Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - eplerenone, quantity: 50 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; hypromellose; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - inspra is indicated: to reduce the risk of cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3-14 days of an acute myocardial infarction (see clinical trials and dosage and administration). to reduce the risk of cardiovascular mortality and morbidity in adult patients with nyha class ii (chronic) heart failure and left ventricular systolic dysfunction (lvef less than or equal to 30% or lvef less than or equal to 35% in addition to qrs duration of greater than 130 msec), in addition to standard optimal therapy (see clinical trials).

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - eplerenone, quantity: 25 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; hypromellose; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - inspra is indicated: to reduce the risk of cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3-14 days of an acute myocardial infarction (see clinical trials and dosage and administration). to reduce the risk of cardiovascular mortality and morbidity in adult patients with nyha class ii (chronic) heart failure and left ventricular systolic dysfunction (lvef less than or equal to 30% or lvef less than or equal to 35% in addition to qrs duration of greater than 130 msec), in addition to standard optimal therapy (see clinical trials).

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - eplerenone (unii: 6995v82d0b) (eplerenone - unii:6995v82d0b) - eplerenone 25 mg - inspra is indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (≤40%) (hfref) after an acute myocardial infarction (mi). inspra is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and mi. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cv risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of

United States - English - NLM (National Library of Medicine)

rebel distributors corp - eplerenone (unii: 6995v82d0b) (eplerenone - unii:6995v82d0b) - eplerenone 25 mg - serum potassium levels should be measured before initiating inspra therapy, and inspra should not be prescribed if serum potassium is >5.5 meq/l. [see contraindications (4)] . inspra is indicated to improve survival of stable patients with left ventricular (lv) systolic dysfunction (ejection fraction ≤40%) and clinical evidence of congestive heart failure (chf) after an acute myocardial infarction (mi). inspra is indicated for the treatment of hypertension. inspra may be used alone or in combination with other antihypertensive agents. for all patients inspra is contraindicated in all patients with: - serum potassium >5.5 meq/l at initiation, - creatinine clearance ≤30 ml/min, or - concomitant administration of strong cyp3a4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir). [see drug interactions (7.1), clinical pharmacology (12.3).] for patients treated for hypertension inspra is contraindicated for the treatment of hypertension in patients w

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - eplerenone 25mg - film coated tablet - 25 mg - active: eplerenone 25mg excipient: croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow ys-1-12524-a purified talc purified water   sodium laurilsulfate - inspra is indicated to reduce the risk of cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3 to 14 days of an acute myocardial infarction.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - eplerenone 50mg; eplerenone 50mg - film coated tablet - 50 mg - active: eplerenone 50mg excipient: croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow purified talc purified water   sodium laurilsulfate active: eplerenone 50mg excipient: croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow purified talc purified water   sodium laurilsulfate - inspra is indicated to reduce the risk of cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3 to 14 days of an acute myocardial infarction.

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - eplerenone - film coated tablets - eplerenone 25 mg - eplerenone - inspra is indicated, in addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (lvef < or = 40 % ) and clinical evidence of heart failure after recent myocardial infarction.inspra is indicated in addition to standard optimal therapy, to reduce the risk of cardiovascular morbidity and mortality in adult patients with nyha class ii (chronic) heart failure and left ventricular systolic dysfunction (lvef < or = 30%).

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - eplerenone - film coated tablets - eplerenone 50 mg - eplerenone - inspra is indicated, in addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (lvef < or = 40 % ) and clinical evidence of heart failure after recent myocardial infarction.inspra is indicated in addition to standard optimal therapy, to reduce the risk of cardiovascular morbidity and mortality in adult patients with nyha class ii (chronic) heart failure and left ventricular systolic dysfunction (lvef < or = 30%).

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - eplerenone -

Singapore - English - HSA (Health Sciences Authority)

viatris private limited - eplerenone - tablet, coated - 25 mg - eplerenone 25 mg