ddorzolamide hydrochloride timolol maleate

FDA Drug Profile — DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE

Drug Details

Generic Name
ddorzolamide hydrochloride timolol maleate
Brand Names
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE
Application Number
ANDA202054
Sponsor
Indoco Remedies Limited
NDC Codes
1
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE

Indications and Usage

1 INDICATIONS & USAGE 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)]. 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)