Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution is an FDA-registered drug product whose active ingredient is BRIMONIDINE TARTRATE AND TIMOLOL MALEATE. It is labelled by Apotex Corp. taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 60505-0589, application ANDA091442, label effective 20260423. It is one of 6 FDA drug label records sharing the active ingredient BRIMONIDINE TARTRATE AND TIMOLOL MALEATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BRIMONIDINE TARTRATE AND TIMOLOL MALEATE are most often described in connection with: ophthalmic solution, brimonidine tartrate, timolol maleate, dosed twice, reduction elevated, intraocular pressure, iop patients, glaucoma ocular. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 a day and brimonidine tartrate ophthalmic solution, 0.2% dosed three times per day. ( 1 )

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 )

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 2 years old) [see Use in Specific Populations ( 8.4 )]. 4.4 Hypersensitivity Reactions Local hypersensitivity reactions have occurred following the use of different components of brimonidine tartrate/timolol maleate ophthalmic solution. Brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.

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 SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Brimonidine Tartrate/Timolol Maleate Ophthalmic 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 discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, eyelid pruritus, foreign body sensation, headache, hypertension, oral dryness, somnolence, superficial punctate keratitis, and visual disturbance. Other adverse reactions that have been reported with the individual components are listed below. Brimonidine Tartrate (0.1% to 0.2%) Abnormal taste, allergic reaction, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival blanching, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, fatigue, flu syndrome, follicular conjunctivitis, gastrointestinal disorder, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), hordeolum, insomnia, keratitis, lid crusting, lid disorder, muscular pain, nasal dryness, ocular allergic reaction, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, superficial punctate keratopathy, tearing, upper respiratory symptoms, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity. Timolol (Ocular Administration) Body as a whole: chest pain Cardiovascular: Arrhythmia, bradycardia, cardiac arrest, cardiac failure, cerebral ischemia, cerebral vascular accident, claudication, cold hands and feet, edema, heart block, palpitation, pulmonary edema, Raynaud's phenomenon, syncope, and worsening of angina pectoris Digestive: anorexia, diarrhea, nausea Immunologic: Systemic lupus erythematosus Nervous System/Psychiatric: Increase in signs and symptoms of myasthenia gravis, insomnia, nightmares, paresthesia, behavioral changes and psychic disturbances including confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss Skin: Alopecia, psoriasiform rash or exacerbation of psoriasis Hypersensitivity: Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and generalized and localized rash Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease) [see Contraindications ( 4.1 )] , dyspnea, nasal congestion, respiratory failure, upper respiratory infections Endocrine: Masked symptoms of hypoglycemia in diabetes patients [see Warnings and Precautions ( 5.7 )] Special Senses: diplopia, choroidal detachment following filtration surgery, cystoid macular edema, decreased corneal sensitivity, pseudopemphigoid, ptosis, refractive changes, tinnitus Urogenital: Decreased libido, impotence, Peyronie's disease, retroperitoneal fibrosis. 6.2 Postmarketing Experience The following reactions have been identified during postapproval use of brimonidine tartrate ophthalmic solutions, timolol ophthalmic solutions, or both in combination, in clinical practice. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Bradycardia, eyelid erythema extending to the cheek or forehead, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, rash, and vasodilation), syncope, and tachycardia. Apnea, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic solutions [see Contraindications ( 4.3 ) and Use in Specific Populations ( 8.4 )]. Oral Timolol/Oral Beta-blockers The following additional adverse reactions have been reported in clinical experience with ORAL timolol maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic timolol maleate: Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress Body as a whole: Decreased exercise tolerance, extremity pain, weight loss Cardiovascular: Vasodilatation, worsening of arterial insufficiency Digestive: Gastrointestinal pain, hepatomegaly, ischemic colitis, mesenteric arterial thrombosis, vomiting Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura Endocrine: Hyperglycemia, hypoglycemia Skin: Increased pigmentation, pruritus, skin irritation, sweating Musculoskeletal: Arthralgia N ervous System/Psychiatric: An acute reversible syndrome characterized by disorientation for time and place, decreased performance on neuropsychometrics, diminished concentration, emotional lability, local weakness, reversible mental depression progressing to catatonia, slightly clouded sensorium, vertigo Respiratory: Bronchial obstruction, rales Urogenital: Urination difficulties

FDA lists 6 drug label records with BRIMONIDINE TARTRATE AND TIMOLOL MALEATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution used for?
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 …

Who makes Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution?
Apotex Corp. is the labeler of record for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution. 6 FDA label records share the active ingredient BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BRIMONIDINE TARTRATE AND TIMOLOL MALEATE?
Yes. 6 FDA drug label records list BRIMONIDINE TARTRATE AND TIMOLOL MALEATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.