Label: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE solution/ drops

  • NDC Code(s): 60219-2067-3, 60219-2068-6, 60219-2138-8
  • Packager: Amneal Pharmaceuticals NY LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 1, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use BRIMONIDINE TARTRATE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated ...
  • 2 DOSAGE AND ADMINISTRATION
    The recommended dose is one drop of brimonidine tartrate and timolol maleate ophthalmic solution in the affected eye(s) twice daily approximately 12 hours apart. If more than one topical ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Solution containing 2 mg/mL brimonidine tartrate, USP and 5 mg/mL timolol (6.8 mg/mL timolol maleate, USP).
  • 4 CONTRAINDICATIONS
    4.1 Reactive - Airway Disease Including Asthma, COPD - Brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in patients with reactive airway disease including bronchial ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Potential for Severe Respiratory or Cardiac Reactions - Brimonidine tartrate and timolol maleate ophthalmic solution contains timolol maleate; and although administered topically can be ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Studies - Experience - Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Antihypertensives/Cardiac - Glycosides - Because brimonidine tartrate and timolol maleate ophthalmic solution may reduce blood pressure, caution in using drugs such as antihypertensives and/or ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenicity studies have been performed in animals. Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 ...
  • 10 OVERDOSAGE
    There have been reports of inadvertent overdosage with timolol ophthalmic solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as ...
  • 11 DESCRIPTION
    Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Brimonidine tartrate and timolol maleate ophthalmic solution is comprised of two components: brimonidine tartrate and timolol. Each of these two components decreases ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - With brimonidine tartrate, no compound-related carcinogenic effects were observed in either mice or rats following a 21-month and ...
  • 14 CLINICAL STUDIES
    Clinical studies were conducted to compare the IOP-lowering effect over the course of the day of brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% administered twice a day ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% is supplied as a sterile, clear, greenish-yellow color solution filled in 10 mL or 15 mL ETO sterile low density ...
  • 17 PATIENT COUNSELING INFORMATION
    Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block or cardiac failure ...
  • PRINCIPAL DISPLAY PANEL
    NDC 60219-2067-3 - Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% Rx only - 5 mL - Amneal Pharmaceuticals LLC - NDC 60219-2068-6 - Brimonidine Tartrate and ...
  • INGREDIENTS AND APPEARANCE
    Product Information