Lamisil Dermgel for treatment of foot fungus, gel 1%, 15g

Product description

Lamizil Dermgel is an antifungal drug in the form of a gel. The Active ingredient of Lamisil terbinafine gel is used for the prevention and treatment of fungal infections of the skin, including foot fungus. It has a fungicidal effect, with the help of which it fights an infection that causes fungi (mycosis) of the foot. * Suitable for use in adults and children from 12 years of age. * * Instructions for medical use, RU No. P N013364 / 01 from 06.08.2010

Composition

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of 1 g of gel contains:

Active ingredient:

terbinafine (in base form)10 mg;

Auxiliary substances:

benzyl alcohol;

carbomer (carbopol 974 P);

isopropyl myristate;

butylhydroxytoluene;

sorbitan laurate;

polysorbate 20;

sodium hydroxide;

ethanol;

purified water;

nitrogen.

Pharmacological action

Antifungal drug for external use, which has a wide spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), mold (mainly Candida albicans) and some dimorphic fungi (Pityrosporum orbiculare). Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic. Terbinafine specifically alters the early stage of sterol biosynthesis occurring in fungi. This leads to ergosterol deficiency and intracellular squalene accumulation, which causes fungal cell death. The action of terbinafine is carried out by inhibiting the squalene oxidase enzyme located on the cell membrane of the fungus. Terbinafine has no effect on the cytochrome P 450 system in humans and, accordingly, on the metabolism of hormones or other drugs.

Clinical pharmacology

When applied externally, the absorption of terbinafine is less than 5%. The systemic effect is insignificant.

Indications

Prevention and treatment of fungal infections of the skin, including mycoses of the feet (tinea pedis), inguinal epidermophytia (tinea cruris), fungal lesions of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum), Microsporum canis and Epidermophyton floccosum; multicolored lichen (Pityriasis versicolor) caused by Pityrosporum orbiculare (Malassezia furfur).

Use during pregnancy and lactation

Clinical experience with Lamizil® Dermgel for external use during pregnancy is very limited, its use is possible if the intended benefit to the mother exceeds the potential risk to the fetus. Terbinafine is excreted in breast milk, so it should not be prescribed to nursing mothers. No teratogenic properties of terbinafine were found in experimental studies. To date, no malformations have been reported with Lamizil® Dermgel.

Recommendations for use

Caution should be exercised when applying the product to damaged areas of the skin, as the alcohol contained in the product can cause irritation.

Contraindications

Hypersensitivity to terbinafine or to any component of the drug. breast-feeding period; children under 18 years of age.

Side effects

Determining the frequency of side effects: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (Immune system disorders: isolated reports of hypersensitivity reactions (rash). From the side of the organ of vision: rarely-eye irritation. From the skin: often-peeling of the skin, itching; infrequently-skin damage, crusting, skin damage, pigmentation disorder, erythema, burning sensation of the skin; rarely-feeling of dry skin, contact dermatitis, eczema; individual reports-rash. Local reactions: infrequently-pain, pain at the site of application, irritation at the site of application; rarely-exacerbation of symptoms of the disease. In places where the drug is applied, itching, peeling of the skin, pain, irritation, changes in skin pigmentation, burning, erythema, crusts may occur. These minor symptoms should be distinguished from hypersensitivity reactions, such as rash, which occur in rare cases and require discontinuation of therapy. In rare cases, the course of a fungal infection may worsen.

Interaction

Currently, the drug interaction of Lamizil® Dermgel is not described.

How to take, course of use and dosage

Externally. Before the first use of Lamizil® Dermgel the sealing membrane should be pierced with a point on the outside of the cap. Lamisil® Dermgel is used in adults 1 time / day for any of the indications. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is lightly rubbed into the areas of both the affected and adjacent intact skin. In the case of infections accompanied by diaper rash (under the mammary glands, between the fingers, in the buttocks and inguinal folds), the area of application of the gel can be covered with gauze, especially at night. Duration and frequency of use of Lamizil® Dermgel for dermatomycosis of the trunk, legs-1 week,1 time/day; for dermatomycosis of the feet-1 week,1 time/day; for multi-colored lichen-1 week,1 time/day. A decrease in the severity 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 recurrence of infection. If there are no signs of improvement after a week of treatment, the diagnosis should be verified. No dosage adjustment is required for elderly patients.

Overdose

About cases of overdose of Lamizil® Dermgel was not reported. Symptoms: accidental ingestion of a 30 g tube containing 300 mg of terbinafine base is comparable to taking 1 tablet of Lamizil® with a dosage of 250 mg (a single dose for an adult). If you accidentally take a larger amount of Lamizil® Oral dermgel can be expected to develop the same side effects as with an overdose of Lamizil® tablets (headache, nausea, epigastric pain and dizziness). Please also note that the spray contains ethyl alcohol (9.4% by volume). Treatment: activated charcoal, if necessary, carry out symptomatic therapy.

Description

Gel for external use 1% shiny, from white to almost white in color.

Special instructions

Lamisil® Dermgel is intended for external use only. The drug should not be applied to the face. Avoid contact with the drug in the eyes, as it may cause irritation. In case of accidental contact, the eyes should be immediately rinsed with running water, and in case of persistent irritation, consult a doctor. The drug contains butylhydroxytoluene, which can cause local allergic reactions (contact dermatitis), as well as irritation of the eyes and mucous membranes at the application sites. Please note that the drug contains 96% ethanol. Caution should be exercised when applying Lamizil® Dermgel on damaged areas of the skin, as the alcohol included in its composition can cause irritation. The ability to drive vehicles and mechanisms is not affected.

Form of production

Gel for external use 1% shiny, from white to almost white in color.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C.

Shelf life

3 years

Active ingredient

Terbinafine

Dosage form

gel for external use