Lamisil cream 1%, 30 g

Prevention and treatment of fungal skin infections:

• mycoses of the feet (tinea pedis); keratinization, cracks, itching and peeling of the skin caused by foot fungus; epidermophytosis inguinal (tinea craris), fungal infections of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum;

• yeast infections of the skin, mainly those caused by fungi of the genus Candida (for example, Candida albicans), in particular diaper rash;

• versicolor versicolor (Pityriasis versicolor) caused by Pityrosporum orbiculare (Malassezia furfur).

In adults and children over 12 years old, LamisilЃ cream can be used 1 or 2 times / day, depending on the indications. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The cream is applied in a thin layer to the affected skin and surrounding areas and rubbed lightly. In case of infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places where the cream is applied can be covered with gauze, especially at night.

In case of extensive fungal infections of the body, it is recommended to use the cream in tubes of 30 g.

The average duration of treatment and the frequency of use of the drug for dermatomycosis of the trunk, legs is 1 week, 1 time / day; with dermatomycosis of the feet - 1 week 1 time / day; with keratinization, cracks, itching and peeling of the skin caused by foot fungus - 2 weeks 1-2 times / day; with candidiasis of the skin - 1-2 weeks 1-2 times / day; with multi-colored lichen - 2 weeks 1-2 times / day.

A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. With irregular use or premature termination of treatment, there is a risk of re-infection. If there are no signs of improvement after 1-2 weeks of therapy, the diagnosis should be verified.

Correction of the dosage regimen of LamisilЃ cream in elderly patients is not required.

Active ingredient: terbinafine hydrochloride - 10 mg

Excipients: benzyl alcohol, sodium hydroxide, sorbitan stearate, cetyl palmitate, stearyl alcohol, cetyl alcohol, polysorbate 60, isopropyl myristate, purified water.

• hypersensitivity to terbinafine or to any of the inactive ingredients that make up the drug;

• breastfeeding period;

• children under 12 years of age (LamisilЃ cream);

• children under 18 years of age (LamisilЃ spray).

The drug is prescribed with caution to patients with hepatic and / or renal insufficiency, patients with chronic alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities.

Clinical and pharmacological group: Antifungal drug for external use

Pharmaco-therapeutic group: Antifungal agent

pharmachologic effect

Antifungal drug for external use with a broad 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), molds (mainly some Candida albicans) and molds (mainly some Candida albicans) and fungi. Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis in fungi. This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the death of the fungal cell. Terbinafine works 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 drugs.

Pharmacokinetics

When applied topically, absorption is less than 5%, it has a slight systemic effect.

Indications

Prevention and treatment of fungal skin infections:

• mycoses of the feet (tinea pedis); keratinization, cracks, itching and peeling of the skin caused by foot fungus; epidermophytosis inguinal (tinea craris), fungal infections of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum;

• yeast infections of the skin, mainly those caused by fungi of the genus Candida (for example, Candida albicans), in particular diaper rash;

• versicolor versicolor (Pityriasis versicolor) caused by Pityrosporum orbiculare (Malassezia furfur).

Dosage regimen

LamisilЃ cream

In adults and children over 12 years old, LamisilЃ cream can be used 1 or 2 times / day, depending on the indications. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The cream is applied in a thin layer to the affected skin and surrounding areas and rubbed lightly. In case of infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places where the cream is applied can be covered with gauze, especially at night.

In case of extensive fungal infections of the body, it is recommended to use the cream in tubes of 30 g.

The average duration of treatment and the frequency of use of the drug for dermatomycosis of the trunk, legs is 1 week, 1 time / day; with dermatomycosis of the feet - 1 week 1 time / day; with keratinization, cracks, itching and peeling of the skin caused by foot fungus - 2 weeks 1-2 times / day; with candidiasis of the skin - 1-2 weeks 1-2 times / day; with multi-colored lichen - 2 weeks 1-2 times / day.

