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Dorzolamide Hydrochloride and Timolol Maleate 20 mg/mL

Dorzolamide Hydrochloride and Timolol Maleate · SOLUTION · Genus Lifesciences

No Recall History
Plain English

Dorzolamide Hydrochloride and Timolol Maleate is a solution containing dorzolamide hydrochloride and timolol maleate at 20 mg/mL, taken ophthalmic. Manufactured by Genus Lifesciences.

Key Facts

Brand Name
Dorzolamide Hydrochloride and Timolol Maleate
Generic Name
Dorzolamide Hydrochloride and Timolol Maleate
NDC Code (Product)
64950-390
Manufacturer
Genus Lifesciences
Strength
20 mg/mL
Dosage Form
SOLUTION
Route
OPHTHALMIC
Marketing Status
Application #
ANDA216308
Marketing Start
08/01/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective171 reports
glaucoma92 reports
treatment failure92 reports
drug intolerance78 reports
bronchitis77 reports
diverticulitis75 reports
colitis microscopic72 reports
synovitis72 reports
drug hypersensitivity70 reports
gait disturbance67 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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) ]. 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 admini…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The dose is one drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution 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 five minutes apart [see Drug Interactions (7.3) ]. The dose is one drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution in the affected eye(s) two times daily. ( 2 )

Contraindications

4 CONTRAINDICATIONS Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with: Bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.( 4.1 ) Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock. ( 4.2 ) Hypersensitivity to any component of this product. ( 4.3 , 5.3 ) 4.1 Asthma, COPD 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) ] . 4.2 Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock [see Warnings and Precautions (5.2) ] . 4.3 Hypersensitivity Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.3) ] .

Drug Interactions

7 DRUG INTERACTIONS Potential additive effect of oral carbonic anhydrase inhibitor with dorzolamide hydrochloride and timolol maleate ophthalmic solution. ( 7.1 ) Potential acid-base and electrolyte disturbances. ( 7.2 ) Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade. ( 7.3 ) Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension. ( 7.4 ) Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. ( 7.5 ) Digitalis and calcium antagonists, may have additive effects in prolonging atrioventricular conduction time. ( 7.6 ) CYP2D6 inhibitors may potentiate systemic beta-blockade. ( 7.7 ) 7.1 Oral Carbonic Anhydrase Inhibitors There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and dorzolamide hydrochloride and timolol maleate ophthalmic solution. The concomitant administration of dorzolamide hydrochloride and timolol maleate ophthalmic solution and oral carbonic anhydrase inhibitors is not recommended. 7.2 High-Dose…

Adverse Reactions

6 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 Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Dorzolamide hydrochloride and timolol maleate ophthalmic solution was evaluated in 1,035 patients with elevated intraocular pressure treated for open-angle glaucoma or ocular hypertension for up to 15 months. Approximately 5% of all patients discontinued therapy because of adverse reactions. The most frequently reported adverse reactions occurring in up to 30% of patients were taste perversion (bitter, sour, or unusual taste) or ocular burning and…

Frequently Asked Questions

What is Dorzolamide Hydrochloride and Timolol Maleate used for?

Dorzolamide Hydrochloride and Timolol Maleate contains Dorzolamide Hydrochloride and Timolol Maleate. It is a solution taken ophthalmic. Consult your doctor for specific uses.

Is Dorzolamide Hydrochloride and Timolol Maleate a controlled substance?

Dorzolamide Hydrochloride and Timolol Maleate is not classified as a controlled substance by the DEA.

What is the generic name for Dorzolamide Hydrochloride and Timolol Maleate?

The generic name for Dorzolamide Hydrochloride and Timolol Maleate is Dorzolamide Hydrochloride and Timolol Maleate. There are 6 other brand versions of Dorzolamide Hydrochloride and Timolol Maleate.

What is the NDC code for Dorzolamide Hydrochloride and Timolol Maleate 20 mg/mL?

The NDC (National Drug Code) for Dorzolamide Hydrochloride and Timolol Maleate 20 mg/mL is 64950-390, listed by Genus Lifesciences.

Product NDC

64950-390

Package NDC

64950-390-60

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