Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

UNDER

Indication¹

To reduce the risk of cardiovascular (CV) mortality and morbidity in stable patients with left ventricular dysfunction and clinical evidence of heart failure after recent myocardial infarction (MI).

Clinical Evidence

First selective aldosterone blocker proven to reduce morbidity and mortality in patients with post-MI heart failure²

Reduced death from CV causes or hospitalization for CV events (p=0.002) and death from any cause or any hospitalization (p=0.02) vs placebo²

Incidence of sex-hormone–related adverse events were comparable to placebo³

Safety Profile¹

CI:	Patients with serum potassium >5 mmol/L at initiation; moderate to severe renal insufficiency (serum creatinine level >2.5 mg/dL or 221 micromol/L); severe hepatic insufficiency (Child-Pugh Class C); those receiving potassium-sparing diuretics or strong CYP3A4 inhibitors, eg, ketoconazole and itraconazole. Hypersensitivity to eplerenone or any of the excipients of Inspra.

SP:	Hyperkalaemia, renal and hepatic impairment. Children, elderly. Pregnancy and lactation.

AR:	Hyperkalaemia, dizziness, hypotension, diarrhoea, nausea, abnormal renal function.

DI:	Nonsteroidal anti-inflammatory drugs (NSAIDs), lithium, potassium-sparing diuretics, eg, spironolactone, amiloride, triamterene.

Dosages¹

Initially, 25 mg once daily titrated to the target dose of 50 mg once daily preferably within 4 weeks.

Strengths¹

25 mg, 50 mg.

Packing¹

Film-coated tab 25 mg x 30's. 50 mg x 30's.

References

1. MIMS Annual Hong Kong. 2007/2008 edition.
2. Pitt B, et al. N Engl J Med 2003;348:1309-1321.
3. Inspra™ full prescribing information. Pfizer; October 2003.

Please review the full product information or package insert before prescribing.