Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution

FDA Drug Profile — Dorzolamide and Timolol, Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution

Drug Details

Generic Name
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
Brand Names
Dorzolamide and Timolol, Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
Application Number
ANDA205295
Sponsor
Leading Pharma, LLC
NDC Codes
3
Dosage Forms
SOLUTION, SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE

Indications and Usage

1 INDICATIONS AND USAGE Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor and timolol maleate, a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers. The IOP-lowering of Dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. ( 1 ) Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of Dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5%timolol administered twice a day and 2% dorzolamide administered three times a day [ see Clinical Studies ( 14 ) ].