Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of
this possibility and cautioned against driving a car or operating dangerous machinery.
Patients should avoid alcoholic beverages while taking this drug.
Due to its potential anticholinergic action, this drug should be used with caution in patients with
asthma, glaucoma, or enlargement of the prostate gland.
Clinical studies establishing safety and effectiveness in children have not been done; therefore,
usage is not recommended in children under 12 years of age.
Pregnancy Category B
Reproduction studies in rats have shown cleft palates at 25–50 times the human dose.
Epidemiological studies in pregnant women, however, do not indicate that meclizine increases
the risk of abnormalities when administered during pregnancy. Despite the animal findings, it
would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other
medication, should be used during pregnancy only if clearly necessary.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in
human milk, caution should be exercised when meclizine is administered to a nursing woman.
The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated.
As meclizine undergoes metabolism, hepatic impairment may result in increased systemic
exposure of the drug. Treatment with meclizine should be administered with caution in patients
with hepatic impairment.
The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated.
Due to a potential for drug/metabolite accumulation, meclizine should be administered with
caution in patients with renal impairment and in the elderly as renal function generally declines