FUNGOTERBIN

Active material: Terʙinafin
When ATH: D01AE15
CCF: Antifungal agents for external use
ICD-10 codes (testimony): B35.2, B35.3, B35.4, B35.6, B36.0, B37.2, L21.0
When CSF: 08.02.02
Manufacturer: NIZHFARM of (Russia)

Pharmaceutical form, composition and packaging

◊ Cream for external application 1% white or nearly white, with a subtle scent.

Excipients: butylhydroksytoluol (diʙunol – 0.1), urea (urea), macrogol cetostearyl ether 20 , cetostearyl alcohol, proksanol-268 (poloxamer 407), imidomočevina, propylene glycol, Vaseline medical oil (Liquid paraffin), Purified water.

15 g – aluminum tuba (1) – packs cardboard.

◊ Spray for external use 1% in the form of a colorless transparent liquid.

Excipients: urea (urea), butylhydroksytoluol (diʙunol), ethanol 95%, polyvinylpyrrolidone (povidone), propylene glycol.

15 ml – plastic bottles (1) complete with dispenser – packs cardboard.
30 ml – plastic bottles (1) complete with dispenser – packs cardboard.

Pharmacological action

Antifungal agent for external use of allylamine. It has a wide range of antifungal activity.

Terbinafine gives derived ergosterol biosynthesis in fungi in the early stages. This leads to a deficiency of ergosterol and to an intracellular accumulation of squalene, causing cell death fungus. Step terbinafine accomplished by inhibition of the enzyme squalene epoxidase, located on the cell membrane of the fungus. This enzyme does not belong to the cytochrome P450.

Terbinafine in small concentrations has fungicidal action against dermatofitov (incl. Red Trychophyton, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violet, Trychophyton tonsurans, Microspores dog, Epidermophyton floccosum), mold (mostly Candida albicans) and some dimorphic fungi (Orbicular Pityrospores), leading to their death. Activity against yeast fungi, depending on the species, It may be fungicidal or fungistatic.

Urea, part of the spray, It has keratolytic (It softens and causes the rejection of a fungal infection of the stratum corneum of the epidermis) and moisturizing effects, Urea can increase penetration into the skin of a dosage form and to create a high concentration of terbinafine in the skin. Urea contributes to the rapid recovery of the epidermis.

Part of the spray butylhydroxytoluene, – antioxidant agent, stimulates the regeneration. When applied topically inhibits free radical reactions.

Terbinafine has no influence on the metabolism of hormones or other drugs.

Pharmacokinetics

When applied topically absorption – 5%, It has little systemic effects.

Testimony

Treatment and prevention:

- Fungal skin infections: tinea pedis (“fungus” feet), jock itch (moth leg), fungal skin smooth body (moth body), caused by dermatophytes Trichophyton spp., incl. Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violet, Microsporum canis и Epidermophyton floccosum;

- Skin infections, drozhepodobnymi caused by Candida species (eg, Candida albicans);

- Multi-colored lichen (Pityriasis versicolor), called Pityrosporum orbiculare (synonym – Malassezia furfur);

- Seborrheic dermatitis of the scalp (dlya spray).

Dosage regimen

Adults and for children 12 and older drug applied to the skin 1-2 times / day. Before applying the medication should be clean and dry affected areas.

Cream put a thin layer to the affected skin and surrounding areas and gently rub.

At infections, accompanied intertrigo (under the breasts, interdigital spaces, between the buttocks, groin), place applying the cream you can cover the gauze, especially at night.

At ringworm of the body, goleneй, stop cream should be applied for 1 of the week 1 time / day; at candidiasis skin – during 1-2 weeks 1-2 times / day; at pityriasis versicolor – during 1 of the week 1-2 times / day.

You do not need to modify the dosing regimen for the drug elderly patients.

Spray sprayed on the affected area in an amount, sufficient for their thorough wetting, and, Besides, is applied to the surrounding areas as a defeat, and intact skin.

At ringworm of the body, goleneй, stop spray should be applied for 1 of the week 1 time / day; at candidiasis skin – during 1-2 weeks 1 or 2 times / day; at pityriasis versicolor – during 1 of the week 1 or 2 times / day.

Experience of treatment in children is limited, therefore the use of spray Fungoterbin^® in children aged 12 years not recommended.

Side effect

Local reactions: rarely – redness, itching or burning sensation at the site of drug application. Discontinuation of treatment is rarely required.

Allergic reactions: rarely – generalized rash and / or redness, hives, angioedema, re allergic reaction.

Contraindications

- Children up to age 12 years;

- Hypersensitivity to terbinafine or any other component of the drug;

FROM caution Spray should be applied Fungoterbin with hepatic and / or renal insufficiency, alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of extremities.

Pregnancy and lactation

Since clinical experience with the drug in pregnant women is very limited, apply Fungoterbin^® Spray should be only on strict conditions, when the intended benefits to the mother exceeds the potential risk to the fetus.

Terbinafine is excreted in breast milk. However, when using a cream or spray Fungoterbin^® lactating mother absorbed through the skin a small amount of active substance, so the adverse effects on the baby are unlikely.

IN experimental studies teratogenic properties of terbinafine have been identified. So far, no reports of any malformation when applying spray Fungoterbin^®.

Cautions

Reducing the severity of the clinical manifestations are usually noted in the first days of treatment. If the irregular use of the drug or premature termination of treatment the risk of renewed infection. If after 2 weeks of treatment were observed signs of improvement, should conduct a verification of the diagnosis.

Cream and spray are for external use only. Avoid contact with the eyes and mucous membranes. In case of contact with the eyes, they should immediately wash with running water. In the case of persistent irritation effects should consult a doctor.

Overdose

Cases of drug overdose Fungoterbin^® not reported.

In case of accidental ingestion we can expect the development of such side effects, nausea, appetite disorders, pain in the upper abdomen, diarrhea. It should also consider the presence of ethanol in the formulation.

Drug Interactions

Currently, drug interactions drug Fungoterbin^® not known.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

Ointment should be stored out of reach of children, dry place at a temperature of 15 ° to 20 ° C. Shelf life – 2 year.

List B. Spray should be kept out of reach of children at or above 20 ° C. Shelf life – 2 year.