Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING ZERVIATE ® is a sterile, buffered, clear, colorless aqueous solution containing cetirizine 0.24% (equivalent to cetirizine hydrochloride 0.29%) supplied in a white low-density polyethylene multi-dose ophthalmic bottle with a low-density polyethylene dropper tip and a white polypropylene cap. ZERVIATE ® is supplied in a 7.5 mL bottle that contains 5 mL and a 10 mL bottle that contains 7.5 mL cetirizine ophthalmic solution, 2.40 mg [equivalent to 2.85 mg cetirizine hydrochloride in one mL solution]. ZERVIATE ® is also supplied in 5 low-density polyethylene 0.2 mL single-use containers within a foil pouch. Carton of 30 single-use containers NDC 82667-015-24 Storage: Store at 15°C to 25°C (59°F to 77°F). Single-use containers should be stored in the original foil pouch.; Principal Display Panel – 2.5 mL Carton Label NDC 82667-015-24 ZERVIATE® (cetirizine ophthalmic solution) 0.24% 30 single use containers 6 pouches x 5 single-use containers (0.2 mL each) FOR TOPICAL OPHTHALMIC USE Rx Only HARROW® Sterile Figure
- 16 HOW SUPPLIED/STORAGE AND HANDLING ZERVIATE ® is a sterile, buffered, clear, colorless aqueous solution containing cetirizine 0.24% (equivalent to cetirizine hydrochloride 0.29%) supplied in a white low-density polyethylene multi-dose ophthalmic bottle with a low-density polyethylene dropper tip and a white polypropylene cap. ZERVIATE ® is supplied in a 7.5 mL bottle that contains 5 mL and a 10 mL bottle that contains 7.5 mL cetirizine ophthalmic solution, 2.40 mg [equivalent to 2.85 mg cetirizine hydrochloride in one mL solution]. ZERVIATE ® is also supplied in 5 low-density polyethylene 0.2 mL single-use containers within a foil pouch. Carton of 30 single-use containers NDC 82667-015-24 Storage: Store at 15°C to 25°C (59°F to 77°F). Single-use containers should be stored in the original foil pouch.
- Principal Display Panel – 2.5 mL Carton Label NDC 82667-015-24 ZERVIATE® (cetirizine ophthalmic solution) 0.24% 30 single use containers 6 pouches x 5 single-use containers (0.2 mL each) FOR TOPICAL OPHTHALMIC USE Rx Only HARROW® Sterile Figure
Overview
ZERVIATE ® is a sterile ophthalmic solution containing cetirizine, which is a histamine-1 (H1) receptor antagonist, for topical administration to the eyes. Cetirizine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 461.8 and a molecular formula of C 21 H 25 ClN 2 O 3 •2HCl. The chemical structure is presented below: Chemical Name: ( RS )-2-[2-[4-[(4-Chlorophenyl) phenylmethyl] piperazin-1-yl] ethoxy] acetic acid, dihydrochloride Each mL of ZERVIATE ® contains an active ingredient [cetirizine 2.40 mg (equivalent to 2.85 mg of cetirizine hydrochloride)] and the following inactive ingredients: benzalkonium chloride 0.010% (preservative); glycerin; sodium phosphate, dibasic; edetate disodium; polyethylene glycol 400; polysorbate 80; hypromellose; hydrochloric acid/sodiumhydroxide (to adjust pH); and water for injection. ZERVIATE ® solution has a pH of approximately 7.0 and osmolality of approximately 300 mOsm/kg. Chemical Structure
Indications & 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. ( 1 )
Dosage & Administration
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. ( 2 )
Warnings & 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 dropper tip of the bottle or 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 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. 5.2 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 ® .
Contraindications
None. None. ( 4 )
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.
Storage & Handling
Storage: Store at 15°C to 25°C (59°F to 77°F). Single-use containers should be stored in the original foil pouch.
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