Universal reference book for medicines
Product name: FUNGOTERBINE ® (FUNGOTERBINE)

Active substance: terbinafine

Type: Antifungal medication for external use

Manufacturer: NIZHFARM (Russia)

Composition, form of production and packaging
?
Cream for external use 1% white or almost white, with a subtle smell.
1 g

terbinafine hydrochloride 10 mg

Auxiliary substances: butylhydroxytoluene (dibunol-0.1), urea (carbamide), cetostearyl ester of macrogol 20, cetostearyl alcohol, proxanol-268 (poloxamer 407), imidourea, propylene glycol, paraffin liquid, water purified by vaseline.

15 g - aluminum tubes (1) - cardboard packs.

?
Spray for external use 1% as a colorless transparent liquid.
1 g

terbinafine hydrochloride 10 mg

Excipients: urea (carbamide), butylhydroxytoluene (dibunol), ethanol 95%, polyvinylpyrrolidone (povidone), propylene glycol.

15 ml - polymer bottles (1) complete with a dispenser - packs cardboard.

30 ml - polymer bottles (1) complete with a dispenser - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Antifungal drug for external use from the group of allylamines.
Has a wide range of antifungal action.
Terbinafine disrupts the biosynthesis of ergosterol in the fungi in the early stages.
This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus.This enzyme does not belong to the cytochrome P450 system.
Terbinafine in small concentrations has a fungicidal effect against dermatophytes (including Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), mold (mainly Candida albicans) and some dimorphic fungi ( Pityrosporum orbiculare), leading to their death.
Activity with respect to yeast-like fungi, depending on their type, may be fungicidal or fungistatic.
Carbamide, which is part of the spray, has keratolytic (softens and causes rejection of the affected epidermal horny epidermis) and moisturizing effects, carbamide is able to increase the penetration of the skin of the dosage form and create high concentrations of terbinafine in the skin.
Carbamide promotes the rapid restoration of the epidermis.
Included in the spray butylhydroxytoluene, - an antioxidant agent that stimulates regeneration processes.
With topical application inhibits free radical reactions.
Terbinafine does not affect the metabolism of hormones or other medications.

PHARMACOKINETICS

At external application absorption - 5%, renders insignificant system action.

INDICATIONS

Treatment and prevention:

- fungal infections of the skin: foot mycoses (foot fungus), inguinal epidermophytia (tinea cruris), fungal lesions of smooth skin of the body (tinea corporis) caused by dermatophytes Trichophyton spp., incl.
Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Microsporum canis and Epidermophyton floccosum;
- skin infections caused by yeast-like fungi of the genus Candida (eg, Candida albicans);

- multi-colored lichen (Pityriasis versicolor), caused by Pityrosporum orbiculare (a synonym for Malassezia furfur);

- seborrheic dermatitis of the scalp (for spray).

DOSING MODE

Adults and children aged 12 years and older are applied to the skin 1-2 times / day.
Before applying the drug, it is necessary to clean and dry the affected areas.
The cream is applied a thin layer on the affected skin and adjacent areas and lightly rubbed.

In infections accompanied by intertrigo (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.

With dermatomycosis of the trunk, shins, feet, the cream should be applied within 1 week 1 time / day;
at a candidiasis of a skin - within 1-2 weeks 1-2 times / sut; withcolored lichen - within 1 week 1-2 times / day.
It is not necessary to change the dosage regimen for elderly patients.

The spray is sprayed on the affected areas in an amount sufficient to thoroughly moisturize them and, in addition, is applied to adjacent areas of both affected and intact skin.

When dermatomycosis of the trunk, shins, stop spray should be applied within 1 week 1 time / day;
with candidiasis of the skin - for 1-2 weeks 1 or 2 times / day; withmulti-colored lichen - for 1 week 1 or 2 times / day.
The experience of drug treatment in children is limited, and therefore the use of Fungoterbin® spray in children under the age of 12 is not recommended.

SIDE EFFECT

Local reactions: rarely - redness, sensation of itching or burning at the site of application.
Termination of treatment is rarely required.
Allergic reactions: rarely - generalized rash and / or redness, hives, angioedema, repeated allergic reaction.

CONTRAINDICATIONS

- children's age till 12 years;

- hypersensitivity to terbinafine or other component of the drug;

Caution should be applied Fungoterbine spray for hepatic and / or renal failure, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities.

PREGNANCY AND LACTATION

Since the clinical experience of using the drug in pregnant women is very limited, Fungoterbin ® spray should be used only under strict indications, when the expected benefit to the mother will exceed the potential risk to the fetus.

Terbinafine is excreted in breast milk.
However, when applying Fungoterbin® cream or spray, a small amount of active substance is absorbed through the skin through the skin, so it is unlikely that the baby will be adversely affected.
In experimental studies teratogenic properties of terbinafine were not revealed.
To date no developmental deficiencies have been reported with the use of Fungoterbin® spray.
APPLICATION FOR FUNCTIONS OF THE LIVER

Caution should be applied Fungoterbine Spray in kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Caution should be applied Fungoterbine spray in liver failure.

APPLICATION FOR CHILDREN

The experience of drug treatment in children is limited, and therefore the use of Fungoterbin® spray in children under the age of 12 is not recommended.

APPLICATION IN ELDERLY PATIENTS

It is not necessary to change the dosage regimen for elderly patients.

SPECIAL INSTRUCTIONS

Reducing the severity of clinical manifestations is usually noted in the first days of treatment.
With irregular use of the drug or premature discontinuation of treatment, there is a risk of renewal of the infection. If after 2 weeks of treatment there are no signs of improvement, the diagnosis should be verified.
Cream and spray are for external use only.
Avoid contact with eyes and mucous membranes. In case of accidental ingestion of the drug into the eyes, they should be rinsed immediately with running water. In case of persistent irritation, consult a physician.
OVERDOSE

No cases of an overdose of Fungoterbin ® have been reported.

If you are accidentally ingested, you can expect the development of side effects such as nausea, anorexia, pain in the upper abdomen, diarrhea.
The presence of ethanol in the preparation should also be considered.
DRUG INTERACTION

Currently, the drug interaction of the preparation Fungoterbin ® has not been studied.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

Ointment should be stored out of reach of children, dry place at a temperature of 15 ° to 20 ° C.
Shelf life - 2 years.
List B. The spray should be stored out of reach of children at a temperature not exceeding 20 ° C.
Shelf life - 2 years.
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