Ertaczo

Topical Dermatological Antifungals

For topical administration only.
Wash hands before and after use. Use universal precautions (i.e., gloves) for application if needed.
Cleanse the affected area and dry thoroughly prior to application.
Apply a thin layer of the cream to the affected area between the toes and the immediately surrounding healthy skin of immunocompetent patients with tinea pedis. Gently rub into the skin.
Avoid the use of occlusive dressings or wrappings.

contact dermatitis / Delayed / 2.0-2.0
erythema / Early / 0-1.0

skin irritation / Early / 2.0-2.0
pruritus / Rapid / 0-1.0
skin hyperpigmentation / Delayed / 0-1.0
vesicular rash / Delayed / 0-1.0
xerosis / Delayed / 2.0

Ertaczo

Rx

Imidazole-type antifungal; used topically for the treatment of interdigital tinea pedis in immunocompetent patients; symptomatic relief usually seen within 7—14 days; duration of therapy is typically 4 weeks.

Apply a thin layer of the 2% cream to the cleansed, dry, infected area twice daily for 4 weeks.

No dosage adjustment needed.

No dosage adjustment needed.

Nystatin: (Moderate) The combination of sertaconazole and nystatin represent duplication of therapy whenever the drugs are used by similar route, and is usually avoided.

Ertaczo Topical Cream: 2%

No maximum dosage information is available.

No maximum dosage information is available.

>= 12 years: No maximum dosage information is available.

< 12 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Mechanism of Action: Sertaconazole, like other azole antifungals, exerts it effect primarily by inhibiting the cytochrome P450-dependent synthesis of ergosterol. Ergosterol is a key component of the cell membrane of fungi, and the lack of this component results in fungal cell injury primarily by leakage of key constituents in the cytoplasm from the cell. Sertaconazole does not appear to have the same effect on human cell cholesterol synthesis. Other antifungal effects of azole compounds have been proposed and include: inhibition of endogenous respiration, interaction with membrane phospholipids, and inhibition of yeast transformation to mycelial phospholipid forms. Other mechanisms may involve inhibition of purine uptake and impairment of triglyceride and/or phospholipid biosynthesis.The azole antifungals have a broad spectrum of activity against common fungal pathogens including: Blastomyces dermatitidis, Candida species, Cryptococcus neoformans, Coccidiodes immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis, and Sporothrix schenckii. In general, sertaconazole is active against the following organisms: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

Sertaconazole cream is administered topically to the skin.

Following topical administration of sertaconazole, systemic absorption is negligible. In a multiple dose pharmacokinetic study of 5 male patients with interdigital tinea pedis, sertaconazole cream 2% was topically applied every 12 hours for a total of 13 doses to the diseased skin. Sertaconazole concentrations in the plasma measured by serial sampling for 72 hours after the thirteenth dose were below the limit of quantitation of the analytical method.

There are no available data for topical sertaconazole use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, there were no adverse developmental effects observed with oral administration of sertaconazole at doses 40 to 80 times the maximum recommended human dose (MRHD) based on body surface area comparisons. In studies involving pregnant rats, a reduction in live birth indices and an increase in the number of still-born pups was observed at oral doses 20 and 40 times the MRHD based on body surface area. In pharmacokinetic trials, sertaconazole plasma concentrations were below the limit of quantitation (2.5 ng/mL).

There are no data available on the presence of sertaconazole in human or animal milk, its effects on the breastfed infant, or its effects on milk production.  However, topical application is not expected to result in significant maternal absorption. Instruct nursing mothers not to apply sertaconazole to the breast. Clotrimazole, miconazole, and nystatin may be potential alternatives to consider during breast-feeding. However, site of infection, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. The development and health benefits of breast-feeding should be considered along with the mother's need for sertaconazole cream and any potential adverse effects on the breastfed infant from sertaconazole cream or from the underlying maternal condition.