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U.S. Department of Health and Human Services

Safety

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Antivert (mecilizine hydrochloride) tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012

Summary View

 

PRECAUTIONS

Hepatic Impairment
  • 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.
Renal 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 with age.

Drug Interactions

  • There may be increased CNS depression when meclizine is administered concurrently with other CNS depressants, including alcohol, tranquilizers, and sedatives. 
  • Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore there is a possibility for a drug interaction between meclizine and CYP2D6 inhibitors.