TEXAMER Film-coated tablet Ref.[51219] Active ingredients: Levocetirizine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Pharma Dynamics (Pty) Ltd, 1<sup>st</sup> Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antihistamine for systemic use, piperazine derivatives
ATC code: R06AE09
Pharmacological classification: A 5.7.1 Antihistaminic

Mechanism of action

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

5.2. Pharmacokinetic properties

Absorption

Levocetirizine is absorbed after oral administration with peak blood levels reached 0,9 hours after oral administration.

Distribution

Levocetirizine is 90% bound to human plasma proteins.

Biotransformation

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

Elimination

The plasma half-life is approximately 8 hours in adults. The half-life is shorter in small children. The main route of excretion is via urine, accounting for approximately 85% of the dose. Approximately 13% is excreted in the faeces.

Linearity/non-linearity

Plasma levels rise in a linear manner between 2,5 mg and 20 mg.

5.3. Preclinical safety data

Not applicable.

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