Description
Therapeutic action
– Antifungal
Indications
– esophageal candidiasis
– Moderate to severe oropharyngeal candidiasis
– Secondary prophylaxis of recurrent candidiasis in immunocompromised patients
– Cryptococcocal meningitis, after treatment with amphotericin B + flucytosine or in combination with
amphotericin B
– Secondary prophylaxis of cryptococcocal infections
Presentation
– 50 mg, 100 mg and 200 mg capsules or tablets
– 50 mg/5 ml oral solution
Dosage and duration
– Oesophageal candidiasis, oropharyngeal candidiasis, secondary prophylaxis o candidiasis
Child over 1 week: 3 to 6 mg/kg once daily
Adult: 50 to 200 mg once daily
These doses may be increased up to 400 mg/day if necessary. The treatment lasts 14 to 21 days for
oesophageal candidiasis; 7 to 14 days for oropharyngeal candidiasis; as long as required for secondary
prophylaxis.
– Cryptococcocal meningitis
– Secondary prophylaxis o cryptococcocal in ections
Child: 6 mg/kg once daily (max. 200 mg/day), as long as required
Adult: 200 mg once daily, as long as required
FluconAzole
Prescription under medical supervision
After treatment with amphotericin B + flucytosine
Child > 1 week
6 to 12 mg/kg once daily (max. 800 mg/day) for 8 weeks
Adult
400 to 800 mg once daily for 8 weeks
or
In combination with amphotericin B
Child > 1 week
12 mg/kg once daily (max. 800 mg/day) for
2 weeks (with amphotericin B) then 6 to
12 mg/kg once daily for 8 weeks
Adult
800 mg once daily for 2 weeks (with amphotericin B) then 400 to 8.
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, saquinavir, zidovudine): increased blood concentration of these drugs.
–Pregnancy and breast- feeding : to be used only in severe or li e-threatening infections, particularly during
the irst trimester o pregnancy (risk o oetal mal ormations).
Remarks
– For cryptococcocal meningitis, when amphotericin B is not available or not tolerated, fluconazole may be
administered alone:
Child over 1 week: 12 mg/kg once daily (max. 1200 mg/d) for 2 weeks then, 12 mg/kg once daily (max.
800 mg/d) for 8 weeks
Adult: 1200 mg once daily for 2 weeks then, 800 mg once daily for 8 weeks
– For the treatment of histoplasmosis, fluconazole is less effective than itraconazole. It should be used
(child: 10 to 12 mg/kg once daily, max. 400 mg/d ; adult: 400 mg on Day 1 then 200 to 400 mg once
daily, for 6 to 12 weeks) only in patients unable to tolerate itraconazole.
– For the treatment of dermatophytosis of the scalp, fluconazole may be used as a secondary option
(child: 6 mg/kg once daily, max. 200 mg/d; adult: 200 mg once daily, for 2 to 4 weeks) but itraconazole is
preferred for this indication.
– For the treatment of genital candidiasis (vulvovaginitis, balanitis), fluconazole is only used if local
treatment fails: 150 mg as a single dose in adults.
– Storage
Once reconstituted, oral solution keeps or 2 weeks
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