Inflammatory eczema, paralysis, intestinal mycosis, onychomycosis induced by dermatophytes (Trichophyton rubrum, T. mentagrophytes, Epidermophyton floccosum) or by other fungi (e.g.Candida albicans), mycosis with bacterial superinfection, mycosis of the external auditory canal.
Composition:
1 g Ointment contains 20 mg of miconazole and 2.5 mg of mazipredon hydrochloride. The preparation contains methyl parahydroxybenzoate, cetostearyl alcohol, propylene glycol.
Action:
Antifungal preparation for topical application. Miconazole has antifungal activity, including for dermatophytes, yeasts and works on Gram-positive bacteria and kernels. Mazipredone has a pronounced corticosteroid effect - it has anti-inflammatory and antipruritic effects. Miconazole is absorbed to a very small extent after application to the skin. Topical Mazipredon can penetrate the skin into the body.
Contraindications:
Hypersensitivity to the active substances or to any of the excipients. Hypersensitivity to isoconazole, thioconazole and oxazonazole. Skin tuberculosis, herpes simplex, chickenpox and other viral and bacterial skin diseases. Fungal infection of the scalp and mucous membranes. Do not use on wounded skin.
Precautions:
In the event of sensitization, skin irritation, skin atrophy or systemic hypersensitivity reactions, treatment should be discontinued immediately. Avoid contact with eyes and mucous membranes. In case of hypersensitivity to isoconazole, thioconazole or oxyconazole, cross-allergy may occur. Corticosteroids are absorbed through the skin, therefore, when taking the drug there is a risk of systemic side effects of mazipredon, characteristic of corticosteroids, including suppression of the adrenal cortex. Therefore, you should also avoid using the product on a large area of the skin, use in high doses, as well as long-term treatment. The use on the skin of the face and on the skin of the armpits and groins should be limited only to the absolutely necessary cases, due to the increased absorption of the corticosteroid by the delicate skin and the associated increased risk of telangiectasia,dermatitis perioralis, skin atrophy, even after a short use. Avoid using the preparation under an occlusive dressing (an oilcloth, diaper), because the dressing enhances the absorption of the corticosteroid into the body. There are no data on use in children. Due to the content of methyl parahydroxybenzoate, the preparation may cause allergic reactions (possible late-type reactions). Due to the cetostearyl alcohol content, the preparation may cause a local skin reaction (eg contact dermatitis). Due to the content of propylene glycol, the preparation may cause skin irritation.
Pregnancy and lactation:
In the treatment of pregnant women, the relationship between the benefits of treatment and the risk of fetal harm should be considered. In breast-feeding women, the drug should be used with extreme caution.
Side effects:
Rare: hypersensitivity reactions (including anaphylactic reactions or angioneurotic edema), local skin irritation, burning sensation, erythema, contact dermatitis, pruritus, rash. Not known: secondary infections, skin atrophy, dermatoses, posteroid acne,dermatitis perioralis (when using the product in the same place, especially for a long time); skin eruptions, dry skin, folliculitis and discoloration of the skin, dilation of the surface blood vessels, symptoms characteristic of corticosteroids, especially in long-term use, application on a large area of the skin, under occlusive dressing (close fitting), as well as suppression of the hypothalamus and pituitary gland and adrenal glands. In case of hypersensitivity to isoconazole, thioconazole or oxyconazole, cross-allergy may occur. Absorption of miconazole is not clinically relevant.In children, due to the greater than in adults the ratio of body surface area to body weight, it is easier than in adults to suppress the hypothalamic-pituitary-adrenal axis and general adverse effects of corticosteroids, including growth and development disorders.
Dosage:
Outwardly.Fungal and nail infections: rub ointment 1-2 times a day in the infected area of the skin. In fungal infections of nails after removal of the damaged part of the nail, the preparation should be applied with a bandage dressing. Treatment should be continued until the nail is completely renewed.Mycosis of the external auditory canal: introduce the rolled gauze soaked in ointment 2 times daily to the external auditory canal until it is completely healed.
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