Label: METOPROLOL TARTRATE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated November 5, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use - METOPROLOL TARTRATE TABLETSsafely and effectively. See full prescribing information for - METOPROLOL TARTRATE TABLETS ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Metoprolol 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 ...
  • 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 ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 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 ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are described elsewhere in labeling: • Worsening angina or myocardial infarction - [see - Warnings and Precautions (5)] • Worsening heart failure ...
  • 7 DRUG INTERACTIONS
    7.1 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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data from published observational studies have not demonstrated an association of adverse developmental outcomes with maternal use of metoprolol during ...
  • 10 OVERDOSAGE
    Signs and Symptoms:Overdosage of metoprolol tartrate tablets may lead to severe bradycardia, hypotension, and cardiogenic shock. Clinical presentation can also include: atrioventricular block ...
  • 11 DESCRIPTION
    Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta - 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 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 ...
  • 14 CLINICAL STUDIES
    14.1 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Metoprolol 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 ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise 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 ...
  • PRINCIPAL DISPLAY PANEL – 25 mg(What is this?)
    label
  • INGREDIENTS AND APPEARANCE
    Product Information