COMBIGAN™ (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
COMBIGAN™ (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, an alpha adrenergic receptor agonist with a beta adrenergic receptor inhibitor approved by the U.S. Food and Drug Administration in 2007, is a twice-daily prescription eye drop indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of COMBIGAN™ ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution, 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution, 0.2% dosed three times per day.8
Glaucoma is one of the leading causes of preventable blindness in the United States1 and affects approximately 3 million people in the United States and 65 million people worldwide.2 Elevated IOP, or pressure inside the eye, represents a major risk factor for vision loss associated with open-angle glaucoma. The higher the IOP, the greater the likelihood of optic nerve damage, which can lead to vision loss and potential blindness. Lowering elevated IOP is the only glaucoma risk factor that can currently be treated. An estimated 3 to 6 million people in the United States have elevated IOP.3
Glaucoma patient compliance is affected by multiple factors including the number of agents a patient is taking. 4,5,6,7 Many patients require more than one medication to meet their target IOP. COMBIGAN™ ophthalmic solution offers the IOP-lowering efficacy of two proven agents in the convenience of one bottle. Talk with your eye care professional about whether COMBIGAN™ is right for you.
Important Safety Information
Contraindications
COMBIGAN™ ophthalmic solution is contraindicated in patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease; in patients with sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock; and in patients with hypersensitivity to any component of this product.
Warnings and Precautions
Severe respiratory reactions including death due to bronchospasm in patients with asthma have been reported following systemic or ophthalmic administration of timolol maleate. Sympathetic stimulation may be essential in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe cardiac 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. Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease should, in general, not receive beta-blocking agents, including COMBIGAN™. COMBIGAN™ may potentiate syndromes associated with vascular insufficiency. While taking beta-blockers, patients may be more reactive to allergens. Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms. Beta-adrenergic receptor blocking agents may mask hypoglycemic symptoms in patients with diabetes mellitus. 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.
Adverse Events
The most common adverse reactions occurring in approximately 5 to 15 percent of patients included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, and ocular burning and stinging.
Drug Interactions
Antihypertensives/cardiac glycosides may lower blood pressure. Concomitant use with systemic beta-blockers may potentiate systemic beta blockade. Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension. Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. Use with CNS depressants may result in an additive or potentiating effect. Digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time. CYP2D6 inhibitors may potentiate systemic beta-blockade. Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. Monoamine oxidase inhibitors may result in increased hypotension.
