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

Excipients: sodium hydroxide 1.2 mg, benzyl alcohol 10 mg, sorbitan stearate 19 mg, cetyl palmitate 20 mg, cetyl alcohol 40 mg, cetostearyl alcohol (cetyl alcohol 60%, stearic alcohol 40%) 40 mg, polysorbate 60 61 mg, isopropyl myristate 80 mg, purified water 718.8 mg.

Description:The cream is white or almost white with a light smell of almonds.

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. Terbinafine has a fungicidal action against dermatophytes (Trychophyton rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. tonsurans, Microsporum canis, Epidermophyton floccosum), molds and certain dimorphic fungi (Pityrosporum orbiculare). Activity with respect to yeast-like fungi (mainly Candida albicans), depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically changes the early stage of biosynthesis of sterols 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 inhibiting 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:At external application absorption - less than 5%, renders insignificant system action. Quickly penetrates through the skin and accumulates in the sebaceous glands. High concentrations are created in the hair follicles and hair, after a few weeks of application penetrates into the nail plates; accumulates in the stratum corneum and in the nails in concentrations that provide fungicidal action. Do not cum in the body. Penetrates into breast milk.

Indications:

Fungal skin diseases caused by sensitive pathogens (trichophytosis, microsporia, epidermophytia, rubrophytic and candidiasis of the skin), multi-colored lichen.

Contraindications:

Hypersensitivity to the components of the drug.

Lactation period.

Children under 12 years of age (lack of sufficient clinical experience).

Carefully:

Renal / hepatic insufficiency, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities, pregnancy.

Pregnancy and lactation:

There are no data on the safety of terbinafine during pregnancy. therefore terbinafine should be used during pregnancy only if the intended benefit to the mother exceeds the possible risk to the fetus.

Lactation period

Terbinafine is excreted in breast milk. Its use during breastfeeding is contraindicated. If necessary, during treatment with terbinafine, breastfeeding should be discontinued.

Dosing and Administration:

Outwardly.

The duration of treatment depends on the nature and severity of the disease.

Adults: Before applying the cream, it is necessary to clean and dry the affected areas. 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 gauze, especially at night.

Average duration of treatment:

Dermatomycosis of the trunk, legs: 1-2 times a day, 1 week.

Dermatomycosis of feet: 1-2 times a day, 2 weeks.

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

Multicolored lichen: 1-2 times a day, 2 weeks.

For elderly patients, dose adjustment is not required.

Side effects:In places where the product is applied, redness, itching or burning sensation may appear. Allergic reactions.

Overdose:

No cases of drug overdose have been reported.

If you accidentally take the cream inside, you may experience symptoms of an overdose of Terbizil® tablets (headache, nausea, epigastric pain, dizziness, frequent urination).

Treatment: Activated charcoal, if necessary - symptomatic

maintenance therapy.

Interaction:Any drug interactions for Terbizil® cream are not known.

Special instructions:

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

Terbizil® cream is for external use only. Avoid contact with eyes, as it can cause irritation. In case of accidental ingestion of the drug into the eyes, they should be washed immediately with running water, and in case of persistent irritation, consult a physician.

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

During treatment, general hygiene rules should be followed to avoid re-infection through linens and shoes.

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

Form release / dosage:

Cream for external use, 1%.

15 grams of cream in an aluminum tube. 1 tuba together with instructions for use in a cardboard bundle.

Packaging:(15) - Aluminum tube (1) / 15 grams of cream in an aluminum tube. 1 tuba together with instructions for use in a cardboard bundle. / - cardboard pack

Storage conditions:

Store at temperatures between 15 and 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:П N013952 / 02

Date of registration:30.12.2011

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER OJSC Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp18.09.2015

Illustrated instructions

Instructions

Terbisil® (Terbisil®)