Name:
Mycocide gel dnar.prim.10mg1g in tubes 30g in pack №1
Description:
Colorless, transparent or almost transparent gel, homogeneous in its consistency. Air bubbles are allowed. The main active ingredient Bifonazole Product form gel Dosage 30g Pharmacological properties Pharmacodynamics Bifonazole is a broad-spectrum antifungal agent. Depending on the dose, it has a fungistatic or fungicidal property. The mechanism of action of the drug is due to a violation of the synthesis of ergosterol, which is part of the cell membrane of fungi. Active against dermatophytes, yeast (including the genus Candida), mold (Malassezia furfur) and other fungi, gram-positive cocci. Corynebacterium minutissimum, Piturosporum orbiculare are also sensitive to the drug. Pharmacokinetics Bifonazole penetrates well into skin layers affected by a fungal infection: 6 hours after application, the concentrations in the surface and papillary layers of the epidermis correspond to and even exceed the required fungicidal concentration: from 1000 mg / cm3 in the stratum corneum of the epidermis to 5 mg / cm3 in the papillary layer. The average half-life of bifonazole in the superficial and middle layers of the epidermis is about 20 hours, in the deep layers of the epidermis – about 33 hours. After topical application of bifonazole gel on healthy skin under occlusive conditions, percutaneous absorption is less than 1%. The absorbed fraction is excreted as metabolites with a half-life of 7 to 42 hours within 5 days. Approximately 45% is excreted in the urine, 39% of the metabolites are excreted in the feces. The retention time of bifonazole in the skin is from 36 to 48 hours, which is the basis for a single application of a daily dose with local therapy. After application to intact human skin, serum concentrations of bifonazole were always below the detection limit. Only in the presence of inflammatory changes in the skin is insignificant absorption possible – as a rule, less than 5 ng / ml. These extremely low concentrations of the active ingredient do not have a systemic effect. Indications for use of dermatomycosis caused by dermatophytes, yeast, mold and other fungi, including mycosis of the feet, hands, smooth skin and skin folds; versicolor versicolor, superficial candidiasis; erythrasma. Dosage and administration The gel is applied once a day in the evening before going to bed with a thin layer on the affected area of the skin and rubbed in. A single dose is set taking into account the size of the lesion – a column of gel about 5 mm long is used to treat an area the size of a palm. The duration of treatment for mycoses of the feet and skin lesions in the interdigital spaces of the legs is 3 weeks; with mycosis of the hands, skin folds and smooth skin – 2-3 weeks; with multi-colored lichen and erythrasma – 2 weeks; with superficial candidiasis – 2-4 weeks. Treatment should always be carried out until the fungus has disappeared in the control and at least another 14 days after the symptoms have disappeared. In order to avoid false negative results, it is recommended to observe an interval of at least 3-4 days after the last topical application of bifonazole and taking material for control analysis. Features of use in patients with impaired liver and kidney function. No data available. Features of the use of the drug in geriatric practice. In elderly patients, adjustment of the dosing regimen is not required. Use during pregnancy and lactation Pregnancy. The use of the drug during pregnancy is contraindicated. lactation period. There are no data on the penetration of bifonazole into breast milk. During the period of treatment, breastfeeding should be stopped. Precautions Use with caution in patients with hypersensitivity to other antifungal drugs from the group of imidazole derivatives (econazole, clotrimazole, miconazole). Avoid getting the drug in the eyes. The propylene glycol contained in the medicinal product may cause skin irritation; cetostearyl alcohol may cause local skin reactions (eg contact dermatitis). Features of the use of the drug in pediatrics Use in children requires caution. Interactions with other drugs have not been described. Contraindications Hypersensitivity to imidazole and its derivatives, as well as to the components of the drug. Composition 1 g of gel contains 10 mg of bifonazole as an active ingredient. Excipients: ethyl alcohol, propylene glycol, macrogol 400, carbomer, glycerin, dimethyl sulfoxide. Overdose In case of accidental ingestion of the gel, gastric lavage should be carried out immediately. Side effect The frequency of occurrence of adverse reactions is indicated as: very often (? 1/10); often (from? 1/100 to <1/10); infrequently (from? 1/1000 to <1/100); rarely (from? 1/10000 to <1/1000); very rarely (<1/10000); unknown (cannot be estimated from the available data). Often: local reactions: slight redness, burning or irritation of the skin. As a rule, they are temporary. In case of hypersensitivity to the active substance or to any of the excipients, allergic reactions may occur, manifested by itching, redness, blistering in the application area. Storage conditions In a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Mycocid gel 10mg/g 30g №1
INN | BIFONAZOL |
---|---|
The code | 15 563 |
Barcode | 4 810 183 002 762 |
Dosage | 10mg/1g 30g |
Active substance | Bifonazole |
Manufacturer | Pharmtekhnologiya LLC, Belarus |
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