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XYZAL (Levocetirizine Dihydrochloride)

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XYZAL (Levocetirizine Dihydrochloride) HIGHLIGHTS OF PRESCRIBING INFORMATION • Patients with end-stage renal impairment at less than 10 mL/min These highlights do not include all the information needed to use XYZAL creatinine clearance or patients undergoing hemodialysis (2.3, 4) safely and effectively. See full prescribing information for XYZAL. • Children 6 to 11 years of age with renal impairment (2.3, 4) ® XYZAL (levocetirizine dihydrochloride) ------------------------WARNINGS AND PRECAUTIONS----------------------- 5 mg tablets 2.5 mg/5 mL (0.5 mg/mL) oral solution • Avoid engaging in hazardous occupations requiring complete mental Initial U.S. Approval: 1995 alertness such as driving or operating machinery when taking XYZAL (5.1). ---------------------------RECENT MAJOR CHANGES--------------------------- • Avoid concurrent use of alcohol or other central nervous system Dosage and Administration (2) 01/2008 depressants with XYZAL (5.1). Dosage and Administration, Adults & Children 12 Years & Older (2.1) 01/2008 ------------------------------ADVERSE REACTIONS------------------------------ Dosage and Administration, Children 6 to 11 Years (2.2) 01/2008 The most common adverse reactions (rate ≥2% and > placebo) were ---------------------------INDICATIONS AND USAGE---------------------------- somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects XYZAL is a histamine H1-receptor antagonist indicated for: 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in • The relief of symptoms associated with seasonal and perennial allergic children 6 to 12 years of age (6.1). rhinitis (1.1) • The treatment of the uncomplicated skin manifestations of chronic To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at idiopathic urticaria (1.2) 866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. -----------------------USE IN SPECIFIC POPULATIONS----------------------- ----------------------DOSAGE AND ADMINISTRATION------------------------ • Renal Impairment • Adults and children 12 years of age and older: 5 mg (1 tablet or 2 Because XYZAL is substantially excreted by the kidneys, the risk of teaspoons [10 mL] oral solution) once daily in the evening (2.1) adverse reactions to this drug may be greater in patients with impaired • Children 6 to 11 years of age: 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] renal function (8.5 and 12.3). oral solution) once daily in the evening (2.2) • Pediatric Use • Renal Impairment Do not exceed the recommended dose of 2.5 mg once daily in children 6 Adjust the dose in patients 12 years of age and older with decreased to 11 years of age. The systemic exposure with the 5 mg dose is renal function (2.3, 8.6, 12.3) approximately twice that of adults (12.3, 6.1). -----------------------DOSAGE FORMS AND STRENGTHS-------------------- • Immediate release breakable (scored) tablets, 5 mg (3) See 17 for PATIENT COUNSELING INFORMATION • Immediate release oral solution, 2.5 mg per 5 mL (0.5 mg per mL) (3) Revised: 01/2008 ------------------------------CONTRAINDICATIONS------------------------------ • Patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to cetirizine (4) ________________________________________________________________________________________________________________________________________ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 8.6 Renal Impairment 1.1 Allergic Rhinitis 8.7 Hepatic Impairment 1.2 Chronic Idiopathic Urticaria 10 OVERDOSAGE 2 DOSAGE AND ADMINISTRATION 11 DESCRIPTION 2.1 Adults and Children 12 Years of Age and Older 12 CLINICAL PHARMACOLOGY 2.2 Children 6 to 11 Years of Age 12.1 Mechanism of Action 2.3 Dose Adjustment for Renal and Hepatic Impairment 12.2 Pharmacodynamics 3 DOSAGE FORMS AND STRENGTHS 12.3 Pharmacokinetics 4 CONTRAINDICATIONS 13 NONCLINICAL TOXICOLOGY 5 WARNINGS AND PRECAUTIONS 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.1 Activities Requiring Mental Alertness 14 CLINICAL STUDIES 6 ADVERSE REACTIONS 14.1 Seasonal and Perennial Allergic Rhinitis 6.1 Clinical Trials Experience 14.2 Chronic Idiopathic Urticaria 6.2 Post-Marketing Experience 16 HOW SUPPLIED/STORAGE AND HANDLING 7 DRUG INTERACTIONS 17 PATIENT COUNSELING INFORMATION 7.1 Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, 17.1 Activities Requiring Mental Alertness Theophylline, and Pseudoephedrine 17.2 Concomitant Use of Alcohol and other Central Nervous 7.2 Ritonavir System Depressants 8 USE IN SPECIFIC POPULATIONS 17.3 Dosing of XYZAL 8.1 Pregnancy *Sections or subsections omitted from the full prescribing information are not 8.3 Nursing Mothers listed 8.4 Pediatric Use 8.5 Geriatric Use Page 1 of 9 FULL PRESCRIBING INFORMATION XYZAL tablets are white, film-coated, oval-shaped, 1 INDICATIONS AND USAGE scored, imprinted (with the letter Y in red color on both halves 1.1 Allergic Rhinitis of the scored tablet) and contain 5 mg levocetirizine dihydrochloride. XYZAL® is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) in 4 CONTRAINDICATIONS adults and children 6 years of age and older. The use of XYZAL is contraindicated in: 1.2 Chronic Idiopathic Urticaria • Patients with known hypersensitivity to levocetirizine or XYZAL is indicated for the treatment of the any of the ingredients of XYZAL, or to cetirizine. uncomplicated skin manifestations of chronic idiopathic Observed reactions range from urticaria to anaphylaxis [see urticaria in adults and children 6 years of age and older. Adverse Reactions (6.2)]. 