SENSAHIST Film-coated tablet Ref.[50519] Active ingredients: Cetirizine

Source: Marketing Authorisation Holder  Revision Year: 2022  Publisher: Oethmaan Biosims (Ply) Ltd, 14 Komatie Road, Emmarentia, Johannesburg, 2195

5.1. Pharmacodynamic properties

Pharmacological classification: A.5.7.1 Antihistaminics

Cetirizine dihydrochloride, a metabolite of hydroxyzine, is a histamine H1 receptor antagonist.

5.2. Pharmacokinetic properties

Peak blood levels are reached within one hour after oral administration of cetirizine dihydrochloride. Cetirizine dihydrocloride does not undergo extensive first pass metabolism. The terminal half-life is approximately 10 hours in adults, 6 hours in children aged 6 to 12 years and 5 hours in children aged 2 to 6 years. These data are consistent with the urinary excretion half-life of cetirizine. The cumulative urinary excretion represents about two thirds of the dose given in both adults and children.

Consequently, the apparent plasma clearance in children is higher than that measured in adults. Plasma levels are linearly related to the dosage given. A high proportion of cetirizine is bound to human plasma proteins. In patients with impaired renal clearance (less than 40 ml/min) and hepatic insufficiency, an increase in half-life and decrease in total clearance occurs.

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