ERTACZO™ Cream, 2%, is not indicated for ophthalmic, oral or intravaginal use.

General: ERTACZO™ Cream, 2%, is for use on the skin only. If irritation or sensitivity develops with the use of ERTACZO™ Cream, 2%, treatment should be discontinued and appropriate therapy instituted.

Diagnosis of the disease should be confirmed either by direct microscopic examination of infected superficial epidermal tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Physicians should exercise caution when prescribing ERTACZO™ Cream, 2%, to patients known to be sensitive to imidazole antifungals, since cross-reactivity may occur.

Drug/Laboratory Test Interactions: Potential interactions between ERTACZO™ Cream, 2%, and other drugs or laboratory tests have not been systematically evaluated.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies to evaluate the carcinogenic potential of sertaconazole nitrate have not been conducted. No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was considered negative for sister chromatid exchange (SCE) in the in vivo mouse bone marrow SCE assay. There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in rat primary hepatocyte cultures. Sertaconazole nitrate exhibited no toxicity or adverse effects on reproductive performance or fertility of male or female rats given up to 60 mg/kg/day orally by gastric intubation (16 times the maximum recommended human dose based on a body surface area comparison).

Pregnancy: Teratogenic Effects. Pregnancy Category C: Oral reproduction studies in rats and rabbits did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity of sertaconazole nitrate at an oral dose of 160 mg/kg/day (40 times (rats) and 80 times (rabbits) the maximum recommended human dose on a body surface area comparison). In an oral peri-postnatal study in rats, a reduction in live birth indices and an increase in the number of still-born pups was seen at 80 and 160 mg/kg/day.

There are no adequate and well-controlled studies that have been conducted on topically applied ERTACZO™ Cream, 2%, in pregnant women. Because animal reproduction studies are not always predictive of human response, ERTACZO™ Cream, 2%, should be used during pregnancy only if clearly needed.

Nursing Mothers: 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 ERTACZO™ Cream, 2%, to a nursing woman.

Pediatric Use: The efficacy and safety of ERTACZO™ Cream, 2%, have not been established in pediatric patients below the age of 12 years.

Geriatric Use: Clinical studies of ERTACZO™ Cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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