FLUCONAZOLE oral

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

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