Label: MIRABEGRON tablet, film coated, extended release

  • NDC Code(s): 68180-151-06, 68180-151-09, 68180-152-06, 68180-152-09
  • Packager: Lupin Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 4, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Adult Overactive Bladder (OAB) Mirabegron Extended-Release Tablets Monotherapy - Mirabegron extended-release tablets are indicated for the treatment of OAB in adult patients with symptoms ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Dosage Information - Mirabegron extended-release tablets and mirabegron for extended-release oral suspension are two different products and they are not substitutable on a ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Mirabegron extended-release tablets are supplied in two different strengths as described below: 25 mg White coloured, oval shaped, biconvex, film coated tablets debossed with "M25" on one side ...
  • 4 CONTRAINDICATIONS
    Mirabegron extended-release tablets are contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet [see Adverse Reactions (6.1 ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Increases in Blood Pressure - Increases in Blood Pressure in Adults - Mirabegron extended-release tablets can increase blood pressure. Periodic blood pressure determinations are recommended ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in more detail in other sections of the labeling.   Hypertension [see Warnings and Precautions (5.1)] Urinary Retention [see Warnings and ...
  • 7 DRUG INTERACTIONS
    Drug interaction studies were conducted in adult patients to investigate the effect of coadministered drugs on the pharmacokinetics of mirabegron and the effect of mirabegron on the ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no studies with the use of mirabegron in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse ...
  • 10 OVERDOSAGE
    Mirabegron has been administered to healthy volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate ...
  • 11 DESCRIPTION
    Mirabegron extended-release tablet for oral use is a beta-3 adrenergic agonist. The chemical name of mirabegron is 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{([(2R)-2-hydroxy-2-phenylethyl ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR) as demonstrated by in vitro laboratory experiments using the cloned human beta-3 AR. Mirabegron ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity - Long-term carcinogenicity studies were conducted in rats and mice dosed orally with mirabegron for two years. Male ...
  • 14 CLINICAL STUDIES
    14.1 Mirabegron Extended-Release Tablets Monotherapy for Adult OAB - Mirabegron extended-release tablets were evaluated in three, 12-week, double-blind, randomized, placebo-controlled, parallel ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 Mirabegron Extended-Release Tablets - Mirabegron extended-release tablets are supplied as oval, film-coated, extended-release tablets, available in bottles as follows: Strength ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information). Increases in Blood Pressure - Inform patients and/or their caregivers that mirabegron ...
  • PATIENT PACKAGE INSERT
    Patient Information - Mirabegron (MIR-a-BEG-ron) extended-release tablets - for oral use - What are mirabegron extended-release tablets? Mirabegron extended-release tablets are prescription ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 68180-151-06 - Bottle of 30 Tablets - ONCE-DAILY - Mirabegron Extended-Release Tablets, 25 mg - Rx only - NDC 68180-151-06 - Carton of 30 Tablets - ONCE-DAILY - Mirabegron Extended-Release Tablets, 25 ...
  • INGREDIENTS AND APPEARANCE
    Product Information