Product Description.:
G, 25mg
tablet , film-coated , yellow , diamond diamond
BiconvexDebossed
INSPRA contains eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is an odorless, white to off-white crystalline powder. It is very slightly soluble in water, with its solubility essentially pH-independent. The octanol/water partition coefficient of eplerenone is approximately 7.1 at pH 7.0.
INSPRA for oral administration contains 25 mg or 50 mg of eplerenone and the following inactive ingredients: lactose, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, talc, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, and iron oxide yellow and iron oxide red.
INDICATIONS
Patient Selection Considerations
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].
Congestive Heart Failure Post-Myocardial Infarction
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).
Hypertension
INSPRA is indicated for the treatment of hypertension. INSPRA may be used alone or in combination with other antihypertensive agents.
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
* Hyperkalemia [See WARNINGS AND PRECAUTIONS]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials Experience
Congestive Heart Failure Post-Myocardial Infarction
In EPHESUS, safety was evaluated in 3307 patients treated with INSPRA and 3301 placebo-treated patients. The overall incidence of adverse events reported with INSPRA (78.9%) was similar to placebo (79.5%). Adverse events occurred at a similar rate regardless of age, gender, or race. Patients discontinued treatment due to an adverse event at similar rates in either treatment group (4.4% INSPRA vs. 4.3% placebo), with the most common reasons for discontinuation being hyperkalemia, myocardial infarction, and abnormal renal function.