Atifin, cream 1%, 15g

Composition

1 g of cream for external use contains:

Active ingredient:

terbinafine hydrochloride – 10 mg.

Auxiliary substances:

sodium hydroxide;

benzyl alcohol;

sorbitan stearate;

cetyl palmitate;

cetyl

alcohol;stearyl alcohol;

polysorbate 60;

isopropyl myristate;

distilled water.

Pharmacological action

Atifin – an antifungal drug for external use, has a wide spectrum of antifungal activity.

In small concentrations, terbinafine exhibits fungicidal activity against dermatophytes:  Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporam canis, Epidermophyton floccosum; certain dimorphic fungi:  Pityrosporam orbiculare; molds:  mostly Candida albicans. Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.

Terbinafine inhibition of the squalene oxidase enzyme located on the fungal cell membrane specifically alters the early stage of sterol biosynthesis in fungi: ergosterol deficiency and intracellular squalene accumulation lead to fungal cell death.

Terbinafine has no effect on cytochrome P 450 isoenzymes in humans and, accordingly, on the metabolism of hormones or other drugs.

Pharmacokinetics

With external use of the drug, the absorption of terbinafine hydrochloride is <5%.

It has a minor systemic effect.

Indications

• Prevention and treatment of fungal skin infections, including athlete’s foot (“fungus” of the foot), Jock itch (tinea cruris), fungal infections 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.
• Multi-colored lichen (Pityriasis versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Use during pregnancy and lactation

No teratogenic properties of terbinafine were found in experimental studies. To date, no malformations have been reported with the use of Atifine. However, since the clinical experience of using the drug in pregnant women is very limited, it should only be used for strict indications.

Terbinafine is excreted in breast milk. However, if a nursing mother uses Atifin cream, a small amount of the Active ingredient is absorbed through the skin, so adverse effects on the child are unlikely.

Contraindications

• Hypersensitivity to terbinafine or other ingredients of the drug.

With caution: hepatic and / or renal insufficiency, alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities, children under 12 years of age (lack of sufficient clinical experience).

Side effects

Redness, itching or burning sensation may appear in the areas where the drug is applied.

Allergic reactions.

Interaction

Any drug interactions for terbinafine in cream form are unknown.

How to take, course of use and dosage

Externally, after thoroughly cleaning and drying the affected areas. Adults and children from 12 years of age — 1 or 2 times a day. The cream is applied in a thin layer on the affected skin, adjacent areas and lightly rubbed. For infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places of application of the cream can be covered with gauze, especially at night. Smooth skin dermatomycosis and inguinal dermatomycosis (including trunk dermatomycosis, lower leg dermatomycosis): dosage-twice a day (morning and evening); duration of treatment-1 week. Dermatomycosis of the feet: between the toes dosage-twice a day (morning and evening); duration of treatment-1 week; upper and side parts of the foot dosage-1 time a day; duration of treatment-2 weeks. Fungal skin infections caused by yeast (candidiasis of the skin): dosage – 1 time per day; duration of treatment-1 week. Multicolored lichen: dosage – 1 time a day; duration of treatment-2 weeks. If there are no signs of improvement after 1-2 weeks of treatment, the diagnosis should be verified. The dosage regimen of the drug in the elderly does not differ from the one described above.

Overdose

No overdose cases have been reported. Symptoms: if Atifine cream is accidentally taken orally, you can expect the development of side effects: headache, nausea, epigastric pain and dizziness. Treatment: use of activated charcoal, if necessary — symptomatic maintenance therapy.

Special instructions

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

Atifin cream is intended for external use only. Avoid contact with the eyes, as irritation may occur. If the drug accidentally gets into the eyes, they should be immediately rinsed with running water, and in case of persistent irritation, consult a doctor. If allergic reactions develop, the drug should be discontinued.

Product form

Cream.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Terbinafine

Dosage form

cream

Description

Children over 12 years of age, Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, For adults

Indications

Fungus, Skin Fungus, Fungal disease prevention