מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
EPLERENONE (UNII: 6995V82D0B) (EPLERENONE - UNII:6995V82D0B)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
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).Control of high blood pressure should be part of comprehensive CV risk management, including, as appropriate, lipid control, diabetes manag
NDC: 63629-9414-1: 90 FILM COATED TABLETs in a BOTTLE
Abbreviated New Drug Application
EPLERENONE- EPLERENONE TABLET, FILM COATED BRYANT RANCH PREPACK ---------- 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 is 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 infarctio( 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 ACCORD HEALTHCARE INC AT 1-866-941- 7875 OR _WWW.ACCORDHEALTHCARE.US_ 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, do קרא את המסמך השלם