CEFOTAN (Page 4 of 6)

Drug Interactions:

Increases in serum creatinine have occurred when CEFOTAN was given alone. If CEFOTAN and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.

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.

Nursing Mothers:

Cefotetan is excreted in human milk in very low concentrations. Caution should be exercised when cefotetan is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children have not been established.

Geriatric Use:

Of the 925 subjects who received cefotetan in clinical studies, 492 (53%) were 60 years and older, while 76 (8%) were 80 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See DOSAGE AND ADMINISTRATION− Impaired Renal Function).

ADVERSE REACTIONS

In clinical studies, the following adverse effects were considered related to CEFOTAN therapy. Those appearing in italics have been reported during postmarketing experience.

Gastrointestinal:

Symptoms occurred in 1.5% of patients, the most frequent were diarrhea (1 in 80) and nausea (1 in 700); pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment or surgical prophylaxis. (See WARNINGS.)

Hematologic:

Laboratory abnormalities occurred in 1.4% of patients and included eosinophilia (1 in 200), positive direct Coombs’ test (1 in 250), and thrombocytosis (1 in 300); agranulocytosis, hemolytic anemia, leukopenia, thrombocytopenia, and prolonged prothrombin time with or without bleeding.

Hepatic:

Enzyme elevations occurred in 1.2% of patients and included a rise in ALT (SGPT) (1 in 150), AST (SGOT) (1 in 300), alkaline phosphatase (1 in 700), and LDH (1 in 700).

Hypersensitivity:

Reactions were reported in 1.2% of patients and included rash (1 in 150) and itching (1 in 700); anaphylactic reactions and urticaria.

Local:

Effects were reported in less than 1% of patients and included phlebitis at the site of injection (1 in 300), and discomfort (1 in 500).

Renal:

Elevations in BUN and serum creatinine have been reported.

Urogenital:

Nephrotoxicity has rarely been reported.

Miscellaneous:

Fever

In addition to the adverse reactions listed above which have been observed in patients treated with cefotetan, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: pruritus, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, vomiting, abdominal pain, colitis, superinfection, vaginitis including vaginal candidiasis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, elevated bilirubin, pancytopenia, and neutropenia.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. (See DOSAGE AND ADMINISTRATIONand OVERDOSAGE.) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

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.

DOSAGE AND ADMINISTRATION

Treatment

Cefotetan injection in Galaxy ® plastic container should not be used for intramuscular administration.

CEFOTAN in the ADD-Vantage Vial is intended for intravenous infusion only, after dilution with the appropriate volume of ADD-Vantage diluent solution.

The usual adult dosage is 1 or 2 grams of CEFOTAN (cefotetan disodium for injection) administered intravenously or intramuscularly or CEFOTAN (cefotetan injection) in the Galaxy® plastic container (PL 2040) administered intravenously every 12 hours for 5 to 10 days. Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organism.

General Guidelines for Dosage of CEFOTAN

Type of Infection

Daily Dose

Frequency and Route

*
Klebsiella pneumoniae skin and skin structure infections should be treated with 1 or 2 grams every 12 hours IV or IM.
Maximum daily dosage should not exceed 6 grams.

Urinary Tract

1-4 grams

500 mg every 12 hours IV or IM

1 or 2 g every 24 hours IV or IM

1 or 2 g every 12 hours IV or IM

Skin & Skin Structure

Mild — Moderate *

2 grams

2 g every 24 hours IV

1 g every 12 hours IV or IM

Severe

4 grams

2 g every 12 hours IV

Other Sites

2 — 4 grams

1 or 2 g every 12 hours IV or IM

Severe

4 grams

2 g every 12 hours IV

Life-Threatening

6 grams

3 g every 12 hours IV

If Chlamydia trachomatis is a suspected pathogen in gynecologic infections, appropriate antichlamydial coverage should be added, since cefotetan has no activity against this organism.

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