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Therapeutic action
- Antifungal
Indications
- Oesophageal candidiasis
- Moderate to severe oropharyngeal candidiasis
- Secondary prophylaxis of recurrent candidiasis in immunocompromised patients
- Cryptococcal meningitis, after treatment with amphotericin B + flucytosine or in combination with amphotericin B or flucytosine
- Secondary prophylaxis of cryptococcal infections
Forms and strengths
- 50 mg and 200 mg capsules
- 50 mg/5 ml oral suspension
Dosage and duration
Oesophageal candidiasis, oropharyngeal candidiasis, secondary prophylaxis of recurrent candidiasis
- Child 1 month and over: 3 to 6 mg/kg (max. 200 mg) once daily
- Adult: 50 to 200 mg (max. 400 mg) once daily
The treatment lasts 14 to 21 days for oesophageal candidiasis; 7 to 14 days for oropharyngeal candidiasis; as long as required for secondary prophylaxis.
Cryptococcal meningitis
After treatment with amphotericin B + flucytosine |
Child ≥ 1 month |
12 mg/kg once daily for 1 week Max. 800 mg once daily |
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Adult | 1200 mg once daily for 1 week then 800 mg once daily for 8 weeks |
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or |
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In combination with amphotericin B or flucytosine |
Child ≥ 1 month |
12 mg/kg once daily for 2 weeks (with amphotericin B or flucytosine) Max. 800 mg once daily |
Adult | 1200 mg once daily for 2 weeks (with amphotericin B or flucytosine) then 800 mg once daily for 8 weeks |
Secondary prophylaxis of cryptococcal infections
- Child: 6 mg/kg (max. 200 mg) once daily, as long as required
- Adult: 200 mg once daily, as long as required
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, haematologic (leukopenia, thrombocytopenia) and cardiac disorders (QT-prolongation). Stop treatment in the event of anaphylactic reaction, hepatic disorders or severe skin reaction.
- In the event of prolonged treatment, monitor hepatic function.
- Do not administer simultaneously with rifampicin, administer 12 hours apart (rifampicin in the morning, fluconazole in the evening).
- 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.
- Pregnancy and breast-feeding: to be used only in severe or life-threatening infections, particularly during the first trimester of pregnancy (risk of foetal malformations).
Remarks
- As in neonates the half-life of fluconazole is prolonged, it should be administered every 72 hours (neonates < 14 days) or every 48 hours (neonates ≥ 14 days).
- For the treatment of histoplasmosis, fluconazole is less effective than itraconazole. In patients unable to tolerate itraconazole, the dose of fluconazole is:
- child: 10 to 12 mg/kg (max. 400 mg) once daily for 6 to 12 weeks
- adult: 400 mg on D1 then 200 to 400 mg once daily for 6 to 12 weeks
- For the treatment of genital candidiasis (vulvovaginitis, balanitis), fluconazole is only used if local treatment fails: 150 mg single dose in adults.
Storage
– Below 25 °C
Once reconstituted, oral suspension keeps for 2 weeks.
Once reconstituted, oral suspension keeps for 2 weeks.