Timolol Maleate

Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol GFS is a beta adrenergic blocker indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma ( 1 ).

Timolol GFS is contraindicated in patients with:

• bronchial asthma
• history of bronchial asthma
• severe chronic obstructive pulmonary disease
• sinus bradycardia
• second or third degree atrioventricular block
• overt cardiac failure
• cardiogenic shock
• hypersensitivity to any component of this product.
• Bronchial asthma (or history of) ( 4 )
• Severe chronic obstructive pulmonary disease ( 4 )
• Sinus bradycardia ( 4 )
• Second or third degree atrioventricular block ( 4 )
• Overt cardiac failure ( 4 )
• Cardiogenic shock ( 4 )
• Hypersensitivity to any component of this product ( 4 )

• Same adverse reactions found with systemic administration of beta-adrenergic receptor inhibitors may occur with topical ophthalmic administration ( 5.1 ).
• Beta-adrenergic receptor inhibitors may mask signs and symptoms of hypoglycemia and should be administered with caution in diabetic patients subject to hypoglycemia ( 5.5 ).
• Beta-adrenergic receptor inhibitors may mask certain clinical signs (e.g. tachycardia) of hyperthyroidism ( 5.6 ).

5.1 Systemic Absorption As with many topically applied ophthalmic drugs, Timolol GFS is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic receptor inhibitors may occur with topical ophthalmic administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and death due to cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate [see Contraindications (4) ].

5.2Cardiac 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-adrenergic receptor inhibitors over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, Timolol GFS should be discontinued.