Atiza (Levocetirizine Dihydrochloride)
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Each Atiza film-coated tablet contains 5 mg of levocetirizine dihydrochloride. Each 5ml Atiza Syrup contains 2.5mg of levocetirizine dihydrochloride. MECHANISM OF ACTION Levocetirizine dihydrochloride is a third generation non-sedative antihistamine, developed from the second generation antihistamine cetirizine.
Levocetirizine, the active enantiomer of cetirizine, is an anti-histamine; its principal effects are mediated via selective inhibition of H1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models.
ECGs did not show relevant effects of levocetirizine on QT interval.
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Levocetirizine is rapidly and extensively absorbed following oral administration. In adults, peak plasma concentrations are achieved 0.9 hour after administration of the oral tablet. Steady state achieve after 2 days. Food had no effect on the extent of exposure (AUC) of the levocetirizine tablet, but Tmax was delayed by about 1.25 hours and Cmax was decreased by about 36% after administration with a high fat meal; therefore, levocetirizine can be administered with or without food.
A dose of 5 mg (10 mL) levocetirizine syrup is bioequivalent to a 5 mg dose of levocetirizine tablets. Following oral administration of a 5 mg dose of levocetirizine syrup to healthy adult subjects, the mean peak plasma concentrations were achieved approximately 0.5 hour post-dose.
The extent of metabolism of levocetirizine in humans is less than 14% of the dose and therefore differences resulting from genetic polymorphism or concomitant intake of hepatic drug metabolizing enzyme inhibitors are expected to be negligible.
Elimination: The plasma half-life in adult healthy subjects was about 8 to 9 hours after administration of oral tablets and oral syrup.The major route of excretion of levocetirizine and its metabolites is via urine, accounting for a mean of 85.4% of the dose. Excretion via feces accounts for only 12.9% of the dose. Levocetirizine is excreted both by glomerular filtration and active tubular secretion.
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The total body clearance of levocetirizine after oral dosing was correlated to the creatinine clearance and was progressively reduced based on severity of renal impairment. The amount of levocetirizine removed during a standard 4-hour hemodialysis procedure was < 10%.
The dosage of levocetirizine should be reduced in patients with mild renal impairment. Both the dosage and frequency of administration should be reduced in patients with moderate or severe renal impairment. In end-stage renal disease patients (CLCR < 10 mL/min) levocetirizine is contraindicated.
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Levocetirizine has not been studied in patients with hepatic impairment. The non-renal clearance (indicative of hepatic contribution) was found to constitute about 28% of the total body clearance in healthy adult subjects after oral administration.
As levocetirizine is mainly excreted unchanged by the kidney, it is unlikely that the clearance of levocetirizine is significantly decreased in patients with solely hepatic impairment.
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