Timolol Maleate 5 mg/mL
Timolol Maleate · SOLUTION, GEL FORMING / DROPS · Somerset Therapeutics, LLC
Timolol Maleate is a solution, gel forming / drops containing timolol maleate at 5 mg/mL, taken ophthalmic. Manufactured by Somerset Therapeutics, LLC.
Key Facts
- Brand Name
- Timolol Maleate
- Generic Name
- Timolol Maleate
- NDC Code (Product)
70069-251- Manufacturer
- Somerset Therapeutics, LLC
- Strength
- 5 mg/mL
- Dosage Form
- SOLUTION, GEL FORMING / DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA210640
- Marketing Start
- 10/31/2024
Recall History
Apotex Corp.
Lack of Assurance of Sterility
Apotex Corp.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
PACK Pharmaceuticals, LLC
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
PACK Pharmaceuticals, LLC
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Akorn, Inc
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Allergan Sales, LLC
Failed Impurities/Degradation Specifications.
FDC Limited
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Rising Pharmaceuticals, Inc.
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
FDC Limited
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & 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 administ…
Dosage & Administration
2 DOSAGE & 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 at 1-833-856-0880 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/or stinging. The fo…
Frequently Asked Questions
What is Timolol Maleate used for?
Timolol Maleate contains Timolol Maleate. It is a solution, gel forming / drops taken ophthalmic. Consult your doctor for specific uses.
Is Timolol Maleate a controlled substance?
Timolol Maleate is not classified as a controlled substance by the DEA.
What is the generic name for Timolol Maleate?
The generic name for Timolol Maleate is Timolol Maleate. There are 6 other brand versions of Timolol Maleate.
What is the NDC code for Timolol Maleate 5 mg/mL?
The NDC (National Drug Code) for Timolol Maleate 5 mg/mL is 70069-251, listed by Somerset Therapeutics, LLC.
Other Timolol Brands
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- Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%5 mg/mL62332-546
- Timolol Maleate Ophthalmic Gel Forming Solution 0.25%2.5 mg/mL43598-747
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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