Drugplain

Brimonidine Tartrate and Timolol Maleate 2 mg/mL

Brimonidine Tartrate and Timolol Maleate · SOLUTION/ DROPS · Somerset Therapeutics, LLC

No Recall History
Plain English

Brimonidine Tartrate and Timolol Maleate is a solution/ drops containing brimonidine tartrate and timolol maleate at 2 mg/mL, taken ophthalmic. Manufactured by Somerset Therapeutics, LLC.

Key Facts

Brand Name
Brimonidine Tartrate and Timolol Maleate
Generic Name
Brimonidine Tartrate and Timolol Maleate
NDC Code (Product)
70069-653
Manufacturer
Somerset Therapeutics, LLC
Strength
2 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA216114
Marketing Start
10/10/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

blindness4 reports
eye disorder4 reports
blindness unilateral3 reports
ocular hyperaemia3 reports
death2 reports
dry eye2 reports
eye pain2 reports
glaucoma2 reports
optic nerve injury2 reports
product substitution issue2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of Brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. Brimonidine tartrate and timolol maleate ophthalmic solution is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of Brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of timol…

Dosage & Administration

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 ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart. One drop in the affected eye(s), twice daily approximately 12 hours apart.

Contraindications

4 CONTRAINDICATIONS Bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease. ( 4.1 , 5.1 , 5.3 ) Sinus bradycardia, atrioventricular block, overt cardiac failure, cardiogenic shock. ( 4.2 , 5.2 ) Neonates and infants (under the age of 2 years). ( 4.3 ) Hypersensitivity to any component of this product. ( 4.4 ) 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 asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see Warnings and Precautions (5.1, 5.3)] . 4.2 Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock Brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure [see Warnings and Precautions (5.2)] ; cardiogenic shock. 4.3 Neonates and Infants (Under the Age of 2 Years) Brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years). 4.4 Hypersensitivity Reactions Loca…

Drug Interactions

7 DRUG INTERACTIONS Antihypertensives/cardiac glycosides may lower blood pressure. ( 7.1 ) Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade. ( 7.2 ) Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension. ( 7.3 ) Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. ( 7.4 ) Use with CNS depressants may result in an additive or potentiating effect.( 7.5 ) Digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time. ( 7.6 ) CYP2D6 inhibitors may potentiate systemic beta-blockade. ( 7.7 ) Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ( 7.8 ) Monoamine oxidase inhibitors may result in increased hypotension. ( 7.9 ) 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 cardiac glycosides with Brimonidine tartrate and timolol maleate ophthalmic solution is advised. 7.2 Beta-adrenergic Blocking Ag…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions occurring in approximately 5 to 15% of patients included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Brimonidine tartrate and timolol maleate ophthalmic solution In clinical trials of 12 months duration with Brimonidine tartrate and timolol maleate ophthalmic solution, the most frequent reactions associated with its use occurring in approximately 5% to 15% of the patients included: allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging. The following adverse reactions were reported in 1% to 5% of patients: asthenia, blepharitis, corneal erosion, depres…

Frequently Asked Questions

What is Brimonidine Tartrate and Timolol Maleate used for?

Brimonidine Tartrate and Timolol Maleate contains Brimonidine Tartrate and Timolol Maleate. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Brimonidine Tartrate and Timolol Maleate a controlled substance?

Brimonidine Tartrate and Timolol Maleate is not classified as a controlled substance by the DEA.

What is the generic name for Brimonidine Tartrate and Timolol Maleate?

The generic name for Brimonidine Tartrate and Timolol Maleate is Brimonidine Tartrate and Timolol Maleate. There are 6 other brand versions of Brimonidine Tartrate and Timolol Maleate.

What is the NDC code for Brimonidine Tartrate and Timolol Maleate 2 mg/mL?

The NDC (National Drug Code) for Brimonidine Tartrate and Timolol Maleate 2 mg/mL is 70069-653, listed by Somerset Therapeutics, LLC.

Product NDC

70069-653

Package NDC

70069-653-01

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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