Company:

Allergan

α₂-agonist + noncardioselective β-blocker

Brimonidine tartrate 0.2%, timolol (as maleate) 0.5%; oph soln; contains benzalkonium chloride.

To reduce elevated intraocular pressure (IOP) in glaucoma or ocular hypertension where adjunctive or replacement therapy is warranted.

Combigan contains two drugs widely used in the treatment of glaucoma: brimonidine tartrate and timolol maleate. Each of these drugs reduces elevated IOP. Brimonidine reduces aqueous humor production and increases non-pressure dependent uveoscleral outflow. Timolol is thought to work in part by lowering the production of aqueous humor, but its exact mechanism in the treatment of glaucoma has not been established.

The effectiveness of Combigan in treating glaucoma and elevated IOP was compared to that of the separate use of brimonidine tartrate 0.2% and timolol 0.5%. Combigan, dosed twice daily, provided an additional IOP-lowering effect of 1–3mm Hg over brimonidine dosed 3 times daily, and an additional IOP-lowering effect of 1–2mm Hg over twice-daily timolol during the first 7hrs post-dosing. However, the IOP-lowering effect of this combination drug, dosed twice daily, was less (by about 1–2mm Hg) than that seen with the concomitant administration of timolol 0.5% dosed twice daily + brim-onidine tartrate 0.2% dosed 3 times daily.

In a study of the concomitant use of brimonidine tartrate 0.2% 3 times a day as adjunctive therapy to β-blockers in patients 2–7yrs old with glaucoma, the most commonly observed adverse reactions were somnolence and reduced alertness.

<2yrs: not recommended. ≥2yrs: 1 drop every 12 hours.

2nd or 3rd-degree AV block. Overt cardiac failure. Cardiogenic shock. Sinus bradycardia. Severe COPD. Bronchial asthma or history of.

Discontinue at 1st sign of cardiac failure and before surgery. Mild to moderate COPD, bronchospastic disease: not recommended. Depression. Cerebral or coronary insufficiency. Raynaud’s phenomenon. Orthostatic hypotension. Thromboangiitis obliterans. Myasthenia gravis. Renal or hepatic impairment. May mask hypoglycemia, thyrotoxicosis. Soft contact lenses (remove; may reinsert 15 minutes after instillation). Separate dosing of other oph drugs by ≥5 minutes. Pregnancy (Cat.C). Nursing mothers: not recommended.

Avoid other topical β-blockers. May potentiate, or be potentiated by, other CNS depressants, systemic β-blockers, reserpine, quinidine, SSRIs, other CYP2D6 inhibitors. Caution with antihypertensives, systemic β-blockers, MAOIs, tricyclics. May cause conduction defects (eg, prolonged AV conduction) with digoxin, calcium channel blockers (avoid concomitant use in impaired cardiac function). May block systemic epinephrine.

Allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, pruritus, ocular burning/stinging, asthenia, corneal erosion, depression, epiphora, visual disturbance, headache, hypertension, dry mouth, somnolence, blepharitis, other local effects.

Soln—5mL, 10mL, 15mL

12/27/07