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Although specific drug interaction studies have not been conducted with brimonidine, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.
Brimonidine did not have clinically significant effects on pulse and blood pressure in chronic clinical studies. However, since alpha-agonists, as a class, may reduce pulse and blood pressure, caution in the concomitant use of drugs such as beta-blockers (ophthalmic and/or systemic), antihypertensives and/or cardiac glycosides is advised.
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 can lead to an interference in IOP lowering effect. No data are available on the level of circulating catecholamines after brimonidine is instilled. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.
In clinical studies including 717 patients on brimonidine, the most frequently reported adverse events were oral dryness [25.8%], ocular hyperemia [24.8%], burning and stinging [22.5%], blurring [17.3%], headache [16.3%], foreign body sensation [15.5%], fatigue/drowsiness [15.2%], corneal staining/erosion [10.0%], ocular allergic reactions [9.9%], and ocular pruritus [9.8%], and conjunctival follicles [9.6%].
Events occurring less frequently included photophobia [7.4%], ocular dryness [7.0%], eyelid erythema [6.1%], ocular ache/pain [6.0%], upper respiratory symptoms [6.0%], tearing [5.6%], conjunctival edema [5.3%], eyelid edema [4.9%], dizziness [4.2%], conjunctival blanching [3.8%], blepharitis [3.6%], ocular irritation [3.1%], gastrointestinal symptoms [3.1%], asthenia [2.8%], abnormal vision [2.6%], abnormal taste [1.4%], conjunctival discharge [1.4%] conjunctival papillae [1.0%], and nasal dryness [1.0%].
The following adverse reactions were reported infrequently (<1%): depression [0.8%], systemic allergic reactions [0.8%], and palpitations [0.4%].
Serious Reports of Adverse Reactions in Pediatric Patients: Several serious adverse reactions have been reported in association with the administration of brimonidine ophthalmic solution to infants in the age range of 28 days to 3 months. These reactions included: bradycardia, hypotension, hypothermia, hypotonia, apnea, dyspnea, hypoventilation, cyanosis and lethargy resulting in hospitalization. Upon discontinuation of brimonidine the infants recovered without sequelae.
No data are available on overdosage of brimonidine ophthalmic solution in humans. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained. Evacuation of the stomach should be considered during the first few hours after an overdosage.
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