Zerviate Drug Information
Generic name: CETIRIZINE
Histamine-1 Receptor Antagonist [EPC]
Uses of 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.
Dosage & Administration of Zerviate
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.
Side Effects of Zerviate
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.
Warnings & Cautions for Zerviate
Contamination 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.
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 ®.
Pregnancy Safety for Zerviate
Pregnancy 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).
Pediatric Use of Zerviate
Pediatric Use The safety and effectiveness of ZERVIATE ® (cetirizine ophthalmic solution) 0.24% has been established in pediatric patients two years of age and older. Use of ZERVIATE ® in these pediatric patients is supported by evidence from adequate and well-controlled studies of ZERVIATE ® in pediatric and adult patients.
Clinical Studies of Zerviate
The efficacy of ZERVIATE ® (cetirizine ophthalmic solution) 0.24% was established in three randomized, double-masked, placebocontrolled, conjunctival allergen challenge (CAC) clinical trials in patients with a history of allergic conjunctivitis. Onset and duration of action were evaluated in two of these trials in which patients were randomized to receive ZERVIATE ® or vehicle ophthalmic solutions. Patients were evaluated with an ocular itching severity score ranging from 0 (no itching) to 4 (incapacitating itch) at several time points after CAC administration.
Table 1 displays data from the mean ocular itching severity scores after ocular administration of an antigen using the CAC model. A one unit difference compared to vehicle is considered a clinically meaningful change in the ocular itching severity score. Patients treated with ZERVIATE ® demonstrated statistically and clinically significantly less ocular itching compared to vehicle at 15 minutes and 8 hours after treatment.
Table 1 Itching Scores in the ITT Population by Treatment Group and Treatment Difference 1 Treatment difference values shown are the group mean active minus the group mean vehicle at each post-CAC time point. * p<0.05 Study 1 Study 2 Statistics 15 minutes post-treatment 8 hours post-treatment 15 minutes post-treatment 8 hours post-treatment ZERVIATE N=50 Vehicle N=50 ZERVIATE N=50 Vehicle N=50 ZERVIATE N=51 Vehicle N=50 ZERVIATE N=51 Vehicle N=50 3 Minute Post-CAC Mean 1.00 2.38 1.76 2.69 1.01 2.54 1.94 2.86 Treatment Difference (95% CI) 1 -1.38 (-1.72, -1.05)* -0.93 (-1.26, -0.61)* -1.53 (-1.92, -1.15)* -0.92 (-1.25, -0.58)* 5 Minute Post-CAC Mean 1.18 2.43 1.85 2.74 1.17 2.51 2.03 2.94 Treatment Difference (95% CI) 1 -1.25 (-1.58, -0.91)* -0.89 (-1.24, -0.54)* -1.34 (-1.71, -0.97)* -0.90 (-1.23, -0.57)* 7 Minute Post-CAC Mean 1.11 2.11 1.54 2.53 1.15 2.23 1.82 2.66 Treatment Difference (95% CI) 1 -1.00 (-1.35, -0.65)* -0.99 (-1.40, -0.59)* -1.07 (-1.46, -0.69)* -0.84 (-1.21, -0.48)*
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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