A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. With irregular use or premature termination of treatment, there is a risk of re-infection. If there are no signs of improvement after 1-2 weeks of therapy, the diagnosis should be verified.

Correction of the dosage regimen of LamisilЃ cream in elderly patients is not required.

Side effect

From the immune system: isolated messages - hypersensitivity reactions (rash).

From the side of the organ of vision: rarely - eye irritation.

On the part of the skin: often - peeling of the skin, itching; infrequently - skin damage, crusting, skin lesions, pigmentation disorders, erythema, burning sensation of the skin; rarely - a feeling of dry skin, contact dermatitis, eczema; isolated messages - 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, crusting are possible. These minor symptoms should be distinguished from hypersensitivity reactions such as rashes, which occur in rare cases and require discontinuation of therapy. In rare cases, the course of a fungal infection may worsen.

If any of these side effects are aggravated, or the patient has noticed any other side effects, the doctor should be informed.

Contraindications for use

• hypersensitivity to terbinafine or to any of the inactive ingredients that make up the drug;

• breastfeeding period;

• children under 12 years of age (LamisilЃ cream);

• children under 18 years of age (LamisilЃ spray).

The drug is prescribed with caution to patients with hepatic and / or renal insufficiency, patients with chronic alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities.

Application during pregnancy and lactation

Since the clinical experience of using LamisilЃ cream in pregnant women is very limited, it should not be used unless absolutely necessary. During pregnancy, the drug is used only if the intended benefit to the mother outweighs the potential risk to the fetus. It is necessary to consult a doctor.

In experimental studies, no teratogenic properties of terbinafine have been identified. So far, no malformations have been reported with the use of LamisilЃ.

Terbinafine is excreted in breast milk, so the drug should not be given to nursing mothers. The baby should not be allowed to come into contact with any skin surface treated with LamisilЃ.

Application for violations of liver function

The drug is prescribed with caution to patients with hepatic insufficiency.

Application for impaired renal function

The drug is prescribed with caution to patients with renal insufficiency.

Application in children

LamisilЃ cream is contraindicated in children under 12 years of age.

Spray LamisilЃ is contraindicated in children under the age of 18.

Use in elderly patients

Correction of the dosage regimen of LamisilЃ cream in elderly patients is not required.

special instructions

A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular use or premature termination, there is a risk of recurrence of the infection.

The drug is intended for external use only.

Avoid getting the drug in the eyes. it can be irritating. In case of accidental contact with eyes, rinse immediately with running water, and in case of persistent irritation, consult a doctor.

With the development of allergic reactions, it is necessary to cancel the drug.

LamisilЃ cream for external use contains cetyl and stearyl alcohols, which can cause local allergic reactions at the application sites (contact dermatitis).

Care should be taken when applying LamisilЃ spray to damaged areas of the skin, because its ethanol may cause irritation. LamisilЃ spray is intended for external use only. Do not use LamisilЃ spray on the face. If LamisilЃ spray was accidentally injected into the respiratory tract during inhalation, then, if any symptoms appear, and especially if they persist, you should consult your doctor. LamisilЃ spray contains propylene glycol, which in some cases can cause skin irritation. It should also be borne in mind that the drug contains 96% ethanol.

Influence on the ability to drive vehicles and mechanisms

Does not affect.

Overdose

No cases of overdose of LamisilЃ have been reported.

Symptoms: Accidental ingestion of 30 ml of LamisilЃ spray containing 300 mg of terbinafine hydrochloride is comparable to taking 1 tablet of LamisilЃ with a dosage of 250 mg (single dose for an adult). If you accidentally take more LamisilЃ spray inside, you can expect the development of the same side effects as with an overdose of LamisilЃ tablets (headache, nausea, epigastric pain and dizziness). It should also be borne in mind that the spray contains ethyl alcohol (28.87% (v / v).

Treatment: activated carbon, if necessary, symptomatic therapy is performed.

Drug interactions

Currently, the drug interaction of LamisilЃ is unknown.