Indications for: COMBIGAN

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

Clinical Trials:

Clinical studies were conducted to compare the IOP-lowering effect over the course of the day of Combigan administered twice a day (BID) to individually-administered brimonidine tartrate ophthalmic solution, 0.2% administered three times per day (TID) and timolol maleate ophthalmic solution, 0.5% BID in patients with glaucoma or ocular hypertension. Combigan BID provided an additional 1 to 3 mm Hg decrease in IOP over brimonidine treatment TID and an additional 1 to 2 mm Hg decrease over timolol treatment BID during the first 7 hours post dosing. However, the IOP-lowering of Combigan BID was less (approximately 1-2 mm Hg) than that seen with the concomitant administration of 0.5% timolol BID and 0.2% brimonidine tartrate TID. Combigan administered BID had a favorable safety profile versus concurrently administered brimonidine TID and timolol BID in the self-reported level of severity of sleepiness for patients over age 40.

Adults and Children:

<2yrs: contraindicated. ≥2yrs: 1 drop every 12 hours.

COMBIGAN Contraindications:

Bronchial asthma or history of. Severe COPD. 2nd- or 3rd-degree AV block. Overt cardiac failure. Cardiogenic shock. Sinus bradycardia. Neonates and infants <2yrs of age.

COMBIGAN Warnings/Precautions:

Potential for severe respiratory or cardiac reactions. 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.

COMBIGAN Classification:

Alpha-2 agonist + noncardioselective beta-blocker.

COMBIGAN Interactions:

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.

Adverse Reactions:

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



Drug Elimination:

Renal. Half-life: ~3 hours (brimonidine), ~7 hours (timolol).

How Supplied:

Soln—5mL, 10mL, 15mL