QUZYTTIR 10 mg/mL

Cetirizine Hydrochloride · INJECTION · TerSera Therapeutics LLC

No Recall History

Plain English

QUZYTTIR is a injection containing cetirizine hydrochloride at 10 mg/mL, taken intravenous. Manufactured by TerSera Therapeutics LLC.

Key Facts

Brand Name: QUZYTTIR
Generic Name: Cetirizine Hydrochloride
NDC Code (Product): 70720-100
Manufacturer: TerSera Therapeutics LLC
Strength: 10 mg/mL
Dosage Form: INJECTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA211415
Marketing Start: 11/13/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective9,256 reports

pain8,734 reports

fatigue8,579 reports

alopecia7,346 reports

abdominal discomfort7,226 reports

rheumatoid arthritis7,223 reports

systemic lupus erythematosus6,943 reports

pemphigus6,826 reports

off label use6,424 reports

rash6,390 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE QUZYTTIR ® is indicated for the treatment of acute urticaria in adults and children 6 months of age and older. QUZYTTIR ® is a histamine-1 (H 1 ) receptor antagonist indicated for the treatment of acute urticaria in adults and children 6 months of age and older ( 1 ) Limitations of Use : Not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function ( 1 ) Limitations of use: QUZYTTIR ® is not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION 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 [see Pediatric Use ( 8.4 )]. If using as an antihistamine prior to infusion product administration, refer to infusion product prescribing information for instructions. For intravenous administration only ( 2 ) Recommended dosages: Adults and adolescents ≥ 12 years of age and older: 10 mg ( 2.1 ) Children 6 to 11 years: 5 mg or 10 mg ( 2.2 ) Children 6 months to 5 years: 2.5 mg ( 2.3 ) Recommended dosage regimen is once every 24 hours as needed for acute urticaria ( 2 ) 2.1 Adults and adolescents 12 years of age and older The recommended dosage is 10 mg administered by intravenous injection. 2.2 Children 6 to 11 years of age The recommended dosage is 5 mg or 10 mg depending on symptom severity administered by intravenous injection. 2.3 Children 6 months to 5 years of age The recommended dosag…

Contraindications

4 CONTRAINDICATIONS 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 )

Drug Interactions

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 theophylline doses could have a greater effect [see Clinical Pharmacology ( 12.3 )].

Adverse Reactions

6 ADVERSE REACTIONS 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 ) To report SUSPECTED ADVERSE REACTIONS, call TerSera Therapeutics LLC at 1-844-334-4035 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 …

Frequently Asked Questions

What is QUZYTTIR used for?

QUZYTTIR contains Cetirizine Hydrochloride. It is a injection taken intravenous. Consult your doctor for specific uses.

Is QUZYTTIR a controlled substance?

QUZYTTIR is not classified as a controlled substance by the DEA.

What is the generic name for QUZYTTIR?

The generic name for QUZYTTIR is Cetirizine Hydrochloride. There are 12 other brand versions of Cetirizine Hydrochloride.

What is the NDC code for QUZYTTIR 10 mg/mL?

The NDC (National Drug Code) for QUZYTTIR 10 mg/mL is 70720-100, listed by TerSera Therapeutics LLC.

Product NDC

70720-100

Package NDC

70720-100-10

Other Cetirizine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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