dorzolamide hydrochloride
dorzolamide hydrochloride is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including DORZOLAMIDE HYDROCHLORIDE. Available dosage forms: powder, solution, solution/ drops.
Drug Details
- Generic Name
- dorzolamide hydrochloride
- Brand Names
- DORZOLAMIDE HYDROCHLORIDE
- Application Number
- ANDA078395
- Sponsor
- FDC Limited
- NDC Codes
- 4
- Dosage Forms
- POWDER, SOLUTION, 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)