Terbinafine 1% cream for external use 30 g

Treatment of fungal skin infections, including foot mycoses ("athlete's foot"), inguinal epidermophyte (tinea cruris), fungal lesions 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, primarily those caused by the genus Candida (e.g., Candida albicans), particularly intertrigo.
Pityriasis versicolor, caused by Pityrosporum orbiculare (also known as Malassezia furfur).

For external use.
Adults and children over 12 years old.
Before applying the cream, the affected areas of the skin should be cleaned and dried. The cream is applied once or twice a day to the affected areas of the skin and surrounding areas in a thin layer, gently rubbing it in. In cases of infections accompanied by chafing (under the breasts, in the spaces between the toes, between the buttocks, in the groin area), the application sites can be covered with gauze, especially at night.
The duration of treatment depends on the indication and severity of the condition.
Average treatment duration:
Dermatomycosis of the trunk and lower legs: once a day for 1 week.
Dermatomycosis of the feet: once a day for 1 week.
Cutaneous candidiasis: 1-2 times a day for 1-2 weeks.
Tinea versicolor: 1-2 times a day for 2 weeks.
A reduction in the severity of clinical manifestations is usually noted within the first few days of treatment. In the case of irregular treatment or premature discontinuation, there is a risk of recurrence of the infection. If there are no signs of improvement after one to two weeks of treatment, the diagnosis should be verified.
Use of the drug in children under 12 years old
Use is not recommended, as safety and efficacy have not been studied.
Elderly patients
No changes in the dosing regimen are required.

Composition per 1 g:
Active ingredient: terbinafine hydrochloride - 10.0 mg;
Excipients: sodium hydroxide - 1.2 mg; benzyl alcohol - 10.0 mg; sorbitan stearate - 24.0 mg; cetyl palmitate - 30.0 mg; polysorbate 60 - 50.0 mg; cetyl alcohol - 60.0 g; isopropyl myristate - 60.0 mg; purified water - up to 1000.0 mg.

Homogeneous shiny cream of white or almost white color with a faint characteristic odor.

Increased sensitivity to terbinafine or other components of the drug; pediatric age (under 12 years); breastfeeding period.
With caution
Renal and/or hepatic insufficiency, alcoholism, bone marrow suppression, tumors, metabolic diseases, occlusive vascular diseases of the extremities, pregnancy.
If you have any of the diseases listed in this section, you should consult a doctor before starting the use of the drug.
Use during pregnancy and breastfeeding
No teratogenic properties of terbinafine have been identified in experimental studies. To date, no developmental defects have been reported with the use of terbinafine cream. However, since clinical experience with terbinafine in pregnant women is very limited, it should not be used except in cases of extreme necessity. During pregnancy, it is used only if the expected benefit to the mother outweighs the potential risk to the fetus. Consultation with a doctor is necessary.
Terbinafine is excreted in breast milk, so the drug should not be used by nursing mothers. Contact between the infant and any skin surface treated with the cream should be avoided.

Reduction in the severity of clinical manifestations is usually observed within the first few days of treatment.
In the case of irregular treatment or premature discontinuation, there is a risk of infection recurrence.
The cream is intended for external use only. Avoid contact with the eyes, as it may cause irritation. In case of accidental contact with the eyes, they should be rinsed immediately with running water, and if persistent irritation occurs, a doctor should be consulted. If allergic reactions develop, the medication should be discontinued. The product contains cetyl alcohol, which may cause local allergic reactions (contact dermatitis) at the application sites.
Effect on the ability to drive vehicles and operate machinery
The product does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased attention and quick psychomotor reactions.

Classification of the frequency of side effects (WHO): very common ≥ 1/10; common - ≥ 1/100, < 1/10; uncommon - ≥ 1/1000, < 1/100; rare - ≥ 1/10000, < 1/1000; very rare - < 1/10000, or frequency unknown (cannot be determined based on available data).Immune system disorders: frequency unknown - hypersensitivity reactions (rash).Eye disorders: rare - eye irritation.Skin and subcutaneous tissue disorders: common - skin peeling, itching; uncommon - skin damage, crust formation, skin lesions, pigmentation disorders, erythema, burning sensation of the skin; rare - dry skin sensation, contact dermatitis, eczema; frequency unknown - rash.General disorders and application site conditions: uncommon - pain, pain at the application site, irritation at the application site; rare - exacerbation of disease symptoms.At the application sites, itching, skin peeling, pain sensations, irritation, changes in skin pigmentation, burning, erythema, and crust formation may occur. These minor symptoms should be distinguished from hypersensitivity reactions, such as rash, which occur in rare cases and require discontinuation of the product. In rare cases, the course of fungal infections may worsen.If any of the side effects listed in the instructions worsen, or if you notice any other side effects not mentioned in the instructions, inform your doctor.Overdose with external use is unlikely. In case of accidental ingestion of the medication, systemic side effects may occur from the gastrointestinal tract (nausea, abdominal pain, loss of appetite, diarrhea), as well as headache, dizziness, increased urination, and rash. If the above symptoms occur, discontinue use of the medication and consult a doctor. Treatment: activated charcoal, symptomatic supportive therapy.Drug interactions of terbinafine in cream form are not described.

Antifungal agent for external use, possessing a broad spectrum of antifungal activity. At low concentrations, terbinafine exerts fungicidal action against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton tonsurans, Microsporum canis, Epidermophyton floccosum), yeast (primarily Candida albicans), and certain dimorphic fungi (Pityrosporum orbiculare, also known as Malassezia furfur). The activity against yeast fungi, depending on their species, may be fungicidal or fungistatic.
Terbinafine specifically alters the early stage of sterol biosynthesis occurring in fungi. This leads to a deficiency of ergosterol and intracellular accumulation of squalene, resulting in fungal cell death. The action of terbinafine is achieved by inhibiting the enzyme squalene epoxidase located in the fungal cell membrane.
Terbinafine does not affect the cytochrome P450 system in humans and, consequently, does not influence the metabolism of hormones or other medications.

With external use, absorption is less than 5%, resulting in minimal systemic effects.