Expiration date: 12/2025
Structure and Composition:
Cream for topical application. 1 g contains terbinafine hydrochloride 10 mg
Excipients: sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate distilled water
in tubes of aluminum and 15 g in the paper cartons 1 tube.
Description pharmaceutical form:
A homogeneous cream white or nearly white.
Pharmacokinetics:
When applied topically absorption - less than 5%, has little systemic effect.
Description of the pharmacological actions:
Antifungal agent for external application having a wide range of antifungal activity. At low concentrations terbinafine has fungicidal activity against dermatophytes (Trychophyton - T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. tonsurans Microsporum canis, Epidermophyton floccosum), mold (mainly - C. albicans) and certain dimorphic fungi (Pityrosporum orbiculare). Activity against yeast fungi, depending on their type, may be a fungicidal or fungistatic.
Terbinafine specifically alters the early stage of the biosynthesis of sterols, occurring in fungi. This leads to a deficiency of ergosterol and to an intracellular accumulation of squalene, which causes death of fungal cells. Terbinafine action effected by the enzyme squalene epoxidase inhibiting located on the cell membrane of the fungus.
Terbinafine has no effect on the cytochrome P450 system in humans and, therefore, the metabolism of hormones or other drugs.
Indications:
- prevention and treatment of fungal skin infections, including foot mycoses ( "mushroom" of the foot), jock itch (tinea cruris), fungal infections of the skin smooth body (tinea corporis), caused by dermatophytes such as by 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 genus Candida (e.g. Candida albicans), in particular diaper rash
- pityriasis versicolor (Pityriasis versicolor), called Pityrosporum orbiculare (also known as Malassezia furfur).
Contraindications:
Increased sensitivity to terbinafine or with the other ingredients of the preparation.
Precautions: hepatic and / or renal failure, alcoholism, depression of bone marrow hematopoiesis, tumors, metabolic diseases, limb occlusive vascular disease, children under 12 years of age (lack of sufficient clinical experience).
Application of pregnancy and breastfeeding:
It was not teratogenic in experimental studies of the properties of terbinafine found. So far no reports of any malformation when applying Atifina. However, as clinical experience with the drug in pregnant women is very limited, it should be used only on strict conditions.
Terbinafine is excreted in breast milk. However, in the case of nursing mother Atifina cream is absorbed through the skin a small amount of the active substance, so an adverse effect on the child is unlikely.
Side effect:
In the field of application of the drug can be redness, itching or burning. Allergic reactions.
Drug Interactions:
Any drug interactions for a cream terbinafine unknown.
Dosage and administration:
Outwardly, thoroughly cleaned and dry the affected area.
Adults and children 12 years of age - 1 or 2 times a day. The cream is applied in a thin layer to the affected skin and surrounding areas and gently rub. For infections involving intertrigo (under the breasts, in the interdigital spaces, between the buttocks, groin), cream application site can cover the gauze, especially at night.
Disease, the dosage and duration of treatment are presented in the table.
| Disease | Dose | Length of treatment |
| Ringworm of the skin smooth and tinea cruris (including body ringworm, tinea shins) | Twice daily (morning and evening) | 1 week |
| Tinea pedis | Between fingers - twice a day (morning and evening) | 1 week |
| The top and sides of the foot - 1 per day | 2 week | |
| Fungal infections of the skin caused by yeast (Candida skin) | 1 time a day | 1 week |
| Colorful lichen | 1 time a day | 2 week |
If after 1-2 weeks of treatment were observed signs of improvement, there should be verification of the diagnosis. The dosage regimen of the drug in the elderly is not different from the above.
Overdose:
No cases of overdose have been reported.
Symptoms: If accidentally Atifin cream will be accepted inside, one can expect the development of side effects: headache, nausea, epigastric pain and dizziness.
Treatment: the appointment of activated charcoal, if necessary - symptomatic supportive therapy.
Special instructions:
Reducing the severity of clinical manifestations are usually noted in the first days of treatment. In the case of irregular or premature treatment termination there is a risk of recurrence of infection.
Atifin Cream is for external use only. Avoid contact with eyes, may cause irritation. In case of accidental contact with the drug in the eyes, they should immediately wash with running water, and in the case of persistent phenomena of irritation consult a doctor. With the development of allergic reactions need to stop the drug.
