Cosopt (Dorzolamide Hydrochloride / Timolol Maleate Ophthalmic) - Indications and Dosage

INDICATIONS AND USAGE

COSOPT is indicated for the reduction of elevated intraocular pressure 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 b.i.d. was slightly less than that seen with the concomitant administration of 0.5% timolol b.i.d. and 2.0% dorzolamide t.i.d. (see CLINICAL PHARMACOLOGY, Clinical Studies).

DOSAGE AND ADMINISTRATION

The dose is one drop of COSOPT in the affected eye(s) two times daily.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart (see also PRECAUTIONS, Drug Interactions).

HOW SUPPLIED

COSOPT Ophthalmic Solution is a clear, colorless to nearly colorless, slightly viscous solution.

No. 3628 -- COSOPT Ophthalmic Solution is supplied in an OCUMETER®* PLUS container, a white, translucent, HDPE plastic ophthalmic dispenser with a controlled drop tip and a white polystyrene cap with dark blue label as follows:

NDC 0006-3628-35, 5 mL in a 7.5 mL bottle

NDC 0006-3628-36, 10 mL in an 18 mL bottle.

STORAGE

Store COSOPT at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light.