QUZYTTIR^™ (cetirizine hydrochloride injection), for intravenous use

INDICATIONS AND USAGE

QUZYTTIR is indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

Limitations of Use: QUZYTTIR is not recommended in pediatric patients <6 years of age with impaired renal or hepatic function.

IMPORTANT SAFETY INFORMATION

Contraindications: Known hypersensitivity to QUZYTTIR or any of its ingredients, to levocetirizine, or hydroxyzine.

Warnings and Precautions: The occurrence of somnolence/sedation has been reported in some patients. Advise patients to exercise due caution when driving or operating potentially dangerous machinery. Avoid concurrent use of QUZYTTIR with alcohol or other CNS depressants because additional reduction in alertness and additional impairment of CNS performance may occur.

Adverse Reactions: The most common adverse reactions (incidence <1%) with QUZYTTIR are dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis.

The most common adverse reactions (incidence ≥2%) with chronic dosing of oral cetirizine hydrochloride in adults are somnolence, fatigue, dry mouth, pharyngitis and dizziness. Adverse reactions observed in pediatric patients with chronic use of oral cetirizine hydrochloride are headache, pharyngitis, abdominal pain, coughing, somnolence, diarrhea, epistaxis, bronchospasm, nausea, and vomiting.

For more information, please see the full Prescribing Information for QUZYTTIR.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.