Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
eplerenone (UNII: 6995V82D0B) (eplerenone - UNII:6995V82D0B)
Rebel Distributors Corp
eplerenone
eplerenone 25 mg
ORAL
PRESCRIPTION DRUG
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
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].
New Drug Application
INSPRA- EPLERENONE TABLET REBEL DISTRIBUTORS CORP ---------- 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) Baca dokumen lengkap