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Levocetirizine Dihydrochloride (Xyzal)

Trade Name : Xyzal

Sanofi-Aventis U.S. LLC

TABLET, FILM COATED

Strength 5 mg/1

LEVOCETIRIZINE DIHYDROCHLORIDE Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Levocetirizine Dihydrochloride (Xyzal) which is also known as Xyzal and Manufactured by Sanofi-Aventis U.S. LLC. It is available in strength of 5 mg/1 per ml. Read more

Levocetirizine Dihydrochloride (Xyzal) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • XYZAL is a histamine H-receptor antagonist indicated for:
  • The relief of symptoms associated with perennial allergic rhinitis ()
  • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ()
  • 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 ()
  • Chronic Idiopathic Urticaria ()
  • XYZAL oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL.
  • XYZAL tablets are white, film-coated, oval-shaped, scored, imprinted (with the letter Y in red color on both halves of the scored tablet) and contain 5 mg levocetirizine dihydrochloride.
  • Immediate release breakable (scored) tablets, 5 mg ()
  • Immediate release oral solution, 2.5 mg per 5 mL (0.5 mg per mL) ()
  • The use of XYZAL is contraindicated in:
  • Patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to cetirizine ()
  • Patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis ()
  • Children 6 months to 11 years of age with renal impairment ()
  • No data
  • Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking XYZAL. ()
  • Avoid concurrent use of alcohol or other central nervous system depressants with XYZAL. ()
  • Use with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia). Discontinue XYZAL if urinary retention occurs. ()
  • Use of XYZAL has been associated with somnolence, fatigue, asthenia, and urinary retention .
  • The most common adverse reactions (rate u22652% 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 u22652% and > placebo) were pyrexia, diarrhea, vomiting, and otitis media. In subjects 6 to 11 months of age, the most common adverse reactions (rate u22653% and > placebo) were diarrhea and constipation. ().
  • 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.
  • No data
  • No data
  • Renal ImpairmentBecause XYZAL is substantially excreted by the kidneys, the risk of adverse reactions to this drug may be greater in patients with impaired renal function. (, )
  • Pediatric UseDo 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. ()
  • Overdosage has been reported with XYZAL.
  • Symptoms of overdose may include drowsiness in adults. In children agitation and restlessness may initially occur, followed by drowsiness. There is no known specific antidote to XYZAL. Should overdose occur, symptomatic or supportive treatment is recommended. XYZAL is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.
  • The acute maximal non-lethal oral dose of levocetirizine was 240 mg/kg in mice (approximately 190 times the maximum recommended daily oral dose in adults, approximately 230 times the maximum recommended daily oral dose in children 6 to 11 years of age, and approximately 180 times the maximum recommended daily oral dose in children 6 months to 5 years of age on a mg/m basis). In rats the maximal non-lethal oral dose was 240 mg/kg (approximately 390 times the maximum recommended daily oral dose in adults, approximately 460 times the maximum recommended daily oral dose in children 6 to 11 years of age, and approximately 370 times the maximum recommended daily oral dose in children 6 months to 5 years of age on a mg/m basis).
  • Levocetirizine dihydrochloride, the active component of XYZAL tablets and oral solution, is an orally active H-receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is CHClNOu22192HCl. The molecular weight is 461.82 and the chemical structure is shown below:
  • Levocetirizine dihydrochloride is a white, crystalline powder and is water soluble.
  • XYZAL 5 mg tablets are formulated as immediate release, white, film-coated, oval-shaped scored tablets for oral administration. The tablets are imprinted on both halves of the scored line with the letter Y in red (Opacode Red). Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and macrogol 400.
  • XYZAL 0.5 mg/mL oral solution is formulated as an immediate release, clear, colorless liquid. Inactive ingredients are: sodium acetate trihydrate, glacial acetic acid, maltitol solution, glycerin, methylparaben, propylparaben, saccharin, flavoring (consisting of triacetin, natural & artificial flavors, dl-alpha-tocopherol), purified water.
  • No data
  • No carcinogenicity studies have been performed with levocetirizine. However, evaluation of cetirizine carcinogenicity studies is relevant for determination of the carcinogenic potential of levocetirizine. In a 2-year carcinogenicity study, in rats, cetirizine was not carcinogenic at dietary doses up to 20 mg/kg (approximately 40, 40, 25, and 10 times the MRHDs in adults, children 6 to 11 years of age, children 2u20135 years, and children 6 months to 2 years of age, respectively, on a mg/m basis). In a 2-year carcinogenicity study in mice, cetirizine caused an increased incidence of benign hepatic tumors in males at a dietary dose of 16 mg/kg (approximately 15, 15, 9, and 5 times the MRHDs in adults, children 6 to 11 years of age, children 2u20135 years, and children 6 months to 2 years of age, respectively, on a mg/m basis). No increased incidence of benign tumors was observed at a dietary dose of 4 mg/kg (approximately 4, 4, 2, and 1 times the MRHDs in adults, children 6 to 11 years of age, children 2u20135 years, and children 6 months to 2 years of age, respectively on a mg/m basis). The clinical significance of these findings during long-term use of XYZAL is not known.
  • Levocetirizine was not mutagenic in the Ames test, and not clastogenic in the human lymphocyte assay, the mouse lymphoma assay, and micronucleus test in mice.
  • Fertility and reproductive performance were unaffected in male and female mice and rats that received cetirizine at oral doses up to 64 and 200 mg/kg/day, respectively (approximately 60 and 390 times the MRHD in adults on a mg/m basis).
  • No data
  • XYZAL tablets are white, film-coated, oval-shaped, scored, imprinted (with the letter Y in red color on both halves of the scored tablet) and contain 5 mg levocetirizine dihydrochloride. They are supplied in unit of use HDPE bottles.
  • 90 Tablets (NDC 0024-5803-90)
  • XYZAL oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL.
  • Oral Solution in 5 oz polypropylene bottles (NDC 0024-5804-05)
  • Storage
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
  • No data
  • Manufactured for:sanofi-aventis, U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
  • XYZAL is a registered trademark of UCB BIOPHARMA SPRL.
  • u00a92019 UCB, Inc. All rights reserved.
  • NDC 0024-5803-90n n
  • XYZALn
  • 5 mg per tablet
  • 90 tablets
  • SANOFI
  • NDC 0024-5804-05 n n
  • XYZALn (levocetirizine dihydrochloride)oral solution2.5 mg/5 mL (0.5 mg/mL)
  • 5 oz (148 mL) bottle
  • SANOFI

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