Meclizine

Meclizine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Meclizine is a antiemetic, antihistamine, antivertigo and central nervous system agent that is FDA approved for the treatment of nausea, vomiting and dizziness associated with motion sickness and vertigo. Common adverse reactions include drowsiness, xerostomia, sedation and somnolence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications as follows:

• Effective:

• Management of nausea and vomiting, and dizziness associated with motion sickness.

• Possibly Effective:

• Management of vertigo associated with diseases affecting the vestibular system.

• Final classification of the less than effective indications requires further investigation.

Dosing Information

Vertigo

• For the control of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 to 100 mg daily, in divided dosage, depending upon clinical response.

Motion Sickness

• The initial dose of 25 to 50 mg of Meclizine should be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Meclizine in adult patients.

Non–Guideline-Supported Use

• Radiation-induced nausea and vomiting; Treatment and Prophylaxis

• Dosage
  • 50 mg Oral, 2 to 12 hrs prior to radiotherapy

• Vomiting of pregnancy

• Dosage
  • 25 to 50 mg oral daily

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Meclizine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Meclizine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Meclizine in pediatric patients.

Contraindications

• Meclizine HCl is contraindicated in individuals who have shown a previous hypersensitivity to it.

Warnings

• 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.

Usage in Children

• Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.

Adverse Reactions

Clinical Trials Experience

• Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Meclizine in the drug label.

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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): 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.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Meclizine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Meclizine during labor and delivery.

Nursing Mothers

• 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.

Pediatric Use

There is no FDA guidance on the use of Meclizine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Meclizine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Meclizine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Meclizine with respect to specific racial populations.

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.

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.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Meclizine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Meclizine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Monitoring of Meclizine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Meclizine in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Meclizine in the drug label.

Pharmacology

Mechanism of Action

• Meclizine is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

Structure

• Chemically, Meclizine HCl is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Meclizine in the drug label.

Pharmacokinetics

• The available pharmacokinetic information for meclizine following oral administration has been summarized from published literature.

Absorption

• 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.

Distribution

• Drug distribution characteristics for meclizine in humans are unknown.

Metabolism

• The metabolic fate of meclizine in humans is unknown. 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.

• The genetic polymorphism of CYP2D6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.

Elimination

• Meclizine has a plasma elimination half-life of about 5-6 hours in humans.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Meclizine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Meclizine in the drug label.

How Supplied

Antivert: 12.5 mg tablets:

Bottles of 100

(NDC 0049-2100-66)

Antivert/25: 25 mg tablets:

Bottles of 100

(NDC 0049-2110-66)

Meclizine/50: 50 mg tablets:

Bottles of 100

(NDC 0049-2140-66)

Storage

There is limited information regarding Meclizine Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Meclizine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 12.5 MG TABLET LABEL

NDC 0049-2100-66

100 Tablets

Meclizine® (meclizine HCl)

12.5 mg

Pfizer Distributed by Roerig Division of Pfizer Inc, NY, NY 10017

This image is provided by the National Library of Medicine.

PRINCIPAL DISPLAY PANEL - 25 MG TABLET LABEL

NDC 0049-2110-66

100 Tablets

Antivert® (meclizine HCl)

25 mg

Pfizer Distributed by Roerig Division of Pfizer Inc, NY, NY 10017

This image is provided by the National Library of Medicine.

PRINCIPAL DISPLAY PANEL - 50 MG TABLET LABEL

NDC 0049-2140-66

100 Tablets

Antivert® (meclizine HCl)

50 mg

Pfizer Distributed by Roerig Division of Pfizer Inc, NY, NY 10017

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Meclizine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Meclizine in the drug label.

Precautions with Alcohol

• Alcohol-Meclizine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Antivert®
• Antivert/25®
• Antivert/50®
• Dramamine II®
• Meclicot®
• Meni-D®
• Motion Sickness Relief®
• Simply Motion®

Look-Alike Drug Names

• Antivert® - Axert®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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