Properties
What is it?
International Nonproprietary Name - naftifine Clinical-pharmacological group: Antifungal agents → Antifungal preparations for external use → Other antifungal preparations Composition Active substance: Naftifine hydrochloride. 1 ml of solution contains 10 mg of naftifine hydrochloride, calculated on 100% dry matter. Excipients: propylene glycol, ethanol 96%, purified water. Dosage form Solution for external (skin) use. Main physical and chemical properties: Transparent solution from colorless to pale yellow, with an alcohol odor. Pharmacotherapeutic group Antimycotic (antifungal) agent for dermatological use. Indications Local treatment of fungal infections caused by naftifine-sensitive pathogens: - Fungal infections of the skin and skin folds; - Interdigital mycoses; - Fungal infections of the nails (onychomycoses); - Cutaneous candidiasis; - Pityriasis versicolor; - Inflammatory dermatomycoses, with or without accompanying itching; - Mycosis of the external auditory canal. Contraindications Hypersensitivity to naftifine or propylene glycol. The preparation should not be applied to wounds. Not for ophthalmic use. Dosage and administration Stiberil solution is used to treat the affected area of the skin and the surrounding skin once a day, after thoroughly cleaning and drying the affected area. In this case, the solution should be applied to an area of approximately 1 cm of healthy skin around the affected area. Duration of treatment: For dermatomycoses - 2-4 weeks (up to 8 weeks if necessary); for candidiasis - 4 weeks; for nail infections - up to 6 months. For fungal nail diseases, it is recommended to use the preparation 2 times a day. Before the first use, it is necessary to remove as much of the affected part of the nail as possible with scissors or clippers (to facilitate the procedure, it is allowed to treat the nails with special softening agents on the recommendation of a doctor). For mycosis of the external auditory canal, treatment lasts at least 14 days. Local treatment is carried out by placing a tampon moistened with Stiberil solution in the ear for 5-8 minutes, 1-2 times a day. To prevent relapses, treatment with the preparation should be continued for at least 2 weeks after the disappearance of the main symptoms. Children. Data on the efficacy and safety of the preparation in children are insufficient, therefore, the administration of the preparation in this group of patients is not recommended. Side effects In isolated cases, local reactions may occur: dry skin, redness and burning sensation, erythema, itching, local irritation. Side effects are reversible and do not require discontinuation of treatment. Pregnancy and lactation When used according to the instructions, the effect of Stiberil on the fetus and newborn is unlikely. Results of teratogenicity studies confirm the absence of embryotoxic effects of naftifine. During pregnancy and lactation, the preparation is prescribed by a doctor after assessing the benefit/risk. Lactating mothers should ensure that the preparation does not come into contact with the child's skin and digestive system.