UCB and Sanofi Aventis
Levocetirizine dihydrochloride 5 mg; scored tabs.
Relief of symptoms associated with allergic rhinitis. Chronic idiopathic urticaria.
Levocetirizine, the l-enantiomer of cetirizine, is a histamine H1 receptor blocker. Its affinity for H1 receptors is two times stronger than that of cetirizine. Peak plasma levels are reached one hour after dosing, and steady state is reached in about two days. Levocetirizine is eliminated by the kidneys. In patients with renal insufficiency, clearance of the drug is reduced.
The efficacy of levocetirizine in relieving symptoms associated with seasonal and perennial allergic rhinitis was assessed in six randomized, placebo-controlled, double-blind studies in patients ≥12 years of age. Efficacy was evaluated using a total symptom score from patient recordings of several symptoms, including sneezing, rhinorrhea, nasal pruritus, and ocular pruritus. Symptom scores were recorded once daily in the evening, reflecting the 24-hour treatment period (“reflective” score), and in one study, they were also recorded one hour before the next dose was due (“instantaneous” score). The primary end point was the mean total symptom score averaged over the first week and over two weeks for seasonal allergic rhinitis trials and four weeks for perennial allergic rhinitis trials. In these studies, levocetirizine was shown to be statistically better than placebo in both the reflective and instantaneous total symptom scores.
The efficacy of levocetirizine in treating uncomplicated skin manifestations of chronic idiopathic urticaria in patients aged 18-85 years was studied in two randomized, placebo-controlled, double-blind, four-week trials. The primary end point was the mean reflective pruritus severity score over the first week and over the entire treatment period. Levocetirizine 5 mg given once daily in the evening was shown to be statistically better than placebo in the reflective pruritus severity score. The duration of pruritus, number and size of wheals, and instantaneous pruritus severity score indicated superiority over placebo, and the instantaneous pruritus severity scale confirmed the end-of-dosing-interval efficacy.
2.5 mg-5 mg once daily in the pm. Renal dysfunction: CrCl 50-80 mL/min: 2.5 mg once daily; CrCl 30-50 mL/min: 2.5 mg every other day; CrCl 10-30 mL/min: 2.5 mg twice per week (every three to four days); CrCl <10 mL/min or hemodialysis: contraindicated.
<6 years: not recommended. 6-11 years: maximum 2.5 mg once daily in the pm. Renal dysfunction: contraindicated.
Impaired renal function (<12 years old). End-stage renal disease (CrCl 12 years old).
Do not exceed recommended dose. Pregnancy (Cat. B). Nursing mothers: not recommended.
Avoid alcohol, other central nervous system depressants. May be potentiated by theophylline. Potentiated by ritonavir.
Adults: nasopharyngitis/pharyngitis, somnolence, fatigue, dry mouth. Children: pyrexia, somnolence, cough, epistaxis.
For more information, call 866.822.0068 or visit www.Xyzal.com