pharmacopeia
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/api/v1/drug/cefotaxime

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Enzyme Inhibitors.

Enzyme

Indications

Sourced from openFDA
  • Treatment 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. (1) 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.ICD-10: J18.9

Contraindications

Sourced from openFDA
  • Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, or the cephalosporin group of antibiotics.contraindicated

Dosage & administration

Sourced from openFDA

Adults Dosage 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 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 Patients The 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.

Warnings & precautions

Sourced from openFDA

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 cefotaxime, 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.

Adverse reactions

Sourced from openFDA

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, and tenderness after IM injection. Hypersensitivity (2.4%) - Rash, pruritus, fever, eosinophilia. Gastrointestinal (1.4%) - Colitis, diarrhea, nausea, and vomiting. Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment. Nausea and vomiting have been reported rarely. Less frequent adverse reactions (less than 1%) are: Hematologic System - Neutropenia, leukopenia, have been reported. 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, and serum alkaline phosphatase levels have been reported. Kidney - As with some other cephalosporins, transient elevations of BUN have been occasionally observed with cefotaxime. Post-Marketing 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.

Use in specific populations

Sourced from openFDA

Pregnancy: Teratogenic Effects Reproduction studies have been performed in pregnant mice given cefotaxime intravenously at doses up to 1200 mg/kg/day (0.4 times the recommended human dose based on mg/m 2 ) or in pregnant rats when administered intravenously at doses up to 1200 mg/kg/day (0.8 times the recommended human dose based on mg/m 2 ). No evidence of embryotoxicity or teratogenicity was seen in these studies. Although cefotaxime has been reported to cross the placental barrier and appear in cord blood, the effect on the human fetus is not known. There are no well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Nov 20, 2002ANDAANDA065071Hikma
  • Nov 20, 2002ANDAANDA065072Hikma

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Cefotaxime Sodium, Powder, for Solution, 1 g (NDC 0143-9931-25)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Demand increase for the drug
    Updated
  • Cefotaxime Sodium, Powder, for Solution, 10 g (NDC 0143-9935-01)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Demand increase for the drug
    Updated
  • Cefotaxime Sodium, Powder, for Solution, 2 g (NDC 0143-9933-25)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Demand increase for the drug
    Updated
  • Cefotaxime Sodium, Powder, for Solution, 500 mg (NDC 0143-9930-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Demand increase for the drug
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,244 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective3638.6%
  2. 2Off Label Use3277.7%
  3. 3Pyrexia2796.6%
  4. 4Drug Reaction With Eosinophilia And Systemic Symptoms2415.7%
  5. 5Acute Kidney Injury1934.5%
  6. 6Thrombocytopenia1493.5%
  7. 7Neutropenia1473.5%
  8. 8Condition Aggravated1353.2%
  9. 9Sepsis1283.0%
  10. 10Toxic Epidermal Necrolysis1273.0%
  11. 11Diarrhoea1252.9%
  12. 12Anaemia1182.8%
  13. 13Rash1182.8%
  14. 14Rash Maculo-papular1142.7%
  15. 15Hepatocellular Injury1122.6%

Literature

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Recent PubMed references pinned to Cefotaxime as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 240 ClinicalTrials.gov registrations naming Cefotaxime as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Cefotaxime work?
Mechanism-of-action class: Enzyme Inhibitors.
What is Cefotaxime used for?
According to FDA labeling, Cefotaxime carries indications including: Treatment 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. (1) 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cefotaxime?
Cefotaxime is classified as Third-generation cephalosporins, Cephalosporin Antibacterial, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair.
What are the brand names for Cefotaxime?
Cefotaxime is marketed under brand names including Claforan.
What are the contraindications for Cefotaxime?
Cefotaxime labeling lists contraindications including: Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, or the cephalosporin group of antibiotics.. Always consult the full prescribing information and a clinician.
Note. Data for cefotaxime is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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