Ertaco 20

Generic

Sertaconazole Nitrate

Indications

Sertaconazole cream is used to treat interdigital tinea pedis and other topical fungal infections caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in immunocompetent patients aged 12 and up.

Pharmacology

Sertaconazole, an imidazole antifungal, inhibits the 14 alpha-lanosterol demethylase enzyme, which is mediated by cytochrome P450 in fungi. Ergosterol is a crucial component of fungal cell membranes, and its absence causes fungal cell damage by allowing important cytoplasmic contents to seep out of the cell.

Dosage & Administration

In the treatment of interdigital tinea pedis, Sertaconazole cream should be applied twice daily for 4 weeks. A sufficient amount of Sertaconazole cream should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis. Not for ophthalmic, oral, or intravaginal use.

Pediatric Use: The efficacy and safety of Fungitac cream 2% have not been established in pediatric patients below the age of 12 years.

Geriatric Use: Clinical trials of Fungitac cream 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Interactions

Sertaconazole cream and other medicines have not been thoroughly studied for potential interactions.

Contraindications

Patients with a known or suspected hypersensitivity to sertaconazole nitrate, any of its components, or other imidazoles should not use sertaconazole cream.

Side Effects

Contact dermatitis, dry skin, burning skin, and skin discomfort at the application site were the most prevalent adverse responses found in clinical trials.

Pregnancy & Lactation

Sertaconazole cream has not been studied in pregnant women in a sufficient and well-controlled manner. Sertaconazole cream should only be taken during pregnancy if the possible benefit outweighs the risk to the unborn child. Sertaconazole cream is not known to be excreted in human milk. When providing Sertaconazole cream to a nursing mother, practice caution.

Precautions & Warnings

Sertaconazole cream is only for external usage. If irritation occurs, the treatment should be stopped and the proper therapy started. Cross-reactivity with azole antifungals is possible with Sertaconazole cream, thus doctors should be cautious when giving it to individuals who are known to be sensitive to them.

Therapeutic Class

Drugs used in Vaginal and Vulval conditions, Topical Antifungal preparations

Storage Conditions

Pharmaceutical Name

ACME Laboratories Ltd.