Quzyttir (cetirizine hydrochloride injection)


What is Quzyttir and how does it work?

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. 

What are the side effects of Quzyttir?

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:

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

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

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.

The adverse reactions with Quzyttir occurred at an incidence of less than 1% and include:

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.





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