Fungoterbine - instructions for use, dose, side effects, contraindications

Excipients - butyl hydroxy toluene (dibunol) 0.10 g, urea (carbamide) 0.50 g, macrogol cetostearate (Eumulgin® B 2) 1.50 g, cetostearyl alcohol [cetyl alcohol not more than 60%, stearyl alcohol not less than 40%] (Lanette® O) - 4.7 g, poloxamer (emixol-268, lutrol F 68) -0.75 g, imidourea (Germall®) 0.20 g, propylene glycol 23.00 mg, liquid paraffin (Vaseline medical oil) 35.00 g, petrolatum 7.00 g, water (purified water) to 100 g.

Description:cream white or almost white with a faint odor.

Pharmacotherapeutic group:antifungal drug.

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

An antifungal agent for topical use is allylamine and has a wide range of antifungal activity. It differs by pronounced epidermotropy. The target for terbinafine is the cytoplasmic membrane of the fungal cell.

Terbinafine acts at the early stages of sterol metabolism, at the level of the squalene epoxidase cycle. Suppressing the enzyme with squalene epoxidase, terbinafine inhibits the formation of ergosterol - the main component of the cell wall of fungi, preventing their further reproduction. The squalene epoxidase is not bound to the P450 system.

Fungicidal effect is due to the accumulation of squalene in the fungal cell, which is extracted from membranes, lipid components. Accumulating inside the cells, lipid granules, gradually increasing in volume, rupture the damaged cytoplasmic membranes, leading the fungal cell to death. Terbinafine highly active against all dermatophytes united in labor Trichophyton, Microsporum and Epidermophyton.

Terbinafine in small concentrations has a fungicidal effect against dermatophytes (Trichophyton rubrum, T.mentagrophytes, T.verrucosum, T. violaceum; Microsporum canis and Epidermophyton floccosum); molds (Aspergillus sppScopulariopis brevicaulis), yeast-like - Candida albicans, C.stellatoidea, C.tropicalis, C.parapsilosis, C.guillermondi, C.kursei, C.pseudotropicalis, Pityrosporum orbiculare (P.ovale and Malassezia furfur); of dimorphic fungi (Sporothrix schenckii and np.).

The effect of terbinafine on yeast-like fungi, depending on their type, may be fungicidal (Candida parapsilosis) or fungistatic (Candida . albicans).

Fungoterbin ® also has anti-inflammatory, antipruritic, keratolytic action. Due to the presence of urea in the cream, the preparation has a moisturizing effect, promotes deeper penetration of terbinafine into the skin.

Pharmacokinetics:

With external use, the drug is absorbed very slightly (absorption - 5%); accumulates in the skin, in the sebaceous glands, hair follicles, subcutaneous tissue and exerts its effect mainly at the site of application.

Indications:

Fungal skin diseases caused by sensitive pathogens (trichophytosis, microsporia, epidemicermophytia, rubrophytic, skin candidiasis):

- Mycosis of feet / "foot fungus" (tinea pedis);

- mycosis of trunk (tinea corporis), including mycosis of smooth skin and mycosis of large folds;

- epidermophytosis inguinal (tinea craris),

- superficial candidiasis of the skin caused by fungi of the genus Candida (eg, Candida albicans);

- colored lichen (pityriasis versicolor)

Contraindications:

Hypersensitivity to terbinafine / or other components of the drug.

Carefully:Pronounced renal or hepatic insufficiency, chronic alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the limbs, pregnancy, lactation, children under 12 years of age (lack of sufficient experience of use).

Pregnancy and lactation:

It is only possible after a careful assessment of the expected benefit for the mother and the risk for the fetus. If you need Fungoterbin® cream during lactation It is necessary to avoid contact of the infant with the Fungoterbine® treated area. Do not use on large surfaces.

Dosing and Administration:

Outwardly.

Before use, it is necessary to clean and dry the affected areas. Fungoterbin® is applied 1 or 2 times a day to affected areas of the skin and adjacent areas. The cream is applied with a thin layer and lightly rubbed.When applying to the area of skin folds (inguinal area, interannual, under the mammary glands) it is recommended to lay a gauze strip / bandage.

Dermatomycosis of the trunk, large folds, feet, legs: 1 time per day, duration of treatment -1 week.

Dermatomycosis of the feet: Once a day, the duration of treatment is 1 week.

Candidiasis of the skin: 1 - 2 times a day, the duration of treatment - 1 - 2 weeks.

Multicolored lichen: 1-2 times a day, the duration of treatment - 1 week.

Side effects:

Local reactions: itching and burning of the skin, hyperemia (redness) at the site of application. Termination of treatment does not require.

Allergic reactions: generalized rash, hives, angioedema. Treatment should be discontinued and consult a doctor.

Overdose:

When external application is unlikely.

Symptoms :, if you accidentally take the cream inside you may have a headache, nausea, gastralgia, dizziness, frequent urination, rash.

Treatment: activated charcoal, if necessary - symptomatic and maintenance therapy.

Interaction:Any interactions of Fungoterbin® cream with other medications are not known.

Special instructions:

Avoid contact with the eyes, nose, and mouth. In case of accidental contact with eyes, rinse immediately with running water.

Restoration of a healthy appearance of the skin is noted in the first days of treatment, which is not a sign of cure. It should be remembered that irregular use or premature discontinuation of treatment increases the risk of relapse.

During the treatment, it is necessary to follow the general rules of hygiene for the prevention of reinfection (re-infection) through linen and shoes. Lack of effect after 1 week of treatment requires clarification of the diagnosis.

Fungoterbin® does not impair the function of the skin and the functioning of its sebaceous and sweat glands. Fungoterbin® has a subtle smell and leaves no residue on clothes.

Effect on the ability to drive transp. cf. and fur:Does not affect.

Form release / dosage:

Cream for external use 1%.

For 15 g tubes, aluminum or polyethylene laminate. Each tube together with instructions for the medical use of the drug in a pack of cardboard.

Packaging:(15) - aluminum or polyethylene laminated tubes (1) / together with instructions for medical use / - Cardboard package

Storage conditions:

Store at a temperature of 10 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:P N000955 / 01

Date of registration:30.11.2011

The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC

Manufacturer: & nbsp

Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSC

Information update date: & nbsp18.09.2015

Illustrated instructions

Instructions

Fungoterbin® (Fungoterbine®)