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- Severe fungal infections, when oral administration is not possible:
- Cryptococcal meningitis, in combination with amphotericin B or flucytosine
- Severe oesophageal candidiasis
Forms and strengths, route of administration
- 200 mg in 100 ml bottle or bag (2 mg/ml), for infusion
Cryptococcal meningitis, in combination with amphotericin B or flucytosine
- Child 1 month and over: 12 mg/kg (max. 800 mg) once daily administered over 20 minutes minimum (max. 5 ml/minute)
- Adult: 1200 mg once daily, administered over 10 minutes minimum (max. 10 ml/minute)
Severe oesophageal candidiasis
- Child 1 month and over: 3 to 6 mg/kg (max. 200 mg) once daily
- Adult: 200 mg (max. 400 mg) once daily
Change to oral treatment as soon as possible.
Contra-indications, adverse effects, precautions
- Administer with caution to patients with hepatic or renal impairment, cardiac disorders (bradycardia, heart rhythm disorders, etc.).
- Reduce the dose by half in patients with renal impairment.
- May cause: gastrointestinal disturbances, headache, skin reactions sometimes severe, anaphylactic reactions; severe hepatic disorders, haematological (leukopenia, thrombocytopenia) and cardiac disorders (QT-prolongation). Stop treatment in the event of anaphylactic reaction, hepatic disorders or severe skin reaction.
- Avoid or monitor combination with:
- drugs that prolong the QT interval (amiodarone, chloroquine, erythromycin, haloperidol, mefloquine, pentamidine, quinine);
- warfarin, carbamazepine, phenytoin, rifabutin, benzodiazepines, calcium-channel blockers, certain antiretrovirals (e.g. nevirapine, zidovudine): increased plasma concentrations of these drugs;
- rifampicin: decreased plasma concentrations of fluconazole.
- Pregnancy and breast-feeding: use only in severe or life-threatening infections, particularly during the first trimester of pregnancy (risk of foetal malformations).
- As in neonates the half-life of fluconazole is prolonged, fluconazole should be administered every 72 hours (neonates < 14 days) or every 48 hours (neonates ≥ 14 days).
- For cryptococcocal meningitis, when amphotericin B is not available or not tolerated, fluconazole may be administered alone during the induction phase (same doses as the oral route).
- Do not add any drug in the infusion bottle or bag.
Below 25 °C. Do not store in a refrigerator.