Ламизил® Dermogel

General characteristics. Structure:

Active agent - тербинафин in the form of the basis of 10 mg.
Excipients:
benzyl alcohol, carbomer (карбопол 974 P), an isopropyl myristate, butyl hydroxytoluene, sorbitan laurate, polysorbate 20, sodium hydroxide, ethanol, the purified water, nitrogen.

Description: brilliant gel, color from white to almost white.

Pharmacological properties:

The antifungal drug for topical administration possessing a wide range of antifungal activity. In small concentration тербинафин has fungicidal effect concerning dermatophytes, mold and certain dimorphous mushrooms. 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:

It is applied at adults and children from 12 years.
Outwardly. Lamizil Dermgel apply on any of indications once a day.
Before use of drug it is necessary to clear and dry affected areas carefully. Lamizil Dermgel slightly rub to sites as struck, and adjacent intact skin. In case of the infections which are followed by an intertrigo (under mammary glands, between fingers, in buttock and inguinal folds), the field of drawing Dermgel can be covered with a gauze, especially at night.
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; 1 time 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 a recurrence of an infection. If in a week of treatment improvement signs are not noted, it is necessary to verify the diagnosis.

Patients of advanced age. Change of the mode of dosing is not required from elderly people.

Features of use:

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

Lamizil Dermgel 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 in a week of treatment improvement signs are not noted, it is necessary to verify the diagnosis.

Before the first use of drug it is necessary to puncture the sealing membrane by means of an edge on outer side of a cap.

Side effects:

In sites of application of drug reddening, feeling of an itch or burning can appear, however the termination of treatment because of these phenomena is required seldom. These, not so serious by-effects, it is necessary to distinguish from seldom arising allergic reactions (for example, generalized rash and/or reddening, a small tortoiseshell, a Quincke's disease, repeated allergic reaction) which development demands the treatment termination.

The patient has to mean that in case of the undesirable phenomenon which is not mentioned in a leaf insert he / she should report about this phenomenon to the attending physician.

Interaction with other medicines:

Any medicinal interactions for Lamizil Dermgel are not described.

Contraindications:

Hypersensitivity to a terbinafin or to any component of drug, the lactation period, children's age (up to 12 years).

Use during pregnancy and a lactation. In the researches conducted at animal, 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 Dermgel for pregnant women is very limited, it should be applied only according to strict indications.

Terbinafin is allocated with breast milk therefore nursing mothers should not appoint drug.

Overdose:

About cases of overdose of Lamizil Dermgel it was not reported. If accidentally drug is accepted inside, it is possible to expect emergence of the same symptoms which is observed at overdose of tablets (for example, a headache, nausea, pain in epigastriums and dizziness).

Storage conditions:

Period of validity: 3 years. Not to use drug after the period of validity specified on packaging. At a temperature not above 30 °C, in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

Gel for external use of 1%.
On 5 g, 15 g or 30 g of drug in an aluminum tuba with a protective membrane from aluminum and the cover from polypropylene supplied with a ledge for perforation of a membrane. The tuba with the application instruction is placed in a cardboard box.