Binafin - instructions for use, dose, side effects, contraindications

1 g of cream contains as active substance terbinafine hydrochloride - 10 mg and auxiliary substances in% by mass: ketomacrogol 1000 - 2.0, ketosterylic alcohol - 8.0, white soft paraffin - 12.0, liquid paraffin - 10.0, isopropyl myristate 5.0, methylparaben 0.15, propylparaben 0.0045, sodium hydrogen phosphate 0.62, purified water 61.10.

Description:

A white homogeneous cream with a soft consistency.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

Binafin in dosage form 1% cream is an antifungal agent for topical application. Terbinafine - active substance binafina, is an allylamine and has a wide range of antifungal effects. Binafin has a fungicidal action against dermatophytes, molds and some dimorphic fungi. Activity with respect to yeast-like fungi, depending on their type, may be fungicidal or fungistatic. Binafin breaks the biosynthesis of ergosterol in the fungi in the early stages. This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes death of the fungal cell. The action of binaphin is carried out by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus. This enzyme does not belong to the cytochrome P450 system. Binafin has no effect on the metabolism of hormones or other medications.

Pharmacokinetics:

When topical application of the cream is absorbed less than 5% of the dose, so the systemic effect of the drug is minimal.

Indications:

Fungal skin infections caused by dermatophytes, such as Trichophyton (eg, T.rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T.interdigitale, T. tonsurans, T. gipseum), Microsporum canis and Epidermophyton floccosum.

Yeast infections of the skin, mainly those that are caused by the genus Candida (eg, Candida albicans).

Multicolored lichen (Pityriasis versicolor), called Pityrosporum orbiculare (also known as Malassezia furfur).

Contraindications:

Hypersensitivity to binafine or to any other component that is part of the cream.

Pregnancy and lactation:

The drug during pregnancy should be apply only on very strict and if the expected benefit for the mother exceeds the potential risk to the fetus and the baby.

If it is necessary to prescribe the drug in lactation period should solve the problem of terminating breastfeeding.

Dosing and Administration:

Adults and children 12 years and older:

Binafin can be applied to the skin once or twice a day. Before applying the cream, it is necessary to clean and dry the affected areas. The cream is applied a thin layer on the affected skin and adjacent areas and lightly rubbed. In infections accompanied by intertrigo (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places of application of the cream can be covered with gauze, especially at night.

Average duration of treatment:

Dermatomycosis of trunk, drumsticks: 1 week 1 time per day.

Reducing the severity of clinical manifestations is usually noted in the first days of treatment. In the case of irregular treatment or premature termination, there is a risk of renewal of infection. In the event that after two weeks of treatment there are no signs of improvement, the diagnosis should be verified.

Application 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 are marked side effects, different from those in patients of younger age.

Use of the drug in children

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

Measures precautions at application:

Cream binafin is intended for external use only. Avoid contact with the eyes.

Side effects:

At the site of application in rare cases of redness, sensation itching or burning, but these phenomena are rare led to the need to stop treatment. These above symptoms should be distinguished from allergic reactions, such as urticaria that occur rarely, but when they appear, stop treatment.

Overdose:

On cases of overdose of binaphin not reported. If by accident the drug will be accepted inside, you can expect development of the same side effects as with an overdose of tablets of binaphin: nausea, a violation of appetite, pain in the upper half of the abdomen, diarrhea.

Interaction:

Currently, medicinal interactions are unknown.

Effect on the ability to drive transp. cf. and fur:It was not noted.

Form release / dosage:

1 % cream.

Packaging:In tubes of 10 g, 15 g, 30 g.

Storage conditions:

In a dry place at a temperature of 2 ° to 30 ° C. Keep out of the reach of children.

Shelf life:

3 years.

The drug should not be used after the period indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N014467 / 02-2002

Date of registration:17.11.2008

Expiration Date:Unlimited

The owner of the registration certificate:SHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India

Manufacturer: & nbsp

SHREYA LIFE SCIENCES, Pvt.Ltd. India

Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India

Information update date: & nbsp11.02.2017

Illustrated instructions

Instructions

Binafin (Binafin)