Alphagan-P Side Effects, and Drug Interactions - Brimonidine

Alphagan-P Side Effects, and Drug Interactions - Brimonidine

SIDE EFFECTS

Adverse events occurring in approximately 10-20% of the subjects included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus.

Adverse events occurring in approximately 5-9% of the subjects included: burning sensation, conjunctival folliculosis, hypertension, oral dryness, and visual disturbance.

Events occurring in approximately 1-4% of subjects included: allergic reaction, asthenia, blepharitis, bronchitis, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, flu syndrome, follicular conjunctivitis, foreign body sensation, headache, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, stinging, superficial punctate keratopathy, visual field defect,vitreous floaters, and worsened visual acuity.

The following events were reported in less than 1% of subjects: corneal erosion, insomnia, nasal dryness, somnolence, and taste perversion.

The following events have been identified during post-marketing use of ALPHAGAN^® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to ALPHAGAN^®, or a combination of these factors, include: bradycardia; hypotension; iritis; miosis; skin reactions (including erythema, eyelid pruritus, rash, and vasodilation) and tachycardia. Apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence have been reported in infants receiving ALPHAGAN^®.

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. Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant drugs such as beta-blockers (ophthalmic and systemic), anti-hypertensives 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 ALPHAGAN^® P in humans can lead to resulting interference with the IOP lowering effect. No data on the level of circulating catecholamines after ALPHAGAN^® P administration are available. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.