Zerviate

1 INDICATIONS AND USAGE ZERVIATE ® (cetirizine ophthalmic solution) 0.24% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. ZERVIATE ® (cetirizine ophthalmic solution) 0.24% is a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis.

The recommended dosage of ZERVIATE ® is to instill one drop in each affected eye twice daily (approximately 8 hours apart). The single-use containers are to be used immediately after opening and can be used to dose both eyes. Discard the single-use container and any remaining contents after administration.

The single-use containers should be stored in the original foil pouch until ready to use. The recommended dose is one drop in each affected eye twice daily.

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 dropper tip of the bottle or tip of the single-use container.

5.1Contamination of Tip and Solution As with

any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle or tip of the single-use container in order to avoid injury to the eye and to prevent contaminating the tip and solution. Keep the multi-dose bottle closed when not in use. Discard the single-use container after using in each eye.

5.2Contact 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 ® .

None. None.

8.1Pregnancy Risk Summary There

were no adequate or well-controlled studies with ZERVIATE ® in pregnant women. Cetirizine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data Cetirizine was not teratogenic in mice, rats, or rabbits at oral doses up to 96, 225, and 135 mg/kg, respectively (approximately 1300, 4930, and 7400 times the maximum recommended human ophthalmic dose (MRHOD), on a mg/m 2 basis).

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. To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.