Sertaconazole Nitrate [Topical]

Sertaconazole cream is indicated for the topical treatment of interdigital tinea pedis and other topical fungal infections in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum.

Sertaconazole, an imidazole antifungal agent, inhibits fungal cytochrome P450-mediated 14 alpha-lanosterol demethylase enzyme. Ergosterol is the key component of fungal cell membranes and lack of this component leads to fungal cell injury by leakage of key constituents in the cytoplasm from the cell.

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.

Potential interactions between Sertaconazole cream and other drugs have not been systematically evaluated.

Sertaconazole cream is contraindicated in patients who have a known or suspected hypersensitivity to sertaconazole nitrate or any of its components or other imidazoles.

Most common adverse reactions observed in clinical trials are contact dermatitis, dry skin, burning skin, application site skin tenderness.

There are no adequate & 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. It is not known if Sertaconazole cream is excreted in human milk. Caution should be exercised when prescribing Sertaconazole cream to a nursing woman.

Sertaconazole cream is for use on the skin only. If irritation develops, treatment should be discontinued and appropriate therapy instituted. Physicians should exercise caution when prescribing Sertaconazole cream to patients known to be sensitive to azole antifungals, since cross-reactivity may occur.

There is no data availalble about overdose of Sertaconazole cream.

Drugs used in Vaginal and Vulval condition, Imidazole antifungal agent

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.