Cefotan (Page 4 of 6)

Pregnancy

Teratogenic Effects.
Pregnancy Category B

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Reproduction studies have been performed in rats and monkeys at doses of up to 2000 and 600 mg/kg/day, or 3 and 2 times the maximum recommended human dose on a body surface area basis. and have revealed no evidence of impaired fertility or harm to the fetus due to cefotetan.

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 pediatric patients 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, andprolonged 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 ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

To report SUSPECTED ADVERSE REACTIONS , contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

The usual adult dosage is 1 gram (g) or 2 grams of CEFOTAN^® (cefotetan for Injection, USP) administered intravenously or intramuscularly. 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® (cefotetan for Injection, USP)
Type of Infection	Daily Dose	Frequency and Route
Urinary Tract	1 g to 4 g	500 mg every 12 hours intravenous or intramuscular1 or 2 g every 24 hours intravenous or intramuscular1 or 2 g every 12 hours intravenous or intramuscular
Skin & Skin Structure Mild — Moderatea
	2 g	2 g every 24 hours intravenous1 g every 12 hours intravenous or intramuscular
	4 g	2 g every 12 hours intravenous
Other Sites	2 g to 4 g	1 g or 2 g every 12 hours intravenous or intramuscular
Severe	4 grams	2 g every 12 hours intravenous
Life-Threatening	6 gramsb	3 g every 12 hours intravenous

^a Klebsiella pneumoniae skin and skin structure infections should be treated with 1 or 2 grams every 12 hours intravenous or intramuscular.

^b Maximum daily dosage should not exceed 6 grams.

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