Therapeutic Action
Antifungal
Source page 402
Individual generic drug information
Extracted information for FLUCONAZOLE only.
Antifungal
Source page 402
Severe fungal infections, when oral administration is not possible: Cryptococcal meningitis, in combination with amphotericin B or flucytosine Severe oesophageal candidiasis
Source page 402
Extracted information for FLUCONAZOLE only.
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).
Source pages 402, 403
Extracted information for FLUCONAZOLE only.
200 mg in 100 ml bottle or bag (2 mg/ml), for IV infusion
Source page 402
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
Source page 402
Change to oral treatment as soon as possible.
Source page 402
Extracted information for FLUCONAZOLE only.
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.
Source page 403
Below 25 °C. Do not store in a refrigerator.
Source page 403
Filter the extracted dose blocks for this individual drug.
12 mg/kg (max. 800 mg) once daily administered over 20 minutes minimum (max. 5 ml/minute)
Candidate age grouping · source page 402
3 to 6 mg/kg (max. 200 mg) once daily
Candidate age grouping · source page 402