EPLERENONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EPLERENONE (UNII: 6995V82D0B) (EPLERENONE - UNII:6995V82D0B)

Available from:

Eon Labs, Inc.

INN (International Name):

EPLERENONE

Composition:

EPLERENONE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Eplerenone tablets are indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (≤40%) (HFrEF) after an acute myocardial infarction (MI). Eplerenone tablets are 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, Ev

Product summary:

Eplerenone Tablets, for oral administration, are available as 25 mg White, round, film-coated tablets, debossed with “SZ” on one side and “12” on the other side and supplied as: NDC 0185-5368-30 bottles of 30 NDC 0185-5368-09 bottles of 90 50 mg Yellow, round, film-coated tablets, debossed with “SZ” on one side and “16” on the other side and supplied as: NDC 0185-5369-30 bottles of 30 NDC 0185-5369-09 bottles of 90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. KEEP TIGHTLY CLOSED. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EPLERENONE- EPLERENONE TABLET
EON LABS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPLERENONE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPLERENONE TABLETS.
EPLERENONE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Eplerenone tablets are an aldosterone antagonist indicated for:
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DOSAGE AND ADMINISTRATION
_HFrEF Post-MI:_ Initiate treatment with 25 mg once daily. Titrate to
maximum of 50 mg once daily within 4 weeks, as
tolerated. Dose adjustments may be required based on potassium levels.
(2.1)
_Hypertension_: 50 mg once daily, alone or combined with other
antihypertensive agents. For inadequate response, increase
to 50 mg twice daily. Higher dosages are not recommended. (2.2)
_For all patients:_
Measure serum potassium before starting eplerenone and periodically
thereafter. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg (3)
CONTRAINDICATIONS
_For all Patients:_
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_For the Treatment of Hypertension:_
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
_HFrEF Post-MI_: Most common adverse reactions (>2% and more frequent
than with placebo): hyperkalemia and increased
creatinine. (6.1)
_Hypertension_: In clinical studies, adverse reactions with eplerenone
were uncommon. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
Improving survival of stable patients with symptomatic heart failure
with reduced ejection fraction (HFrEF) after an
acute myocardial infarction. (1.1)
The treatment of hypertension, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and
nonfatal cardiovascular events, primarily strokes and myocardial
infarctions. (1.2)
Serum potassium >5.5 mEq/L at initiation (4)
Creatinine clearance ≤30 mL/min (4)
Concomitant use with strong CYP3A inhibitors (4,7.1)
Type 2 diabetes with microalbuminuria (4)
Serum creatin