MECLIZINE HYDROCHLORIDE tablet
Meclizine Hydrochloride by
Drug Labeling and Warnings
Meclizine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Epic Pharma LLC, Epic Pharm LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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DESCRIPTION
Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.
C25H27CIN2·2HCl·H20 M.W. 481.89
Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg. Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate. The 12.5 mg tablet also contains FD&C Blue #1 Aluminum Lake.
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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.
Metabolism
The metabolic fate of meclizine in humans is unknown. In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP 2D6 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.
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
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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 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
- DOSAGE AND ADMINISTRATION
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HOW SUPPLIED
Meclizine Hydrochloride Tablets, USP are available as follows:
12.5 mg, blue, modified oval-shaped tablets, de-bossed “Є12” on one side and plain on the other side. They are supplied as follows:
NDC: 42806-012-01 in bottles of 100
NDC: 42806-012-10 in bottles of 1000
25 mg, white, modified oval-shaped tablets, de-bossed “Є14” on one side and plain on the other side. They are supplied as follows:
NDC: 42806-014-01 in bottles of 100
NDC: 42806-014-10 in bottles of 1000
Store at 20º to 25ºC (68 to 77ºF) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required.
Manufactured by:
Epic Pharma, LLC
Laurelton, NY 11413
Rev.05-2018-00
MF012REV05/18
OE1035
- PRINCIPAL DISPLAY PANEL – 12.5 mg, 100ct
- PRINCIPAL DISPLAY PANEL – 25 mg, 100ct
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INGREDIENTS AND APPEARANCE
MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 42806-012 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE Score no score Shape OVAL Size 10mm Flavor Imprint Code E12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 42806-012-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012 03/31/2020 2 NDC: 42806-012-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012 03/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200294 04/30/2012 03/31/2020 MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 42806-014 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color WHITE Score no score Shape OVAL Size 13mm Flavor Imprint Code E14 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 42806-014-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012 01/31/2020 2 NDC: 42806-014-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200294 04/30/2012 04/30/2020 Labeler - Epic Pharma, LLC (827915443)
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