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

Sertaconazole is an imidazole antifungal agent that inhibits fungal cytochrome P450–dependent 14α-lanosterol demethylase enzyme. Ergosterol is an essential component of fungal cell membranes, and its inhibition leads to disruption of the fungal cell membrane, resulting in leakage of intracellular contents and cell death.

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 with known or suspected hypersensitivity to sertaconazole nitrate, any of its components, or other imidazole antifungal agents.

Most common adverse reactions observed in clinical trials include contact dermatitis, dry skin, burning sensation, and tenderness at the application site.

There are no adequate and well-controlled studies 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 whether it is excreted in human milk. Caution should be taken when prescribing to nursing mothers.

For external use only. If irritation develops, treatment should be discontinued and appropriate therapy started. Caution is advised in patients sensitive to azole antifungals due to possible cross-reactivity.

No data are available regarding overdose of sertaconazole cream.

Drugs used in vaginal and vulval conditions; imidazole antifungal agent

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