Cefotan (Cefotetan Disodium) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Drug/Laboratory Test Interactions:

The administration of CEFOTAN may result in a false positive reaction for glucose in the urine using Clinitest^®‡, Benedict's solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase be used.

As with other cephalosporins, high concentrations of cefotetan may interfere with measurement of serum and urine creatinine levels by Jaffe´ reaction and produce false increases in the levels of creatinine reported.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Although long-term studies in animals have not been performed to evaluate carcinogenic potential, no mutagenic potential of cefotetan was found in standard laboratory tests.

Cefotetan has adverse effects on the testes of prepubertal rats. Subcutaneous administration of 500 mg/kg/day (approximately 8-16 times the usual adult human dose) on days 6-35 of life (thought to be developmentally analogous to late childhood and prepuberty in humans) resulted in reduced testicular weight and seminiferous tubule degeneration in 10 of 10 animals. Affected cells included spermatogonia and spermatocytes; Sertoli and Leydig cells were unaffected. Incidence and severity of lesions were dose-dependent; at 120 mg/kg/day (approximately 2-4 times the usual human dose) only 1 of 10 treated animals was affected, and the degree of degeneration was mild.

Similar lesions have been observed in experiments of comparable design with other methylthiotetrazole-containing antibiotics and impaired fertility has been reported, particularly at high dose levels. No testicular effects were observed in 7-week-old rats treated with up to 1000 mg/kg/day SC for 5 weeks, or in infant dogs (3 weeks old) that received up to 300 mg/kg/day IV for 5 weeks. The relevance of these findings to humans is unknown.

Pregnancy:

Teratogenic Effects: Pregnancy Category B:

Reproduction studies have been performed in rats and monkeys at doses up to 20 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefotetan. There are, however, no adequate and 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

Information on overdosage with CEFOTAN in humans is not available. If overdosage should occur, it should be treated symptomatically and hemodialysis considered, particularly if renal function is compromised.

CONTRAINDICATIONS

CEFOTAN is contraindicated in patients with a known allergy to the cephalosporin group of antibiotics and in those individuals who have experienced a cephalosporin associated hemolytic anemia.

REFERENCES

1.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.

2.National Committee for Clinical Laboratory Standards. Performance Standards 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, Vol 13, No. 26, NCCLS, Villanova, PA, December 1993.

*Galaxy^® is a registered trademark of Baxter Healthcare Corporation.

†ADD-Vantage is a registered trademark of Abbott Laboratories Inc.

‡Clinitest^® is a registered trademark of Ames Division, Miles Laboratories, Inc.

All other trademarks are the property of the AstraZeneca group of companies.

^© AstraZeneca 2002, 2004

CEFOTAN^® (cefotetan injection) in Galaxy^® plastic container (PL 2040) is manufactured by Baxter Healthcare Corporation, Deerfield, Illinois 60015 USA for AstraZeneca Pharmaceuticals LP.

CEFOTAN^® (cefotetan disodium for injection) is manufactured by GlaxoSmithKline for:

AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

Rev 01/04 SIC 64165-03