EPLERENONE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Rebel Distributors Corp.

INN (Alþjóðlegt nafn):

EPLERENONE

Samsetning:

EPLERENONE 50 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Serum potassium levels should be measured before initiating eplerenone therapy and eplerenone should not be prescribed if serum potassium is >5.5 mEq/L. [See 4 CONTRAINDICATIONS]. Eplerenone is 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 is indicated for the treatment of hypertension. Eplerenone may be used alone or in combination with other antihypertensive agents. For All Patients Eplerenone tablets are contraindicated in all patients with: - serum potassium >5.5 mEq/L at initiation, - creatinine clearance ≤30 mL/min, or - concomitant administration of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir and nelfinavir). [See DRUG INTERACTIONS , 7.1 CYP3A4 Inhibitors, CLINICAL PHARMACOLOGY , 12.3 Pharmacokinetics.]  For Patients Treated for Hypertension Eplerenon

Vörulýsing:

Eplerenone Tablets, 50 mg, are round, yellow, film-coated tablets. They are debossed with “SZ” on one side and “16” on the other. They are supplied as: NDC 42254-011-90 bottles of 90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

EPLERENONE- EPLERENONE TABLET
REBEL DISTRIBUTORS CORP.
----------
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.
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Eplerenone is an aldosterone antagonist indicated for: (1)
Improving survival of stable patients with LV systolic dysfunction
(LVEF ≤40%) and CHF after an acute myocardial
infarction. (1.2)
Hypertension, alone or combined with other agents. (1.3)
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) (2)
_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) (2)
_For all patients:_ (2)
Measure serum potassium before starting eplerenone and periodically
thereafter. (2.3) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg (3) (3)
CONTRAINDICATIONS
For all patients: (4)
Serum potassium >5.5 mEq/L at initiation (4)
Creatinine clearance ≤30 mL/min (4)
Concomitant use with strong CYP3A4 inhibitors (4, 7.1)
For the treatment of hypertension: (4)
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 and diabetics
with proteinuria are at increased risk. Proper patient
selection and monitoring and avoiding certain concomitant medications
can minimize the risk. (5.1)
Eplerenone Tablets 50 mg contain FD&C Yellow No. 5 (tartrazine) which
may cause allergic-type reactions (including
bronchial asthma) in certain susceptible persons. Although the overall
incidence of FD&C Yellow N