Dorzolamide and Timolol 20 mg/mL
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution · SOLUTION · Leading Pharma, LLC
This eye drop medication combines two drugs that work together to lower eye pressure in patients with glaucoma or ocular hypertension. Dorzolamide reduces fluid production in the eye while timolol helps increase fluid drainage, making this combination effective for managing these eye conditions.
Key Facts
- Brand Name
- Dorzolamide and Timolol
- Generic Name
- Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
- NDC Code (Product)
69315-305- Manufacturer
- Leading Pharma, LLC
- Strength
- 20 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA205295
- Marketing Start
- 05/18/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. ( 1 ) 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 an…
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. ( 2 ) 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 ) ].
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 LEADING PHARMA at 1-844-740-7500 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 1035 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/or stin…
Frequently Asked Questions
What is Dorzolamide and Timolol used for?
This eye drop medication combines two drugs that work together to lower eye pressure in patients with glaucoma or ocular hypertension. Dorzolamide reduces fluid production in the eye while timolol helps increase fluid drainage, making this combination effective for managing these eye conditions.
Is Dorzolamide and Timolol a controlled substance?
Dorzolamide and Timolol is not classified as a controlled substance by the DEA.
What is the generic name for Dorzolamide and Timolol?
The generic name for Dorzolamide and Timolol is Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution. There are 2 other brand versions of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution.
What is the NDC code for Dorzolamide and Timolol 20 mg/mL?
The NDC (National Drug Code) for Dorzolamide and Timolol 20 mg/mL is 69315-305, listed by Leading Pharma, LLC.