MECLIZINE HYDROCHLORIDE tablet

Meclizine Hydrochloride by

Drug Labeling and Warnings

Meclizine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by American Health Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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

    Tablets
    Meclizine hydrochloride tablets must be swallowed whole.

  • 3 DOSAGE FORMS AND STRENGTHS

    • 12.5 mg: light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side.
    • 25 mg: light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side.
    • 50 mg: white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other 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, 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 [see Drug Interactions (7.1)].

    5.2 Concurrent Medical Conditions

    Because of its potential anticholinergic action, meclizine hydrochloride 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 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 is 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 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 mg/kg 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/m 2) 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 and any potential adverse effects on the breastfed infant from meclizine hydrochloride 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 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 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 is administered to patients with CYP2D6 polymorphism, monitor for adverse reactions and clinical effect accordingly.

  • 11 DESCRIPTION

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

    Structural Formula

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

    Inactive ingredients for the tablets are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. 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.

    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.

    Each meclizine hydrochloride 50 mg tablet contains 50 mg of meclizine dihydrochloride equivalent to 42.14 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 T max 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 supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side.
    They are available as follows:
    Unit dose packages of 100 (10 x 10) NDC: 68084-490-01

    Meclizine Hydrochloride Tablets USP, 25 mg are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side.
    They are available as follows:
    Unit dose packages of 100 (10 x 10) NDC: 68084-491-01

    16.2 Storage and Handling

    Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    Keep this and all medication out of the reach of children.

  • 17 PATIENT COUNSELING INFORMATION

    Administration Instructions
    Advise patients that the tablets must be swallowed whole [see Dosage and Administration (2.1)].

    Adverse Reactions
    Advise patients that meclizine hydrochloride 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 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 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)] .

  • PACKAGING INFORMATION

    American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals, LLC as follows:
    (12.5 mg / 100 UD) NDC: 68084-490-01 packaged from NDC: 65162-441
    (25 mg / 100 UD) NDC: 68084-491-01 packaged from NDC: 65162-442

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8249001/0919

  • Package/Label Display Panel – Carton – 12.5 mg

    12.5 mg Meclizine HCl Tablets Carton

    NDC 68084- 490-01

    Meclizine
    Hydrochloride
    Tablets, USP

    12.5 mg

    100 Tablets (10 x 10)                Rx Only

    Each Tablet Contains:
    12.5 mg meclizine dihydrochloride equivalent to 10.53 mg of
    meclizine free base.

    Usual Dosage: See package insert for full prescribing information.

    VERTIGO: 25 mg to 100 mg in divided doses daily depending on
    the clinical response.

    Store at 20° to 25°C (68° to 77°F); excursions permitted between
    15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

    Keep this and all drugs out of reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    The drug product contained in this package is from
    NDC # 65162-441, Amneal Pharmaceuticals LLC.

    Packaged and Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    049001
    0249001/0919

  • Package/Label Display Panel – Blister – 12.5 mg

    12.5 mg Meclizine HCl Tablet Blister

    Meclizine
    Hydrochloride
    Tablet, USP    12.5 mg

  • Package/Label Display Panel – Carton – 25 mg

    25 mg Meclizine HCl Tablets Carton

    NDC 68084- 491-01

    Meclizine
    Hydrochloride
    Tablets, USP

    25 mg

    100 Tablets (10 x 10)                Rx Only

    Each Tablet Contains:
    25 mg meclizine dihydrochloride equivalent to 21.07 mg of
    meclizine free base.

    Usual Dosage: See package insert for full prescribing information.

    VERTIGO: 25 mg to 100 mg in divided doses daily depending on
    the clinical response.

    Store at 20° to 25°C (68° to 77°F); excursions permitted between
    15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

    Keep this and all drugs out of reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    The drug product contained in this package is from
    NDC # 65162-442, Amneal Pharmaceuticals LLC.

    Packaged and Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    049101
    0249101/1219

  • Package/Label Display Panel – Blister – 25 mg

    25 mg Meclizine HCl Tablet Blister

    Meclizine
    Hydrochloride
    Tablet, USP    25 mg

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 68084-490(NDC:65162-441)
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (Light) Scoreno score
    ShapeOVALSize10mm
    FlavorImprint Code AN;441
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 68084-490-01100 in 1 BOX, UNIT-DOSE07/18/2011
    1NDC: 68084-490-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20145107/18/2011
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 68084-491(NDC:65162-442)
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    Coloryellow (Light) Scoreno score
    ShapeOVALSize13mm
    FlavorImprint Code AN;442
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 68084-491-01100 in 1 BOX, UNIT-DOSE07/14/2011
    1NDC: 68084-491-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20145107/14/2011
    Labeler - American Health Packaging (929561009)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(68084-490, 68084-491)
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