Available Formats

• DESCRIPTION

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

  

       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%).

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• 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.

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• INDICATIONS AND USAGE

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

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• CONTRAINDICATIONS

  Meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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

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• PRINCIPAL DISPLAY PANEL

  

  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
  

  

  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

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• 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)

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