Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Dorzolamide and Timolol. Available dosage forms: solution/ drops, 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 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 ) ].