Meclozine Other names: Meclizine

Chemical formula: C₂₅H₂₇ClN₂  Molecular mass: 390.948 g/mol  PubChem compound: 4034

Interactions

Meclozine interacts in the following cases:

Central nervous system depressants

There may be increased CNS depression when meclizine tablets are administered concurrently with other CNS depressants, including alcohol.

Anticholinergics, monoamine oxidase inhibitors

at least one of
Anticholinergics
MAO inhibitors

CYP2D6 inhibitors

Based on in vitro evaluation, meclizine is metabolized by CYP2D6. Therefore, there is a possibility for a drug interaction between meclizine and CYP2D6 inhibitors. Therefore, monitor for adverse reactions and clinical effect accordingly.

Asthma

Because of its potential anticholinergic action, meclizine should be used with caution in patients with asthma.

Enlargement of the prostate gland

Because of its potential anticholinergic action, meclizine should be used with caution in patients with enlargement of the prostate gland.

Pyloric stenosis, stenosis of duodenum

at least one of
PS - Pyloric stenosis
Stenosis of duodenum

Glaucoma

Because of its potential anticholinergic action, meclizine should be used with caution in patients with glaucoma.

Hypotension

Hypotension

Obstruction of urethra

Obstruction of urethra

Pregnancy

Risk Summary

Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Data

Human Data

Epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects.

Animal Data

In a published study, oral administration of meclizine (25 to 250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations. These effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m²) basis.

Nursing mothers

Risk Summary

There are no data on the presence of meclizine in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meclizine and any potential adverse effects on the breastfed infant from meclizine or from the underlying maternal condition.

Carcinogenesis, mutagenesis and fertility

Carcinogenesis

Animal studies to assess the carcinogenic potential of meclizine have not been conducted.

Mutagenesis

Genetic toxicology studies of meclizine have not been conducted.

Impairment of Fertility

Animal studies to assess the effects of meclizine on fertility and early embryonic development have not been conducted.

Effects on ability to drive and use machines

Since drowsiness may occur with use of meclizine, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.

Adverse reactions


The following adverse reactions associated with the use of meclizine hydrochloride tablets were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported.

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