MECLIZINE HYDROCHLORIDE tablet MECLIZINE HYDROCHLORIDE tablet, chewable

Meclizine Hydrochloride by

Drug Labeling and Warnings

Meclizine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Nortic Pharma, LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    Meclizine hydrochloride is 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.

    Chewable Tablets
    Meclizine hydrochloride chewable tablets must be chewed or crushed completely before swallowing. Do not swallow chewable tablets whole.

  • 3 DOSAGE FORMS AND STRENGTHS

    Tablets


    • 12.5 mg: oval-shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “34” and one white to off white layer debossed with “L”.
    • 25 mg: oval-shaped, biconvex, two-layered tablet, one yellow to pale yellow layer debossed with “49” and one white to off white layer debossed with “L”.
    • 50 mg: oval-shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “50” and one yellow to pale yellow layer and debossed with “L”.

    Chewable Tablets


    • 25 mg: pink colored round tablets debossed with “M 25” on one side and break line on other side.
  • 4 CONTRAINDICATIONS

    Meclizine hydrochloride is 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 2-4% and 15-20%, 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 (25-250 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 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:


    struct-1

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

    Tablets
    Inactive ingredients for the tablets are: corn starch; dibasic calcium phosphate; magnesium stearate; polyethylene glycol; sucrose. The 12.5 mg tablets also contain: FD&C Blue # 1. The 25 mg tablets also contain: FD&C Yellow # 6 and D&C Yellow # 10. The 50 mg tablets also contain: FD&C Blue # 1, FD&C Yellow # 6 and D&C Yellow # 10.

    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.

    Chewable Tablets
    Inactive ingredients for the chewable tablets are: corn starch, colloidal silicon dioxide, FD&C Red # 40, lactose monohydrate, magnesium stearate, raspberry flavor, saccharin sodium, and talc.

    Each meclizine hydrochloride 25 mg chewable 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 5-6 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

    Tablets
    Meclizine hydrochloride 12.5 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “34” and one white to off white layer debossed with “L”.
    Bottles of 100                   NDC: 74074-001-01
    Bottles of 500                   NDC: 74074-001-05
    Meclizine hydrochloride 25 mg tablets are oval shaped, biconvex, two-layered tablet, one yellow to pale yellow layer debossed with “49” and one white to off white layer debossed with “L”.
    Bottles of 100                   NDC: 74074-002-01
    Bottles of 1000                 NDC: 74074-002-99
    Meclizine hydrochloride 50 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “50” and one yellow to pale yellow layer and debossed with “L”.
    Bottles of 100                   NDC: 74074-003-01
    Bottles of 1000                 NDC: 74074-003-99

    Chewable Tablets
    Meclizine hydrochloride 25 mg chewable tablets are pink colored round tablets debossed with “M 25” on one side and break line on other side.
    Bottles of 100                   NDC: 74074-004-01

    16.2 Storage and Handling

    Store at 20oC to 25oC (68oF to 77oF) [See USP Controlled Room Temperature].
    Dispense in a tight, light-resistant container (USP).

  • 17 PATIENT COUNSELING INFORMATION

    Administration Instructions
    Advise patients that the tablets must be swallowed whole, but chewable tablets must be chewed or crushed completely before swallowing [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)].

    PIN00399-00

    Distributed by:
    Nortic Pharma, LLC
    East Brunswick, NJ 08816

    Issued: 05/2020

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC: 74074-003-01
    Meclizine Hydrochloride Tablets, USP
    50 mg
    Rx Only
    Container Label
    meclizine-50-mg

    NDC: 74074-004-01
    Meclizine Hydrochloride Chewable Tablets
    25 mg
    Rx Only
    Container Label
    meclizine-25-mg-chew

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 74074-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorBLUE (Pale Blue to Yellow) Score2 pieces
    ShapeOVAL (Biconvex, two layered tablet) Size16mm
    FlavorImprint Code 50;L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 74074-003-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    2NDC: 74074-003-991000 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA AUTHORIZED GENERICNDA01072106/23/2020
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 74074-004
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code M;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 74074-004-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA AUTHORIZED GENERICNDA01072106/23/2020
    Labeler - Nortic Pharma, LLC (117463806)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(74074-003, 74074-004) , MANUFACTURE(74074-003, 74074-004) , PACK(74074-003, 74074-004)

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