2 DOSAGE AND ADMINISTRATION • Patients with end-stage renal disease (CLCR < 10 mL/min) and patients undergoing hemodialysis. 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 • Pediatric patients 6 to 11 years of age with impaired renal administration of 2.5 mg, if needed. XYZAL can be taken function [see Use in Specific Populations (8.4)]. without regard to food consumption. 5 WARNINGS AND PRECAUTIONS 2.1 Adults and Children 12 Years of Age and Older 5.1 Activities Requiring Mental Alertness The recommended dose of XYZAL is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. In clinical trials the occurrence of somnolence, fatigue, Some patients may be adequately controlled by 2.5 mg and asthenia has been reported in some patients under therapy (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the with XYZAL. Patients should be cautioned against engaging in evening. hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a 2.2 Children 6 to 11 Years of Age motor vehicle after ingestion of XYZAL. Concurrent use of XYZAL with alcohol or other central nervous system The recommended dose of XYZAL is 2.5 mg depressants should be avoided because additional reductions in (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the alertness and additional impairment of central nervous system evening. The 2.5 mg dose should not be exceeded because the performance may occur. systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)]. 6 ADVERSE REACTIONS XYZAL is not indicated for children under 6 years of Use of XYZAL has been associated with somnolence, age. fatigue, and asthenia [see Warnings and Precautions (5.1)]. 2.3 Dose Adjustment for Renal and Hepatic Impairment 6.1 Clinical Trials Experience In adults and children 12 years of age and older with: The safety data described below reflect exposure to XYZAL in 2549 patients with seasonal or perennial allergic • Mild renal impairment (creatinine clearance [CLCR] rhinitis and chronic idiopathic urticaria in 12 controlled clinical = 50-80 mL/min): a dose of 2.5 mg once daily is trials of 1 week to 6 months duration. The short-term (exposure recommended; up to 6 weeks) safety data for adults and adolescents are based upon eight clinical trials in which 1896 patients (825 males and • Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is 1071 females aged 12 years and older) were treated with recommended; XYZAL 2.5, 5, or 10 mg once daily in the evening. The short- term safety data from pediatric patients are based upon two • Severe renal impairment (CLCR = 10-30 mL/min): a clinical trials in which 243 children with seasonal or perennial dose of 2.5 mg twice weekly (administered once allergic rhinitis (162 males and 81 females 6 to 12 years of age) every 3-4 days) is recommended; were treated with XYZAL 5 mg once daily for 4 to 6 weeks. The long-term (exposure of 4 or 6 months) safety data are based • End-stage renal disease patients (CL < 10 mL/min) CR upon two clinical trials in adults and adolescents in which 428 and patients undergoing hemodialysis should not patients (190 males and 238 females) with allergic rhinitis were receive XYZAL. exposed to treatment with XYZAL 5 mg once daily. Because No dose adjustment is needed in patients with solely clinical trials are conducted under widely varying conditions, hepatic impairment. In patients with both hepatic impairment adverse reaction rates observed in the clinical trials of a drug and renal impairment, adjustment of the dose is recommended. cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. 3 DOSAGE FORMS AND STRENGTHS XYZAL oral solution is a clear, colorless liquid containing 0.5 mg of levocetirizine dihydrochloride per mL. Page 2 of 9 Adults and Adolescents 12 years of Age and Older Table 2 Adverse Reactions in Subjects Aged 6-12 Years Reported in ≥2%* for XYZAL 5 mg in Placebo- In studies up to 6 weeks in duration, the mean age of Controlled Clinical Trials 4 and 6 Weeks in Duration the adult and adolescent patients was 32 years, 44% of the patients were men and 56% were women, and the large majority Adverse XYZAL 5 mg/day Placebo (more than 90%) was Caucasian. Reactions (n = 243) (n = 240) In these trials 43% and 42% of the subjects in the Pyrexia 10 (4%) 5 (2%) XYZAL 2.5 mg and 5 mg groups, respectively, had at least one Cough 8 (3%) 2 (<1%) adverse event compared to 43% in the placebo group.
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