– Severe fungal infections, when oral administration is not possible:
• Cryptococcal meningitis, in combination with amphotericin B
• Severe oesophageal candidiasis
Forms and strengths, route of administration
– 200 mg in 100 ml bag (2 mg/ml), for infusion
– Cryptococcal meningitis, in combination with amphotericin B
Child over 1 week: 12 mg/kg once daily (max. 800 mg daily) administered over 20 minutes minimum (max. 5 ml/minute)
Adult: 800 mg once daily, administered over 10 minutes minimum (max. 10 ml/minute)
– Severe oesophageal candidiasis
Child over 1 week: 3 to 6 mg/kg once daily
Adult: 200 mg once daily
These doses may be increased up to 400 mg daily if necessary.
– 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, thrombo cytopenia) 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, saquinavir, zidovudine): increased blood concentration of these drugs.
– 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 bag.
– Storage: below 25 °C. Do not store in a refrigerator.