Claforan (Cefotaxime Sodium) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Drug/Laboratory Test Interactions

Cephalosporins, including cefotaxime sodium, are known to occasionally induce a positive direct Coombs' test.

Urinary glucose testing with non-specific reducing agents may yield a false-positive reaction in patients treated with cefotaxime. This phenomenon is not seen when a glucose-oxidase specific method is used.

Carcinogenesis, Mutagenesis

Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. CLAFORAN was not mutagenic in the mouse micronucleus test or in the Ames test. CLAFORAN did not impair fertility to rats when administered subcutaneously at doses up to 250 mg/kg/day (0.2 times the maximum recommended human dose based on mg/m²) or in mice when administered intravenously at doses up to 2000 mg/kg/day (0.7 times the recommended human dose based on mg/m²).

Pregnancy

Teratogenic Effects

Pregnancy Category B: Reproduction studies have been performed in pregnant mice given CLAFORAN intravenously at doses up to 1200 mg/kg/day (0.4 times the recommended human dose based on mg/m²) 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/m²). 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.

Nonteratogenic Effects

Use of the drug in women of child-bearing potential requires that the anticipated benefit be weighed against the possible risks.

In perinatal and postnatal studies with rats, the pups in the group given 1200 mg/kg/day of CLAFORAN were significantly lighter in weight at birth and remained smaller than pups in the control group during the 21 days of nursing.

OVERDOSAGE

The acute toxicity of CLAFORAN 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.

CONTRAINDICATIONS

CLAFORAN is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, any component of CLAFORAN, or the cephalosporin group of antibiotics.

REFERENCES

• 1)Richmond, M. H. and Sykes R. B.: The β-Lactamases of Gram-Negative Bacteria and their Possible Physiological Role, Advances in Microbial Physiology 9:31–88, 1973.
• 2)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.
• 3)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.
• 4)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.
• 5)Cockcroft, D.W. and Gault, M.H.: Prediction of Creatinine Clearance from Serum Creatinine, Nephron 16:31–41, 1976.

Revised September 2008

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

Claforan Injection in Galaxy Containers:

Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

© 2008 sanofi-aventis U.S. LLC