Fluconazol-TEVA (fluconazole) hard capsules 100 mg. №10

Description

Fluconazol-TEVA 100 mg Composition
active substance: fluconazole;

1 hard capsule contains 100 mg of fluconazole;

Fluconazol-TEVA 100 mg Excipients:

capsule contents: lactose, corn starch, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate;

capsule shell: titanium dioxide (E 171), brilliant blue FCF (E 133), gelatin, azorubin (E 122) (only for 200 mg capsules).

Fluconazol-TEVA 100 mg Dosage form
The capsules are hard.

Basic physical and chemical properties: hard gelatin capsules filled with a white or yellowish-white homogeneous powder, with an opaque blue lid and an opaque white body.

Pharmacotherapeutic group
Antifungal drugs for systemic use, derivatives of triazole. ATX code J02A C01.

Pharmacodynamics
Mechanism of action.

Fluconazole is an antifungal drug that belongs to the triazole class. Its primary mechanism of action is inhibition of fungal 14-α-lanosterol demethylation mediated by cytochrome P450, which is an integral step in the biosynthesis of fungal ergosterol. The accumulation of 14-alpha-methyl sterols correlates with the subsequent loss of ergosterol by the membrane of the fungal cell and may be responsible for the antifungal effect of fluconazole. Fluconazole is more selective for fungal cytochrome P450 enzymes than for various mammalian cytochrome P450 enzyme systems.

The use of fluconazole 50 mg per day for 28 days did not affect the plasma testosterone concentration in men or the concentration of endogenous steroids in women of reproductive age. Fluconazole at a dose of 200 to 400 mg per day showed no clinically significant effect on endogenous steroid levels or response to ACTH stimulation (ACTH) in healthy male volunteers.

Indications
Treatment of such diseases in adults as:

cryptococcal meningitis;
coccidioidosis;
invasive candidiasis;
candidiasis of the mucous membranes, including candidiasis of the oropharynx and candidiasis of the esophagus, candiduria, chronic candidiasis of the skin and mucous membranes;
chronic atrophic candidiasis (candidiasis caused by the use of dentures) with the ineffectiveness of local dental hygiene products;
vaginal candidiasis (acute or recurrent) when local therapy is not appropriate;
candidal balanitis when local therapy is not appropriate;
dermatomycosis, including mycosis of the feet, mycosis of smooth skin, inguinal ringworm, tinea versicolor and candidal skin infections, when systemic therapy is indicated,
dermatophytic onychomycosis, when the use of other drugs is not appropriate.

Contraindications
Hypersensitivity to fluconazole, other azole substances or to any of the excipients of the drug;
the simultaneous use of fluconazole with terfenadine is contraindicated in patients taking fluconazole multiple times in doses of 400 mg per day or higher (based on the results of interaction studies with repeated use);
the simultaneous use of fluconazole with other drugs that cause prolongation of the QT interval and are metabolized by the CYP3A4 enzyme (for example, cisapride, astemizole, pimozide, quinidine, amiodarone and erythromycin), see also the sections “Peculiarities of use” and “Interaction with other drugs and others types of interactions. “