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warnings and cautions
5 WARNINGS AND PRECAUTIONS Contamination of Tip and Solution. To prevent contaminating the dropper tip and solution, advise patients not to touch the eyelids or surrounding areas with the tip of the single-use container. ( 5.1 ) 5.1 Contamination of Tip and Solution As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the tip of the single-use container in order to avoid injury to the eye and to prevent contaminating the tip and solution. Discard the single-use container after using in each eye. 5.2 Contact Lens Wear Patients should be advised not to wear a contact lens if their eye is red. ZERVIATE ® should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of ZERVIATE ® . The preservative in ZERVIATE ® , benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted 10 minutes following administration of ZERVIATE ® .
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates in practice. In seven clinical trials, patients with allergic conjunctivitis or those at a risk of developing allergic conjunctivitis received one drop of either cetirizine (N=511) or vehicle (N=329) in one or both eyes. The most commonly reported adverse reactions occurred in approximately 1–7% of patients treated with either ZERVIATE ® or vehicle. These reactions were ocular hyperemia, instillation site pain, and visual acuity reduced. The most common adverse reactions (1–7%) were ocular hyperemia, instillation site pain, and visual acuity reduced. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.