Label: MECLIZINE HYDROCHLORIDE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 3, 2019

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  • DESCRIPTION

    Meclizine hydrochloride, USP, an oral antiemetic, is a white or slightly yellowish, crystalline powder. It has the following structural formula:

    c89547bf-figure-01

    Chemically, meclizine HCl, USP 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.

  • 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 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 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 

    Teratogenic Effects

    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

    The recommended dosage is 25 mg to 100 mg daily administered orally, 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.

    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:

    Blistercards of 30:               NDC 0615-8224-39

    Meclizine Hydrochloride Tablets USP, 50 mg are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side.

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

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

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

    Distributed by:
    Amneal Pharmaceuticals LLC
    Bridgewater, NJ 08807

    Rev. 02-2019-03

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Meclizine 25mg tab bingo card label

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0615-8224(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)  
    CELLULOSE, MICROCRYSTALLINE (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:0615-8224-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product07/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20145102/12/2010
    Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
    Establishment
    NameAddressID/FEIBusiness Operations
    NCS HealthCare of KY, Inc dba Vangard Labs050052943REPACK(0615-8224)