EPLERENONE- eplerenone tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

American Health Packaging

INN (Alþjóðlegt nafn):

EPLERENONE

Samsetning:

EPLERENONE 25 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Eplerenone tablets are indicated to improve survival of stable patients with left ventricular (LV) systolic dysfunction (ejection fraction less than or equal to 40%) and clinical evidence of congestive heart failure (CHF) 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

Vörulýsing:

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: Unit dose packages of 30 (5 x 6) NDC 68084-948-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

EPLERENONE- EPLERENONE TABLET
AMERICAN HEALTH PACKAGING
----------
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:
Improving survival of stable patients with LV systolic dysfunction
(LVEF less than or equal to 40%) and CHF 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)
DOSAGE AND ADMINISTRATION
_CHF 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:_
Serum potassium greater than 5.5 mEq/L at initiation (4)
Creatinine clearance less than or equal to 30 mL/min (4)
Concomitant use with strong CYP3A inhibitors (4,7.1)
_For the treatment of hypertension:_
Type 2 diabetes with microalbuminuria (4)
Serum creatinine greater than 2.0 mg/dL in males, greater than 1.8
mg/dL in females (4)
Creatinine clearance less than 50 mL/min (4)
Concomitant use of potassium supplements or potassium-sparing
diuretics (4)
WARNINGS AND PRECAUTIONS
Hyperkalemia: Patients with decreased renal function, diabetes,
proteinuria or patients who are taking ACEs and ARBs,
NSAIDs or moderate CYP3A inhibitors are at increased risk. Monitor
serum potassium l