Ketoconazole Cream 2%
Each gm contains:
Ketoconazole USP 20mg
Cream base q.s.
MECHANISM OF ACTION
Ketoconazole is an imidazole antifungal agent which interferes with ergosterol synthesis and therefore alters the pemeability of the cell membrane of sensitive fungi. It is reported to be fungistatic at concentration achieved clinically. Ketoconazole has a wide spectrum of antimicrobial activity including activity against Candida spp., Blastomyces dermatitidis, Coccidioides immitis, Epidermophyton floccosum, Histoplasma capsulatum, Paracoccidiodes brasiliensis, Malassezia farfur, Microsporum canis, Trichophyton mentagrophytes and some strains of Aspergillus spp., Cryptococcus neoformans and Sporothrix schenckii are sensitive. MIC values for ketoconazole are dependent on the method used for their determination and are not always predictive of in vivo activity. Ketoconazole has activity against some grampositive bacteria. There are rare reports of Candida albicans acquiring resistance to ketoconazole.
Tinea corporis (ringworm; fungal skin infection first causes a red scaly rash on different parts of the body), Tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), Tinea pedis (athlete’s toot; fungal infection of the skin on the feet and between the toes), Tinea versicolor (fungal infection that causes brown or light colored spots on the chest back, arms, legs or neck), yeast infections of the skin. Ketoconazole cream is sometimes used to treat Tinea manuum (fungai infection of the skin on the hands).
Ketoconazole cream is sometimes used with other medications to treat skin conditions that are often worsened by fungal infection such as diaper rash, eczema (skin irritation caused by allergies), impetigo (blisters caused by a bacterial infection) and psoriasis (a lifelong skin condition). With the use of ketoconazole cream, your symptoms should improve at the beginning of your treatment. Continue to use ketoconazole cream even if you are feeling well. If you stop using ketoconazole cream too soon, your infection may not be completely cured and your symptoms may return.
Ketoconazole cream is only for use on the skin or scalp. Do not let ketoconazole cream get into your eyes or mouth and do not swallow the medication. If you do get katoconazole cream in your eyes, wash with plenty of water.
To use the cream, apply enough cream to cover the affected area and all of the skin around it.
KETORAL Cream is contraindicated in patients who have shown hypersensitivity to the drug.
Apply twice a day on affected area for 4-6 weeks.
KEEP MEDICINE OUT OF REACH OF CHILDREN
Store in a cool, dry and dark place.
FOR EXTERNAL USE ONLY
Available in 30 gms tube in monocarton and such 10 monocartons in an outer carton.
NAFDAC REG. NO.: A4-1907
EMBASSY PHARMACEUTICALS & CHEMICAL LTD.
41, Ademola Street, South West Ikoyi,
Yash Medicare Pvt. Ltd.
Near Sabar Diary, Talod Road,
P.O.: Hajipur, Dist.: Himatnagar-383 006,