Secondary prophylaxis of recurrent candidiasis in immuno compromised 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 capsules50 mg/5 ml oral suspension
Dosage and duration
Oesophageal candidiasis, oropharyngeal candidiasis, secondaryprophylaxis of recurrentcandidiasis
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
then 6 to 12 mg/kg once daily for 8 weeks Max. 800 mg once daily
Adult
1200 mg once daily for 1 week then 800 mg once daily for 8 weeks
or
In combination with amphotericin B
or flucytosine
Child
≥ 1 month
12 mg/kg once daily for 2 weeks (withamphotericin B orflucytosine)
then 6 to 12 mg/kg once daily for 8 weeks Max. 800 mg oncedaily
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 longas 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 to12 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.