国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
METOPROLOL SUCCINATE (UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23)
NCS HealthCare of KY, LLC dba Vangard Labs
METOPROLOL SUCCINATE
METOPROLOL TARTRATE 25 mg
ORAL
PRESCRIPTION DRUG
Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 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). Numerous antihypertensive drugs, from a variety of pharmacologic
Metoprolol succinate extended-release tablets USP, 25 mg are white to off-white, oval shaped, film-coated tablets, debossed with “M” and “1” separated by breakline on one side and breakline on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10). Blistercards of 30 NDC 0615-7823-39 Blistercards of 15 NDC 0615-7823-05 Unit dose boxes of 30 NDC 0615-7823-30 Metoprolol succinate extended-release tablets USP, 50 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “2” separated by breakline on one side and plain on other side. They are supplied in bottles of 30, 60, 100, 500 and unit dose packages of 100 (10x10). Blistercards of 30 NDC 0615-7824-39 Blistercards of 15 NDC 0615-7824-05 Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
METOPROLOL SUCCINATE- METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1992 INDICATIONS AND USAGE Metoprolol succinate extended-release tablets are a beta-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Angina Pectoris. (1.2) Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3) DOSAGE AND ADMINISTRATION Administer once daily. Titrate at weekly or longer intervals as needed and tolerated. (2) Hypertension: Starting dose is 25 to 100 mg. (2.1) Angina Pectoris: Starting dose is 100 mg. (2.2) Heart Failure: Starting dose is 12.5 or 25 mg. (2.3) Switching from immediate-release metoprolol to metoprolol succinate extended-release tablets: use the same total daily dose of metoprolol succinate extended-release tablets. (2) DOSAGE FORMS AND STRENGTHS • Metoprolol succinate extended-release tablets: 25 mg and 50 mg. (3) CONTRAINDICATIONS Known hypersensitivity to product components. (4) Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker. (4) Cardiogenic shock or decompensated heart failure (4) WARNINGS AND PRECAUTIONS Abrupt cessation may exacerbate myocardial ischemia. (5.1) Heart Failure: Worsening cardiac failure may occur. (5.2) Bronchospastic Disease: Avoid beta-blockers. (5.3) Concomitant use of glycosides, clonidine, diltiazem and verapamil with beta-blockers can increase the risk of bradycardia. (5.4) Pheochromocytoma: I 阅读完整的文件