QUZYTTIR (cetirizine hydrochloride injection), 10 mg/mL, pH between 4.5 to 6.5, is supplied as a sterile, clear, colorless, non-pyrogenic isotonic aqueous solution in single-use 2 mL amber glass vials. The following packaging configuration is available: Page 11 of 12 Reference ID: 4501880
�NDC 70720-100-01: 10 mg/mL cetirizine hydrochloride single- use vial �NDC 70720-100-25: Carton containing 25 single-use vials (10 mg/mL cetirizine hydrochloride) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use QUZYTTIRTM safely and effectively. See full prescribing information for QUZYTTIRTM. QUZYTTIRTM (cetirizine hydrochloride injection), for intravenous use Initial U.S. Approval: 1995 ----------------------INDICATIONS AND USAGE-------------------------QUZYTTIRTMis a histamine-1 (H1) receptor antagonistindicated for the treatment of acute urticaria in adults and children 6 months of age and older (1)Limitations of Use:Not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function (1)-------------------DOSAGE AND ADMINISTRATION-------------------For intravenous administration only (2) Recommended dosages: �Adults and adolescents ? 12 years of age and older: 10 mg (2.1) �Children 6 to 11 years: 5 mg or 10 mg (2.2) �Children 6 months to 5 years: 2.5 mg (2.3) Recommended dosage regimen is once every 24 hours as needed for acute urticaria (2) -----------------DOSAGE FORMS AND STRENGTHS-------------------Injection: 10 mg/mL cetirizine hydrochloride (3) -------------------------CONTRAINDICATIONS--------------------------Known hypersensitivity to cetirizine hydrochloride or any of its ingredients, levocetirizine, or hydroxyzine (4) ---------------------WARNINGS AND PRECAUTIONS-- ----------------Somnolence/Sedation: Exercise caution when driving a car or operating potentially dangerous machinery (5.1) ----------------------------ADVERSE REACTIONS------------------------The most common adverse reactions (incidence less than 1%) with QUZYTTIR are dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis. Most common adverse reactions (incidence equal to or greater than 2%) with use of oral cetirizine hydrochloride are somnolence, fatigue, dry mouth, pharyngitis, and dizziness. (6) To report SUSPECTED ADVERSE REACTIONS, call TerSera Therapeutics LLC at 1-844-334-4035 or FDA at 1- 800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION Revised: 10/2019
