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Active ingredients
Sertaconazole
Release form
Cream
Composition
1 g of sertaconazole nitrate 0.02 g. Excipients: cetyl alcohol - 0.
Pharmacological effect
Antifungal agent for external use, a derivative of imidazole and benzothiophene with a broad spectrum of action. The mechanism of action is to inhibit the synthesis of ergosterol (the main sterol membranes of fungi and yeast) and increase the permeability of the cell membrane, which leads to the lysis of the cell of the fungus. In therapeutic doses, it has fungistatic and fungicidal action against pathogenic fungi (Candida spp., Including Candida albicans, Candida tropicalis, Pityrosporum orbiculare), dermatophytes (Trichophyton and Microsporum) and is active against pathogens of the skin and mucous membranes (gram). strains of staphylococci and streptococci).
Pharmacokinetics
With the external use of sertaconazole in the blood and urine is not detected. During the pharmacokinetic study of multiple doses involving patients with interdigital foot dermatophytosis (area range of the affected area: 42-140 cm2; average - 93 cm2), the solution was applied externally every 12 hours (a total of 13 times) on the affected skin (0.5 g sertaconazole nitrate per 100 cm2). Plasma sertaconazole concentration, measured by a series of blood samples taken within 72 hours after the thirteenth dose, was below the limit of quantification (2.5 ng / ml) of the analytical method used.
Indications
Treatment of superficial mycoses of the skin: - ringworm - Tinea pedis (athlete's foot), Tinea crusis (inguinal ringworm), Tinea corporis (smooth skin mycosis), Tinea barbae (beard mycosis), Tinea manus (hand dermatophytosis) - candidiasis (Monolisisisis). versicolor (Pityrosporum orbiculare) (pityriasis versus versicolor). Pityriasis versicolor in immunocompetent patients older than 12 years (solution for external use).
Contraindications
- Hypersensitivity to sertaconazole and other components of the drug, including to other imidazole derivatives - lactation period - children's age up to 12 years (solution for external use).
Use during pregnancy and lactation
In pregnancy, apply only if the intended benefit to the mother outweighs the potential risk to the fetus. During lactation, the drug should not be applied to the area of the mammary glands. If necessary, the use of the drug during lactation should consider stopping breastfeeding.
Dosage and administration
Outwardly.Cream for external use For adults, the cream is applied to the affected skin with a uniform thin layer 2 times / day, capturing approximately 1 cm of the surface of healthy skin. Before using the drug, the skin at the site of application must be cleaned with water and soap, and dried. The duration of treatment depends on the etiology (pathogen) and the localization of the infection, on average, 4 weeks. Solution for external use For adults and children over the age of 12 years, the solution for external use is applied on the affected skin with an even thin layer 2 times / day, capturing approximately 1 cm of the surface of healthy skin. The duration of treatment depends on the etiology (pathogen) and the localization of the infection, on average, 4 weeks. In the treatment of pityriasis versicolor, a sufficient amount of the solution for external use should be applied on the dry skin from the neck down, excluding the genitals. Repeat twice a day for 4 weeks.
Side effects
Local reactions: contact dermatitis, rapid erythematous reactions are possible at the site of use, which does not require discontinuation of the drug. If any of the above side effects are exacerbated, or any other side effects occur, the patient should inform the physician.
Overdose
Given the method of use, overdose of the drug is unlikely. In case of accidental ingestion of the drug, it is necessary to carry out symptomatic treatment.
Interaction with other drugs
Not found.
special instructions
Do not use in ophthalmic practice. After applying the drug is not recommended the use of acidic detergents (in an acidic environment increases the reproduction of Candida spp.). Use in pediatrics There is no data on the use of the drug in children. Influence on the ability to drive vehicles and control mechanisms The use of the drug in accordance with the instructions for use does not affect the performance of potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (driving, working with moving machinery).