Neonates and Infants (under the age of 2 years): Brimonidine Tartrate Ophthalmic Solution 0.1% is contraindicated in neonates and infants (under the age of 2 years).
Hypersensitivity Reactions: Brimonidine Tartrate Ophthalmic Solution 0.1% is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.
Neonates and Infants (under the age of 2 years): Brimonidine Tartrate Ophthalmic Solution 0.1% is contraindicated in neonates and infants (under the age of 2 years).
Hypersensitivity Reactions: Brimonidine Tartrate Ophthalmic Solution 0.1% is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.
Potentiation of Vascular Insufficiency: Brimonidine Tartrate Ophthalmic Solution 0.1% may potentiate syndromes associated with vascular insufficiency. Brimonidine Tartrate Ophthalmic Solution 0.1% 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 Brimonidine Tartrate Ophthalmic Solution 0.1% may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with Brimonidine Tartrate Ophthalmic Solution 0.1% is advised.
CNS Depressants: Although specific drug interaction studies have not been conducted with Brimonidine Tartrate Ophthalmic Solution 0.1%, 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 Brimonidine Tartrate Ophthalmic Solution 0.1% 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.
To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp at 1-800-706-5575 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
Please see Full Prescribing Information.
