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Meclizine Hydrochloride (American Health Packaging)

Available Formats

Dosage Form Package Information Links
TABLET 10 BLISTER PACK in 1 CARTON (68084-490-01) > 10 TABLET in 1 BLISTER PACK (68084-490-11) Label Information

Complete Meclizine Hydrochloride Information

  • DESCRIPTION

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

    Structural Formula

    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.


  • CLINICAL PHARMACOLOGY

    Meclizine hydrochloride 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 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.

    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 to 6 hours in humans.


  • INDICATIONS AND USAGE

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


  • CONTRAINDICATIONS

    Meclizine hydrochloride 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.


  • PRECAUTIONS

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

    Pregnancy
    Pregnancy Category B.
    Reproduction studies in rats have shown cleft palates at 25 to 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.

    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.


  • ADVERSE REACTIONS

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

    To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


  • DOSAGE AND ADMINISTRATION

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


  • 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

    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.

    Rx only


  • 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

    8249001/0119


  • 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:
    Meclizine Hydrochloride, USP ............................................... 12.5 mg

    Usual Dosage: See package insert for full prescribing information.
    VERTIGO: 25 mg to 100 mg in divided dosage 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
    0249001/0119


  • 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 Tablet Carton

    NDC 68084- 491-01

    Meclizine
    Hydrochloride

    Tablets, USP

    25 mg

    100 Tablets (10 x 10) Rx Only

    Each Tablet Contains:
    Meclizine Hydrochloride, USP .................................................. 25 mg

    Usual Dosage: See package insert for full prescribing information.
    VERTIGO: 25 mg to 100 mg in divided dosage 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
    0249101/0119


  • Package/Label Display Panel – Blister - 25 mg

    25 mg Meclizine HCl Tablet Blister

    Meclizine
    Hydrochloride
    Tablets, USP 25 mg


  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-490(NDC:65162-441)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color blue (Light) Score no score
    Shape OVAL Size 10mm
    Flavor Imprint Code AN;441
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68084-490-01 100 in 1 BOX, UNIT-DOSE 07/18/2011
    1 NDC:68084-490-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA201451 07/18/2011
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-491(NDC:65162-442)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color yellow (Light) Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code AN;442
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68084-491-01 100 in 1 BOX, UNIT-DOSE 07/14/2011
    1 NDC:68084-491-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA201451 07/14/2011
    Labeler - American Health Packaging (929561009)
    Establishment
    Name Address ID/FEI Business Operations
    American Health Packaging 929561009 repack(68084-490, 68084-491)