Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
Drug Details
- Generic Name
- Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
- Brand Names
- Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Dorzolamide and Timolol
- Application Number
- ANDA213099
- Sponsor
- Alembic Pharmaceuticals Limited
- NDC Codes
- 3
- Dosage Forms
- SOLUTION/ DROPS, SOLUTION
- Routes
- OPHTHALMIC
- Active Ingredients
- DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
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 combination of dorzolamide hydrochloride 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 )