Description

Compound: Each hard gelatin capsule contains:

Fluconazole – 150 mg.

Auxiliary components: microcrystalline cellulose, dibasic calcium phosphate, Povidone K30, croscarmellose sodium, magnesium stearate, purified talc, gelatin, titanium dioxide.

Properties: Fluconazole is an antifungal triazole. It is a potent and selective inhibitor of fungal enzymes required for the synthesis of ergosterol. Active against opportunistic mycoses such as infections caused by Candida spp. including systemic candidiasis in immunocompromised animals; with Cryptococcus neoformans, including intracranial infections, with Microsporum spp. and with Trichophyton spp. Fluconazole is very specific for fungal cytochrome P450-dependent enzymes. Fluconazole has not been shown to affect plasma testosterone concentrations in men or steroid concentrations in women of childbearing age when taken at 50 mg daily for up to 28 days. No clinically significant effect was observed on endogenous steroid levels or on the ACTH-stimulated response in healthy male volunteers taking fluconazole 200-400 mg daily. Interaction studies with antipyrine show that a single or multiple dose of fluconazole 50 mg does not affect metabolism. Indications: For the treatment of cryptococcal meningitis, coccidioidomycosis, invasive candidiasis. Treatment of vaginal candidiasis, acute or recurrent; candidal balanitis when topical therapy is not suitable. To prevent a decrease in the frequency of recurrence of vaginal candidiasis (4 or more episodes per year). Prevention of candidal infections in patients with prolonged neutropenia (eg, in patients with hematologic malignancies receiving chemotherapy or in patients receiving hematopoietic stem cell transplantation).

Mode of application: Capsules should be swallowed whole and taken with or without food. The dose should be based on the nature and severity of the fungal infection. Treatment of infections requiring multiple doses should be continued if clinical parameters or laboratory tests show that the active fungal infection has subsided. Inadequate treatment period may lead to recurrence of active infection. In adults: Genital candidiasis: Acute vaginal candidiasis: 150 mg as a single dose. Shackle balanitis single dose. Treatment and prevention of recurrent vaginal candidiasis 150 mg on three days for a total of 3 doses (days 1, 4 and 7), followed by 150 mg once a week maintenance dose. Maintenance dose: 6 months. Ringworm: foot fungus, ringworm, groin fungus and candida infections: 150 mg once a week for 2-4 weeks, foot fungus may require treatment for up to 6 weeks. Pityriasis versicolor: 300-400 mg once a week for 1-3 weeks. Onychomycosis: 150 mg once a week. Treatment should be continued until the infected nail is replaced (an uninfected nail grows back). Recovery of fingernails usually takes 3 to 6 months and toenails 6 to 12 months. Growth rates in different people can vary greatly by age. Special Populations: Elderly: Dosage should be adjusted according to renal function (Renal insufficiency: No adjustment required for single therapy). Patients on regular dialysis should receive 100% of the recommended dose after each dialysis; on dialysis days, patients should receive a reduced dose according to hepatic insufficiency: there are limited data in patients with genital clearance and creatinine impairment, so fluconazole should be administered with caution to patients with liver dysfunction. Children: Safety and efficacy for genital candidiasis in children have not been established. If treatment for genital candidiasis is mandatory for adolescents (12 to 17 years of age), then the dosage should be the same as for adults.

Contraindications: Hypersensitivity to fluconazole, related azole compounds or any of the excipients in the formulation. Fluconazole should not be taken concomitantly with terfenadine, cisapride or ergot derivatives. Precautionary measures: Use with caution in patients with renal and hepatic dysfunction. The drug is associated with rare cases of serious liver toxicity. In cases of hepatotoxicity associated with fluconazole, there was no clear relationship with the total daily dose, duration of therapy, sex or age of the patient. It is reversible upon discontinuation of therapy. The patient should be informed of the symptoms of a serious hepatic effect (important asthenia, anorexia, persistent nausea, vomiting and jaundice). Treatment with fluconazole should be stopped immediately and the patient should consult a doctor. Cardiovascular: Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. Co-administration of fluconazole and halofantrine is not recommended.