INDICATIONS AND USAGE
ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%
is an alpha-adrenergic receptor agonist indicated for the reduction of elevated
intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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 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
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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.
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.