Lamisil^® (Tablets, Cream, Gel) Instructions for Use

ATC Code

D01AE15 (Terbinafine)

Active Substance

Terbinafine

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

An antifungal drug for external use with a broad spectrum of antifungal activity. In low concentrations, Terbinafine exerts a fungicidal effect against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton tonsurans, Microsporum canis, Epidermophyton floccosum), molds (mainly Candida albicans), and some dimorphic fungi (Pityrosporum orbiculare). The activity against yeast fungi, depending on the species, can be fungicidal or fungistatic.

Terbinafine specifically alters an early stage of sterol biosynthesis in fungi. This leads to a deficiency of ergosterol and to the intracellular accumulation of squalene, which causes the death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase, located on the fungal cell membrane.

Terbinafine does not affect the human cytochrome P450 system and, accordingly, does not affect the metabolism of hormones or other drugs.

Pharmacokinetics

With topical application, absorption is less than 5%, it has a slight systemic effect.

Indications

Prevention and treatment of fungal skin infections

• Foot mycoses (tinea pedis); callosity, cracks, itching and peeling of the skin caused by foot fungus; jock itch (tinea cruris), 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 intertrigo;
• Pityriasis versicolor, caused by Pityrosporum orbiculare (Malassezia furfur).

ICD codes

Dosage Regimen

Tablets

Take orally.

The duration of the treatment course and the dosing regimen are established individually and depend on the localization of the process and the severity of the disease.

For adults – at a dose of 250 mg once a day.

For children – at a dose of 125 mg once a day.

Cream

Lamisil^® Cream

In adults and children over 12 years of age, Lamisil^® cream can be applied once or twice a 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 adjacent areas and rubbed in gently. For infections accompanied by intertrigo (under the breasts, in the interdigital spaces, between the buttocks, in the groin area), the areas where the cream is applied can be covered with gauze, especially at night.

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

The average duration of treatment and frequency of application of the drug for dermatomycosis of the trunk, shins is 1 week once a day; for dermatomycosis of the feet – 1 week once a day; for callosity, cracks, itching and peeling of the skin caused by foot fungus – 2 weeks once or twice a day; for skin candidiasis – 1-2 weeks once or twice a day; for pityriasis versicolor – 2 weeks once or twice a day.

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

No adjustment of the dosing regimen of Lamisil^® cream is required for elderly patients.

Lamisil^® Spray

In adults, Lamisil^® spray can be applied once or twice a day, depending on the indications. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is sprayed onto the affected areas in an amount sufficient to thoroughly moisten them, and, in addition, applied to adjacent areas, both affected and intact skin.

For extensive fungal infections of the body, it is recommended to use the spray in 30 ml bottles.

Frequency of application of the drug and duration of treatment: dermatomycosis of the trunk, shins – once a day for 1 week; dermatomycosis of the feet – once a day for 1 week; pityriasis versicolor – twice a day for 1 week; tinea cruris, intertrigo – once a day for 1 week.

Gel

Externally.

Before the first use of the Lamisil^® Dermgel, the sealing membrane should be pierced using the point on the outside of the cap.

Lamisil^® Dermgel is used in adults once a day for any of the indications. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is gently rubbed into the areas of both affected and adjacent intact skin. In case of infections accompanied by intertrigo (under the breasts, between the fingers, in the gluteal and inguinal folds), the area where the gel is applied can be covered with gauze, especially at night.

The duration and frequency of application of Lamisil^® Dermgel for dermatomycosis of the trunk, shins – 1 week, once a day; for dermatomycosis of the feet – 1 week, once a day; for pityriasis versicolor – 1 week, once a day.

A reduction in the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or its premature discontinuation, there is a risk of recurrence of the infection. If no signs of improvement are noted after a week of treatment, the diagnosis should be verified.

For elderly patients, no dose adjustment is required.

Adverse Reactions

Definition of frequency of adverse effects (WHO): 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 (<1/10,000), including isolated reports.

Immune system disorders: isolated reports – hypersensitivity reactions (rash).

Eye disorders: rare – eye irritation.

Skin and subcutaneous tissue disorders: common – skin peeling, itching; uncommon – skin abrasion, crusting, skin lesion, pigmentation disorder, erythema, skin burning sensation; rare – feeling of skin dryness, contact dermatitis, eczema; isolated reports – rash.

Local reactions: uncommon – pain, application site pain, application site irritation; rare – exacerbation of the symptoms of the disease. At the application sites, itching, skin peeling, pain, irritation, skin pigmentation change, burning, erythema, crusts may be observed. 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 the fungal infection may worsen.

If any of the indicated adverse effects worsen, or the patient notices any other adverse effects, they should inform their doctor.

Contraindications

• Hypersensitivity to terbinafine or to any of the inactive ingredients that are part of the drug;
• Breastfeeding period;
• Children under 12 years of age (Lamisil^® cream);
• Children under 18 years of age (Lamisil^® spray).

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

Use in Pregnancy and Lactation

Since clinical experience with the use of Lamisil^® cream in pregnant women is very limited, it should not be used except in cases of extreme necessity. 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 were identified. To date, no malformations have been reported with the use of Lamisil^®.

Terbinafine is excreted in breast milk, so the drug should not be prescribed to nursing mothers. The infant should not come into contact with any skin surface treated with Lamisil^®.

Use in Hepatic Impairment

With caution, the drug is prescribed to patients with hepatic insufficiency.

Use in Renal Impairment

With caution, the drug is prescribed to patients with renal insufficiency.

Pediatric Use

Lamisil^® cream is contraindicated in children under 12 years of age.

Lamisil^® spray is contraindicated in children under 18 years of age.

Geriatric Use

No adjustment of the dosing regimen of Lamisil^® cream is required for elderly patients.

Special Precautions

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

The drug is intended for external use only.

Avoid contact of the drug with the eyes, as it may cause irritation. In case of accidental contact, the eyes should be immediately rinsed with running water, and if persistent irritation develops, it is necessary to consult a doctor.

If allergic reactions develop, the drug should be discontinued.

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

Caution should be exercised when applying Lamisil^® spray to damaged areas of the skin, as the ethanol contained in it may cause irritation. Lamisil^® spray is for external use only. Lamisil^® spray should not be applied to the skin of the face. If Lamisil^® spray is accidentally inhaled into the respiratory tract, then, in case of any symptoms and especially if they persist, it is necessary to consult a doctor. Lamisil^® spray contains propylene glycol, which in some cases can cause skin irritation. It should also be taken into account that the drug contains 96% ethanol.

Effect on ability to drive vehicles and operate machinery

No effect.

Overdose

No cases of overdose with Lamisil^® have been reported.

Symptoms accidental ingestion of 30 ml of Lamisil^® spray containing 300 mg of terbinafine hydrochloride is comparable to taking 1 Lamisil^® tablet with a dosage of 250 mg (a single dose for an adult). If a larger amount of Lamisil^® spray is accidentally ingested, the same side effects as with an overdose of Lamisil^® tablets can be expected (headache, nausea, epigastric pain and dizziness). It should also be taken into account that the spray contains ethyl alcohol (28.87% (v/v)).

Treatment activated charcoal, if necessary, symptomatic therapy is carried out.

Drug Interactions

Currently, drug interactions of Lamisil^® are unknown.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F). Do not freeze (for spray).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.