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Basic Drug Info
Drug Name:Timolol Maleate
Manufacturer:FALCON Pharmaceuticals, Ltd.
Other Info:



Clinical Trials:


Indications and Usage
Timolol maleate ophthalmic solution USP is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Intraocular pressure disorder --

Ocular Hypertension -- A condition in which the intraocular pressure is elevated above normal and which may lead to glaucoma.

Open Angle Glaucoma -- Glaucoma in which the angle of the anterior chamber is open and the trabecular meshwork does not encroach on the base of the iris.

Contraindications
Timolol maleate is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.
Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Heart failure -- inability of the heart to pump blood at an adequate rate to fill tissue metabolic requirements or the ability to do so only at an elevated filling pressure.

Cardiogenic shock -- Shock resulting from diminution of cardiac output in heart disease.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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 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 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 of 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 should be discontinued.Obstructive Pulmonary Disease: Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma, in which timolol is contraindicated [see CONTRAINDICATIONS]), should, in general, not receive beta-blockers, including timolol.Major Surgery: The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial.

Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli.

This may augment the risk of general anesthesia in surgical procedures.

Some patients receiving beta-adrenergic receptor blocking agents have experienced protracted severe hypotension during anesthesia.

Difficulty in restarting and maintaining the heartbeat has also been reported.

For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents.If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists.Diabetes Mellitus: Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents.

Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.Thyrotoxicosis: Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.

Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.
Branded Drugs
The following US Branded drugs contain Timolol Maleate


COMBIGAN -- ALLERGAN INC

COSOPT -- MERCK RESEARCH LABORATORIES DIV MERCK CO INC

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE -- APOTEX INC

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE -- HI TECH PHARMACAL CO INC

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE -- SANDOZ INC

TIMOLIDE 10-25 -- MERCK AND CO INC

TIMOPTIC-XE -- ATON PHARMA INC

ISTALOL -- ISTA PHARMACEUTICALS

TIMOPTIC -- ATON PHARMA INC

TIMOPTIC IN OCUDOSE -- ATON PHARMA INC

BLOCADREN -- MERCK RESEARCH LABORATORIES DIV MERCK CO INC


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