Brimonidine tartrate and Timolol maleate

FDA Drug Profile — Brimonidine tartrate and Timolol maleate

Drug Details

Generic Name
Brimonidine tartrate and Timolol maleate
Brand Names
Brimonidine tartrate and Timolol maleate
Application Number
ANDA201949
Sponsor
Florida Pharmaceutical Products, LLC
NDC Codes
1
Dosage Forms
SOLUTION
Routes
OPHTHALMIC
Active Ingredients
BRIMONIDINE TARTRATE, TIMOLOL MALEATE

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