Quzyttir

Quzyttir (cetirizine hydrochloride injection) is a histamine-1 (H1) receptor antagonist used to treat acute hives (urticaria) in adults and children 6 months of age and older. 

Common side effects of Quzyttir include:

• changes in taste,
• headache,
• numbness and tingling,
• lightheadedness,
• indigestion,
• feeling hot,
• increased sweating,
• drowsiness,
• fatigue,
• dry mouth,
• sore throat, and
• dizziness

The following clinically significant adverse reaction is described elsewhere in the labeling:

• Somnolence/Sedation

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Oral Cetirizine Hydrochloride

The following adverse reactions associated with the use of oral cetirizine hydrochloride were identified in clinical trials.

In clinical trials in patients 12 years and older the most common adverse reactions to oral cetirizine hydrochloride occurring with a 2% or greater incidence and greater than placebo were

• somnolence (14%),
• fatigue (6%),
• dry mouth (5%),
• pharyngitis (2%), and
• dizziness (2%).

In clinical trials in children 6 to 11 years of age with oral cetirizine hydrochloride the most common adverse reactions occurring with a 2% or greater incidence and greater than placebo were

• headache,
• pharyngitis,
• abdominal pain,
• coughing,
• somnolence,
• diarrhea,
• epistaxis,
•  bronchospasm,
• nausea, and
• vomiting.

Somnolence appeared to be dose related. Adverse reactions reported in placebocontrolled trials with oral cetirizine hydrochloride in pediatric patients 2 to 5 years were qualitatively similar in nature and generally similar in frequency to those reported in trials with children 6 to 11 years of age.

In placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences were similar in the oral cetirizine hydrochloride and placebo treatment groups in each trial. In a trial of 1 week duration in children 6 to 11 months of age patients who received oral cetirizine hydrochloride exhibited greater irritability/fussiness than patients on placebo.

In a trial of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received oral cetirizine hydrochloride compared to patients who received placebo.

Quzyttir

The safety data of Quzyttir was evaluated in a randomized, double-blind, single-dose, non-inferiority study comparing Quzyttir to intravenous diphenhydramine in 262 adults with acute urticaria.

• dyspepsia,
• feeling hot,
• dysgeusia,
• headache,
• paresthesia,
• presyncope, and
• hyperhidrosis.

An additional randomized, double-blind, single dose study was conducted in 33 adults which showed similar safety results.

Sedation

Subject-rated sedation scores were assessed at baseline, 1 hr, and/or 2 hrs, and/or "Readiness for Discharge”. Sedation was rated on a 0 to 3 scale (0 = none, to 3 = severe) with lower sedation scores indicating less sedation. Subjects in the Quzyttir treatment group reported less sedation at all time points compared to subjects treated with diphenhydramine.

Quzyttir is a single-use injectable product for intravenous administration only. The recommended dosage regimen is once every 24 hours as needed for treatment of acute urticaria.

Administer Quzyttir as an intravenous push over a period of 1 to 2 minutes. Quzyttir is not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function.

Adults And Adolescents 12 Years Of Age And Older

The recommended dosage is 10 mg administered by intravenous injection.

Children 6 To 11 Years Of Age

The recommended dosage is 5 mg or 10 mg depending on symptom severity administered by intravenous injection.

Children 6 Months To 5 Years Of Age

The recommended dosage is 2.5 mg administered by intravenous injection.

Dosage Forms And Strengths

Quzyttir is a sterile, clear, colorless, non-pyrogenic, isotonic aqueous solution of cetirizine hydrochloride for intravenous injection; supplied in 2 mL size amber glass vials for single use. Each 2 mL size amber glass vial contains 1 mL drug solution with 10 mg cetirizine hydrochloride (equivalent to 8.42 mg of cetirizine).

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:

• NDC 70720-100-01: 10 mg/mL cetirizine hydrochloride single-use vial
• NDC 70720-100-10: Carton containing 1 single-use vial (10 mg/mL cetirizine hydrochloride)
• NDC 70720-100-25: Carton containing 25 single-use vials (10 mg/mL cetirizine hydrochloride)

Limitations Of Use

Quzyttir is not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function.

No clinically significant drug interactions with oral cetirizine hydrochloride, the active ingredient in Quzyttir, have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. There was a small decrease in the clearance of oral cetirizine hydrochloride caused by a 400-mg dose of theophylline; it is possible that larger theophylline doses could have a greater effect.

There are no adequate and well-controlled studies in pregnant women with cetirizine hydrochloride the active ingredient in Quzyttir. Cetirizine hydrochloride has been reported to be present in human breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Quzyttir and any potential adverse effects on the breastfed child from Quzyttir or from the underlying maternal condition.