Terbix (Cream, Spray) Instructions for Use

ATC Code

D01AE15 (Terbinafine)

Active Substance

Terbinafine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

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 (for example, Scopulariopsis brevicaulis) and certain dimorphic fungi (Pityrosporum orbiculare). Activity against yeast fungi, mainly Candida albicans, depending on the species, may be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis occurring in fungi. This leads to ergosterol deficiency 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

With external application, absorption is less than 5%. It has a slight systemic effect.

Indications

Prevention and treatment of fungal skin infections caused by susceptible pathogens, including tinea pedis (“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 (for example, Candida albicans), in particular intertrigo; pityriasis versicolor, caused by Pityrosporum orbiculare (also known as Malassezia furfur).

ICD codes

Dosage Regimen

Cream, Spray

Apply externally 1-2 times/day.

For adults and children 12 years and older, before applying the cream, it is necessary to clean and dry the affected areas. The cream 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 areas where the cream is applied 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).

Tinea pedis 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)

Dosage adjustment is not required in the elderly.

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 if the potential benefit to the mother outweighs the possible risk to the fetus/child.

Terbinafine penetrates into breast milk in very small amounts. 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

Dosage adjustment is not required in elderly patients.

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 application or premature discontinuation, there is a risk of infection recurrence.

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 if persistent irritation develops, 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 30°C (86°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.