Fungitac20 gm

Sertaconazole cream 2% is an azole antifungal indicated 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.

Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations

Sertaconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Sertaconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis.

In the treatment of interdigital tinea pedis, Sertaconazole cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Sertaconazole cream, 2%, 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.

None

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving Sertaconazole cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site skin tenderness.In a dermal sensitization trial, 8 of 202 evaluable subjects tested with Sertaconazole cream, 2%, and 4 of 202 evaluable subjects tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.

Pregnancy Category C. There are no adequate and 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.Nursing Mothers: It is not known if sertaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prescribing ERSertaconazole TACZO cream, 2%, to a nursing woman.

If irritation develops, treatment should be discontinued and appropriate therapy instituted. Physicians should exercise caution when prescribing Sertaconazole cream, 2%, to patients known to be sensitive to azole antifungals, since crossreactivity may occur.

Store at 20°C - 25°C; excursions permitted to 15°- 30°C

Pediatric Use: The efficacy and safety of Sertaconazole cream, 2%, have not been established in pediatric patients below the age of 12 years.Geriatric Use: Clinical trials of Sertaconazole cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.