Meclizine

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PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Meclizine Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Meclizine HCl 12.5mg, 25mg; tabs.

    Pharmacological Class

    Antihistamine.

    How Supplied

    Contact supplier

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    The precise mechanism by which meclizine exerts its therapeutic effect is unknown but is presumed to involve antagonism of the histamine H1 receptor.

    Meclizine Indications

    Indications

    Motion sickness prophylaxis. Vertigo of vestibular origin.

    Meclizine Dosage and Administration

    Adult

    Motion sickness: 25–50mg 1 hour prior to departure, repeated every 24 hours as needed. Vertigo: 25–100mg/day in divided doses.

    Children

    Not established.

    Renal Impairment

    • Use caution in patients with renal impairment because the elderly population may have a decline in renal function with age.

    • The pharmacokinetics of meclizine has not been evaluated in patients with renal impairment.

    Hepatic Impairment

    • Use caution in patients with hepatic impairment.

    • Hepatic impairment may result in increased systemic exposure of meclizine.

    • The pharmacokinetics of meclizine has not been evaluated in patients with hepatic impairment.

    Other Modifications

    Genetic CYP2D6 Polymorphism

    • Monitor for adverse reactions and clinical effect in patients with CYP2D6 polymorphism.

    Meclizine Contraindications

    Not Applicable

    Meclizine Boxed Warnings

    Not Applicable

    Meclizine Warnings/Precautions

    Warnings/Precautions

    Asthma. Glaucoma. GI or GU obstruction. Hepatic or renal impairment. Elderly. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Drowsiness

    • Warn patients that drowsiness may occur. Caution against driving a car or operating dangerous machinery.

    • Avoid alcoholic beverages while taking meclizine hydrochloride.

    Concurrent Medical Conditions

    • Use caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

    Pregnancy Considerations

    Risk Summary

    • Epidemiological studies have not generally indicated a drug-associated risk of major birth defects during pregnancy.

    • However, in a published study, there has been an increased incidence of fetal malformations observed in pregnant rats.

    • The risk of major birth defects and miscarriage for the indicated population is unknown.

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding 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.

    Pediatric Considerations

    Safety and efficacy in pediatric patients have not been established.

    Geriatric Considerations

    Use caution, usually starting at the low end of the dosing range because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    Renal Impairment Considerations

    • Use caution in patients with renal impairment because the elderly population may have a decline in renal function with age.

    • The pharmacokinetics of meclizine has not been evaluated in patients with renal impairment.

    Hepatic Impairment Considerations

    • Use caution in patients with hepatic impairment.

    • Hepatic impairment may result in increased systemic exposure of meclizine.

    • The pharmacokinetics of meclizine has not been evaluated in patients with hepatic impairment.

    Other Considerations for Specific Populations

    Genetic CYP2D6 Polymorphism

    • Monitor for adverse reactions and clinical effect in patients with CYP2D6 polymorphism.

    Meclizine Pharmacokinetics

    Absorption

    Maximum plasma concentrations reached at a median Tmax value of 3 hours post-dose (range: 1.5 to 6 hours).

    Metabolism

    Hepatic (CYP2D6).

    Elimination

    Renal. Half-life: 5-6 hours.

    Meclizine Interactions

    Interactions

    Alcohol, tranquilizers, sedative-hypnotics potentiate CNS depression. May be potentiated by CYP2D6 inhibitors.

    Meclizine Adverse Reactions

    Adverse Reactions

    Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, vomiting; rare: blurred vision.

    Meclizine Clinical Trials

    See Literature

    Meclizine Note

    Notes

    Formerly known under the brand name Antivert.

    Meclizine Patient Counseling

    Patient Counseling

    Administration Instructions

    • Swallow whole.

    Adverse Reactions

    • May cause anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, vomiting, and, on rare occasions, blurred vision.

    • May impair the ability to operate machinery or vehicles.

    Concomitant Drug Interactions

    • Advise patients on medications that should not be taken with meclizine or medications that may need increased monitoring.

    • Advise patients that alcohol may increase adverse reactions.

    Concurrent Medical Conditions

    • Notify healthcare provider regarding all medical conditions.

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