Label: METOPROLOL TARTRATE tablet
- NDC Code(s): 67046-1091-3
- Packager: Coupler LLC
- This is a repackaged label.
- Source NDC Code(s): 57664-506
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated November 5, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use - METOPROLOL TARTRATE TABLETSsafely and effectively. See full prescribing information for - METOPROLOL TARTRATE TABLETS ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGE1.1 Hypertension - Metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and ...
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2 DOSAGE AND ADMINISTRATION2.1 Hypertension - Individualize the dosage of metoprolol tartrate tablets. Metoprolol tartrate tablets should be taken with or immediately following meals. The usual initial dosage is 100 mg ...
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3 DOSAGE FORMS AND STRENGTHSMetoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg, 100 mg of metoprolol tartrate, USP.: 25 mg tablet – White, circular, film coated tablets debossed with "|" on one side and ...
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4 CONTRAINDICATIONS(What is this?)Metoprolol tartrate tablets are contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, systolic blood pressure <100, decompensated heart failure, sick sinus ...
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5 WARNINGS AND PRECAUTIONS5.1 Abrupt Cessation of Therapy - Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have ...
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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)] • Worsening heart failure ...
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7 DRUG INTERACTIONS7.1 Catecholamine Depleting Drugs - Catecholamine depleting drugs (e.g., 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 - Risk Summary - Available data from published observational studies have not demonstrated an association of adverse developmental outcomes with maternal use of metoprolol during ...
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10 OVERDOSAGESigns and Symptoms:Overdosage of metoprolol tartrate tablets may lead to severe bradycardia, hypotension, and cardiogenic shock. Clinical presentation can also include: atrioventricular block ...
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11 DESCRIPTIONMetoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta - 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Metoprolol is a beta - 1-selective (cardioselective) adrenergic receptor blocking agent. This preferential effect is not absolute, however, and at higher plasma ...
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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 STUDIES14.1 Hypertension - In controlled clinical studies, metoprolol tartrate tablets have been shown to be an effective antihypertensive agent when used alone or as concomitant therapy with ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGMetoprolol Tartrate Tablets, USP are available containing 25 mg, 50 mg, or 100 mg of metoprolol tartrate, USP. Tablets 25 mg -White, circular, film coated tablets debossed with "|" on one side and ...
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17 PATIENT COUNSELING INFORMATIONAdvise patients to take metoprolol tartrate tablets regularly and continuously, as directed, preferably with or immediately following meals. If a dose is missed, the patient should take only the ...
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PRINCIPAL DISPLAY PANEL – 25 mg(What is this?)
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INGREDIENTS AND APPEARANCEProduct Information