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MECLIZINE HYDROCHLORIDE (JUBILANT CADISTA PHARMACEUTICALS, INC.)

Available Formats

Dosage Form Package Information Links
TABLET 1000 TABLET in 1 BOTTLE (59746-121-10) Label Information
TABLET 100 TABLET in 1 BOTTLE (59746-121-06) Label Information

Complete MECLIZINE HYDROCHLORIDE Information

  • DESCRIPTION

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

    Structure of Meclizine HCl

         C25H27ClN2 2HClH2O                                        Molecular Weight 481.88

    Meclizine hydrochloride tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose. Also, Meclizine hydrochloride tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine hydrochloride tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%).


  • 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 ultra-rapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.

    Elimination
    Meclizine has a plasma elimination half-life of about 5-6 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 tablets are 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 25-50 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 Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 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 to 100 mg daily, in divided dosage, depending upon clinical response.


  • HOW SUPPLIED

    Meclizine hydrochloride tablets, USP are available in the following strengths and package sizes:

    12.5 mg (Blue, oval shaped tablets, debossed with “TL 122” with score on one side and plain on the other side.)
    Bottles of 100           NDC 59746-122-06
    Bottles of 1000         NDC 59746-122-10

    25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.)
    Bottles of 100            NDC 59746-121-06
    Bottles of 1000          NDC 59746-121-10

    Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

    Manufactured By:
    Jubilant Cadista Pharmaceuticals Inc.
    Salisbury, MD 21801, USA

    Revised 05/2018


  • PRINCIPAL DISPLAY PANEL

    100 Counts of 12.5mg Tablets

    NDC 59746-122-06

    Meclizine Hydrochloride Tablets, USP

    12.5 mg

    CADISTAâ„¢

    100 Tablets

    Rx Only

    Each tablet Contains 12.5 mg of meclizine HCl

    DOSAGE AND USE 
    See accompanying prescribing information

    MOTION SICKNESS:
    25 mg to 50 mg daily.

    Dispense in tight, light-resistant containers (USP).

    Store at 20-25°C (68-77°F)
    [See USP Controlled Room Temperature].

    Manufactured by:
    Jubilant Cadista Pharmaceuticals Inc.
    Salisbury, MD 21801, USA

    Rev.# 02/17

    TL 122

    100 Counts of 25mg Tablets

    NDC 59746-121-06

    Meclizine Hydrochloride Tablets, USP

    25 mg

    CADISTAâ„¢

    100 Tablets

    Rx Only

    Each tablet Contains 25 mg of meclizine HCl

    DOSAGE AND USE 
    See accompanying prescribing information

    MOTION SICKNESS:
    25 mg to 50 mg daily.

    Dispense in tight, light-resistant containers (USP).

    Store at 20-25°C (68-77°F)
    [See USP Controlled Room Temperature].

    Manufactured by:
    Jubilant Cadista Pharmaceuticals Inc.
    Salisbury, MD 21801, USA

    Rev.# 02/17

    TL 121


  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-122
    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)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Fd&c Blue No. 1 (UNII: H3R47K3TBD)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color BLUE Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code TL122
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59746-122-06 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2010
    2 NDC:59746-122-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040659 06/04/2010
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrocloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-121
    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)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    D&c Yellow No. 10 (UNII: 35SW5USQ3G)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color YELLOW Score 2 pieces
    Shape OVAL Size 13mm
    Flavor Imprint Code TL121
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59746-121-06 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2010
    2 NDC:59746-121-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040659 06/04/2010
    Labeler - JUBILANT CADISTA PHARMACEUTICALS INC. (022490515)
    Establishment
    Name Address ID/FEI Business Operations
    JUBILANT CADISTA PHARMACEUTICALS INC. 022490515 manufacture(59746-121, 59746-122)