Xyzal 5 tablet

Xyzal (UCB Farchim), manufactured drug form of Levocetirizine dihydrochloride, 5mg/tablet levocetirizine dihydrochloride tablet, NDC 28877-0070

Available in:

NDC Product ID:

  • 28877-0070

Manufacturer:

Manufactured drug form

Manufactured form of:

Generic drug:

  • No

Label date:

  • Mar 15, 2010

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • Recent Major Changes Section
  • No
  • 43683-2
  • 1 Indications And Usage
  • No
  • XYZAL is a histamine H 1 ‑receptor antagonist indicated for: The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2) The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3)
  • 34067-9
  • 2 Dosage And Administration
  • No
  • Adults and children 12 years of age and older: 5 mg once daily in the evening (2.1) Children 6 to 11 years of age: 2.5 mg once daily in the evening (2.2) Children 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening (2.3) Renal Impairment Adjust the dose in patients 12 years of age and older with decreased renal function (2.4, 12.3)
  • 34068-7
  • 3 Dosage Forms And Strengths
  • No
  • Immediate release breakable (scored) tablets, 5 mg (3) Immediate release oral solution, 2.5 mg per 5 mL (0.5 mg per mL) (3)
  • 43678-2
  • 4 Contraindications
  • No
  • Patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to cetirizine (4) Patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis (4) Children 6 months to 11 years of age with renal impairment (4)
  • 34070-3
  • 5 Warnings And Precautions
  • No
  • Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking XYZAL (5.1). Avoid concurrent use of alcohol or other central nervous system depressants with XYZAL (5.1).
  • 43685-7
  • 6 Adverse Reactions
  • No
  • 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 UCB, Inc. at 866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 34084-4
  • 7 Drug Interactions
  • No
  • 34073-7
  • 8 Use In Specific Populations
  • No
  • Renal Impairment Because XYZAL is substantially excreted by the kidneys, the risk of adverse reactions to this drug may be greater in patients with impaired renal function (8.6 and 12.3). Pediatric Use Do not exceed the recommended doses of 2.5 mg and 1.25 mg once daily in children 6 to 11 years and 6 months to 5 years of age, respectively. Systemic exposure with these doses in respective pediatric age groups is comparable to that from a 5 mg once daily dose in adults. (12.3).
  • 43684-0
  • 10 Overdosage
  • No
  • 34088-5
View entire collection »

Discontinued:

  • No

Marketing start date:

  • Feb 19, 2008

Patents:

Patent expiry date:

  • Sep 24, 2012

FDA application number:

  • NDA022064

Color:

Shape:

Size:

  • 8 mm (0.31 in )

Scoring:

  • 2

Imprint:

  • Y

Therapeutic equivalents:

View entire collection »
top ↑

Consumer product

Brand:

top ↑

You can help improve this topic by adding more facts here

Edit this topic
Edit and Show details

Add or delete facts, download data in JSON or RDF formats, and explore topic metadata.

Freebase Logo
What is Freebase?

Freebase is a huge collection of facts, built by people like you. Freebase connects facts in ways other sites can't, giving you new ways to explore millions of subjects.
You can help improve it!