Ламизил®

General characteristics. Structure:

Active agent - 10 mg of a terbinafin of a hydrochloride
excipients:
macrogoal cetostearyl ether, ethanol, the water purified propylene glycol, nitrogen.

Description. Transparent colourless or light yellow liquid.

Pharmacological properties:

The antifungal drug for topical administration possessing a wide range of antifungal activity. In small concentration тербинафин has fungicidal effect concerning dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T.tonsurans, Microsporum canis, Epidermophyton floccosum), mold (in the main C.albicans) and certain dimorphous mushrooms (Pityrosporum orbiculare). Activity concerning barmy mushrooms, depending on their look, can be fungicidal or fungistatic.

Terbinafin in unusual way changes an early stage of the biosynthesis of sterol happening in mushrooms. It leads to deficit of ergosterol and to intracellular accumulation of squalene that causes death of a cell of a mushroom. Action of a terbinafin is carried out by inhibition of the enzyme of a skvalenepoksidaza located on a cellular membrane of a mushroom.

Terbinafin does not exert impact on system of P450 cytochrome at the person and, respectively, on metabolism of hormones or other medicines.

Pharmacokinetics. At topical administration absorption - less than 5%, have insignificant systemic action.

Indications to use:

Prevention and treatment of fungal infections of skin, including mycoses of feet (foot "fungus"), an inguinal epidermophitia (tinea cruris), fungal infections of smooth skin of a body (tinea corporis) caused by such dermatophytes as Trichophyton (including, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

Multi-colored deprive (Pityriasis versicolor), the caused Pityrosporum orbiculare (also known under the name Malassezia furfur).

Route of administration and doses:

Outwardly.

Adults. Lamizil it is possible to apply spray or solution 1 or 2 times a day, depending on indications. Before use of drug it is necessary to clear and dry affected areas carefully. Drug spray (spray) or apply (solution) on affected areas in the quantity sufficient for their careful moistening, and, besides, apply on adjacent sites as struck, and intact skin. At extensive fungal infections of a body it is recommended to apply spray of 30 ml.

Duration of treatment and frequency rate of use of drug:
dermatomycosis of a trunk, shins: 1 week; 1 time a day
dermatomycosis of feet: 1 week; 1 time a day
multi-colored deprive: 1 week; 2 times a day

The mode of dosing of Lamizil of spray or solution at elderly people does not differ from the aforesaid.

Lamizil's use spray or solution at children. Experience of use of Lamizil of spray or solution for children is limited in this connection use of drug for children is not recommended.

Features of use:

Reduction of expressiveness of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or its premature termination there is a risk of a recurrence of an infection. If in a week of treatment improvement signs are not noted, it is necessary to verify the diagnosis.

It is necessary to be careful when drawing Lamizil's on the damaged sites of skin as alcohol can cause irritation.

Lamizil spray or solution is intended only for external use. It is necessary to avoid hit it in eyes as it can cause irritation. At accidental hit of drug in eyes, they should be washed out immediately flowing water, and in case of development of the resistant phenomena of irritation it is necessary to consult with the doctor.

If the drug was accidentally administered in respiratory tracts at inhalation, then, in case of any symptoms and especially at their permanent preservation, it is necessary to consult with the doctor.

At development of allergic reactions it is necessary to cancel drug.

Side effects:

In sites of application of drug reddening, feeling of an itch or burning can appear. Allergic reactions.

Interaction with other medicines:

Any medicinal interactions for Lamizil of spray or solution are not known.

Contraindications:

Hypersensitivity to a terbinafin or to any of the inactive ingredients which are a part of drug.

With care: liver and/or renal failure, alcoholism, oppression of a marrowy hemopoiesis, tumor, metabolism disease, occlusal diseases of vessels of extremities, children's age (lack of sufficient clinical experience). Pregnancy and lactation. In pilot studies of teratogenic properties of a terbinafin it was not revealed. So far it was not reported about any malformations at Lamizil's use. However, as clinical experience of use of Lamizil for pregnant women is very limited, it should be applied only according to strict indications.

Terbinafin is allocated with breast milk. However, in case of use by the nursing mother of Lamizil of spray or solution through skin a small amount of active agent therefore an adverse effect on the baby is improbable is soaked up.

Overdose:

About cases of overdose of drug it was not reported. If accidentally Lamizil spray or solution is accepted inside, it is possible to expect development of the same by-effects, as well as at overdose of tablets of Lamizil (a headache, nausea, pains in epigastriums and dizziness). It is also necessary to consider the content in alcohol drug (23.5%).

Treatment: absorbent carbon, if necessary - a symptomatic maintenance therapy.

Storage conditions:

At a temperature below 30 °C, in the places unavailable to children. Not to freeze. A period of validity - 3 years. Not to use after expiry date.

Issue conditions:

Without recipe

Packaging:

Spray for external use of 1%: on 15 ml or 30 ml in a bottle of a cylindrical form from polypropylene of high density with a corrugated metal neck, a tip sprayer from polypropylene, a cap from polyethylene of the high density (PEVP). The bottle with the application instruction is packed into a cardboard pack.

Solution for external use of 1%: On 30 ml in a bottle of a flyazhkovidny form from PEVP with a cone-shaped nozzle dropper from polyethylene of the low density (PENP) and the screw-on cover from PEVP supplied with the control system of the first opening. The bottle with the application instruction is placed in a cardboard pack.