Terbinafine - instructions for use, doses, side effects, contraindications

Composition:Ingredients per 100 g: active substance: terbinaphin hydrochloride (in terms of 100% substance) - 1.0 g; Excipients: wax emulsion - 10.0 g, glycerol - 5.0 g, sunflower oil (refined, deodorized, grade P) 5.0 g, glyceride monostearate 2.0 g, urea 0.5 g, sodium benzoate 0 , 2 g, propylene glycol - 15.0 g, trolamine - 0.45 g, purified water - up to 100.0 g.

Description:

a cream from white to white with a yellowish or cream shade of color with a weak specific smell.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

Antifungal drug for external use, which has a wide range of antifungal activity. Has a fungicidal action against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), yeast-like fungi (mainly Candida albicans) and certain dimorphic (Pityrosporum orbiculare). Activity with respect to yeast-like fungi, depending on their type, may be fungicidal or fungistatic.

Terbinafine specifically changes the early stage of sterol biosynthesis occurring in fungi. This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes death of the fungal cell. The action of terbinafine is carried out by inhibition the enzyme squalene epoxidase, located on the cell membrane of the fungus.

Terbinafine has no effect on the cytochrome P450 system in humans and, accordingly, on the metabolism of hormones or other medications.

Pharmacokinetics:

When applied externally, the drug quickly penetrates the dermal layer of the skin and accumulates in the lipophilic stratum corneum. When external application is absorbed less than 5 % dose of the drug, so the absorption of terbinafine into the systemic blood flow is extremely low. With external application, the potential for drug to enter breast milk is not excluded.

Indications:

Prevention and treatment of fungal infections of the skin, including foot mycoses (fungus of the foot), hornfels, cracks, itching and flaking of the skin caused by the fungus of the foot; inguinal epidermophytes {tinea cruris), fungal lesions of the smooth skin of the body {tinea corporis), caused by such dermatophytes as Trychophyton (including, Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum), Microsporum canis and Epidermophyton floccosum.

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

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

Contraindications:

Hypersensitivity to terbinafine or to any of the inactive ingredients that make up the drug, children under 12 years of age (lack of sufficient clinical experience).

Carefully:

Hepatic and / or renal failure, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities.

Pregnancy and lactation:

In experimental studies teratogenic properties of terbinafine were not revealed. To date, no developmental deficiencies have been reported with terbinafine. However, since the clinical experience of terbinafine in pregnant women is very limited, it should be used only on strict indications.

Terbinafine is excreted in breast milk. However, in the case of the use of a nursing mother Terbinafine cream through the skin absorbed a small amount of active substance, so adverse effects on the baby is unlikely.

The use of the drug during pregnancy and lactation is possible only if the potential benefit to the mother exceeds the possible risk to the fetus and the baby.

Dosing and Administration:

Outwardly.

Adults and children from the age of 12:

Before applying the cream, it is necessary to clean and dry the affected areas of the skin.The cream is applied once or twice a day with 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 a gauze dressing, especially at night.

Average duration of treatment:

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

Dermatomycosis of the feet: 1 week 1 time per day; keratinism, cracks, itching and flaking of the skin caused by the "fungus" of the foot - 2 weeks 1-2 times a day.

Candidiasis of the skin: 1-2 weeks 1 or 2 times a day.

Multicolored lichen: 2 weeks 1 or 2 times a 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-week treatment there are no signs of improvement, the diagnosis should be verified.

The dosage regimen of terbinafine cream in elderly people does not differ from the above.

Side effects:Skin allergic reactions; burning sensation, redness and itching of the skin at the site of application.

Overdose:

No cases of drug overdose were reported in the local application.

In case of deliberate or accidental intake of terbinafine cream inside, you can expect the development of nausea, headache, epigastric pain and dizziness.

Treatment: gastric lavage, the reception of activated charcoal, if necessary - symptomatic maintenance therapy.

Interaction:

The drug interaction terbinafine in the form of a cream is not described.

Possible joint use with systemic antimycotics (terbinafine, fluconazole, itraconazole, nystatin).

Special instructions:

Terbinafine cream is for external use only. Avoid getting the drug on the mucous membranes of the eyes, nose, mouth. If the cream gets into the eyes, they should be washed immediately with running water, and in case of persistent irritation, consult a doctor.

When developing allergic reactions, it is necessary to cancel the drug.

When applying the cream, you should follow the rules of personal hygiene to prevent re-infection through underwear or shoes. In the process and at the end of treatment it is necessary to carry out antifungal treatment of shoes, socks, and linen.

Effect on the ability to drive transp. cf. and fur:Does not affect.

Form release / dosage:

Cream for external use 1%.

For 15 g in tubes are aluminum. Each tube, together with instructions for use, is placed in a cardboard pack.

Packaging:

In the dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-000045

Date of registration:22.11.2010

The owner of the registration certificate:BELMEDPREPARATY, RUP BELMEDPREPARATY, RUP Republic of Belarus

Manufacturer: & nbsp

BELMEDPREPARATY, RUP Republic of Belarus

Representation: & nbsp"Belmedpreparaty" RUP "Belmedpreparaty" RUP

Information update date: & nbsp20.09.2015

Illustrated instructions

Instructions

Terbinafine (Terbinafine)