Lamifungin^® (Gel) Instructions for Use

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

ATC Code

D01AE15 (Terbinafine)

Active Substance

Terbinafine (Rec.INN registered by WHO)

Dosage Form

Lamifungin®

Gel for external use 1%: 15 g, 30 g, or 50 g tubes

Dosage Form, Packaging, and Composition

Gel for external use is homogeneous, white or almost white in color, with a slight characteristic odor.

* (calculated as 100% dry substance Terbinafine).

Excipients: butylated hydroxytoluene, benzyl alcohol (calculated as 100% substance), sorbitan laurate, polysorbate 20, isopropyl myristate, ethanol (ethyl alcohol) 95%, carbomer (carbopol 974P) (calculated as dry substance), sodium hydroxide, purified water.

15 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agents used in dermatology; external antifungal agents; other external antifungal agents

Pharmacological Action

Antifungal agent for external use, possessing 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 (e.g., Scopulariopsis brevicaulis) and certain dimorphic fungi (Pityrosporum orbiculare). Activity against yeast fungi, mainly Candida albicans, depending on the species, can be fungicidal or fungistatic.

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

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

Pharmacokinetics

When applied externally, absorption is less than 5%. It has a slight systemic effect.

Indications

Prevention and treatment of fungal skin infections caused by susceptible pathogens, including foot mycoses (“athlete’s foot”), 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 the genus Candida (e.g., Candida albicans), in particular intertrigo; pityriasis versicolor, caused by Pityrosporum orbiculare (also known as Malassezia furfur).

ICD codes

Dosage Regimen

Apply externally 1-2 times/day.

Adults and children 12 years and older Before applying the gel, it is necessary to clean and dry the affected areas. The gel is applied 1 or 2 times a day in a thin layer to the affected skin and adjacent areas and gently rubbed in. For infections accompanied by intertrigo (under the breasts, in the interdigital spaces, between the buttocks, in the groin area), the application sites can be covered with gauze, especially at night.

Duration of treatment and frequency of drug application

Dermatomycosis of smooth skin and inguinal dermatomycosis (including dermatomycosis of the trunk, dermatomycosis of the shins): 1 week 2 times a day (morning and evening).

Dermatomycosis of the feet 1 week 2 times a day between the toes (morning and evening), 2 weeks 1 time a day (top and sides of the foot).

Fungal skin infections caused by yeasts (skin candidiasis) 1 week 1 time a day.

Pityriasis versicolor 2 weeks 1 time a day.

If after 1-2 weeks of treatment there are no signs of improvement, the diagnosis should be verified.

Elderly patients (over 65 years)

In elderly individuals, dose adjustment is not required.

Adverse Reactions

Local reactions at the application sites, redness, itching, or a burning sensation may occur. Allergic reactions may occur.

Contraindications

Hypersensitivity to terbinafine, children under 12 years of age.

With caution

Renal and/or hepatic insufficiency, alcoholism, bone marrow depression, tumors, metabolic diseases, occlusive vascular diseases of the extremities.

Use in Pregnancy and Lactation

Use during pregnancy is possible only if the potential benefit to the mother outweighs the possible risk to the fetus/child.

Terbinafine penetrates into breast milk in very small quantities. Terbinafine should not be applied to the breasts during breastfeeding.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal insufficiency.

Pediatric Use

With caution in children (due to lack of sufficient clinical experience).

Geriatric Use

Elderly patients do not require dose adjustment.

Special Precautions

Terbinafine is for external use only.

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

During the use of terbinafine, general hygiene rules should be observed to prevent reinfection (via linen, shoes).

If terbinafine accidentally gets into the eyes, they should be immediately rinsed with running water, and in case of persistent irritation, a doctor should be consulted.

If allergic reactions develop, the use of terbinafine should be discontinued.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.