Country: United States
Language: English
Source: NLM (National Library of Medicine)
DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1), TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)
Akorn
DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE 20 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
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 betablockers (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 contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see Warnings and Precautions (5.1) ] . Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia, second or third degree atrioventric
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied sterile in 10 mL white LDPE plastic dropper bottles with white LDPE dropper tips and blue P/P caps of the following sizes: 5 mL 10 mL Storage Store Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution between 20 and 25°C (68-77°F). Protect from light. After opening, Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution can be used until the expiration date on the bottle.
Abbreviated New Drug Application
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE- DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS AKORN ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION INITIAL U.S. APPROVAL: 1998 INDICATIONS AND USAGE • • DOSAGE AND ADMINISTRATION The dose is one drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution in the affected eye(s) two times daily. (2) (2) DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing dorzolamide 20 mg/mL (2%) and timolol 5 mg/mL (0.5%). (3) (3) CONTRAINDICATIONS Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with: (4) • • • WARNINGS AND PRECAUTIONS • • • • • • • • • • ADVERSE REACTIONS The most frequently reported adverse reactions were taste perversion (bitter, sour, or unusual taste) or ocular burning and/or stinging in up to 30% of patients. Conjunctival hyperemia, blurred vision, superficial punctate keratitis or eye itching were reported between 5 to 15% of patients. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AKORN OPERATING COMPANY LLC AT 1- 800-932-5676 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • 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 conc Read the complete document