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INDICATIONS AND IMPORTANT SAFETY INFORMATION

What is Brimonidine Tartrate Ophthalmic Solution 0.1%?

Brimonidine tartrate ophthalmic solution is an eyedrop medication used to reduce intraocular pressure (IOP) in people with open-angle glaucoma or ocular hypertension (high pressure in the eye).

Who should not take Brimonidine Tartrate Ophthalmic Solution 0.1%?

Neonates and Infants (under the age of 2 years): Brimonidine tartrate ophthalmic solution should not be taken by neonates and infants (under the age of 2 years).

Hypersensitivity Reactions: Brimonidine tartrate ophthalmic solution should not be taken by people who have exhibited a hypersensitivity reaction to any component of this medication in the past.

 
 

INDICATIONS AND IMPORTANT SAFETY INFORMATION

What is Brimonidine Tartrate Ophthalmic Solution 0.1%?

Brimonidine tartrate ophthalmic solution is an eyedrop medication used to reduce intraocular pressure (IOP) in people with open-angle glaucoma or ocular hypertension (high pressure in the eye).


Who should not take Brimonidine Tartrate Ophthalmic Solution 0.1%?

Neonates and Infants (under the age of 2 years): Brimonidine tartrate ophthalmic solution should not be taken by neonates and infants (under the age of 2 years).

Hypersensitivity Reactions: Brimonidine tartrate ophthalmic solution should not be taken by people who have exhibited a hypersensitivity reaction to any component of this medication in the past.


What is the most important information I should know about Brimonidine Tartrate Ophthalmic Solution 0.1%?

Potentiation of Vascular Insufficiency: Brimonidine tartrate ophthalmic solution may increase the likelihood of syndromes associated with vascular insufficiency. Brimonidine tartrate ophthalmic solution should be used with caution in people 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 when using brimonidine tartrate ophthalmic solution in people with severe cardiovascular disease.

Contamination of Topical Ophthalmic Products After Use: There have been reports of bacterial keratitis (an infection in the cornea) associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by people who, in most cases, had corneal disease at the same time or a disruption of the ocular epithelial surface (the protective surface of the eye).


What should I tell my healthcare provider before taking Brimonidine Tartrate Ophthalmic Solution 0.1%?

Tell your healthcare provider if you are taking any of the following medications:

Antihypertensives/Cardiac Glycosides: Because brimonidine tartrate ophthalmic solution may reduce blood pressure, caution in using drugs such as antihypertensives (high blood pressure medications) and/or cardiac glycosides (certain heart medications) with brimonidine tartrate ophthalmic solution is advised.

CNS Depressants: Although specific drug interaction studies have not been conducted with brimonidine tartrate ophthalmic solution, 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 using these medications with brimonidine tartrate ophthalmic solution in humans can lead to resulting interference with the IOP-lowering effect. Caution is advised in people 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 people taking MAO inhibitors, which can affect the metabolism and uptake of circulating amines.


What are the possible side effects of Brimonidine Tartrate Ophthalmic Solution 0.1%?

Adverse reactions occurring in approximately 10% to 20% of the subjects receiving brimonidine ophthalmic solution 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.

These are not all the possible side effects of Brimonidine Tartrate Ophthalmic Solution 0.1%. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to the Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.