COMPOSITION:

Active substance: fluconazole;

1 g of gel contains 5 mg of Fluconazole;

Excipients:

carbomer, benzyl alcohol, polysorbate 80, propylene glycol, octyldodecanol, sodium hydroxide, Delite flavor, purified water.

INDICATIONS:

Dermatomycosis caused by yeasts and dermatophytes, that is: tinea pedis, trichophytosis of smooth skin, tinea cruris, tinea versicolor, infections caused by Candida.

DOSAGE:

The preparation is applied once a day by gently rubbing in the affected skin area and surrounding area. On the interior parts the gel should be applied in small amounts and should be well rubbed all over the affected surface area to avoid maceration.

The treatment duration for infectious etiological factors varies, but for the most patients for recovering it is usually enough 1 – 3 weeks treatment.

In particular, the treatment period for resistant forms can be increased up to 6 weeks. The treatment duration is determined by a physician.

ADVERSE REACTIONS:

Skin irritation is possible. In case of such reaction it is necessary to discontinue the treatment.

Drug interactions:

There are no reports on interaction or incompatibility with other medicines. Separate studies of interaction of Fluconazole gel and other medicines have not been carried out. It is not applied on skin simultaneously with other agents for topical use

Pregnancy and lactation:

During pregnancy or lactation period the preparation is administered only when the expected benefit to the mother overweights the potential risk to the fetus or child.

Children:

There is no data concerning this preparation use in children.

PRECAUTIONS:

The use, especially long-term, of preparations for external use, including Fusys®, may cause sensitization and side effects. In such case it is necessary to discontinue the treatment and consult a doctor.

Fusys® gel is not used in ophthalmology.

Overdose:

There were no reports on case of overdose.

Ability to influence reaction velocity while driving or operating any other mechanisms.

It does not have an influence.

CONTRAINDICATIONS:

Hypersensitivity to Fluconazole or other azoles with chemical structure similar to Fluconazole one.

PHARMACOLOGICAL PROPERTIES:

Fluconazole is an antifungal agent of a new class of triazole antifungal compounds; it is a powerful selective inhibitor of sterol synthesis in fungi.

It was shown its activity in such fungi infections as Candida spp. (including systemic candidosis in animals with suppressed immunity), Cryptococcus neoformans (including intracranial infections), Miсrosporum spp. and Trichophyton spp.

Topically Fluconazole is used as an agent with a wide antifungal spectrum of activity.

It was shown its activity against dermatophytes and yeasts. Fluconazole is a highly specific to cytochrome P450 dependent fungal enzymes. It inhibits lanosterol C-14-demethylase enzyme, which converts lanosterol to sterol present in fungi membrane, i.e., ergosterol.

Pharmacokinetic studies of Fusys® gel showed that plasma Fluconazole levels are so low that systemic effect of the preparation is excluded.

In addition, the combination of gel and oil-water emulsion gives an opportunity to develop sufficient tolerance.

Pharmacokinetic studies of Fusys® gel in children were not carried out, but studies in adults showed that the preparation is systemically absorbed in parvo.

Studies carried out for the evaluation of tolerability and skin phototoxicity showed that in human Fusys® gel wais well tolerated by skin and wais not a phototoxic one.

PHARMACEUTICAL CHARACTERISTICS:

General physic-chemical properties:

Colorless transparent or opaque homogeneous gel with characteristic odor.

Shelf-life:

2 years.

Storage:

Store at the temperature not more 25 °С in a protected from sun light place.

Keep it out of reach of children.

Do not freeze it.

Package:

30 g of gel is in a tubes. 1 tube is in a carton box.

Conditions of supply:

Without prescription.