LEVOCETIRIZINE DIHYDROCHLORIDE - levocetirizine dihydrochloride tablet
Camber Pharmaceuticals, Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use levocetirizine dihydrochloride safely and effectively. See full prescribing information for levocetirizine dihydrochloride.
Levocetirizine Dihydrochloride Tablets Initial U.S. Approval: 1995 Rx only INDICATIONS AND USAGELevocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for: • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3) DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHS• Immediate release breakable (scored) tablets, 5 mg (3) CONTRAINDICATIONS• Patients with a known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets 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 to 11 years of age with renal impairment (4) WARNINGS AND PRECAUTIONSADVERSE REACTIONSThe 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. (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS• Renal Impairment Because levocetirizine dihydrochloride 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 once daily in children 6 to 11 years. Systemic exposure with this dose in pediatric age groups is comparable to that from a 5 mg once daily dose in adults. (12.3). Pediatric use information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. See 17 for PATIENT COUNSELING INFORMATION. Revised: 04/2012 |
Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions (6.2 )].
Adverse
Reactions | Levocetirizine dihydrochloride
2.5 mg (n = 421) | Levocetirizine dihydrochloride
5 mg (n = 1070) | Placebo
(n = 912) |
Somnolence | 22 (5%) | 61 (6%) | 16 (2%) |
Nasopharyngitis | 25 (6%) | 40 (4%) | 28 (3%) |
Fatigue | 5 (1%) | 46 (4%) | 20 (2%) |
Dry Mouth | 12 (3%) | 26 (2%) | 11 (1%) |
Pharyngitis | 10 (2%) | 12 (1%) | 9 (1%) |
Adverse
Reactions | Levocetirizine Dihydrochloride5 mg
(n = 243) | Placebo (n = 240)
|
Pyrexia | 10 (4%) | 5 (2%) |
Cough | 8 (3%) | 2 (<1%) |
Somnolence | 7 (3%) | 1 (<1%) |
Epistaxis | 6 (2%) | 1 (<1%) |
Clinical trial information in pediatric patients (age 6 months to 5 years) is approved for UCB Inc.’s levocetirizine dihydrochloride drug product labeling. However, due to UCB Inc.‘s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Treatment |
N |
Baseline |
On Treatment Adjusted Mean |
Difference from Placebo |
||
Estimate | 95% CI
| p-value
|
||||
Dose-Ranging Trial - Reflective pruritis severity score
|
||||||
Levocetrizine dihydrochloride 2.5 mg |
69 |
2.08 |
1.02 |
0.82 | (0.58, 1.06)
| <0.001
|
Levocetrizine dihydrochloride 5 mg |
62 |
2.07 |
0.92 |
0.91 | (0.66, 1.16)
|
<0.001 |
Levocetrizine dihydrochloride 10 mg |
55 |
2.04 |
0.73 |
1.11 | (0.85, 1.37)
| <0.001
|
Placebo |
60 |
2.25 |
1.84 | |||
Chronic Idiopathic Urticaria Trial - Reflective pruritis severity score |
||||||
Levocetrizine dihydrochloride 5 mg | 80
| 2.07
| 0.94
| 0.62
| (0.38, 0.86)
| <0.001
|
Placebo
| 82
| 2.06
| 1.56
|
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LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride tablet |
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Labeler - Camber Pharmaceuticals, Inc. (826774775) |
Registrant - Hetero Labs Limited (676162024) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Hetero Labs Limited | 676162024 | ANALYSIS(31722-551), MANUFACTURE(31722-551) |