Eyelia Ophthalmic Solution – 5ml

Although specific drug interaction studies have not been conducted with Eyelia ophthalmic solution, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant drugs such as beta-blockers (ophthalmic and 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 Eyelia ophthalmic solution in humans can lead to resulting interference with the IOP lowering effect. No data on the level of circulating catecholamines after administration of Eyelia ophthalmic solution are available. Caution, however, is advised in patients taking Tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.

Brimonidine Tartrate ophthalmic solution is contraindicated in patients with hypersensitivity to Brimonidine Tartrate. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.

Adverse events occurring in approximately 10-30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. Events occurring in approximately 3-9% of the subjects, in descending order included corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision and muscular pain. The following adverse reactions were reported in less than 3% of the patients: lid crusting, conjunctival hemorrhage, abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope.

There are no adequate and well-controlled studies in pregnant women. In animal studies, Brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Brimonidine Tartrate ophthalmic solution 0.2% should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk; in animal studies Brimonidine Tartrate was excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Although Eyelia 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. Eyelia ophthalmic solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension or thromboangiitis obliterans.