EPLERENONE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Mylan Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

EPLERENONE

Σύνθεση:

EPLERENONE 25 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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, E

Περίληψη προϊόντος:

Eplerenone Tablets are available containing 25 mg or 50 mg of eplerenone. The 25 mg tablets are yellow, film-coated, round, unscored tablets debossed with EP1 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-1030-93 bottles of 30 tablets NDC 0378-1030-77 bottles of 90 tablets The 50 mg tablets are yellow, film-coated, round, unscored tablets debossed with EP2 on one side of the tablet and M   on the other side. They are available as follows: NDC 0378-1031-93 bottles of 30 tablets NDC 0378-1031-77 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

EPLERENONE- EPLERENONE TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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
tablets and periodically thereafter. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg (3)
CONTRAINDICATIONS
_For all patients:_
•
•
•
_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
tablets were uncommon. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) 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)
Typ