Miconazole Cream 2% 30g Finished Medicines with GMP

Miconazole Cream 2% 30g

Composition
Each tube 30gm contains Micona nitrate 600mg.

Pharmacological Classification
A.13.9.2 Dermatological preparations: fungicides.

Pharmacological Action
Micon nitrate is a synthetic 1-phenethylimidazole derivative. It is a broad spectrum anti-fungal agent. In vitro, low concentrations of miconl 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.
Micon 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
Micona nitrate is contra-indicated in those patients who have shown hypersensitivity to miconaz.

Dosage and Directions for use
For external use only.
Micona  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 micona nitrate.
The safety of use during pregnancy has not been established.

Interactions
Systemic absorption of micona, although low after topical administration, may potentiate the activity of warfarin.

Storage Instructions
Store in a cool and dry place between 15-30ºC .protect from light.

KEEP OUT OF REACH OF CHILDREN.