Combigan- Two glaucoma drugs in one product

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Company:

Allergan

Pharmacologic class:

alpha2-agonist + noncardioselective beta blocker

Active ingredients:

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

Indication:

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

Pharmacology:

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.

Clinical trials:

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

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

Adults and children:

<2 years: not recommended. ≥2 years: one drop every 12 hours.

Contraindications:

Second- or third-degree AV block. Overt cardiac failure. Cardiogenic shock. Sinus bradycardia. Severe COPD. Bronchial asthma or history of.

Precautions:

Discontinue at first 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 re-insert 15 minutes after instillation). Separate dosing of other ophthalmic drugs by ≥5 minutes. Pregnancy (Cat. C). Nursing mothers: not recommended.

Interactions:

Avoid other topical beta blockers. May potentiate, or be potentiated by, other CNS depressants, systemic beta blockers, reserpine, quinidine, SSRIs, other CYP2D6 inhibitors. Caution with antihypertensives, systemic beta blockers, MAOIs, tricyclics. May cause conduction defects (e.g., 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, other local effects.

How supplied:

Solution—5 mL, 10 mL, 15 mL.

For more information, call 800.433.8871 or visit www.allergan.com

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