Label: ANTIVERT- meclizine hydrochloride tablet

  • NDC Code(s): 0049-2100-66, 0049-2100-82, 0049-2110-66, 0049-2110-82, view more
    0049-2140-66
  • Packager: Roerig
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 11/12

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  • DESCRIPTION

    Chemically, ANTIVERT® (meclizine HCl) is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.

    Chemical Structure

    Inert ingredients for the tablets are: dibasic calcium phosphate; magnesium stearate; polyethylene glycol; starch; sucrose. The 12.5 mg tablets also contain: Blue 1. The 25 mg tablets also contain: Yellow 6 Lake; Yellow 10 Lake. The 50 mg tablets also contain: Blue 1 Lake; Yellow 10 Lake.

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  • CLINICAL PHARMACOLOGY

    ANTIVERT 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.

    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.

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  • INDICATIONS

    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.

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  • CONTRAINDICATIONS

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

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  • 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.

    Usage in Pregnancy

    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.

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  • PRECAUTIONS

    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.

    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. (see WARNINGS)

    Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore there is a possibility for a drug interaction between meclizine and CYP2D6 inhibitors.

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  • ADVERSE REACTIONS

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

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  • DOSAGE AND ADMINISTRATION

    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 Antivert 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.

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  • 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)

    Antivert/50: 50 mg tablets:
      Bottles of 100
        (NDC 0049-2140-66)

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  • SPL UNCLASSIFIED SECTION

    Rx only

    Logo

    LAB-0142-4.0
    October 2012

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  • PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

    NDC 0049-2100-66

    100 Tablets

    Antivert®
    (meclizine HCl)

    12.5 mg

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

    PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label
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  • 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

    PRINCIPAL DISPLAY PANEL - 25 mg Tablet Label
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  • 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

    PRINCIPAL DISPLAY PANEL - 50 mg Tablet Label
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  • INGREDIENTS AND APPEARANCE
    ANTIVERT 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0049-2100
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    SUCROSE  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color BLUE, WHITE Score no score
    Shape OVAL Size 10mm
    Flavor Imprint Code Antivert;210
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0049-2100-66 100 in 1 BOTTLE
    2 NDC:0049-2100-82 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA010721 04/11/1997
    ANTIVERT 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0049-2110
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    SUCROSE  
    FD&C YELLOW NO. 6  
    D&C YELLOW NO. 10  
    ALUMINUM OXIDE  
    Product Characteristics
    Color YELLOW, WHITE Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code Antivert;211
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0049-2110-66 100 in 1 BOTTLE
    2 NDC:0049-2110-82 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA010721 04/11/1997
    ANTIVERT 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0049-2140
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    SUCROSE  
    FD&C BLUE NO. 1  
    D&C YELLOW NO. 10  
    ALUMINUM OXIDE  
    Product Characteristics
    Color YELLOW, BLUE Score 2 pieces
    Shape OVAL Size 16mm
    Flavor Imprint Code Antivert;214
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0049-2140-66 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA010721 04/11/1997
    Labeler - Roerig (829076996)
    Establishment
    Name Address ID/FEI Business Operations
    UCB Pharma S.A. 372274485 MANUFACTURE(0049-2140, 0049-2110, 0049-2100)
    Establishment
    Name Address ID/FEI Business Operations
    Pfizer Pharmaceuticals LLC 829084545 API MANUFACTURE(0049-2140)
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