Indication: COMBIGAN® is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated IOP in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of COMBIGAN® 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.
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 (eg, 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® ophthalmic solution. 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 (eg, 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 reactions: The most common adverse reactions occurring in approximately 5% to 15% 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.
Please click here for full prescribing information.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.