Sertaconazole

Pregnancy Category C.

There are no adequate and well-controlled studies conducted with sertaconazole cream in pregnant women. Sertaconazole cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Reproduction studies have not been performed with sertaconazole cream. Sertaconazole nitrate did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity in rats and rabbits at an oral dose of 160 mg/kg/day (40 times (rats) and 80 times (rabbits) the maximum recommended human dose based on a body surface area comparison). A reduction in live birth indices and an increase in the number of still-born pups were seen at doses of 80 and 160 mg/kg/day sertaconazole nitrate in an oral peri- and post-natal development study in rats.

It is not known if sertaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prescribing sertaconazole cream, 2%, to a nursing woman.

In a rat dermal carcinogenicity study, topical administration of sertaconazole nitrate cream for up to 102 weeks did not increase the number of neoplastic lesions compared to control animals, at sertaconazole nitrate doses of up to 800 mg/kg/day (approximately 200 times the maximum recommended human dose based on a body surface area comparison).

No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was considered nonclastogenic in the in vivo mouse sister chromatid exchange assay. There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in primary rat hepatocyte cultures.

At oral doses up to 60 mg/kg/day (16 times the maximum recommended human dose based on a body surface area comparison), sertaconazole nitrate exhibited no toxicity or adverse effects on reproductive performance or fertility in male or female rats.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving sertaconazole cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site skin tenderness.

In a dermal sensitization trial, 8 of 202 evaluable subjects tested with sertaconazole cream, 2%, and 4 of 202 evaluable subjects tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of sertaconazole cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In post-marketing surveillance for sertaconazole cream, 2%, the following were reported:

Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.