timolol maleate

FDA Drug Profile — timolol maleate, TIMOLOL MALEATE, Timolol GFS, Timolol Maleate

Drug Details

Generic Name
timolol maleate
Brand Names
timolol maleate, TIMOLOL MALEATE, Timolol GFS, Timolol Maleate
Application Number
ANDA078771
Sponsor
Lifestar Pharma LLC
NDC Codes
18
Dosage Forms
SOLUTION/ DROPS, POWDER, SOLUTION, GEL FORMING / DROPS, TABLET
Routes
OPHTHALMIC, ORAL
Active Ingredients
TIMOLOL MALEATE

Indications and Usage

1 INDICATIONS & USAGE Brimonidine tartrate and 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 and 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 and timolol maleate ophthalmic solution 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 and 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.