Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL
Brimonidine Tartrate and Timolol Maleate · SOLUTION · Apotex Corp.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution is a solution containing brimonidine tartrate and timolol maleate at 2 mg/mL, taken ophthalmic. Manufactured by Apotex Corp..
Key Facts
- Brand Name
- Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
- Generic Name
- Brimonidine Tartrate and Timolol Maleate
- NDC Code (Product)
60505-0589- Manufacturer
- Apotex Corp.
- Strength
- 2 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA091442
- Marketing Start
- 10/19/2022
Recall History
Apotex Corp.
Lack of Assurance of Sterility
Apotex Corp.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Allergan Sales, LLC
Failed Impurities/Degradation Specifications.
Apotex Corp.
Lack of Assurance of Sterility
Allergan Sales, LLC
cGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution is 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 Ophthalmic Solution is a combination of brimonidine tartrate, an alpha-adrenergic receptor agonist, and timolol maleate, 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% dosed twice …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop 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 (pediatric patients younger than 2 years old). ( 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 (Pediatric Patients Younger than 2 Years Old) Brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in neonates and infants (pediatric patients younger than…
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 Pa…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Contraindications ( 4.4 )] Potential for Severe Respiratory or Cardiac Reactions [see Warnings and Precautions ( 5.1 )] Cardiac Failure [see Warnings and Precautions ( 5.2 )] Potentiation of Vascular Insufficiency [see Warnings and Precautions ( 5.4 )] Increased Reactivity to Allergens [see Warnings and Precautions ( 5.5 )] Potentiation of Muscle Weakness [see Warnings and Precautions ( 5.6 )] Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus [see Warnings and Precautions ( 5.7 )] Masking of Thyrotoxicosis [see Warnings and Precautions ( 5.8 )] Ocular Hypersensitivity [see Warnings and Precautions ( 5.9 )] Contamination of Topical Ophthalmic Products after Use [see Warnings and Precautions ( 5.10 )] Impairment of Beta-adrenergically Mediated Reflexes During Surgery [see Warnings and Precautions ( 5.11 )] 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 SUSPECT…
Frequently Asked Questions
What is Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution used for?
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution contains Brimonidine Tartrate and Timolol Maleate. It is a solution taken ophthalmic. Consult your doctor for specific uses.
Is Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution a controlled substance?
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution is not classified as a controlled substance by the DEA.
What is the generic name for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution?
The generic name for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution is Brimonidine Tartrate and Timolol Maleate. There are 8 other brand versions of Brimonidine Tartrate and Timolol Maleate.
What is the NDC code for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL?
The NDC (National Drug Code) for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 2 mg/mL is 60505-0589, listed by Apotex Corp..
Other Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution Dosages
Other Brimonidine Brands
See all →- Brimonidine Tartrate/Timolol Maleate2 mg/mL72485-634
- Brimonidine Tartrate and Timolol Maleate2 mg/mL62332-706
- Brimonidine Tartrate and Timolol Maleate2 mg/mL70069-651
- Brimonidine Tartrate and Timolol Maleate2 mg/mL46708-706
- Brimonidine Tartrate and Timolol Maleate2 mg/mL70069-652
- Brimonidine tartrate and Timolol maleate2 mg/mL72603-931
- Brimonidine Tartrate and Timolol Maleate2 mg/mL0781-7186
- Brimonidine Tartrate and Timolol Maleate2 mg/mL0832-1425
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)