Fluconazol-CR (fluconazole) capsules 50 mg. №7

Description

Fluconazol-CR 50 mg Storage
active substance: fluconazole;

1 capsule contains fluconazole 50 mg or 100 mg or 150 mg;

Excipients: lactose monohydrate, corn starch, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium;

shell:

50 mg capsules – gelatin, titanium dioxide (E 171), quinoline yellow (E 104), erythrosine (E 127);

100 mg capsules – gelatin, titanium dioxide (E 171), quinoline yellow (E 104), erythrosine (E 127);

150 mg capsules – gelatin, titanium dioxide (E 171), quinoline yellow (E 104), erythrosine (E 127).

Fluconazol-CR 50 mg Dosage form
Capsules.

Basic physical and chemical properties:

50 mg capsules: hard gelatin capsules with a white body and a yellow cap;

100 mg capsules: hard gelatin capsules with a white body and a yellow cap;

150 mg capsules: yellow hard gelatin capsules.

Capsule content – white or almost white powder.

Fluconazol-CR 50 mg Pharmacotherapeutic group
Antifungal agents for systemic use. Triazole derivatives. ATX code J02A C01.

Pharmacological properties

Pharmacodynamics.

Mechanism of action.

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

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

Indication
Fluconazole-KR is indicated for the treatment of the following fungal infections in adults (see section “Pharmacodynamics”):

cryptococcal meningitis (see section “Features of use”);
coccidioidosis (see section “Features”);
invasive candidiasis;
candidiasis of the mucous membranes, including candidiasis of the oropharynx and candidiasis of the esophagus, candidiasis, chronic candidiasis of the skin and mucous membranes;
chronic atrophic candidiasis of the oral cavity (candidiasis caused by the use of dentures) with ineffective oral hygiene or local therapy;
vaginal candidiasis, acute or recurrent, when local therapy is not appropriate;
candidal balanitis, when local therapy is not appropriate;

Contraindication
Hypersensitivity to fluconazole, other azole compounds or to any of the excipients listed in the section “Composition”.
Concomitant use of fluconazole and terfenadine in patients receiving fluconazole repeatedly at doses of 400 mg / day and above (according to the results of a study of the interaction of repeated use).
Concomitant use of fluconazole and other drugs that prolong the QT interval and are metabolized by the enzyme CYP3A4 (eg cisapride, astemizole, pimozide, quinidine and erythromycin) (see sections “Peculiarities” and “Interaction with other medicinal products” and other interactions ).