Indications
Adults: Treatment of: Cryptococcal meningitis; Coccidioidomycosis; mucosal candidiasis; vaginal candidiasis when local therapy is not appropriate; Candidal balanitis when local therapy is not appropriate; dermatomycosis when systemic therapy is indicated; onychomycosis when other agents are not considered appropriate. Prophylaxis of: relapse of cryptococcal meningitis; relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV; reduce the incidence of recurrent vaginal candidiasis (³ 4 episodes a year); candidal infections in patients with prolonged neutropenia. Children 0 – 17 years old: Treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Prevent relapse of cryptococcal meningitis. Therapy may be instituted before the results of the cultures are known; however, once these results become available, anti-infective therapy should be adjusted.
Contraindications
Hypersensitivity to fluconazole, to related azole substances, or to any of the excipients. Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4.
Compositon/Ingredients
Fluconazol 150mg
Dosage and administration
Cryptococcosis: Treatment of cryptococcal meningitis: 400 mg on day 1, subsequent dose: 200 – 400 mg once daily, at least 6 – 8 weeks. In life threatening infections the daily dose can be increased to 800 mg. Maintenance therapy to prevent relapse of cryptococcal meningitis: 200 mg once daily. Coccidioidomycosis: 1 capsule for 11 – 24 months or longer depending on the patient. Mucosal candidiasis: Oropharyngeal candidiasis: 2 capsules on day 1, subsequent dose: 1 capsule daily for 7 – 21 days. Oesophageal candidiasis: 2 capsules on day 1, subsequent dose: 1 capsule daily for 14 – 30 days. Candiduria: 2 capsules daily for 7 – 21 days. Longer periods may be used in patients with severely compromised immune function. The prophylaxis of relapse of mucosal candidiasis in patients infected with HIV: 1 capsule daily. Genital candidiasis: Acute vaginal candidiasis, Candidal balanitis: A single oral dose 1 capsule. Treatment and prophylaxis of recurrent vaginal candidiasis (³ 4 episodes a year): 1 capsule every third day for 1 week, followed by 1 capsule once weekly maintenance dose (6 months). Dermatomycosis: Tinea pedis, tinea corporis, tinea cruris, dermal candida infections: 1 capsule once weekly for 2 – 4 weeks, tinea pedis may require up to 6 weeks. Tinea versicolor: 2 capsules once weekly for 1 – 3 weeks. Onychomycosis: 1 capsule once weekly until infected nail is replaced. Prophylaxis of candidal infections in patients with prolonged neutropenia: 2 capsules. Treatment should start several days before the anticipated onset of neutropenia and continue for 7 days after recovery from neutropenia after the neutrophil count rises above 1000 cells per mm3. Elderly: Dosage should be adjusted based on the renal function. Renal impairment: No adjustments in single dose therapy are necessary. In receiving multiple doses of fluconazole, patients with ClCr £ 50 ml/minute: An initial dose of the recommended daily dose, followed by 50% the daily dose the recommended daily dose.
Precaution
Fluconazole STELLA 150 mg should not be used for tinea capitis. Caution in patients with: renal/hepatic dysfunction; potentially proarrhythmic conditions; concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP2C9, CYP2C19 and CYP3A4; coadministration of fluconazole at doses < 400 mg per day with terfenadine. Risk of: adrenal insufficiency (rarely); prolongation of the QT interval; severe cutaneous reactions (rarely); anaphylaxis (rarely). Immediately discontinued fluconazole and consult a physician when symptoms such as important asthenia, anorexia, persistent nausea, vomiting and jaundice occur. The concomitant use of fluconazole and halofantrine is not recommended. If a rash, which is considered attributable to fluconazole, develops in a patient treated for a superficial fungal infection, further therapy with this medicinal product should be discontinued. If patients with invasive/systemic fungal infections develop rashes, monitor closely and discontinue fluconazole if bullous lesions or erythema multiforme develop. Should not use this medicine for patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption; wheat allergy (different from Coeliac disease). Fluconazole should be used during pregnancy only when benefits justify the possible risks to fetus. Breast-feeding may be maintained after a single dose of 150 mg fluconazole. Breast-feeding is not recommended after repeated use or after high dose fluconazole. Patients should be aware of how they react to drug before driving or operating machinery.
Storage
Store at temperature below 30°C, protect from light.
