Timolol Maleate Ophthalmic Gel Forming Solution 0.5% 5 mg/mL

Timolol Maleate Ophthalmic Gel Forming Solution 0.5% · SOLUTION/ DROPS · Dr. Reddy's Laboratories, Inc.

No Recall History

Plain English

Timolol Maleate Ophthalmic Gel Forming Solution 0.5% is a solution/ drops containing timolol maleate ophthalmic gel forming solution 0.5% at 5 mg/mL, taken ophthalmic. Manufactured by Dr. Reddy's Laboratories, Inc..

Key Facts

Brand Name: Timolol Maleate Ophthalmic Gel Forming Solution 0.5%
Generic Name: Timolol Maleate Ophthalmic Gel Forming Solution 0.5%
NDC Code (Product): 43598-748
Manufacturer: Dr. Reddy's Laboratories, Inc.
Strength: 5 mg/mL
Dosage Form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing Status
Application #: ANDA215733
Marketing Start: 11/15/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1 reports

eye pain1 reports

lacrimation increased1 reports

visual impairment1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Timolol maleate ophthalmic gel forming solution is indicated in the treatment of elevatedintraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Dosage & Administration

DOSAGE AND ADMINISTRATION Patients should be instructed to invert the closed container and shake once before each use. It is not necessary to shake the container more than once. Other topically applied ophthalmic medications should be administered at least 10 minutes before timolol maleate ophthalmic gel forming solution [see PRECAUTIONS, Information for Patients and accompanying INSTRUCTIONS FOR USE ]. Timolol maleate ophthalmic gel forming solution is available in concentrations of 0.25% and 0.5%. The dose is one drop of timolol maleate ophthalmic gel forming solution (either 0.25% or 0.5%) in the affected eye(s) once a day.Because in some patients the pressure-lowering response to timolol maleate ophthalmic gel forming solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with timolol maleate ophthalmic gel forming solution.Dosages higher than one drop of 0.5% timolol maleate ophthalmic gel forming solution once a day have not been studied. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy can be considered. The concomi…

Warnings

WARNINGS As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta adrenergic blocking agents may occur with topical ophtalmic administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patient with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophtalmic administration of timolol maleated [see CONTRAINDICATIONS ]. Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In Patients without a History of Cardiac Failure continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, timolol maleate ophthalmic gel forming solution should be discontinued. Obstructive PulmonaryDisease Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or…

Contraindications

CONTRAINDICATIONS Timolol maleate ophthalmic gel forming solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease [see WARNINGS ,Obstructive Pulmonary Disease ]; (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure[see WARNINGS , Cardiac Failure ]; (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

Drug Interactions

Drug Interactions Beta-Adrenergic Blocking Agents Patients who are receiving a beta-adrenergic blocking agent orally and timolol maleate ophthalmic gel forming solution should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. Calcium Antagonists Caution should be used in the coadministration of beta-adrenergic blocking agents, such as timolol maleate ophthalmic gel forming solution, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, or hypotension. In patients with impaired cardiac function, coadministration should be avoided. Catecholamine-Depleting Drugs Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope,or postural hypotension. Digitalis and CalciumAntagonists The concomitant use of beta-adrenergic blocking agents with digital…

Adverse Reactions

ADVERSE REACTIONS In clinical trials, transient blurred vision upon instillation of the drop was reported in approximately one in three patients (lasting from 30 seconds to 5 minutes). Less than 1% of patients discontinued from the studies due to blurred vision.The frequency of patients reporting burning and stinging upon instillation was comparable between timolol maleate ophthalmic gel forming solution and TIMOPTIC (approximately one in eight patients). Adverse experiences reported in 1 to 5% of patients were: Ocular: Pain, conjunctivitis, discharge (e.g., crusting), foreign body sensation, itching and tearing; Systemic: Headache, dizziness, and upper respiratory infections. The following additional adverse experiences have been reported with the ocular administration of this or other timolol maleate formulations: BODY AS A WHOLE Asthenia/fatigue, and chest pain. CARDIOVASCULAR Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebrovascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet. DIGESTIVE Nausea, diarrhea,…

Frequently Asked Questions

What is Timolol Maleate Ophthalmic Gel Forming Solution 0.5% used for?

Timolol Maleate Ophthalmic Gel Forming Solution 0.5% contains Timolol Maleate Ophthalmic Gel Forming Solution 0.5%. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Timolol Maleate Ophthalmic Gel Forming Solution 0.5% a controlled substance?

Timolol Maleate Ophthalmic Gel Forming Solution 0.5% is not classified as a controlled substance by the DEA.

What is the generic name for Timolol Maleate Ophthalmic Gel Forming Solution 0.5%?

The generic name for Timolol Maleate Ophthalmic Gel Forming Solution 0.5% is Timolol Maleate Ophthalmic Gel Forming Solution 0.5%. There are no other listed brand versions of Timolol Maleate Ophthalmic Gel Forming Solution 0.5%.

What is the NDC code for Timolol Maleate Ophthalmic Gel Forming Solution 0.5% 5 mg/mL?

The NDC (National Drug Code) for Timolol Maleate Ophthalmic Gel Forming Solution 0.5% 5 mg/mL is 43598-748, listed by Dr. Reddy's Laboratories, Inc..

Product NDC

43598-748

Package NDC

43598-748-11