QUZYTTIR

Generic Name/API: cetirizine hydrochloride injection

Manufacturer: TerSera Therapeutics LLC

Dosage Forms & Strength & Pack Size:
Injection: 10 mg/mL cetirizine hydrochloride, 1ml or Carton 25 x 1ml Single-dose vials

PYRUKYND 28-Day Packs
Tablet
Strength Description Imprint NDC
5 mg Round, blue, film-coated tablets “M5” printed on one side 71334-205-05
20 mg Round, blue, film-coated tablets “M20” printed on one side 71334-210-20
50 mg Oblong, blue, film-coated tablets “M50” printed on one side 71334-215-50

PYRUKYND Taper Packs
Tablet strength(s) Blister Wallet Configuration Tablet Description Imprint NDC
5 mg • 5 mg blister wallet containing 7 tablets round, blue, film-coated tablets “M5” printed on one side 71334-220-11

20 mg and 5 mg • 20 mg blister wallet containing 7 tablets • 5 mg blister wallet containing 7 tablets round, blue, film-coated tablets round, blue, film-coated tablets “M20” printed on
one side “M5” printed on one side 71334-225-12
50 mg and 20 mg • 50 mg blister wallet containing 7 tablets • 20 mg blister wallet containing 7 tablets oblong, blue, film coated tablets round, blue, film-coated tablets
“M50” printed on one side “M20” printed on one side 71334-230-13

PYRUKYND 28-Day Packs
Tablet
Strength Description Imprint NDC
5 mg Round, blue, film-coated tablets “M5” printed on one side 71334-205-05
20 mg Round, blue, film-coated tablets “M20” printed on one side 71334-210-20
50 mg Oblong, blue, film-coated tablets “M50” printed on one side 71334-215-50

PYRUKYND Taper Packs
Tablet strength(s) Blister Wallet Configuration Tablet Description Imprint NDC
5 mg • 5 mg blister wallet containing 7 tablets round, blue, film-coated tablets “M5” printed on one side 71334-220-11

20 mg and 5 mg • 20 mg blister wallet containing 7 tablets • 5 mg blister wallet containing 7 tablets round, blue, film-coated tablets round, blue, film-coated tablets “M20” printed on
one side “M5” printed on one side 71334-225-12
50 mg and 20 mg • 50 mg blister wallet containing 7 tablets • 20 mg blister wallet containing 7 tablets oblong, blue, film coated tablets round, blue, film-coated tablets
“M50” printed on one side “M20” printed on one side 71334-230-13

Storage:
Storage:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F
and 86°F) [see USP Controlled Room Temperature]. Store the blister wallets in the original
carton until use.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
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
IMPORTANT SAFETY INFORMATION
Contraindications: Known hypersensitivity to QUZYTTIR or any of its ingredients, to levocetirizine, or hydroxyzine.
Additional 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.

Scroll to Top