Dorzolamide

FDA Drug Profile — Dorzolamide Hydrochloride

Dorzolamide is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Dorzolamide Hydrochloride. Available dosage form: solution/ drops.

Drug Details

Generic Name
Dorzolamide
Brand Names
Dorzolamide Hydrochloride
Application Number
ANDA202053
Sponsor
Indoco Remedies Limited
NDC Codes
1
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
DORZOLAMIDE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND 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 carbonic anhydrase inhibitor with 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)