Terbinafine-MFF - instructions for use, dose, side effects, contraindications

Pharmacological properties. Antifungal agent for topical use, with a wide range of antifungal activity. In small concentrations terbinafine has a fungicidal action against dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T. violaceum, T.tonsurans, Microsporum canis, Epidermophyton floccosum), moldy Candida albicans and certain dimorphic fungi (Pityrosporum orbiculare). Activity with respect to yeast fungi, depending on their type, may 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:

With topical application, absorption - less than 5%, has a minor systemic effect.

Indications:

Prevention and 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 ccinis 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 any of the inactive ingredients that make up the drug. Chronic or active liver disease, CRF (CK 50 ml / min), 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.The use of the drug during pregnancy is possible in those cases when the intended use for the mother exceeds the possible risk for the fetus. Terbinafine excreted in breast milk. If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

Dosing and Administration:

Outwardly.

Adults and children from the age of 12:

Before applying the ointment, it is necessary to clean and dry the affected areas. Ointment 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 ointment can be covered with gauze, especially at night.

Average duration of treatment:

Dermatomycosis of the trunk, drumsticks: 1 week 1 time per day Dermatomycosis stop: 1 week 1 time per 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 one or two weeks of treatment there are no signs of improvement, the diagnosis should be verified.

The mode of dosing of terbinafine ointment in elderly people does not differ from the above.

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

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 by accident terbinafine ointment will be taken orally, it is possible to expect the development of the same side effects as in the case of an overdose of terbinafine tablets (headache, nausea, epigastric pain and dizziness).

Treatment: Activated charcoal, if necessary - symptomatic maintenance therapy.

Interaction:

Any drug interactions for terbinafine ointments 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.

Terbinafine ointment 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.

Form release / dosage:

Ointment for external use 1%.

By 10 g or 15 g in aluminum tubes with bush of polymeric materials. The tube with instruction for use is packed in a cardboard box.

Packaging:(1) - aluminum tubes (1) - cardboard packs

Storage conditions:

Storage conditions. Store at a temperature not exceeding + 25 ° C.

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:LSR-008761/09

Date of registration:02.11.2009

The owner of the registration certificate:MOSCOW PHARMACEUTICAL FACTORY, CJSC MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia

Manufacturer: & nbsp

MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia

Information update date: & nbsp20.09.2015

Illustrated instructions

Instructions

Terbinafine-MFF (Terbinafine-MFF)