Cleocin Vaginal (Clindamycin Hydrochloride Vaginal) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Genotoxicity tests performed included a rat micronucleus test and an Ames test. Both tests were negative. Fertility studies in rats treated orally with up to 300 mg/kg/day (31 times the human exposure based on mg/m²) revealed no effects on fertility or mating ability.

Pregnancy

Teratogenic effects

Pregnancy Category B

There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women.

CLEOCIN Vaginal Cream, 2%, has been studied in pregnant women during the second trimester. In women treated for 7 days, abnormal labor was reported more frequently in patients who received CLEOCIN Vaginal Cream compared to those receiving placebo (1.1% vs. 0.5% of patients, respectively).

Reproduction studies have been performed in rats and mice using oral and parenteral doses of clindamycin up to 600 mg/kg/day (62 and 25 times, respectively, the maximum human dose based on mg/m²) and have revealed no evidence of harm to the fetus due to clindamycin. Cleft palates were observed in fetuses from one mouse strain treated intraperitoneally with clindamycin at 200 mg/kg/day (about 10 times the recommended dose based on body surface area conversions). Since this effect was not observed in other mouse strains or in other species, the effect may be strain specific.

CLEOCIN Vaginal Ovules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

OVERDOSAGE

Vaginally applied clindamycin phosphate contained in CLEOCIN Vaginal Ovules could be absorbed in sufficient amounts to produce systemic effects (see WARNINGS and ADVERSE REACTIONS).

CONTRAINDICATIONS

CLEOCIN Vaginal Ovules are contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal suppository. CLEOCIN Vaginal Ovules are also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.