Inspra Indications, Dosage, Storage, Stability - Eplerenone

Inspra Indications, Dosage, Storage, Stability - Eplerenone

INDICATIONS AND USAGE

INSPRA is indicated to improve survival of stable patients with left ventricular systolic dysfunction (ejection fraction £40%) and clinical evidence of congestive heart failure after an acute myocardial infarction. (See CLINICAL STUDIES, Congestive Heart Failure Post-Myocardial Infarction.)

INSPRA is indicated for the treatment of hypertension. INSPRA may be used alone or in combination with other antihypertensive agents. (See CLINICAL STUDIES, Hypertension.)

The recommended dose of INSPRA is 50 mg once daily. Treatment should be initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks as tolerated by the patient. INSPRA may be administered with or without food.

Serum potassium should be measured before initiating INSPRA therapy, within the first week and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Factors such as patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate. (See PRECAUTIONS, Hyperkalemia in Patients Treated for Congestive Heart Failure and ADVERSE REACTIONS, Clinical Laboratory Test Findings, Congestive Heart Failure Post-Myocardial Infarction, Potassium.) In EPHESUS, the majority of hyperkalemia was observed within the first three months after randomization. The dose should be adjusted based on the serum potassium level and the dose adjustment table shown below (Table 10).

Following withholding INSPRA due to serum potassium ³6.0 mEq/L, INSPRA can be restarted at a dose of 25 mg QOD when serum potassium levels have fallen below 5.5 mEq/L.

INSPRA may be used alone or in combination with other antihypertensive agents. The recommended starting dose of INSPRA is 50 mg administered once daily. The full therapeutic effect of INSPRA is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of INSPRA should be increased to 50 mg twice daily. Higher dosages of INSPRA are not recommended either because they have no greater effect on blood pressure than 100 mg or because they are associated with an increased risk of hyperkalemia. (See CLINICAL STUDIES, Hypertension.)

No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment. For patients receiving weak CYP3A4 inhibitors, such as erythromycin, saquinavir, verapamil, and fluconazole the starting dose should be reduced to 25 mg once daily. (See CONTRAINDICATIONS and PRECAUTIONS, Congestive Heart Failure Post-Myocardial Infarction and Hypertension, Drug Interactions .)

INSPRA Tablets, 25 mg, are yellow diamond biconvex film-coated tablets. They are debossed with Pfizer on one side and NSR over 25 on the other. They are supplied as follows:

INSPRA Tablets, 50 mg, are yellow diamond biconvex film-coated tablets. They are debossed with Pfizer on one side and NSR over 50 on the other. They are supplied as follows:

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

U.S. Patent No. 4,559,332,NSPRA Tablets are manufactured for: G.D. Searle LLC October 2003, Distributed by : G.D. Searle LLC, Subsidiary of Pfizer Inc, NY, NY.