Originally approved in 1995 for use in adults only.
The FDA has approved cetirizine hydrochloride injection (Quzyttir, JDP Therapeutics) to treat acute urticaria in pediatric patients down to 6 months of age.
Cetirizine HCL is a histamine-1 receptor antagonist originally approved in 1995 as the first IV formulation of cetirizine for adults with acute urticaria. The IV is still not recommended in pediatric patients under 6 years of age with impaired renal or hepatic function.
The recent approval stems from the results of a randomized, active-controlled, double-blind, single-dose study in which cetirizine HCL demonstrated non-inferiority when compared to diphenhydramine regarding the baseline change in patient-related pruritus score assessed 2 hours post-treatment.
Efficacy related to pediatric patients down to 6 months of age was extrapolated from the adult results and supported by pharmacokinetic data with oral cetirizine HCL in patients 6 months to 17 years of age, according to OptumRx.
Cetirizine HCL is contraindicated in patients with a known hypersensitivity to the injection, any of its ingredients, levocetirizine, or hydroxyzine.
Warnings and precautions issued with the use of cetirizine HCL include the potential for somnolence and sedation-caution should be taken if patients anticipate driving or operating machinery.
Adverse reactions reported with cetirizine HCL include dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis.