ITRACONAZOLE oral

Prescription under medical supervision


Therapeutic action

– Antifungal

Indications

– Histoplasmosis and penicilliosis: treatment and secondary prophylaxis
– Dermatophytosis of the scalp (Tinea capitis)

Forms and strengths

– 100 mg capsule
Also comes in 50 mg/5 ml oral solution.

Dosage and duration

– Histoplasmosis (moderate symptoms)
Child: 5 mg/kg once daily for 6 to 12 weeks
Adult: 200 mg 3 times daily for 3 days then 200 mg 1 to 2 times daily for 6 to 12 weeks

– Histoplasmosis (severe symptoms, disseminated form)
Same treatment for 12 weeks, preceded by one to 2 weeks of treatment with amphotericin B

– Penicilliosis (moderate symptoms)
Adult: 200 mg 2 times daily for 8 weeks

– Penicilliosis (severe symptoms)
Same treatment for 10 weeks, preceded by 2 weeks of treatment with amphotericin B

– Secondary prophylaxis of histoplasmosis and penicilliosis
Adult: 200 mg once daily as long as required

– Dermatophytosis of the scalp
Child: 3 to 5 mg/kg once daily for 4 weeks
Adult: 200 mg once daily for 2 to 4 weeks

Contra-indications, adverse effects, precautions

– Administer with caution and monitor use in patients > 60 years or with hepatic or renal impairment or congestive heart failure.
– May cause: gastrointestinal disturbances, headache, skin reactions sometimes severe, anaphylactic reaction, hepatic disorders sometimes severe, paraesthesia, oedema, cardiac failure. Stop treatment in the event of anaphylactic reaction, hepatic disorders or severe skin reaction.
– In case of prolonged treatment, monitor liver function.
– Do not combine with quinidine (risk of arrhythmia).
– Avoid or monitor combination with amiodarone, calcium-channel blockers, benzodiazepines, certain antiretrovirals (e.g. indinavir, ritonavir, saquinavir), corticosteroids (dexamethasone, prednisolone), warfarin, carbamazepine, digoxin: increased blood concentration of these drugs.
– Efficacy of itraconazole may be reduced when combined with: rifampicin, rifabutin, isoniazid, efavirenz, phenytoin, phenobarbital.
– Do not administer simultaneously with aluminium or magnesium hydroxide: administer 2 hours apart.
– Pregnancy and breast-feeding: avoid; for histoplasmosis, amphotericin B alone for 4 to 6 weeks is an alternative in pregnant women. Do not administer in the event of dermatophytosis of the scalp (apply a topical treatment until it is possible to use itraconazole).

Remarks

– Do not open the capsules; take with meals.
  Storage: below 25 °C