MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet
American Health Packaging

----------

Meclizine Hydrochloride Tablets, USP
8249001/0119
Rx only

DESCRIPTION

Chemically, meclizine hydrochloride, USP is 1-( p -chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate.

Structural Formula

Inactive ingredients for the tablets are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and talc. The 12.5 mg tablets also contain FD&C Blue #1 Aluminum Lake. The 25 mg tablets also contain D&C Yellow #10 Aluminum Lake.

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 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.

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 ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.

Elimination
Meclizine has a plasma elimination half-life of about 5 to 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 is 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 to 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 Amneal Pharmaceuticals at 1-877-835-5472 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 mg to 100 mg daily, in divided dosage, depending upon clinical response.

HOW SUPPLIED

Meclizine Hydrochloride Tablets, USP 12.5 mg, are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side.
They are available as follows:
Unit dose packages of 100 (10 x 10) NDC 68084-490-01

Meclizine Hydrochloride Tablets, USP 25 mg, are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side.
They are available as follows:
Unit dose packages of 100 (10 x 10) NDC 68084-491-01

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Rx only

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals, LLC as follows:
(12.5 mg / 100 UD) NDC 68084-490-01 packaged from NDC 65162-441
(25 mg / 100 UD) NDC 68084-491-01 packaged from NDC 65162-442

Distributed by:
American Health Packaging
Columbus, OH 43217

8249001/0119

Package/Label Display Panel – Carton - 12.5 mg

12.5 mg Meclizine HCl Tablets Carton

NDC 68084- 490 -01

Meclizine
Hydrochloride
Tablets, USP

12.5 mg

100 Tablets (10 x 10) Rx Only

Each Tablet Contains:
Meclizine Hydrochloride, USP ............................................... 12.5 mg

Usual Dosage: See package insert for full prescribing information.
VERTIGO: 25 mg to 100 mg in divided dosage daily depending on
the clinical response..

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 65162-441, Amneal Pharmaceuticals, LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

049001
0249001/0119

Package/Label Display Panel – Blister - 12.5 mg

12.5 mg Meclizine HCl Tablet Blister

Meclizine
Hydrochloride
Tablet, USP 12.5 mg

Package/Label Display Panel – Carton - 25 mg

25 mg Meclizine HCl Tablet Carton

NDC 68084- 491 -01

Meclizine
Hydrochloride

Tablets, USP

25 mg

100 Tablets (10 x 10) Rx Only

Each Tablet Contains:
Meclizine Hydrochloride, USP .................................................. 25 mg

Usual Dosage: See package insert for full prescribing information.
VERTIGO: 25 mg to 100 mg in divided dosage daily depending on
the clinical response.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 65162-442, Amneal Pharmaceuticals LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

049101
0249101/0119

Package/Label Display Panel – Blister - 25 mg

25 mg Meclizine HCl Tablet Blister

Meclizine
Hydrochloride
Tablets, USP 25 mg

MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-490(NDC:65162-441)
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)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Product Characteristics
Color blue (Light) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code AN;441
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68084-490-01 100 in 1 BOX, UNIT-DOSE 07/18/2011
1 NDC:68084-490-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201451 07/18/2011
MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-491(NDC:65162-442)
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)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
Product Characteristics
Color yellow (Light) Score no score
Shape OVAL Size 13mm
Flavor Imprint Code AN;442
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68084-491-01 100 in 1 BOX, UNIT-DOSE 07/14/2011
1 NDC:68084-491-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201451 07/14/2011
Labeler - American Health Packaging (929561009)
Establishment
Name Address ID/FEI Business Operations
American Health Packaging 929561009 repack(68084-490, 68084-491)

Revised: 3/2019
Document Id: 83d5aaa4-7a1e-e2b3-e053-2991aa0a1a05
Set id: a620e9aa-fda7-487a-ab5b-0648e2ec60eb
Version: 5
Effective Time: 20190311
American Health Packaging