Ламизил®

General characteristics. Structure:

Active agent - 10 mg of a terbinafin of a hydrochloride
Excipients:
benzyl alcohol, sodium hydroxide, sorbitan stearate, tsetit palmitate, stearyl alcohol, cetyl alcohol, polysorbate 60, an isopropyl myristate, the water purified.

Description. White homogeneous cream with a slight characteristic smell.

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"), orogovelost, cracks, an itch and the peeling of skin caused by a 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.

Barmy infections of skin, generally those which are caused by the sort Candida (for example, Candida albicans), in particular an intertrigo.

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

Route of administration and doses:

Outwardly.

Adults and children since 12 years: Before putting cream it is necessary to clear and dry affected areas. Cream is applied by one or two times a day with a thin layer on the affected skin and adjacent sites and slightly rub. At the infections which are followed by an intertrigo (under mammary glands, in interdigital intervals, between buttocks, in inguinal area), sites of application of cream can be covered with a gauze, especially for the night. At extensive fungal infections of a body it is recommended to apply cream in tubas on 30 g.

Average duration of treatment:
Dermatomycosis of a trunk, shins: 1 week once a day
Dermatomycosis of feet: 1 week once a day; orogovelost, cracks, an itch and a peeling of skin caused by a foot fungus - 2 weeks 1-2 times a day;
Skin candidiasis: 1-2 weeks 1 or 2 times a day;
Multi-colored deprive: 2 weeks 1 or 2 times a day.

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 resuming of an infection. If in one-two weeks of treatment improvement signs are not noted, it is necessary to carry out verification of the diagnosis.

The mode of dosing of Lamizil of cream at elderly people does not differ from the aforesaid.

Use of drug for children. Use of this drug for children up to 12 years 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.

Lamizil cream 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. 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 cream 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 cream 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).

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

Storage conditions:

Period of validity. 5 years. Not to use after expiry date. To store at a temperature not above 30 °C, in the places unavailable to children.

Issue conditions:

Without recipe

Packaging:

On 15 g or 30 g - a tuba aluminum with a protective membrane from aluminum, the cover from polypropylene supplied with a ledge for perforation of a membrane. The tuba with the application instruction is packed into a cardboard pack.