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for medical use of the drug
international name: omokonazole;
General physic-chemical properties: white homogeneous cream odourless;
composition: 1 g of cream contains omoconazole nitrate micronized 0.01 g;
other ingredients: light liquid paraffin, carbopol 934 P, Polysorbate 40, glared polglase rich, benzoic acid, sodium hydroxide (30% aqueous solution), purified water.
The release form. The cream.
Pharmacotherapeutic group. Antifungals for topical use.
Code ATC D01А 13.
Pharmacodynamics. Nitrate omoconazole is a derivative of imidazole, has antifungals and antibacterial properties. Provides fungistatic activity at the main pathogenic fungal diseases of the skin and mucous membranes in humans, such as yeast fungi (Candida albicans, Candida glabrata and other species of the genus Candida, dermatophytes (Trichophyton, Epidermophyton, Microsporum), Pityrosporum orbiculare, Pityrosporum ovale and Aspergilus species. According to in vitro studies, the drug is effective against certain gram positive bacteria. The mechanism of action is based on blocking the biosynthesis in the cell of a fungus, which leads to the disruption of the cell membrane and thus prevents a fungus nutrients.
The pharmacokinetics. When using vaginal suppositories once a day for 6 days a measurement of the concentration in plasma after administration, conducted after the first, third and sixth day of treatment did not reveal concentrations of omoconazole that had been subjected to detection (25 ng/ml or 2-3 % of the applied dose). However, despite weak vaginal absorption, the application of high doses of omoconazole can accumulate in the body. The degree of suction in inflammation of the mucous membrane can be increased. Omoconazole quickly and in a significant number metabolized. The majority of metabolites kongugiruut with glucuronide or sulfate. The main route of metabolism is alcohol ggraccoon.
Indications for use. Treatment of all types of fungal infections of the skin and mucous membranes, caused by fungi of the genus Candida, dermatophytes, treatment of multi-colored lichen, erythrasma, and lesions caused by Corynebacterium minutissimum.
In the case of severe fungal infections topical application to omoconazole well complements the system antimation treatment.
Way of application and dose. Depending on the nature of the disease the drug is applied on the affected skin 1-2 times per day. Cream applied in a thin layer and gently rubbed. Depending on the nature of mycosis minimum average course of treatment is 2 to 6 weeks. Treatment should continue for one week after full cure (disappearance of symptoms of inflammation, subjective complaints) in order to prevent the resumption of the disease.
The side effects. The drug is generally well tolerated. In individual cases during treatment may feel local burning or mild skin irritation. In most cases, these symptoms are temporary and do not require discontinuation of treatment.
Contraindications. The drug is contraindicated in hypersensitivity to the active or auxiliary substances.
Interaction with other drugs. Unknown.
The overdose. Data are not available.
Features of the application. You have to be more careful when applying the cream on large areas of damaged skin, in the treatment of infants and children up to 5 years. During treatment it is advisable not to use soap with acidic pH.
Cream “Magal” contains paraffin light liquid, which reduces the strength and protective properties of latex condoms. If necessary, the simultaneous treatment of sexual partner of the patient to prevent the so-called “ping-pong” infection. Because the cream contains a preservative - benzoic acid, in patients with hypersensitivity to it it is not necessary to apply it.
Use in pregnancy and lactation. Animal experiments have shown that the use of therapeutic doses of omoconazole has no embryotoxic action, also has harmful effects on postnatal development. As the studies on the use of drugs during pregnancy in humans has not been conducted, it can be applied only after evaluation of the balance of "benefit / risk".
In the period of breast-feeding is not recommended to put the drug on the nipples and breast area.
Conditions and period of storage. Store at room temperature (15-25 ° C), out of the reach of children. Shelf life - 3 years.
Terms of release. Without prescription.
The packing. 20 g in a tube, in a cardboard box.