Label: METOPROLOL SUCCINATE- metoprolol succinate er tablets tablet, film coated, extended release

  • NDC Code(s): 68001-500-00, 68001-500-03, 68001-500-08, 68001-501-00, view more
  • Packager: BluePoint Laboratories
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 30, 2023

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  • 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 ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS & USAGE
    1.1 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 ...
  • 2 DOSAGE & ADMINISTRATION
    2.1 Hypertension - Adults: The usual initial dosage is 25 mg to 100 mg daily in a single dose. Adjust dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved ...
  • 3 DOSAGE FORMS & STRENGTHS
    Metoprolol Succinate Extended-Release Tablets, USP are available containing 23.75 mg, 47.5 mg, 95 mg or 190mg of metoprolol succinate, USP equivalent to 25 mg, 50 mg, 100 mg or 200 mg of ...
  • 4 CONTRAINDICATIONS
    Metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second- or third-degree heart block, cardiogenic shock, decompensated heart failure, sick sinus syndrome ...
  • 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)] ...
  • 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 - Untreated hypertension and heart failure during pregnancy can lead to adverse outcomes for the mother and the fetus - (see Clinical Considerations) ...
  • 10 OVERDOSAGE
    Signs and Symptoms - Overdosage of metoprolol succinate extended-release tablets may lead to severe bradycardia, hypotension, and cardiogenic shock. Clinical presentation can also include ...
  • 11 DESCRIPTION
    Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate ...
  • 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 ...
  • 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 a double-blind study, 1092 patients with mild-to-moderate hypertension were randomized to once daily metoprolol succinate extended-release tablets (25 mg, 100 mg, or 400 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Metoprolol Succinate Extended-Release Tablets, USP are available containing 23.75 mg, 47.5 mg, 95 mg or 190 mg of metoprolol succinate, USP equivalent to 25 mg, 50 mg, 100 mg or 200 mg of ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise 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 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 68001-500-00 25mg 100 Tablets Rx Only
  • Package/Label Display Panel
    NDC 68001-501-00 50mg 100 Tablets Rx Only
  • Package/Label Display Panel
    NDC 68001-502-00 100mg 100 Tablets Rx Only
  • Package/Label Display Panel
    NDC 68001-503-00 200mg 100 Tablets Rx Only
  • INGREDIENTS AND APPEARANCE
    Product Information