INSPRA- eplerenone tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

eplerenone (UNII: 6995V82D0B) (eplerenone - UNII:6995V82D0B)

Tilgjengelig fra:

Rebel Distributors Corp

INN (International Name):

eplerenone

Sammensetning:

eplerenone 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Serum potassium levels should be measured before initiating INSPRA therapy, and INSPRA should not be prescribed if serum potassium is >5.5 mEq/L. [See CONTRAINDICATIONS (4)] . INSPRA 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). INSPRA is indicated for the treatment of hypertension. INSPRA may be used alone or in combination with other antihypertensive agents. For All Patients INSPRA is 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), CLINICAL PHARMACOLOGY (12.3).] For Patients Treated for Hypertension INSPRA is contraindicated for the treatment of hypertension in patients w

Produkt oppsummering:

INSPRA Tablets, 25 mg, are yellow diamond biconvex film-coated tablets. They are debossed with Pfizer on one side and NSR over 25 on the other. They are supplied as follows: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature].

Autorisasjon status:

New Drug Application

Preparatomtale

INSPRA- EPLERENONE TABLET
REBEL DISTRIBUTORS CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INSPRA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR INSPRA.
INSPRA (EPLERENONE) TABLET FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
INSPRA is an aldosterone antagonist indicated for:
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)
_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 INSPRA 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 CYP3A4 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 and diabetics
with proteinuria are at increased risk. Proper patient
selection and monitoring and avoiding certain concomitant medications
can minimize the risk. (5.1)
ADVERSE REACTIONS
_CHF Post-MI_: Most common adverse reactions (>2% and more frequent
than with placebo): hyperkalemia and increased
creatinine. (6.1)
_Hypertension_: Most common adverse reactions (≥2% and more frequent
than with placebo)