dorzolamide hydrochloride and timolol maleate
Drug Details
- Generic Name
- dorzolamide hydrochloride and timolol maleate
- Brand Names
- COSOPT, COSOPT PF
- Application Number
- NDA020869
- Sponsor
- Thea Pharma Inc.
- NDC Codes
- 2
- Dosage Forms
- SOLUTION/ DROPS
- Routes
- OPHTHALMIC
- Active Ingredients
- DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
Indications and Usage
1 INDICATIONS AND USAGE COSOPT ® 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 COSOPT 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) ] . COSOPT 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 COSOPT 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 )