Fluzamed (fluconazole) hard capsules 150 mg. №1

Description

Fluzamed Composition
active substance: fluconazole;

1 capsule contains fluconazole 150 mg;

excipients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium lauryl sulfate;

capsule composition: gelatin, titanium dioxide (E 171), carmoizine (E 122), diamond blue (E 133).

Fluzamed Dosage form

Hard capsules.

Hard gelatin capsule (size № 1, dark blue cap, white body) containing white powder.

Name and location of the manufacturer

“E.I.P.I.Co.”, Egypt / “E.I.P.I.Co.”, Egypt.

Tens ov Ramadan City, First Industrial Zone, B1, a / a 149 Tens, Egypt / Tenth of Ramadan City, First Industrial Area B1, P.O. box: 149 Tenth, Egypt.

Holder of the registration certificate – “WORLD MEDICINE LIMITED”, Great Britain / “WORLD MEDICINE LIMITED”, United Kingdom.

Fluzamed Pharmacotherapeutic group

Antifungal agents for systemic use. Triazole derivatives. ATX code J02A C01.

Fluconazole, an antifungal agent of the triazole class, is a potent and selective inhibitor of fungal enzymes required for ergosterol synthesis. 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. The accumulation of 14-alpha-methyl-sterols correlates with the 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 ACTH stimulation in healthy male volunteers.

An antipyrine interaction study has shown that administration of 50 mg fluconazole once or repeatedly does not affect antipyrine metabolism.

Indications
Acute vaginal candidiasis when topical therapy is not appropriate.

Candidal balanitis, when local therapy is not appropriate.

Contraindications
Hypersensitivity to fluconazole, other azole compounds or to any of the excipients.

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 CYP2A4 (eg, cisapride, astemizole, pimozide, quinidine and erythromycin).