Label: MECLIZINE HYDROCHLORIDE tablet

  • NDC Code(s): 62559-841-01, 62559-841-10, 62559-842-01, 62559-842-10
  • Packager: ANI Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 17, 2021

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS.

    MECLIZINE HYDROCHLORIDE tablets, for oral use
    Initial U.S. Approval: 1957

    INDICATIONS AND USAGE

    Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults (1).

    DOSAGE AND ADMINISTRATION

    Recommended dosage: 25 mg to 100 mg daily, in divided doses (2.1).
    Tablets: Swallow whole (2.2).

    DOSAGE FORMS AND STRENGTHS

    Tablets: 12.5 mg and 25 mg (3).

    CONTRAINDICATIONS

    Meclizine hydrochloride tablets are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients (4).

    WARNINGS AND PRECAUTIONS

    May cause drowsiness: Use caution when driving a car or operating dangerous machinery (5.1).
    Potential anticholinergic action: this drug should be prescribed with care to patients with a history of asthma, glaucoma, or enlargement of the prostate gland (5.2).

    ADVERSE REACTIONS

    Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported (6).

    To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

    Coadministration of meclizine hydrochloride tablets with other CNS depressants, including alcohol, may result in increased CNS depression (7.1).
    CYP2D6 inhibitors: As meclizine is metabolized by CYP2D6, there is a potential for drug-drug interactions between meclizine hydrochloride tablets and CYP2D6 inhibitors (7.2).

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 1/2021

  • Table of Contents
  • 1 INDICATIONS AND USAGE

    Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Recommended Dosage

    The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response.

    2.2 Administration Instructions

    Meclizine hydrochloride tablets must be swallowed whole.

  • 3 DOSAGE FORMS AND STRENGTHS

    12.5 mg: Blue and light blue double layered, oval tablets, debossed “ANI” on the blue side and “841” on the light blue side.
    25 mg: Yellow and light yellow double layered, oval tablets, debossed “ANI” on the yellow side and “842” on the light yellow side.
  • 4 CONTRAINDICATIONS

    Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions (6) and Description (11)].

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Drowsiness

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

    Patients should avoid alcoholic beverages while taking meclizine hydrochloride tablets [see Drug Interactions (7.1)].

    5.2 Concurrent Medical Conditions

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

  • 6 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.

  • 7 DRUG INTERACTIONS

    7.1 CNS Depressants

    There may be increased CNS depression when meclizine hydrochloride tablets are administered concurrently with other CNS depressants, including alcohol [see Warnings and Precautions (5.1)].

    7.2 CYP2D6 Inhibitors

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

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 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.

    8.2 Lactation

    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 hydrochloride tablets and any potential adverse effects on the breastfed infant from meclizine hydrochloride tablets or from the underlying maternal condition.

    8.4 Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    8.5 Geriatric Use

    In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    8.6 Hepatic Impairment

    The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As meclizine hydrochloride undergoes metabolism, hepatic impairment may result in increased systemic exposure of meclizine. Treatment with meclizine hydrochloride tablets should be administered with caution in patients with hepatic impairment.

    8.7 Renal Impairment

    The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. Because of a potential for drug/metabolite accumulation, meclizine hydrochloride tablets should be administered with caution in patients with renal impairment and in the elderly, as renal function generally declines with age.

    8.8 Genetic CYP2D6 Polymorphism

    The genetic polymorphism of CYP2D6 that results in poor-, intermediate-, extensive-, and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure. Therefore, when meclizine hydrochloride tablets are administered to patients with CYP2D6 polymorphism, monitor for adverse reactions and clinical effect accordingly.

  • 11 DESCRIPTION

    Meclizine hydrochloride USP, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula:

    Structure

    Chemically, meclizine hydrochloride USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.

    Meclizine Hydrochloride Tablets USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hydrogenated vegetable oil, sodium starch glycolate, and magnesium stearate. The 12.5 mg tablets also contain: FD&C Blue # 1 aluminum lake. The 25 mg tablets also contain: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake.

    Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base.

    Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base.

  • 12 CLINICAL PHARMACOLOGY

    12.1 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.

    12.2 Pharmacodynamics

    There are no relevant pharmacodynamic data regarding meclizine.

    12.3 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.

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

    Metabolism
    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.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of 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.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    16.1 How Supplied

    Meclizine Hydrochloride Tablets USP 12.5 mg are blue and light blue double layered, oval tablets, debossed “ANI” on the blue side and “841” on the light blue side.
    Bottles of 100           NDC 62559-841-01
    Bottles of 1000         NDC 62559-841-10

    Meclizine Hydrochloride Tablets USP 25 mg are yellow and light yellow double layered, oval tablets, debossed “ANI” on the yellow side and “842” on the light yellow side.
    Bottles of 100           NDC 62559-842-01
    Bottles of 1000         NDC 62559-842-10

    16.2 Storage and Handling

    Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

    Dispense in a tight, light-resistant container as defined in the USP.

  • 17 PATIENT COUNSELING INFORMATION

    Administration Instructions
    Advise patients that the tablets must be swallowed whole [see Dosage and Administration (2.2)].

    Adverse Reactions
    Advise patients that meclizine hydrochloride tablets may cause anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision [see Warnings and Precautions (5.1), Adverse Reactions (6)].

    Inform patients that meclizine hydrochloride tablets may impair their ability to engage in potentially dangerous activities, such as operating machinery or vehicles.

    Concomitant Drug Interactions
    Advise patients regarding medications that should not be taken in combination with meclizine hydrochloride tablets or that may necessitate increased monitoring [see Drug Interactions (7.1, 7.2)]. Inform patients that alcohol may increase adverse reactions.

    Concurrent Medical Conditions
    Advise patients to notify their healthcare provider about all of their medical conditions, including if they are pregnant or plan to become pregnant or if they are breastfeeding [see Warnings and Precautions (5.2), Use in Specific Populations (8.1, 8.2)].

    Manufactured by:
    ANI Pharmaceuticals Canada, Inc.
    Oakville, ON L6H 1M5
    Canada

    Distributed by:
    ANI Pharmaceuticals, Inc.
    Baudette, MN 56623
    logo

    N6820 Rev 01/21

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC 62559-841-01
    Meclizine Hydrochloride Tablets USP
    12.5 mg
    Rx only
    100 Tablets
    Label-12.5 mg

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC 62559-842-01
    Meclizine Hydrochloride Tablets USP
    25 mg
    Rx only
    100 Tablets
    Label-25 mg

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62559-841
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorBLUE (Blue) , BLUE (Light Blue) Scoreno score
    ShapeOVALSize10mm
    FlavorImprint Code ANI;841
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62559-841-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
    2NDC:62559-841-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08465712/27/2021
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62559-842
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorYELLOW (Yellow) , YELLOW (Light Yellow) Scoreno score
    ShapeOVALSize13mm
    FlavorImprint Code ANI;842
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62559-842-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
    2NDC:62559-842-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08465712/27/2021
    Labeler - ANI Pharmaceuticals, Inc. (145588013)