CETIZAL Film-coated tablet Ref.[50452] Active ingredients: Levocetirizine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, a Sun Pharma Company, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa

5.1. Pharmacodynamic properties

A 5.7.1 Antihistaminics

Levocetirizine, the (R) enantiomer of cetirizine, is a histamine H1 receptor antagonist.

5.2. Pharmacokinetic properties

Absorption

Levocetirizine is absorbed following oral administration.

Distribution

Levocetirizine is 90% bound to human plasma proteins. Peak plasma concentrations are achieved 0,9 hour after administration of the oral tablet.

Biotransformation

The extent of metabolism of levocetirizine in humans is less than 14 % of the dose.

Elimination

The plasma half-life in adults is about 8 hours. The main route of excretion is via urine, accounting for approximately 85% of the dose. Excretion via the faeces accounts for only 13% of the dose.

Linearity/non-linearity

Plasma levels are linearly related between 2,5 mg and 20 mg.

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