Dorzolamide Hydrochloride and Timolol Maleate Preservative Free
Dorzolamide Hydrochloride and Timolol Maleate Preservative Free is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Dorzolamide Hydrochloride and Timolol Maleate Preservative Free. Available dosage form: solution/ drops.
Drug Details
- Generic Name
- Dorzolamide Hydrochloride and Timolol Maleate Preservative Free
- Brand Names
- Dorzolamide Hydrochloride and Timolol Maleate Preservative Free
- Application Number
- ANDA207630
- Sponsor
- Aurobindo Pharma Limited
- NDC Codes
- 1
- Dosage Forms
- SOLUTION/ DROPS
- Routes
- OPHTHALMIC
- Active Ingredients
- DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
Indications and Usage
1 INDICATIONS AND USAGE Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free 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 (14.1) ]. Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free 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)