ALPHAGAN® P (brimonidine tartrate ophthalmic solution)
0.1% and 0.15%
ALPHAGAN® P 0.1%, approved by the U.S. Food and Drug Administration (FDA) in 2005, and ALPHAGAN® P 0.15%, approved by the FDA in 2001, are indicated to lower IOP in patients with open-angle glaucoma and ocular hypertension. They are revised formulations of ALPHAGAN® developed to further minimize drug exposure while maintaining the drug's efficacy profile.
Glaucoma is one of the leading causes of preventable blindness in the United States1,2 and affects more than two million people in the United States3 and 70 million people worldwide.2 Elevated intraocular pressure (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. Lowering elevated IOP is a glaucoma risk factor that can currently be treated.
Important Safety Information
Neonates and Infants (under the age of 2 years): ALPHAGAN® P is contraindicated in neonates and infants (under the age of 2 years).
Hypersensitivity Reactions: ALPHAGAN® P is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.
Warnings and Precautions
Potentiation of Vascular Insufficiency: ALPHAGAN® P may potentiate syndromes associated with vascular insufficiency. ALPHAGAN® P should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
Severe Cardiovascular Disease: Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.
Contamination of Topical Ophthalmic Products After Use: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Antihypertensives/Cardiac Glycosides: Because ALPHAGAN® P(brimonidine tartrate ophthalmic solution) 0.1% and 0.15% may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with ALPHAGAN® P is advised.
CNS Depressants: Although specific drug interaction studies have not been conducted with ALPHAGAN® P, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.
Tricyclic Antidepressants: Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with ALPHAGAN® P in humans can lead to resulting interference with the IOP-lowering effect. Caution is advised in patients taking tricyclic antidepressants, which can affect the metabolism and uptake of circulating amines.
Monoamine Oxidase Inhibitors: Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side effect such as hypotension. Caution is advised in patients taking MAO inhibitors, which can affect the metabolism and uptake of circulating amines.
Adverse reactions occurring in approximately 10% to 20% of the subjects receiving brimonidine ophthalmic solution (0.1% to 0.2%) included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus. Adverse reactions occurring in approximately 5% to 9% included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.