EPLERENONE- eplerenone tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Eplerenone (UNII: 6995V82D0B) (Eplerenone - UNII:6995V82D0B)

থেকে পাওয়া:

Apotex Corp

INN (আন্তর্জাতিক নাম):

EPLERENONE

রচনা:

EPLERENONE 25 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Eplerenone tablets are indicated to improve survival of stable patients with left ventricular (LV) systolic dysfunction (ejection fraction ≤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 Education Program’s J

পণ্য সারাংশ:

Eplerenone tablets 25 mg are available for oral administration as yellow, round, film-coated tablets, unscored and engraved “EP” over “25” on one side, and “APO” on the other side. They are supplied as follows:  Bottles of 30 (NDC 60505-2651-3) Bottles of 90 (NDC 60505-2651-9) Bottles of 500 (NDC 60505-2651-5) Bottles of 1,000 (NDC 60505-2651-8) Blisters of 100 (NDC 60505-2651-7)  Eplerenone tablets 50 mg are available for oral administration as yellow, round, film-coated tablets, unscored and engraved “EP” over “50” on one side, and “APO” on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2652-3) Bottles of 90 (NDC 60505-2652-9) Bottles of 1,000 (NDC 60505-2652-8) Blisters of 100 (NDC 60505-2652-7) Storage Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86° F) [see USP Controlled Room Temperature].  Dispense in a tight, light-resistant container [see USP].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

EPLERENONE- EPLERENONE TABLET
APOTEX CORP
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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:
Improving survival of stable patients with LV systolic dysfunction
(LVEF ≤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 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 ACEs and ARBs,
NSAIDs or moderate CYP3A inhibitors are at increased risk. Monitor
serum potassium levels and adjust dose as
needed. (5.1)
ADVERSE REACTIONS
_CHF Post-MI:_ Most common adve