Finished product reference

Timolol / Brimonidine Tartrate

Solution, Drops · Ophthalmic · 0.5 %/0.2 % · 5 mL

List code
53528
Salt form
Maleate

What it is and how it works

Mechanism of Action Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% is comprised of two components: brimonidine tartrate and timolol. Each of these two components decreases elevated intraocular pressure, whether or not associated with glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss. The higher the level of intraocular pressure, the greater the likelihood of glaucomatous field loss and optic nerve damage.

Indications

Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% 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 and timolol maleate ophthalmic solution, 0.2%/0.5% 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, 0.2%/0.5% 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.

Dosage and administration (summary)

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.

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). • Hypersensitivity to any component of this product.

Warnings and precautions

• Potential for Severe Respiratory or Cardiac Reactions • Cardiac Failure • Obstructive Pulmonary Disease • Potentiation of Vascular Insufficiency • Increased Reactivity to Allergens • Potentiation of Muscle Weakness • Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus • Masking of Thyrotoxicosis • Ocular Hypersensitivity Potential for Severe Respiratory or Cardiac Reactions Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% contains timolol maleate; and although administered topically can be absorbed systemically.

Pregnancy

Pregnancy Risk Summary There are no adequate and well-controlled studies with brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% in pregnant women. Limited available data from postmarketing safety reports and published literature reviews with brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% use in pregnan…

Storage and supply

Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% is supplied sterile, in a white LDPE plastic bottle with a natural LDPE dropper tip and a blue polypropylene cap as follows: NDC 0781-7186-75 – 5 mL fill in 8 mL bottle NDC 0781-7186-70 – 10 mL fill in 10 mL bottle NDC 0781-7186-85 – 15 mL fill in 15 mL bottle Storage: Store at…

Source: Brimonidine Tartrate And Timolol Maleate (Brimonidine Tartrate And Timolol Maleate) — US FDA prescribing information, 2026-03-31, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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