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Drug Catalog - Product Detail

Levocetirizine Dihydrochloride Tab 5 MG 30 EA UoU

NDC Mfr Size Str Form
45802-0594-65 PADAGIS 30 5MG TABLET
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Description
11 DESCRIPTION Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets and oral solution, is an orally active H 1 -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 C 21 H 25 ClN 2 O 3 •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. Levocetirizine dihydrochloride 5 mg tablets are formulated as immediate release, white to off-white, film-coated, scored, oval, biconvex tablets for oral administration. The tablets are debossed with “L9CZ 5” on the unscored side and nothing on the scored side. Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and macrogol 400. Levocetirizine dihydrochloride 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. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Levocetirizine dihydrochloride tablets are white to off-white, film-coated, scored, oval, biconvex, debossed with “L9CZ 5” on the unscored side and nothing on the scored side, and contain 5 mg levocetirizine dihydrochloride. They are supplied in the following HDPE bottle configurations: 30 Tablets (NDC 45802- 594 -65) (Unit of Use) 90 Tablets (NDC 45802- 594 -75) (Unit of Use) 300 Tablets (NDC 45802- 594 -87) Storage: Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Levocetirizine dihydrochloride 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) 1.1 Seasonal Allergic Rhinitis Levocetirizine dihydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older. Pediatric use information in pediatric patients (age 2 to 5 years) with seasonal allergic rhinitis is approved for UCB Inc.’s levocetirizine dihydrochloride drug product. However, due to UCB Inc.’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. 1.2 Perennial Allergic Rhinitis Levocetirizine dihydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older. Pediatric use information in pediatric patients (age 6 months to 5 years) with perennial allergic rhinitis is approved for UCB Inc.’s levocetirizine dihydrochloride drug product. However, due to UCB Inc.’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. 1.3 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. Pediatric use information in pediatric patients (age 6 months to 5 years) with chronic idiopathic urticaria is approved for UCB Inc.’s levocetirizine dihydrochloride drug product. However, due to UCB Inc.’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Levocetirizine dihydrochloride 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. Levocetirizine dihydrochloride can be taken without regard to food consumption. • 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) [2.5 mL] 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) 2.1 Adults and Children 12 Years of Age and Older The recommended dose of levocetirizine dihydrochloride is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. 2.2 Children 6 to 11 Years of Age The recommended dose of levocetirizine dihydrochloride is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3) ]. 2.3 Children 6 months to 5 Years of Age The recommended initial dose of levocetirizine dihydrochloride 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) ]. Pediatric use information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product. However, due to UCB Inc.’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. 2.4 Dose Adjustment for Renal and Hepatic Impairment In adults and children 12 years of age and older with: • Mild renal impairment (creatinine clearance [CL CR ] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; • Moderate renal impairment (CL CR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; • Severe renal impairment (CL CR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; • End-stage renal disease patients (CL CR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride. No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.