Epoprostenol

1). 1).

FLOLAN (epoprostenol powder for injection) is indicated for the long-term intravenous treatment of idiopathic or heritable pulmonary arterial hypertension (PAH) or PAH associated with connective tissue diseases (CTD) in patients with WHO Functional Class III-IV symptoms who did not respond adequately to conventional therapy.

Prior to initiation of therapy, the potential benefit of FLOLAN should be weighed against the risks associated with use of the drug and the presence of an indwelling central venous catheter. FLOLAN should be used only by clinicians experienced in the diagnosis and treatment of PAH.

The diagnosis of idiopathic or heritable PAH or PAH/CTD should be carefully established by standard clinical tests. 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

2 Geriatrics Geriatrics (≥65 years of age): Clinical studies of FLOLAN did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be made carefully, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.