Cefotaxime sodium

Cefotaxime sodium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Cefotaxime is generally well tolerated. The most common adverse reactions have been local reactions following IM or IV injection. Other adverse reactions have been encountered infrequently.

The most frequent adverse reactions (greater than 1%) are:

Local (4.3%)

• Injection site inflammation with IV administration
• Pain
• Induration
• Tenderness after IM injection

Hypersensitivity (2.4%)

• Rash
• Pruritus
• Fever
• Eosinophilia

Gastrointestinal (1.4%)

• Colitis
• Diarrhea
• Nausea, and vomiting (have been reported rarely.)
• Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.

Less frequent adverse reactions (less than 1%) are:

Hematologic System

• Neutropenia
• Transient leukopenia
• Some individuals have developed positive direct Coombs Tests during treatment with cefotaxime and other cephalosporin antibiotics.

Genitourinary System

• Moniliasis
• Vaginitis

Central Nervous System

• Headache

Liver

Transient elevations in:

• AST
• ALT
• Serum LDH
• Serum alkaline phosphatase

Kidney

• As with some other cephalosporins, transient elevations of BUN have been occasionally observed with cefotaxime.

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.