Drugplain

Brimonidine tartrate 2 mg/mL

Brimonidine tartrate · SOLUTION/ DROPS · Micro Labs Limited

No Recall History
Plain English

Brimonidine tartrate is a prescription eye drop medication used to treat high pressure inside the eye, commonly prescribed for glaucoma and ocular hypertension. It works by reducing fluid production in the eye and increasing fluid drainage to help lower eye pressure.

Key Facts

Brand Name
Brimonidine tartrate
Generic Name
Brimonidine tartrate
NDC Code (Product)
42571-419
Manufacturer
Micro Labs Limited
Strength
2 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA217846
Marketing Start
04/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

eye pain280 reports
eye irritation220 reports
fatigue202 reports
drug ineffective192 reports
ocular hyperaemia181 reports
headache178 reports
vision blurred171 reports
off label use147 reports
product dose omission issue134 reports
dizziness132 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Brimonidine tartrate/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/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/Timolol Maleate 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/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution, 0.5% …

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dose is one drop of brimonidine tartrate/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. ( 2 )

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/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/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/timolol maleate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years). 4.4 Hypersensitivity Reactions Local hyper…

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/timolol maleate ophthalmic solution may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with brimonidine tartrate/timolol maleate ophthalmic solution is advised. 7.2 Beta-adrenergic Blocking Agents P…

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 Sentiss at 1-855-473-6847 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. B rimonidine t artrate / t imolol m aleate o phthalmic solution In clinical trials of 12 months duration with brimonidine tartrate/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, depression, epiphora, eye dis…

Frequently Asked Questions

What is Brimonidine tartrate used for?

Brimonidine tartrate is a prescription eye drop medication used to treat high pressure inside the eye, commonly prescribed for glaucoma and ocular hypertension. It works by reducing fluid production in the eye and increasing fluid drainage to help lower eye pressure.

Is Brimonidine tartrate a controlled substance?

Brimonidine tartrate is not classified as a controlled substance by the DEA.

What is the generic name for Brimonidine tartrate?

The generic name for Brimonidine tartrate is Brimonidine tartrate. There are 11 other brand versions of Brimonidine tartrate.

What is the NDC code for Brimonidine tartrate 2 mg/mL?

The NDC (National Drug Code) for Brimonidine tartrate 2 mg/mL is 42571-419, listed by Micro Labs Limited.

Product NDC

42571-419

Package NDC

42571-419-56

Other Brimonidine tartrate Dosages

Other Brimonidine Brands

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

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