The composition 1 capsules:
- active substance: fluconazole;
- 1 capsule contains fluconazole 50 mg or 100 mg
- excipients: lactose monohydrate, potato starch; magnesium stearate silicon dioxide colloidal
- capsule shell composition: gelatin, titanium dioxide (E 171), indigo blue (E 132).
Dosage form. Capsules.
Basic physical and chemical properties: hard gelatin capsules № 2, cylindrical with hemispherical edges, white body, a cap for 50 mg blue capsules, a cap for 100 mg blue or blue capsules contents of capsules – white or almost white powder without smell.
Fluconazole 50 mg - 7 or 10 capsules in a blister, 1 blister in a box.
Antifungal agents for systemic use. Triazole derivatives.
Treatment of such diseases in adults as:
– cryptococcal meningitis;
– сalifornia disease;
– 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 dermatomycosis, tinea versicolor and candidal skin infections, when systemic therapy is indicated,
– dermatophytic onychomycosis, when the use of other drugs is not advisable.
Prevention of such diseases in adults as:
– relapse of cryptococcal meningitis in patients at high risk of its development;
– relapse of oropharyngeal or esophageal candidiasis in patients with HIV at high risk of its development;
– a decrease in the frequency of relapses of vaginal candidiasis (4 or more cases per year);
– prevention of candidal infections in patients with long-term neutropenia (for example, patients with malignant blood diseases who receive chemotherapy, or patients with hematopoietic stem cell transplantation).
It is possible to use the drug in the form of capsules for this category of patients when children are able to safely swallow the capsule, usually at the age of 5 years.
Fluconazole is prescribed to children for the treatment of mucosal candidiasis (oropharyngeal candidiasis, esophageal candidiasis), invasive candidiasis, cryptococcal meningitis, and for the prevention of candidal infections in immunocompromised patients. The drug can be used as supportive therapy to prevent the recurrence of cryptococcal meningitis in children at high risk of developing it.
Fluconazole therapy can be started before the results of culture and other laboratory studies; after the results are obtained, antibiotic therapy should be adjusted accordingly.
– Hypersensitivity to fluconazole, other azole compounds, or to any of the excipients of the drug.
– Simultaneous use of fluconazole and terfenadine in patients who use fluconazole multiple times in 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 CYP3A4 enzyme (for example, cisapride, astemizole, pimozide, quinidine, amiodarone and erythromycin).
The daily dose of fluconazole depends on the type and severity of the fungal infection. For most cases of vaginal candidiasis, a single use of the drug is sufficient.
If necessary, repeated use of the drug, the treatment of infections should be continued until the clinical and laboratory manifestations of the activity of the fungal infection disappear. Insufficient duration of treatment can lead to the resumption of an active infectious process.
Fluconazole is used depending on the dosage form, orally or by infusion. The method of administration of the drug depends on the clinical condition of the patient. There is no need to change the daily dose of the drug when changing the route of its administration from administration to intravenous administration and vice versa.
The capsules should be swallowed whole. Taking the drug does not depend on food intake.