Cetirizine IV Approved for Pediatric Acute Urticaria

October 18, 2019

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. 

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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. 

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