Miconazole Nitrate Cream

Composition: Each tube 30gm contains Miconazole nitrate 600mg.

Pharmacological Classification:

A.13.9.2 Dermatological preparations: fungicides. Pharmacological Action: Miconazole nitrate is a synthetic 1-phenethylimidazole derivative. It is a broad spectrum anti-fungal agent. In vitro, low concentrations of miconazole nitrate are fungistatic against all Phycomycetes, Ascomycetes and Adelomycetes tested (e.g.

Saprolegnia, Candida, Cryptococcus, Aspergillus, Dermatophytes, Phialophora, Sporotrichum), and fungicidal against Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum. Trichophyton interdigitale and Microsporum canis. Miconazole nitrate also possesses some anti-bacterial activity against Gram-positive organisms.

Indication: Dermatomycoses, e.g,: -Tinea pedis (Athlete’s foot) -Tinea corporis (Tinea circinata) -Tinea manuum Tinea cruris due to: -Trichophyton mentagrophytes -Trichophyton rubrum -Microsporum audouinii -Epidermophyton floccosum Candidial infections: Infections of the skin (e.g. intertrigo) Perianal infections Stomatitis angularis (cheilitis, perleche) Balanoposthitis Contra-indications: Miconazole nitrate is contra-indicated in those patients who have shown hypersensitivity to miconazole.

Dosage and Directions for use: For external use only. Miconazole nitrate should be applied to the lesions twice daily and thoroughly rubbed into the skin. When all lesions have disappeared (usually after 2 to 5 weeks) treatment should be continued for a further 10 to 14 days to prevent relapse.

Side-effects and special precautions: Minimal absorption of the active ingredient takes place through the skin and systemic side-effects are therefore most unlikely to arise. Local irritation and sensitivity reactions may occur with miconazole nitrate. The safety of use during pregnancy has not been established.

Interactions: Systemic absorption of miconazole, although low after topical administration, may potentiate the activity of warfarin. Storage Instructions: Store in a cool and dry place between 15-30℃ .protect from light. KEEP OUT OF REACH OF CHILDREN.