Eplerenone is contraindicated in all patients with serum potassium greater than 5.5 mEq/L at initiation, creatinine clearance less than or equal to 30 mL/min, or concomitant administration of strong CYP3A4 inhibitors. Eplerenone is also contraindicated for the treatment of hypertension in patients with type 2 diabetes with microalbuminuria, serum creatinine greater than 2.0 mg/dL in males or greater than 1.8 mg/dL in females, creatinine clearance less than 50 mL/min, or concomitant administration of potassium supplements or potassium sparing diuretics.

Serum potassium should be measured before initiating eplerenone therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter, especially in patients at risk for the development of hyperkalemia such as elderly patients with renal insufficiency and patients with type 2 diabetes and microalbuminuria.

Most common adverse reactions (greater than 2% and more frequent than with placebo) in patients with CHF Post-MI: hyperkalemia and increased creatinine. Most common adverse reactions (greater than or equal to 2% and more frequent than with placebo) in hypertensive patients: dizziness, diarrhea, coughing, fatigue and flu-like symptoms.

In the European Union, eplerenone is indicated, in addition to standard optimal therapy, 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 ≤30%). Eplerenone is also indicated to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤40%) and clinical evidence of heart failure after recent myocardial infarction.

In Japan, eplerenone is approved for the treatment of hypertension.

For additional product information in the US, visit: http://media.pfizer.com/files/products/uspi_inspra.pdf

UK prescribing information is available at: http://www.medicines.org.uk/EMC/medicine/16746/SPC/Inspra+25mg+%26+50+mg+film-coated+tablets/

Other countries should refer to local prescribing information.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

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