QUZYTTIR (cetirizine hydrochloride)

In a single dose crossover study in healthy volunteers under fasting conditions, cetirizine reached a mean C max of 495 ng/mL and 1344 ng/mL following single dose intravenous (IV) administration of 5 mg and 10 mg, respectively, injected over a period of 1 to 1.5 minutes. Peak concentrations were reached at 0.06 hour (range 0.03 to 0.07 hour) and 0.03 hour (range 0.03 to 2.00 hour) for cetirizine hydrochloride 5 mg and 10 mg IV injection, respectively. The mean systemic exposure (AUC 0-inf ) for ...

The safety and efficacy of QUZYTTIR for the treatment of acute urticaria was demonstrated in a randomized, active-controlled, double-blind, single dose, multicenter (US and Canada), parallel group trial in 262 patients 18 years of age and older presenting to Emergency Departments or Urgent care Centers (NCT02935699). Subjects were treated with 10 mg of QUZYTTIR or 50 mg diphenhydramine injection. Patients with acute urticaria with or without other diseases were enrolled, including patients with concomitant angioedema. The majority of the patients were Caucasian (48%) and female (63%) with a me...

The following clinically significant adverse reaction is described elsewhere in the labeling: Somnolence/Sedation [see Warnings and Precautions ( 5.1 )] The most common adverse reactions (incidence less than 1%) with QUZYTTIR are dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis. Most common adverse reactions (incidence equal to or greater than 2%) with use of oral cetirizine hydrochloride are somnolence, fatigue, dry mouth, pharyngitis, and dizziness. ( 6 )...

The use of QUZYTTIR is contraindicated in patients with a known hypersensitivity to cetirizine hydrochloride or any of its ingredients, levocetirizine, or hydroxyzine. Known hypersensitivity to cetirizine hydrochloride or any of its ingredients, levocetirizine, or hydroxyzine ( 4 )

Somnolence/Sedation: Exercise caution when driving a car or operating potentially dangerous machinery ( 5.1 ) 5.1 Somnolence/Sedation In clinical trials with QUZYTTIR and cetirizine hydrochloride tablets, the occurrence of somnolence/sedation has been reported in some patients. Exercise due caution when driving a car or operating potentially dangerous machinery. Avoid concurrent use of QUZYTTIR with alcohol or other CNS depressants because additional reduction in alertness and additional impairm...

7 DRUG INTERACTIONS 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 theophyll...