mg vial (IV)1 g vial (IV)2 g vial (IV) | 235101010 | 2.23.4610.210.411 | 2303003305095180 |
Compatibility and Stability
| 500 mg vial IM1 g vial IM2 g vial IM500 mg vial IV1 g vial IV2 g vial IV | 2303003305095180 | 12 hours12 hours12 hours24 hours24 hours12 hours | 7 days7 days7 days7 days7 days7 days | 5 days5 days5 days5 days5 days5 days |
HOW SUPPLIED
- Richmond, M. H. and Sykes R. B.: The ß-Lactamases of Gram-Negative Bacteria and their Possible Physiological Role, Advances in Microbial Physiology 9:31-88, 1973.
- National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December, 1993.
- National Committee for Clinical Laboratory Standards. Performance Standard for Antimicrobial Disk Susceptibility Tests - Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December, 1993.
- National Committee for Clinical Laboratory Standards. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria - Third Edition. Approved Standard NCCLS Document M11-A3, NCCLS, Villanova, PA, December, 1993.
- Cockcroft, D.W. and Gault, M.H.: Prediction of Creatinine Clearance from Serum Creatinine, Nephron 16:31-41, 1976.