Magazine article Drug Topics

New Antihistamine Gets FDA Green Light

Magazine article Drug Topics

New Antihistamine Gets FDA Green Light

Article excerpt

NEW DRUG

Adults and children six years of age and older who suffer with seasonal and perennial allergic rhinitis will now have another option for relief of their symptoms. Levocetirizine (Xyzal), from UCB Inc. and SanofiAventis, has received regulatory approval from the Food & Drug Administration. Levocetirizine is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in the same age group.

"Xyzal is the active R-enantiomer of cetirizine [Zyrtec, Pfizer]," said H. William Kelly, Pharm.D., Professor Emeritus of Pediatrics at the University of New Mexico School of Medicine in Albuquerque. As such, the new antihistamine exerts its effect quickly and is long-lasting. According to the manufacturer, peak plasma concentrations of levocetirizine are achieved 0.9 hours after dosing, with activity persisting for at least 24 hours; it is dosed once daily.

Specifically, for adults and children 12 years of age and older, the recommended dose of levocetirizine is 5 mg once daily in the evening, but some patients may be adequately controlled with just 2.5 mg once a day. Children six to 11 years of age should be given 2.5 mg once daily in the evening. In this age group, the 2.5-mg dose should not be exceeded, because the systemic exposure (area under the curve) with 5 mg is about twofold that observed in adults.

"As [the drug] is primarily excreted unchanged, the manufacturer recommends adjusting the dose in renal dysfunction and provides adequate guidelines for that/' Kelly explained. As described in the prescribing information, in cases of mild renal impairment (creatinine clearance [CrCl] = 50-80 ml/ min), a dose of 2.5 mg once daily is recommended. For moderate renal impairment (CrCl = 30-50 ml/min), the dose should be modified to 2.5 mg once every other day, and for patients with severe renal imimpairment (CrCl = 10-30 ml/min), a dose of 2.5 mg twice weekly (given once every three to four days) is recommended. In addition, children aged six to 11 years with impaired renal function, as well as those with end-stage renal disease and patients undergoing hemodialysis, should not receive levocetirizine.

"Much of the safety data come from evidence of racemic cetirizine, which is reasonable since it is the active component," explained Kelly of levocetirizine. …

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