Zolanix
(Fluconazole) 150 mg CapsuleCOMPOSITION: each capsule contains 150 mg of fluconazole.
INDICATIONS:
ZOLANIX is indicated in adults for the treatment of the following fungal infection:
Cryptococcal meningitis, coccidioidomycosis, invasive candidiasis, mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis, chronic oral atrophic candidiasis if dental hygiene or topical treatment are insufficient, (vaginal candidiasis, acute or recurrent and candidal balanitis (when local therapy is not appropriate)), dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated and tinea unguinium when other agents are not considered appropriate.
Also for prophylaxis of relapse of: cryptococcal meningitis, oroharyngeal or oesophageal candidiasis, recurrent vaginal candidiasis and candidal infection in patients with prolonged neutropenia.
DOSAGE AND ADMINISTRATION
Adults and adolescents: Cryptococcosis: 4 mg on day 1, subsequent dose: 200 mg to 400 mg daily. Inv asive candidiasi: 800 mg on day 1, subsequent dose: 400 mg daliy. coccidioidomycosis, treatment of mucosal candidiasis and prophylaxis of candidal infections in patintes with prolonged neutropenia: 200 mg to 400 mg. prevention of relapse of mucosal candidiasis in patients in fected with or risk of HIV: 100 mg 200 mg daily. genital candidiasis 150 mg as single dose. dermantomycosis: 150 mg once weekly.
CONTRACTIONS: Hypersensitivy to the active substance, or to of the excipients coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYO) 3AA such as cisapride, astemizole, pimozide, quinidine and erythromycin. coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg per day or higher.
Pregnancy and Lactation: Fluconazole in high dose and/or in prolonged regimens should not be used during pregnancy except for potentially life-threatening infections. An observational study has suggested an increased risk of spontaneous abortion in woman treated with fluconazole during the first trimester. Breast-feeding is not recommended after repeated use or after high dose fluconazole.
OVERDOSAGE
Hallucinatin and paranoid behaviour have been concmitantly reported. In the event of overdose, symptomatic treatment (with supportive measures) may be adequate. A three-hour haemodialysis session decreases plasma level by approximately 50%. Further management should be as clinically indicated or as recommended by the national poisons canter, where available.
Zolanix (Fluconazole) 150 mg Capsule
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