EPLERENONE tablet, film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Breckenridge Pharmaceutical, Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in rando

পণ্য সারাংশ:

Eplerenone Tablets, 25 mg, are yellowish red color diamond shaped biconvex film coated tablets, debossed with "E" on one side and "25" on other side. Eplerenone Tablets, 50 mg, are yellowish red color diamond shaped biconvex film coated tablets, debossed with "E" on one side and "50" on other side. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

EPLERENONE- EPLERENONE TABLET, FILM COATED
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
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:
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
_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 BRECKENRIDGE
PHARMACEUTICAL, INC. AT 1-800-367-3395
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,
dosing