Initial treatment of superficial skin fungal infections with concomitant strong inflammatory or eczematous skin lesions, e.g. hands, interdigital spaces of the feet and the inguinal and genital areas.
Composition:
1 g of cream contains 10 mg of isoconazole nitrate and 1 mg of diflucortolone valerate.
Action:
A topical preparation for the skin. Isoconazole - an imidazole derivative - has antifungal activity on dermatophytes, yeasts, yeast-like fungi, molds as well as pathogens inducing erythematous dandruff.In vitro also has antibacterial activity against Gram-positive bacteria. Isoconazole is absorbed quickly, reaching the maximum concentration in the stratum corneum of the epidermis and dermis after one hour. Isoconazole is not metabolized in the skin. The absorption through the skin is small, only 1% of the dose penetrates into the bloodstream within 4 hours. The valluclortonone valerate is a glucocorticosteroid with a strong local effect, reduces inflammatory and allergic skin reactions, relieves skin ailments, i.e. pruritus, burning and pain. It penetrates quickly into the skin, where it is partially hydrolyzed. The amount of corticosteroid absorbed by the skin is low. Within 4 hours after application to the skin, less than 1% of the administered dose penetrates into the systemic circulation.
Contraindications:
Hypersensitivity to active substances or to any of the excipients. Syphilis or tuberculous lesions. Changes caused by viral skin diseases (eg chickenpox, shingles). Changes caused by rosacea, common. Periorbital dermatitis. Local reactions after vaccination.
Precautions:
Avoid contact of the preparation with eyes and mucous membranes. The use of topical glucocorticosteroids on large areas of the skin or for a long time, in particular under an occlusive dressing, can significantly increase the risk of systemic side effects (including glaucoma). Particularly with caution and for a short period of time, use of the drug on the face and children's skin (in children there is a greater risk of systemic topical corticosteroids use than in adults). If the preparation is used in the genital area, liquid paraffin and white vaseline (auxiliary substances) may cause damage to concurrent latex contraceptive contraceptives, such as condoms and membranes, thereby affecting their effectiveness. Due to the cetostearyl alcohol content, the drug may cause a skin reaction.
Pregnancy and lactation:
There are no data on the use of the preparation during pregnancy. Do not use during the first trimester of pregnancy. In the case of pregnant women and breastfeeding mothers, the balance of risks to the benefits of treatment should be carefully estimated. In particular, the drug should be avoided for large areas of the skin and (or) long-term or under occlusive dressings, on the breast skin during lactation.
Side effects:
Common: irritation / burning at the injection site. Uncommon: erythema, dryness, skin prickiness. Frequency unknown: pruritus, vesicles. In addition: thinning of the skin (atrophy), inflammation of the hair follicles at the injection site, excessive hair growth, dilation of superficial blood vessels (telangiectasia), peridural dermatitis, skin discoloration, acne-like lesions, allergic reactions, general side effects of corticosteroids.
Dosage:
Locally, on the skin. Adults and children> 2 years: a thin layer of cream is applied twice a day to the affected skin surface. Treatment should be discontinued after the onset of inflammation or eczematous skin lesions, no later than after 2 weeks of use. After this period, treatment can be continued with a corticosteroid-free antifungal medicine, in particular when using the drug in the groin and around the external genital area. There are no data on the safety of the preparation in children under 2 years.
(C)
