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 INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEBrimonidine 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 ...
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2 DOSAGE AND ADMINISTRATIONThe 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 ...
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3 DOSAGE FORMS AND STRENGTHSSolution containing 2 mg/mL brimonidine tartrate, USP and 5 mg/mL timolol (6.8 mg/mL timolol maleate, USP).
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4 CONTRAINDICATIONS4.1 Reactive - Airway Disease Including Asthma, COPD - Brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in patients with reactive airway disease including bronchial ...
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5 WARNINGS AND PRECAUTIONS5.1 Potential for Severe Respiratory or Cardiac Reactions - Brimonidine tartrate and timolol maleate ophthalmic solution contains timolol maleate; and although administered topically can be ...
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6 ADVERSE REACTIONS6.1 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 ...
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7 DRUG INTERACTIONS7.1 Antihypertensives/Cardiac - Glycosides - Because brimonidine tartrate and timolol maleate ophthalmic solution may reduce blood pressure, caution in using drugs such as antihypertensives and/or ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGEThere 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 ...
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11 DESCRIPTIONBrimonidine 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 ...
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12 CLINICAL PHARMACOLOGY12.1 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 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 ...
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14 CLINICAL STUDIESClinical 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGBrimonidine 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 ...
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17 PATIENT COUNSELING INFORMATIONPatients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block or cardiac failure ...
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PRINCIPAL DISPLAY PANELNDC 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 ...
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INGREDIENTS AND APPEARANCEProduct Information