Información de la droga para XYZAL (levocetirizine dihydrochloride) 5 mg tablets 2.5 mg/5 mL (0.5 mg/mL) oral solution Initial U.S. Approval: 1995 (Physicians Total Care, Inc.): 11 DESCRIPTION

  • Levocetirizine dihydrochloride, the active component of XYZAL tablets and oral solution, is an orally active H1-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 C21H25ClN2O3•2HCl. 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.

  • Drug Information Provided by National Library of Medicine (NLM).