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

Excipients: Macrogol-400 - 100 mg; propylene glycol 50 mg; povidone-K17-50 mg; macrogol glyceryl hydroxy stearate-5 mg; ethanol 95% (in terms of anhydrous) - 330 mg; purified water - up to 1 g.

Description:a clear, colorless or light yellow liquid with a characteristic odor of ethanol.Weak opalescence is allowed.

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. At low concentrations, it has fungicidal activity against dermatophytes (Trychophyton rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. tonsurans, Microsporum canis, Epidermophyton floccosum), moldy C. albicans) and certain dimorphic fungi (Pityrosporum orbiculare).

Activity with respect to yeast is fungicidal or fungistatic in nature depending on the type of fungi.

Terbinafine, by inhibiting squalene epoxidase in the cell membrane of the fungus (not related to the cytochrome P450 system), specifically inhibits the early stage of sterol synthesis in the fungal cell, resulting in ergosterol deficiency, squalene accumulation and fungal cell death.

Terbinafine has no effect on the metabolism of hormones or other drugs.

Pharmacokinetics:With topical application, absorption is less than 5%, has a minor systemic effect.

Indications:

Treatment of fungal infections of the skin, including mycosis of the feet ("fungus" of the foot), inguinal epidermophyte (tinea cruris), fungal lesions of smooth skin of the body (tinea corporis), caused by such dermatophytes as Trichophyton (including, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

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

Contraindications:Hypersensitivity to terbinafine and any other components of the drug, children's age (up to 12 years).

Carefully:

Renal / hepatic insufficiency, 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 clinical experience with terbinafine in pregnant women is limited, it should only be used if the intended benefit to the mother exceeds the potential risk to the fetus.

Terbinafine in small amounts excreted in breast milk. It is not known whether this small amount can have a negative impact on the baby during breastfeeding. If it is necessary to use the drug during lactation it is recommended to stop breastfeeding.

Dosing and Administration:

Outwardly.

Adults and children from 12 years of age are sprayed on the affected areas of the skin (after cleansing and drying) and adjacent areas 1 or 2 times a day in an amount sufficient for moisturizing.

Duration and frequency of application: dermatomycosis of the trunk, shins - 1 time per day for 1 week; inguinal dermatomycosis- 1 time per day for 1 week; dermatomycosis stop -1 once a day for 1 week; multicolored lichen-2 once a day for 1 week.

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

Side effects:

When assessing the frequency of occurrence of various adverse reactions, the following grades are used: often 1-10%; infrequently, 0.1-1%; rarely - 0,01-0,1%; the frequency is unknown (it is not possible to determine the frequency of occurrence from the available data). Immune system disorders Frequency unknown: hypersensitivity.

Vision disorders Rarely: eye irritation.

General disorders and reactions at the site of application

Infrequently: pain, irritation, redness, itching and burning sensation in the place of application. Rarely: deterioration of the condition (increased clinical manifestations of fungal infection). Frequency unknown: hypersensitivity, systemic allergic reactions are possible (skin itch skin rash, bullous rashes, urticaria), requiring the drug to be withdrawn.

If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose:

Due to low systemic absorption, an overdose of the spray is extremely unlikely. If by accident Terbinafine the spray will be taken orally, you can expect the development of the same side effects as in overdose tablets (headache, nausea, epigastric pain and dizziness). It should also take into account the content in the preparation of ethyl alcohol (33 % by weight).

Treatment: Activated charcoal, if necessary - symptomatic

maintenance therapy.

Interaction:

Any drug interactions for terbinafine spray are not known. Since compatibility studies have not been conducted, it is not recommended to use the drug together with other agents for external use.

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.

Caution should be exercised when applying terbinafine spray to damaged areas of the skin, since alcohol can cause irritation.

Terbinafine spray 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.

If the drug has been accidentally injected into the respiratory tract by inhalation, then if any symptoms occur and, especially if they persist, it is necessary to consult a doctor.

Terbinafine spray contains propylene glycol, which can cause skin irritation.

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

Effect on the ability to drive transp. cf. and fur:After external use of terbinafine, no effects were reported,affecting the ability to drive vehicles or work with other mechanisms.

Form release / dosage:

Spray for external use 10 and 20 g.

10 and 20 g in neutral glass bottles, sealed with a crimping microsprayer, with a spray nozzle and a protective cap. Each bottle is placed in a pack of cardboard.

Packaging:(10) - tube (1) / with instruction for use / - Package made of cardboard
(15) - tube (1) / with instructions for use / - Cardboard package

Storage conditions:

At a temperature of 2 to 20 ° C in a dark place. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-002176

Date of registration:25.01.2012

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp18.09.2015

Illustrated instructions

Instructions

Terbinafine (Terbinafine)