Binafin cream 1%, 10 g (terbinafine)

Latin name

BINAFIN



packing 10 gt

Pharmacological action

binafin - a wide spectrum antifungal.

Pharmacodynamics

Terbinafine is allylamine, which has a wide spectrum of action against fungi that cause diseases of the skin, hair and nails, including dermatophytes such as Trichophyton (e.g. T.rubrum, T.mentagrophytes, T.tonsurans, T.verrucosum, T.violaceum), Microsporum (e.g. M. canis), Epidermophyton floccosum, as well as yeast-like fungi of the genus Candida (e.g. Candida albicans) and Pityrosporum . In low concentrations, terbinafine has a fungicidal effect against dermatophytes, molds, and some dimorphic fungi. Activity against yeast-like fungi, depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically inhibits the early stage of biosynthesis of sterols in the fungal cell. This leads to a deficiency of ergosterol and intracellular accumulation of squalene, which causes the death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase in the cell membrane of the fungus. This enzyme does not belong to the cytochrome P450 system. Terbinafine does not affect the metabolism of hormones or other drugs. When Binafin is administered orally in the skin, hair and nails, drug concentrations are created that provide a fungicidal effect.

Pharmacokinetics

After a single oral administration of terbinafine at a dose of 250 mg of Cmax in plasma, it is reached after 2 hours and is 0, 97 mcg / ml. The half-absorption period is 0.8 hours and the half-life is 4.6 hours. No dose adjustment is required when taken with food. Terbinafine largely binds to blood plasma proteins (99%), quickly penetrates the dermal layer of the skin and concentrates in the lipophilic stratum corneum. Terbinafine also penetrates the secretion of the sebaceous glands, which leads to the creation of high concentrations in the hair follicles, hair and in the skin, rich in sebaceous glands. Terbinafine has also been shown to penetrate the nail plates in the first few weeks after starting therapy.

Terbinafine is metabolized rapidly and substantially with the participation of at least seven isoenzymes of cytochrome P450, with the major role played by the isoenzymes CYP2C9, CYP1A2, CYP3A4, CYP2C8 and CYP2C19. As a result of the biotransformation of terbinafine, metabolites are formed that do not have antifungal activity and are excreted mainly in the urine. The final T1 / 2 of the drug is 17 hours. There is no evidence of cumulation of the drug in the body. No changes in plasma Css of Binafin were detected depending on age, but in patients with impaired renal or hepatic function, the drug excretion rate may be slowed, which leads to higher concentrations of terbinafine in blood plasma. In pharmacokinetic studies of a single dose of binafin in patients with concomitant liver diseases, the possibility of reducing the clearance of the drug by 50% was shown.

Indications of

fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T.rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T.interdigitale, T. tonsurans, T. gipseum), Microsporum canis and Epidermrdlpcoscos yeast skin infections mainly those caused by the genus Candida (e.g. Candida albicans)

versicolor (Pityriasis versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Contraindications

Hypersensitivity to terbinafine or any other component that is part of binafin.

Use during pregnancy and lactation

The drug during pregnancy should be used only according to very strict indications and if the expected benefit to the mother outweighs the potential risk to the fetus and the baby. If necessary, the appointment of the drug during lactation should decide on the termination of breastfeeding.

Composition

1 g of cream contains: Active substance: terbinafine hydrochloride 10 mg

Excipients: ketosteryl alcohol, white soft paraffin, liquid paraffin, ketomacrogol, methyl paraben, propyl paraben, isopropyl myristate, sodium phosphate acid, purified water.

Dosage and Administration

Externally. Adults and children from 12 years of age and older Binafin can be applied to the skin 1 or 2 times a day. Before applying the cream, it is necessary to clean and dry the affected areas. The cream is applied in a thin layer to the affected skin and adjacent areas and rubbed lightly.

For infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the inguinal region), the place of application of the cream can be covered with gauze, especially at night.

Average duration of treatment: dermatomycosis of the trunk, lower legs and feet - 1 week, once a day, skin candidiasis - 1-2 weeks, 1 or 2 times a day, versicolor versicolor - 2 weeks, 1 or 2 times a day.

A decrease in the severity of clinical manifestations is usually observed in the early days of treatment. In the case of irregular treatment or premature termination of it, there is a risk of a renewed infection. In the event that after 2 weeks of treatment there are no signs of improvement, the diagnosis should be verified.

Use of the drug in the elderly. There is no reason to assume that for the elderly it is required to change the dosage of the drug or that they have side effects that differ from those in patients of a younger age.

Use of the drug in children. The use of this drug in children under 12 years of age is not recommended.

Side effects of

In rare cases, redness, itching or burning sensation were noted at the site of application of the drug, however, these phenomena rarely led to the need to discontinue treatment. The above symptoms should be distinguished from allergic reactions (for example, urticaria) that rarely occur, but if they occur, stop treatment.

Overdose

Symptoms: headache, dizziness, nausea, epigastric pain.

Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy.

Storage conditions

The cream should be stored out of the reach of children at 2 ° to 30 ° C.

Shelf life

3 years.

Deystvuyushtee substance

Terbinafine

Terms and conditions

without prescription

dosage form

cream

Shreya, India



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