Fluconazole STELLA 150 mg

Rx

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.

Dosage:

• 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.

Usage:

Fluconazole STELLA 150 mg is administered orally.

• 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..

• Common: Abdominal pain, vomiting, diarrhoea, nausea. Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased. Rash.
• Uncommon: Anaemia. Decreased appetite. Somnolence, insomnia. Seizures, paraesthesia, dizziness, taste perversion. Vertigo. Constipation, dyspepsia, flatulence, dry mouth. Cholestasis, jaundice, bilirubin increased. Drug eruption, urticaria, pruritus, increased sweating. Myalgia. Fatigue, malaise, asthenia, fever.

• 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.