Source: FDA, National Drug Code (US) Revision Year: 2020
The precise mechanism by which meclizine exerts its therapeutic effect is unknown but is presumed to involve antagonism of the histamine H1 receptor.
There are no relevant pharmacodynamic data regarding meclizine.
The available pharmacokinetic information for meclizine following oral administration has been summarized from published literature.
Meclizine is absorbed after oral administration with maximum plasma concentrations reaching at a median Tmax value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form.
Drug distribution characteristics for meclizine in humans are unknown.
Meclizine has a plasma elimination half-life of about 5-6 hours in humans.
In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP2D6 was found to be the dominant enzyme for metabolism of meclizine.
Animal studies to assess the carcinogenic potential of meclizine have not been conducted.
Genetic toxicology studies of meclizine have not been conducted.
Animal studies to assess the effects of meclizine on fertility and early embryonic development have not been conducted.
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