ARGUMEL COMBI Instructions for the medicinal product Trade name: Argumel Combi. International Nonproprietary Name: Ketoconazole + Clobetasol + Neomycin. Dosage form: cream for external use. Composition: Each gram contains: Ketoconazole BP 10 mg Clobetasol Propionate BP 0.25 mg Neomycin Sulphate BP 5000 IU Pharmacotherapeutic group: Corticosteroids, potent, other combinations. ATC code: D07XC. Pharmacologic property: Cream Argumel Combi is an effective anti-fungal, anti-bacterial, anti-inflammatory and anti-pruritic compound cream for treatment of fungal infections such as tinea manus, tinea pedis, tinea corporis and tinea cruris.It is also proved effective on the treatment of many kinds of dermatitis, eczema and pruritus. Ketoconazole has a potent antimycotic action against dermatophytes and yeasts. Ketoconazole cream acts rapidly on the pruritus, which is commonly seen in dermatophyte and yeast infections. This symptomatic improvement often occurs before the first signs of healing are observed. Clobetasol propionate is a highly active corticosteroid with topical anti-inflammatory activity. The major effect of clobetasol propionate on skin is a non-specific anti-inflammatory response, partially due to vasoconstriction and decrease in collagen synthesis. Pharmacodynamics: Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare). At external application of the cream, ketoconazole is not absorbed. Development of resistance to ketoconazole has not been reported. Clobetasol - is a corticosteroid used to treat various skin disorders including eczema and psoriasis. It is also highly effective for contact dermatitis caused by exposure to poison ivy/oak. Neomycin sulfate - is effective primarily against gram-negative bacilli but does have some activity against gram-positive organisms. Neomycin is a broad-spectrum antibiotic of aminoglycoside, it is active against of Gram-positive (Staphylococcus spp., Enterococcus spp.) and Gram-negative (Klebsiella spp., Proteus spp., Escherichia coli, etc.) bacteria. Cream Argumel Combi is effective against fungi, bacteria, itching and inflammatory processes. Pharmacokinetics: For exterior use ketoconazole slightly exposed systemic absorption. Even with prolonged use of the drug ketoconazole is not detected in the blood. Cmax of Clobetasol propionate in plasma reached after 13 hours after the first application and is 0.63 ng/ml. Systemic metabolism of clobetasol propionate after percutaneous absorption is not studied. Neomycin practically not absorbed through intact skin and mucous membranes. Possible absorption of neomycin through broken skin in contact with the drug for wounds and ulcers. Indications for use: џ Athlete's foot (tinea pedis; ringworm of the foot); џ Ringworm of the body (tinea corporis); џ Ringworm of the groin (tinea cruris; jock itch); џ Seborrheic dermatitis; "Sun fungus" (tinea versicolor; pityriasis versicolor); џ Yeast infection of the skin (cutaneous candidiasis). Contraindications: џ Hypersensitivity to any of the ingredients; џ Skin reactions to the vaccine; џ Scrapie; џ Rosacea; џ Children under 18 years; џ Pregnancy. Precaution: Local irritation or allergic reaction occurs, the treatment should be discontinued. Pregnancy and lactation: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you are a breast-feeding mother and are using this medication, it may affect your baby. Talk to your doctor before taking this medicine. Dosage and Direction for use: Apply externally to the affected area after cleaning twice daily. It is suggested to use Argumel Combi for 2 weeks on ordinary tinea corporis and tinea cruris, and for 4 weeks on tinea pedis and tinea manus. Side effects: Usually the drug is well tolerated. When applied topically were observed minor side effects: red spots; burning; dermography and telangiectasia; hyperfunction of the adrenal cortex; allergic contact dermatitis. Overdose: No data. Interaction with other drugs: Interaction not studied. An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed. Cautions: If necessary to use cream Argumel Combi on the face or large areas of the skin for long period need to take constant medical supervision. Do not exceed prescribed dosage. Only for external use. Avoid contact with eyes. Presentation: 15 gm aluminium tube in a monocarton, insert enclosed. Storage: Keep in dry place protected from light at a temperature below 30°С. Keep out of reach of children. Do not freeze. Expire date: Labeled. Do not use after expiry date. Distribution conditions: Non-prescribed medicine. 02.