GYNOMIX

Sertaconazole nitrate is an antifungal medication of the imidazole class.

It is available in topical formulations for the treatment of skin infections such as athlete's foot.

For the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

Sertaconazole is an imidazole/triazole type antifungal agent.

Sertaconazole is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14 α-demethylation via the inhibition of the enzyme cytochrome P450 14α-demethylase.

This enzyme converts lanosterol to ergosterol, and is required in fungal cell wall synthesis.

The subsequent loss of normal sterols correlates with the accumulation of 14 α-methyl sterols in fungi and may be partly responsible for the fungistatic activity of fluconazole.

Mammalian cell demethylation is much less sensitive to fluconazole inhibition.

Sertaconazole exhibits in vitro activity against

Cryptococcus neoformans and Candida spp.

Fungistatic activity has also been demonstrated in normal and immunocompromised animal models for systemic and intracranial fungal infections due to Cryptococcus neoformans and for systemic infections due to Candida albicans.

Bioavailability is negligible.

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ERTACZO cream, 2% twice daily for 4 weeks.

Apply a sufficient amount of

ERTACZO cream, 2% to cover both the affected areas between the toes and the immediately surrounding healthy skin.

ERTACZO cream, 2% for the full treatment time recommended by the physician, even though symptoms may have improved.

Dry the affected area(s) thoroughly before application, if using ERTACZO cream, 2% after bathing.

Wash hands after use.

Avoid the use of occlusive dressings or wrappings.

For topical use.

Not for ophthalmic, oral, or intravaginal use.

ERTACZO cream, 2% to the affected and immediate surrounding area(s) twice daily for 4 weeks.

cream, 2%, is white in color and supplied in tubes in the following size: 60-gram tube NDC 73159-004-60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Risk Summary There are no available data on ERTACZO cream, 2% use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal reproduction studies, there were no adverse developmental effects observed with oral administration of sertaconazole nitrate to pregnant rats and rabbits during organogenesis at doses and 80 times, respectively, the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison.

In rats, when maternal dosing was continued until weaning, a reduction in live birth indices and an increase in the number of still-born pups was observed at doses and 40 times the MRHD based on BSA comparison.

The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of major birth defects, loss and other adverse outcomes.

In the

U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Animal embryofetal development studies have not been conducted with ERTACZO cream, 2%.

Embryofetal development studies performed in pregnant rats and rabbits administered oral doses of sertaconzaole nitrate up to 160 mg/kg/day (40 times [rats] and 80 times [rabbits] the MRHD based on a BSA comparison) during the period of organogenesis revealed no malformations or embryofetal developmental toxicity.

In a pre.

• and postnatal development study, pregnant rats were administered oral doses of sertaconazole nitrate from pregnancy day to lactation day 20.

A reduction in live birth indices and an increase in the number of still-born pups were seen at doses and 40 times the MRHD based on BSA comparison.

The safety and effectiveness of

ERTACZO cream, 2%, have not been established in pediatric patients younger than 12 years of age.

Clinical trials of

ERTACZO cream, 2%, did not include sufficient numbers of subjects aged and over to determine whether they respond differently from younger subjects.