Xyzal .5 mg/mL

levocetirizine dihydrochloride · SOLUTION · Chattem, Inc.

No Recall History

Plain English

Xyzal is a solution containing levocetirizine dihydrochloride at .5 mg/mL, taken oral. Manufactured by Chattem, Inc..

Key Facts

Brand Name: Xyzal
Generic Name: levocetirizine dihydrochloride
NDC Code (Product): 41167-5804
Manufacturer: Chattem, Inc.
Strength: .5 mg/mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: NDA022064
Marketing Start: 07/24/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective3,013 reports

somnolence2,121 reports

fatigue1,655 reports

headache1,325 reports

pruritus1,235 reports

nausea1,078 reports

dyspnoea1,056 reports

diarrhoea1,004 reports

dizziness882 reports

cough782 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE XYZAL is a histamine H 1 -receptor antagonist indicated for: The relief of symptoms associated with perennial allergic rhinitis ( 1.1 ) The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.1 Perennial Allergic Rhinitis XYZAL is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. 1.2 Chronic Idiopathic Urticaria XYZAL is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION XYZAL is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. XYZAL can be taken without regard to food consumption. Perennial Allergic Rhinitis ( 2.1 ) Children 6 months to 2 years of age: 1.25 mg (1/2 teaspoon oral solution) (2.5 mL) once daily in the evening Chronic Idiopathic Urticaria ( 2.2 ) Adults and children 12 years of age and older: 5 mg once daily in the evening Children 6 to 11 years of age: 2.5 mg once daily in the evening Children 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) (2.5 mL) once daily in the evening Renal Impairment Adjust the dose in patients 12 years of age and older with decreased renal function ( 12.3 ) 2.1 Perennial Allergic Rhinitis Children 6 months to 2 Years of Age The recommended initial dose of XYZAL is 1.25 mg (1/2 teaspoon oral solution) (2.5 mL) once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology ( 12.3 )] . 2.2 Chronic Idiopathic Urticaria Adults and Children 12 Years of Age and Older The recommended…

Contraindications

4 CONTRAINDICATIONS The use of XYZAL is contraindicated in: Patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to cetirizine ( 4.1 ) Patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis ( 4.2 ) Children 6 months to 11 years of age with renal impairment ( 4.3 ) 4.1 Patients with Known Hypersensitivity Patients with known hypersensitivity to levocetirizine or any of the ingredients of XYZAL, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions ( 6.2 ) ] . 4.2 Patients with End-Stage Renal Disease Patients with end-stage renal disease (CL CR <10 mL/min) and patients undergoing hemodialysis 4.3 Pediatric Patients with Impaired Renal Function Children 6 months to 11 years of age with impaired renal function

Drug Interactions

7 DRUG INTERACTIONS In vitro data indicate that levocetirizine is unlikely to produce pharmacokinetic interactions through inhibition or induction of liver drug-metabolizing enzymes. No in vivo drug-drug interaction studies have been performed with levocetirizine. Drug interaction studies have been performed with racemic cetirizine. 7.1 Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline, and Pseudoephedrine Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. There was a small decrease (~16%) in the clearance of cetirizine caused by a 400 mg dose of theophylline. It is possible that higher theophylline doses could have a greater effect. 7.2 Ritonavir Ritonavir increased the plasma AUC of cetirizine by about 42% accompanied by an increase in half-life (53%) and a decrease in clearance (29%) of cetirizine. The disposition of ritonavir was not altered by concomitant cetirizine administration.

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Somnolence [see Warnings and Precautions ( 5.1 )] Urinary Retention [see Warnings and Precautions ( 5.2 )] Risk of New Onset Pruritus After Discontinuation of XYZAL [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (rate ≥2% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age. In subjects 1 to 5 years of age, the most common adverse reactions (rate ≥2% and > placebo) were pyrexia, diarrhea, vomiting, and otitis media. In subjects 6 to 11 months of age, the most common adverse reactions (rate ≥3% and > placebo) were diarrhea and constipation. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 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 cli…

Frequently Asked Questions

What is Xyzal used for?

Xyzal contains levocetirizine dihydrochloride. It is a solution taken oral. Consult your doctor for specific uses.

Is Xyzal a controlled substance?

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

What is the generic name for Xyzal?

The generic name for Xyzal is levocetirizine dihydrochloride. There are 12 other brand versions of levocetirizine dihydrochloride.

What is the NDC code for Xyzal .5 mg/mL?

The NDC (National Drug Code) for Xyzal .5 mg/mL is 41167-5804, listed by Chattem, Inc..

Product NDC

41167-5804

Package NDC

41167-5804-5

Other Levocetirizine Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)