Label: METOPROLOL SUCCINATE tablet, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 68071-2455-1 - Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 69097-407
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 22, 2021
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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BOXED WARNING
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WARNING: ISCHEMIC HEART DISEASE
Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol succinate extended-release tablets, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 - 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, metoprolol succinate extended-release tablets administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Warn patients against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue metoprolol succinate extended-release tablets therapy abruptly even in patients treated only for hypertension ( 5.1).
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1 INDICATIONS AND USAGE1.1 Hypertension - 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 ...
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2 DOSAGE AND ADMINISTRATIONMetoprolol succinate is an extended-release tablet intended for once daily administration. For treatment of hypertension and angina, when switching from immediate-release metoprolol to ...
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3 DOSAGE FORMS AND STRENGTHS50 mg tablets: White, circular, biconvex, film coated tablet debossed with 'C' and 'L' on either side of deep score line on one side and '407' on other side. 100 mg tablets: White circular ...
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4 CONTRAINDICATIONSMetoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, decompensated cardiac failure, sick sinus ...
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5 WARNINGS AND PRECAUTIONS5.1 Ischemic Heart Disease - Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred ...
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6 ADVERSE REACTIONSThe following adverse reactions are described elsewhere in labeling: Worsening angina or myocardial infarction. [see Warnings and Precautions ( 5) ...
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7 DRUG INTERACTIONS7.1 Catecholamine Depleting Drugs - Catecholamine depleting drugs (eg, reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents. Observe ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Pregnancy Category C - Metoprolol tartrate has been shown to increase post-implantation loss and decrease neonatal survival in rats at doses up to 22 times, on a mg/m ...
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10 OVERDOSAGESigns and Symptoms - Overdosage of metoprolol succinate may lead to severe bradycardia, hypotension, and cardiogenic shock. Clinical presentation can also include: atrioventricular block ...
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11 DESCRIPTIONMetoprolol succinate is a beta - 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Hypertension: The mechanism of the antihypertensive effects of beta-blocking agents has not been elucidated. However, several possible mechanisms have been proposed ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals have been conducted to evaluate the carcinogenic potential of metoprolol tartrate. In 2-year studies in ...
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14 CLINICAL STUDIESIn five controlled studies in normal healthy subjects, the same daily doses of extended-release metoprolol and immediate-release metoprolol were compared in terms of the extent and duration of ...
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15 REFERENCES1. Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGTablets containing metoprolol succinate equivalent to the indicated weight of metoprolol tartrate, USP, are white, biconvex, film-coated, and scored. NDC 68071-2455-1 BOTTLES OF 100 - Store at 25°C ...
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17 PATIENT COUNSELING INFORMATIONAdvise patients to take metoprolol succinate extended-release tablets regularly and continuously, as directed, preferably with or immediately following meals. If a dose is missed, the patient ...
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