Cefotaxime sodium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]
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Overview
Cefotaxime sodium is a 3rd Generation Cephalosporin that is FDA approved for the treatment of lower respiratory tract infections, genitourinary infections, gynecologic infections, bacteremia/septicemia, skin and skin structure infections, intra-abdominal infections, bone and/or joint infections and central nervous system infections. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Cefotaxime for Injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.
Lower respiratory tract infections
- Inncluding 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
- Pseudomonas species (including P. aeruginosa).
Uncomplicated gonorrhea (cervical/urethral and rectal)
- Caused by:
- Neisseria gonorrhoeae, including penicillinase producing strains.
Gynecologic infections
Including:
- Pelvic inflammatory disease
- Endometritis
- 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
- Anaerobic cocci (including Peptostreptococcus species and Peptococcus species)
- Fusobacterium species (including F. nucleatum)
- Cefotaxime for Injection, USP, 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
- Serratia marcescens
- Staphylococcus aureus
- Streptococcus species (including S. pneumoniae).
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
- Anaerobic cocci (including Peptostreptococcus species and Peptococcus species).
Intra-abdominal infections
Including:
- Peritonitis:
Caused by:
- Streptococcus species
- Escherichia coli
- Klebsiella species
- Bacteroides species
- Anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species)
- Proteus mirabilis
- 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)
- Proteus mirabilis
Central nervous system infections
- Meningitis
- Ventriculitis
Caused by:
- Neisseria meningitidis
- Haemophilus influenzae
- Streptococcus pneumoniae
- Klebsiella pneumoniae
- Escherichia coli
Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, Cefotaxime for Injection, USP 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 for Injection, USP 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 for Injection, USP is used concomitantly with an aminoglycoside.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cefotaxime sodium in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefotaxime sodium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Cefotaxime sodium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cefotaxime sodium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefotaxime sodium in pediatric patients.
Contraindications
There is limited information regarding Cefotaxime sodium Contraindications in the drug label.
Warnings
There is limited information regarding Cefotaxime sodium Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Cefotaxime sodium Clinical Trials Experience in the drug label.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of cefotaxime. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular System
Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.
Central Nervous System
Administration of high doses of beta-lactam antibiotics, including cefotaxime, particularly in patients with renal insufficiency may result in encephalopathy (e.g. impairment of consciousness, abnormal movements and convulsions).
Cutaneous
As with other cephalosporins, isolated cases of:
- Toxic epidermal necrolysis
- Stevens-Johnson syndrome
- Erythema multiforme
Hematologic System
- Hemolytic anemia
- Agranulocytosis
- Thrombocytopenia
Hypersensitivity
- Anaphylaxis (e.g., angioedema, bronchospasm, malaise possibly culminating in shock)
- Urticaria
Kidney
- Interstitial nephritis
- Transient elevations of creatinine.
Liver
- Hepatitis
- Jaundice
- Cholestasis
- Elevations of gamma GT and bilirubin.
Cephalosporin Class Labeling
In addition to the adverse reactions listed above which have been observed in patients treated with cefotaxime sodium, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: allergic reactions, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and false-positive test for urinary glucose. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
Drug Interactions
There is limited information regarding Cefotaxime sodium Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Cefotaxime sodium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefotaxime sodium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Cefotaxime sodium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Cefotaxime sodium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Cefotaxime sodium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Cefotaxime sodium in geriatric settings.
Gender
There is no FDA guidance on the use of Cefotaxime sodium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Cefotaxime sodium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Cefotaxime sodium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Cefotaxime sodium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cefotaxime sodium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Cefotaxime sodium in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Cefotaxime sodium Administration in the drug label.
Monitoring
There is limited information regarding Cefotaxime sodium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Cefotaxime sodium and IV administrations.
Overdosage
- The acute toxicity of cefotaxime was evaluated in neonatal and adult mice and rats.
- Significant mortality was seen at parenteral doses in excess of 6000 mg/kg/day in all groups.
- Common toxic signs in animals that died were a decrease in spontaneous activity, tonic and clonic convulsions, dyspnea, hypothermia, and cyanosis. *Cefotaxime sodium overdosage has occurred in patients.
- Most cases have shown no overt toxicity.
- The most frequent reactions were elevations of BUN and creatinine.
- There is a risk of reversible encephalopathy in cases of administration of high doses of beta-lactam antibiotics including cefotaxime.
- No specific antidote exists.
- Patients who receive an acute overdosage should be carefully observed and given supportive treatment.
Pharmacology
There is limited information regarding Cefotaxime sodium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Cefotaxime sodium Mechanism of Action in the drug label.
Structure
There is limited information regarding Cefotaxime sodium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Cefotaxime sodium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Cefotaxime sodium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Cefotaxime sodium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Cefotaxime sodium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Cefotaxime sodium How Supplied in the drug label.
Storage
There is limited information regarding Cefotaxime sodium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Cefotaxime sodium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Cefotaxime sodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Cefotaxime sodium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Cefotaxime sodium Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.