EPLERENONE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Accord Healthcare, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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, Evaluation, and Treatment of High Blood Pressure (JNC).Control of high blood pressure should be part of comprehensive CV risk management, including, as appropriate, lipid control, diabetes manag

leaflet_short:

Eplerenone tablets, 25 mg, are yellow diamond shape biconvex film-coated tablets, debossed with “E1” on one side and plain on the other side. They are supplied as follows: Eplerenone tablets, 50 mg, are yellow diamond shape biconvex film-coated tablets, debossed with “E2” on one side and plain on the other side. They are supplied as follows: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

EPLERENONE- EPLERENONE TABLET, FILM COATED
ACCORD HEALTHCARE, 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 is an aldosterone antagonist indicated for:
The treatment of hypertension, to lower blood pressure. Lowering blood
pressure reduces the risk of
fatal and nonfatal cardiovascular events, primarily strokes and
myocardial infarctio( 1.2)
DOSAGE AND ADMINISTRATION
_Hypertension_: 50 mg once daily. 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:_
Serum potassium >5.5 mEq/L at initiation ( 4)
Creatinine clearance ≤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 >2.0 mg/dL in males, >1.8 mg/dL in females ( 4)
Creatinine clearance <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
ARBs, NSAIDs or moderate CYP3A inhibitors are at increased risk.
Monitor serum potassium levels and
adjust dose as needed. ( 5.1)
ADVERSE REACTIONS
_Hypertension_: In clinical studies, adverse reactions with eplerenone
were uncommon. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACCORD HEALTHCARE INC
AT 1-866-941-
7875 OR _WWW.ACCORDHEALTHCARE.US_ OR FDA AT 1-800-FDA-1088 OR
_WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
CYP3A Inhibitors: In patients with hypertension initiate at 25 mg once
daily. For inadequate blood
pressure response,