Drugplain

timolol maleate ophthalmic gel forming solution 5 mg/mL

timolol maleate ophthalmic gel forming · SOLUTION, GEL FORMING / DROPS · Gland Pharma Limited

No Recall History
Plain English

timolol maleate ophthalmic gel forming solution is a solution, gel forming / drops containing timolol maleate ophthalmic gel forming at 5 mg/mL, taken ophthalmic. Manufactured by Gland Pharma Limited.

Key Facts

Brand Name
timolol maleate ophthalmic gel forming solution
Generic Name
timolol maleate ophthalmic gel forming
NDC Code (Product)
68083-458
Manufacturer
Gland Pharma Limited
Strength
5 mg/mL
Dosage Form
SOLUTION, GEL FORMING / DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA214645
Marketing Start
02/14/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

eye irritation3 reports
drug ineffective2 reports
eyelid margin crusting2 reports
ocular hyperaemia2 reports
product availability issue2 reports
product quality issue2 reports
vision blurred2 reports
accidental exposure to product1 reports
aphasia1 reports
chills1 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 elevated intraocular 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 Sterile 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. T…

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 ophthalmic administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate [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 betablocking 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 Pulmonary Disease Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild …

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 Calcium Antagonists The concomitant use of beta-adrenergic blocking agents with digit…

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 1-5% 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, d…

Frequently Asked Questions

What is timolol maleate ophthalmic gel forming solution used for?

timolol maleate ophthalmic gel forming solution contains timolol maleate ophthalmic gel forming. It is a solution, gel forming / drops taken ophthalmic. Consult your doctor for specific uses.

Is timolol maleate ophthalmic gel forming solution a controlled substance?

timolol maleate ophthalmic gel forming solution is not classified as a controlled substance by the DEA.

What is the generic name for timolol maleate ophthalmic gel forming solution?

The generic name for timolol maleate ophthalmic gel forming solution is timolol maleate ophthalmic gel forming. There are 10 other brand versions of timolol maleate ophthalmic gel forming.

What is the NDC code for timolol maleate ophthalmic gel forming solution 5 mg/mL?

The NDC (National Drug Code) for timolol maleate ophthalmic gel forming solution 5 mg/mL is 68083-458, listed by Gland Pharma Limited.

Product NDC

68083-458

Package NDC

68083-458-01

Other timolol maleate ophthalmic gel forming solution Dosages

Other Timolol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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