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Active ingredients
Terbinafin
Release form
Cream
Composition
Lyophilisate: each vial contains: Active ingredient: famotidine 20 mg. ; Excipients: aspartic acid - 8.8 mg, mannitol - 44.0 mg. ; Solvent: 0.9% sodium chloride solution: each ampoule contains: sodium chloride - 45.0 mg, water for injections - up to 5.0 ml.
Pharmacological effect
Mechanism of action; Terbinafine is allylamine, which has a wide range of antifungal activity. In low concentrations, terbinafine has fungicidal activity against dermatophytes, molds and some dimorphic fungi. The effect on yeast fungi can be fungicidal or fungistatic, depending on the type of fungus. The drug has a long-lasting effect, which allows to achieve the effect in a short period of treatment. ; Terbinafine affects the early stage of sterol biosynthesis by inhibiting squalene epoxidase, and this causes a deficiency of ergosterol and intracellular accumulation of squalene, which leads to the death of the fungal cell. ; Terbinafine inhibits the enzyme squalene epoxidase, located on the cell membrane of the fungus. The enzyme squalene epoxidase does not belong to the cytochrome P450 system. ; Terbinafine does not affect the metabolism of hormones or other drugs.
Pharmacokinetics
When applied topically, the absorption is less than 5%, the drug exhibits a slight systemic effect. With the use of the drug Terbisil cream for 7 days, the concentration in the stratum corneum of the skin exceeds the fungicidal and persists for at least 7 days after discontinuing the use of the drug.
Indications
Dermatomycoses of smooth skin caused by the fungi Trichophyton, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum; Candida infections of the skin caused by Candida yeasts; Mycosis of the scalp (hairy part); The versicolor versicolor caused by Pityrosporum orbiculare (Malassezia furfur).
Contraindications
Hypersensitivity to the active substance or auxiliary components of the drug.
Use during pregnancy and lactation
Use during pregnancy and lactation. Gestation period During animal studies, no embryotoxic action of terbinafine was observed. Since clinical experience with the drug during pregnancy is limited, the drug should not be used in pregnant women, unless, according to the doctor, the expected positive effect for the mother outweighs the potential risk to the fetus. ; The period of breastfeeding.Terbinafine penetrates into breast milk, so the drug should not be prescribed by breastfeeding. It is necessary to avoid contact of children with skin areas on which the drug is applied, including the mammary glands. The effect on fertility. In studies conducted on animals, no effect on fertility was observed.
Dosage and administration
used in adults and children over the age of 12 years. ; The drug Terbisil cream can be applied 1 or 2 times a day depending on the evidence. Before applying the cream must be carefully cleaned and dried the affected areas. To apply cream with a thin layer on the affected skin and adjacent sites, slightly rubbing. In case of infections with diaper rash (under the mammary glands, in the interdigital zone, in the inguinal region and between the buttocks), the places of application can be covered with gauze, especially at night. The duration and frequency of use of the drug depends on the severity of the course of the disease: foot dermatophytosis, inguinal dermatophytosis and torso dermatophytosis - once a day for 1 week; ; squamous-hyperkeratotic dermatophytosis of the feet (mocasin foot) - 2 times a day for 2 weeks; ; skin candidiasis - 1-2 times a day for 1 week; ; versicolor versicolor - 1-2 times a day for 2 weeks. ; For elderly patients, dose adjustment is not required. The reduction in symptoms is usually noted within a few days after the start of treatment. In the case of irregular use or premature termination of treatment, there is a risk of recurrence of the infection. In the absence of signs of improvement after 2 weeks. treatment should consult a doctor.
Side effects
in places where the preparation is applied, itching, peeling, pain, irritation, pigmentation disturbance, burning, redness of the skin, formation of a crust may occur. These safe symptoms should be distinguished from a hypersensitivity reaction accompanied by a rash. Such reactions are rare, but it should stop using the drug. ; Eye contact may cause irritation. ; In rare cases, possible exacerbation of the main fungal infection. ; Possible side effects: on the part of the immune system: hypersensitivity reactions, including urticaria *. ; On the part of the organ of vision: eye irritation.; On the part of the skin and connective tissue: peeling of the skin, itching, skin integrity problems, skin formation, skin lesions, pigmentation disorders, erythema, burning sensation of the skin, dry skin, contact dermatitis (including bullous dermatitis), eczema, rash *. ; General disturbances and reactions at the site of application: pain, pain at the site of application, irritation at the site of application, exacerbation of symptoms, increase in skin temperature at the site of application. ; * Data obtained in the process of post-marketing observations.
Overdose
low systemic absorption of terbinafine in the form of a cream determines the extremely low probability of overdose. Random ingestion of 2 tubes of cream of 15 g (300 mg of terbinafine) corresponds to the intake of the active ingredient 1 tablet of the drug Terbisil 250 mg. ; In case of accidental ingestion of the cream, symptoms of an overdose of pills of terbinafine (for example, headache, nausea, pain in the epigastric region and dizziness) may occur. The treatment recommended in case of overdose includes measures for the removal of the drug, primarily through the administration of activated carbon, and, if necessary, the use of symptomatic maintenance therapy.
Interaction with other drugs
drug interactions for terbinafine in cream form are unknown.
special instructions
Terbisil Cream is for external use only. ; Avoid getting the cream in the eyes, because it can cause irritation. In case of accidental ingestion of the drug in the eyes, they should be immediately washed with running water. ;Keep out of the reach of children. ; The cream contains cetyl and cetostearyl alcohols, which can cause local skin reactions (for example, contact dermatitis). ;Children. Experience with the use of terbinafine in children under the age of 12 years is limited, so the drug should not be administered to patients in this age group. ; The ability to influence the reaction rate when driving vehicles or other mechanisms. Terbisil cream does not affect the ability to drive vehicles and other mechanisms.