Meclizine Hydrochloride (Page 2 of 2)

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 T max 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 to 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

Meclizine Hydrochloride Tablets USP 12.5 mg are blue and light blue double layered, oval tablets, debossed “ANI” on the blue side and “841” on the light blue side.
Bottles of 100 NDC 62559-841-01
Bottles of 1000 NDC 62559-841-10

Meclizine Hydrochloride Tablets USP 25 mg are yellow and light yellow double layered, oval tablets, debossed “ANI” on the yellow side and “842” on the light yellow side.
Bottles of 100 NDC 62559-842-01
Bottles of 1000 NDC 62559-842-10

16.2 Storage and Handling

Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

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

17 PATIENT COUNSELING INFORMATION

Administration Instructions
Advise patients that the tablets must be swallowed whole [see Dosage and Administration ( 2.2)] .

Adverse Reactions
Advise patients that meclizine hydrochloride tablets 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 tablets 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 tablets 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)] .

Manufactured by:
ANI Pharmaceuticals Canada, Inc.
Oakville, ON L6H 1M5
Canada

Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
logo

N6820 Rev 01/21

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 62559-841-01
Meclizine Hydrochloride Tablets USP
12.5 mg
Rx only
100 Tablets

Label-12.5 mg
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 62559-842-01
Meclizine Hydrochloride Tablets USP
25 mg
Rx only
100 Tablets

Label-25 mg
(click image for full-size original)

MECLIZINE HYDROCHLORIDE meclizine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1849(NDC:62559-842)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE 102
HYDROGENATED COTTONSEED OIL
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
Product Characteristics
Color yellow (Yellow) , yellow (Light Yellow) Score no score
Shape OVAL Size 13mm
Flavor Imprint Code ANI;842
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-1849-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084657 12/27/2021
Labeler — Redpharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
Redpharn Drug, Inc. 828374897 repack (67296-1849)

Revised: 02/2023 Redpharm Drug, Inc.

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