Antifungal agents for systemic use. Triazole derivatives.
Treating such diseases of adults as:
- Cryptococcal meningitis;
- invasive candidiasis;
- mucosal candidiasis including oropharyngeal candidiasis, esophageal candidiasis, candiduria, chronic candidiasis of the skin and mucous membranes;
- chronic atrophic candidiasis (candidiasis, caused by the use of dentures) in the ineffectiveness of the local dental hygiene products;
- Vaginal candidiasis, acute or recurrent when local therapy is not appropriate;
- candida balanitis when local therapy is not appropriate;
- dermatomycosis, including athlete's foot, tinea corporis, tinea groin, pityriasis versicolor and candida infections of the skin, when systemic therapy is not appropriate;
- dermatophyte onychomycosis, when the use of other drugs is not relevant.
Prevention of diseases in adults as:
- a relapse of cryptococcal meningitis in patients with high risk of its developing;
- recurrent oropharyngeal candidiasis or esophagus in patients with HIV with a high risk of its developing;
- reducing of the frequency of relapses of vaginal candidiasis (4 or more times a year);
- prevention of Candida infections in patients with prolonged neutropenia (such as patients with malignant blood diseases who are receiving chemotherapy or in patients with hematopoietic stem cell transplantation).
Hypersensitivity to fluconazole, to other azole substances, or to any of the excipients.
Coadministration of terfenadine and fluconazole is contraindicated for patients receiving Fluconazole at multiple doses of 400 mg per day or higher (based upon results of a multiple dose interaction study).
Coadministration of Fluconazole and other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome CYP3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin.
Hard gelatin capsules.
Store in the original packaging at temperature not exceeding 30 оС. Keep out of the reach of children.