Expiration date: 04/2025
Clinico-pharmacological group:
An antifungal drug for external use
Release form, composition and packaging
Cream or gel for external use white or almost white, with a subtle scent.
1 g contains:
terbinafine hydrochloride 10 mg
urea 100 mg
Excipients: butylhydroxytoluene (dibunol), macrogol cetostearyl (Eumulgin B2), cetostearyl alcohol (cetyl alcohol - 60%, stearyl alcohol 40%), poloxamer (amoxil-268), imagemachine (Germall), propylene glycol, liquid paraffin (vaseline oil), purified water - up to 1 year
Pharmacological action
Antifungal drug for local use. Terbinafine is the active ingredient Fungoterbine NEO, is allylamine and has a broad spectrum of antifungal activity.Terbinafine violates occurring in fungi the biosynthesis of ergosterol in the early stages. This leads to a deficiency of ergosterol and to an intracellular accumulation of squalene, which causes cell death of the fungus. The action of terbinafine by inhibiting the enzyme squalene epoxidase, located on the cell membrane of the fungus. This enzyme does not belong to cytochrome system P450, therefore, terbinafine does not affect the metabolism of hormones or other drugs.Terbinafine has fungicidal action against dermatophytes, molds and certain dimorphic fungi. Activity against yeasts, depending on their type, may be fungicidal or fungistatic.Urea, the second active ingredient Fungoterbine NEO, it has a soothing, exfoliating and moisturizing effect, can improve dermatovenerology (skin penetration) and create high concentrations of terbinafine in the skin. Urea helps to bind water and softening the Horny layer of the skin.
Pharmacokinetics
The local application of the cream is absorbed less than 5% of the dose, thus, the systemic effect of the drug is minimal. Very drying on the skin surface area of 30 cm2 in the urine detected 3.5% of the dose. The drug quickly penetrates the skin and accumulates in the sebaceous glands.
Dosage
Externally. The drug applied to the skin once or twice a day. Before applying the cream should be clean and dry affected areas. Cream applied in a thin layer to the affected skin and gently RUB.To increase the effectiveness of treatment, the use of occlusive dressings. Infections accompanied by diaper rash (under Breasts, in the interdigital intervals, between the buttocks, in the inguinal region), place of applying the cream can be covered with gauze, especially at night.The duration of the treatment depends on the indications and severity of the disease.Duration and frequency of use:ringworm of the body, legs: 1 per day 1 week.Ringworm of the feet: 1 per day 1 week.Candidiasis of the skin: 1 or 2 times a day for 1-2 weeks.Pityriasis versicolor: 1 or 2 times a day for 2 weeks.
Overdose
The cases of drug overdose were reported. In case of accidental ingestion can be expected to develop the same side effects as the overdose of tablets Fungoterbine, including: headache, nausea, gastralgia, dizziness, frequent urination, rash.Treatment: activated charcoal, if necessary, symptomatic therapy. Phenomena of overdose of urea when applied topically is not known.
Drug interactions
Any drug interactions with the use of terbinafine and urea topically is not known.Pregnancy and lactarian experimental studies of teratogenic properties of terbinafine have been identified. The use of the drug during pregnancy is possible in cases where the potential benefit to the mother outweighs risk to the fetus. The use of the drug with caution during lactation.
Side effects
In rare cases redness, itching or burning sensation at the site of application of the cream, however, these phenomena have rarely led to the need to stop treatment. The above symptoms must be distinguished from allergic reactions such as hives, which occur rarely, however, when they occur, discontinue treatment.
Terms and conditions storage
At temperatures above 20°C. Keep out of reach of children. Shelf life - 2 years.
Testimony
Treatment and prevention of fungal infections:— fungal infections of the skin caused by dermatophytes, including Trychophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum, infection of the skin caused by yeast fungi of the genus Candida(e.g. Candida albicans),— pityriasis versicolor (Pityrosporum versicolor), called Pityrosporum orbiculare (also called Malassezia furfur).
Contraindications
— hypersensitivity to the drug, children's age (up to 2 years).With astronautica and/or kidney failure, alcoholism, blood diseases, skin tumors, metabolic diseases, pathology receptacles limbs, children up to age 12 years, pregnancy, lactation.
Special instructions
The decrease in the severity of clinical manifestations usually noted in the first days of treatment. In the case of irregular treatment or premature termination there is a risk of renewed infection. If no signs of improvement after 1-2 weeks of therapy should be to verify the diagnosis.The cream is intended for external use only. You should avoid contact with the mucous membrane of the eyes, nose, mouth. At contact of the drug with mucous membranes, rinse with water and if necessary consult a doctor.Used in the dysfunction of packrellerey with caution in renal failure.Used in the dysfunction of pictipennis with care at hepatic insufficiency.
