Invasive aspergillosis in patients w/ disease refractory to amphotericin B, itraconazole or intolerant to these drugs. Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis & mycetoma in patients w/ disease refractory or intolerant to other therapy. Prophylaxis of invasive fungal infections in adults w/ AML or myelodysplastic syndrome (MDS), haematopoietic stem cell transplant recipients & who are at high risk of developing these infections.
Refractory invasive fungal infections (IFI)/intolerant patient w/ IFI & prophylaxis of IFI Loading dose: 300 mg bd on 1st day then 300 mg once daily thereafter. Duration of therapy: AML or MDS Start prophylaxis several days before anticipated onset of neutropenia & continue for 7 days after neutrophil count rises >500 cells/mm3.
Hypersensitivity to other azoles. Pro-arrhythmic conditions eg, congenital or acquired QTc prolongation, cardiomyopathy, sinus bradycardia, existing symptomatic arrhythmias; severe GI dysfunction eg, diarrhoea or vomiting. Monitor & correct electrolyte disturbances prior to & during therapy. Evaluate LFTs prior to & during therapy; consider discontinuation if clinical signs & symptoms of hepatic disease develops. Not to be administered w/ CYP3A4 substrates & drugs prolonging QTc interval. Avoid use w/ rifamycin antibacterials (eg, rifampicin, rifabutin), certain anticonvulsants (eg, phenytoin, carbamazepine, phenobarb, primidone), efavirenz. Concomitant use w/ benzodiazepines eg, midazolam, triazolam, alprazolam; vincristine. May affect ability to drive & use machines. Severe renal & hepatic impairment. Women of childbearing potential must use effective contraceptive during treatment. Not to be used during pregnancy & lactation. Not recommended in patients <18 yr.
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