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 5-6 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

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

25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.)
Bottles of 20 NDC 51655-107-20
Bottles of 30 NDC 51655-107-52

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F) [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 [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)].

Manufactured by:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA
Rev. # 07/2019

Principal Display Panel

NDC: 51655-107-52

Label
(click image for full-size original)
MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-107(NDC:59746-121)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
D&C YELLOW NO. 10
ALUMINUM OXIDE
Product Characteristics
Color yellow Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code TL121
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-107-52 30 TABLET in 1 BOTTLE, DISPENSING None
2 NDC:51655-107-20 20 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040659 07/24/2014
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-107)

Revised: 01/2024 Northwind Pharmaceuticals, LLC

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