Label: MECLIZINE HYDROCHLORIDE tablet
- NDC Code(s): 62559-841-01, 62559-841-10, 62559-842-01, 62559-842-10
- Packager: ANI Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 17, 2021
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS.
MECLIZINE HYDROCHLORIDE tablets, for oral use
Initial U.S. Approval: 1957
INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults (1).
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
- Tablets: 12.5 mg and 25 mg (3).
Meclizine hydrochloride tablets are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients (4).
WARNINGS AND PRECAUTIONS
Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported (6).
To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Coadministration of meclizine hydrochloride tablets with other CNS depressants, including alcohol, may result in increased CNS depression (7.1).
- CYP2D6 inhibitors: As meclizine is metabolized by CYP2D6, there is a potential for drug-drug interactions between meclizine hydrochloride tablets and CYP2D6 inhibitors (7.2).
See 17 for PATIENT COUNSELING INFORMATION.
Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
- Sections or subsections omitted from the full prescribing information are not listed.
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
Since drowsiness may occur with use of meclizine hydrochloride tablets, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.
Patients should avoid alcoholic beverages while taking meclizine hydrochloride tablets [see Drug Interactions (7.1)].
6 ADVERSE REACTIONS
The following adverse reactions associated with the use of meclizine hydrochloride tablets were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported.
7 DRUG INTERACTIONS
7.1 CNS Depressants
There may be increased CNS depression when meclizine hydrochloride tablets are administered concurrently with other CNS depressants, including alcohol [see Warnings and Precautions (5.1)].
8 USE IN SPECIFIC POPULATIONS
Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects.
In a published study, oral administration of meclizine (25 to 250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations. These effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m2) basis.
There are no data on the presence of meclizine in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for meclizine hydrochloride tablets and any potential adverse effects on the breastfed infant from meclizine hydrochloride tablets or from the underlying maternal condition.
8.5 Geriatric Use
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
8.6 Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As meclizine hydrochloride undergoes metabolism, hepatic impairment may result in increased systemic exposure of meclizine. Treatment with meclizine hydrochloride tablets should be administered with caution in patients with hepatic impairment.
8.7 Renal Impairment
The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. Because of a potential for drug/metabolite accumulation, meclizine hydrochloride tablets should be administered with caution in patients with renal impairment and in the elderly, as renal function generally declines with age.
8.8 Genetic CYP2D6 Polymorphism
The genetic polymorphism of CYP2D6 that results in poor-, intermediate-, extensive-, and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure. Therefore, when meclizine hydrochloride tablets are administered to patients with CYP2D6 polymorphism, monitor for adverse reactions and clinical effect accordingly.
Meclizine hydrochloride USP, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula:
Chemically, meclizine hydrochloride USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.
Meclizine Hydrochloride Tablets USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hydrogenated vegetable oil, sodium starch glycolate, and magnesium stearate. 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 and FD&C Yellow # 6 aluminum lake.
Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base.
Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base.
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.
The available pharmacokinetic information for meclizine following oral administration has been summarized from published literature.
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.
Drug distribution characteristics for meclizine in humans are unknown.
Meclizine has a plasma elimination half-life of about 5 to 6 hours in humans.
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
Animal studies to assess the carcinogenic potential of meclizine have not been conducted.
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
17 PATIENT COUNSELING INFORMATION
Advise patients that the tablets must be swallowed whole [see Dosage and Administration (2.2)].
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)].
ANI Pharmaceuticals Canada, Inc.
Oakville, ON L6H 1M5
N6820 Rev 01/21
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
meclizine hydrochloride tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-841 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) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color BLUE (Blue) , BLUE (Light Blue) Score no score Shape OVAL Size 10mm Flavor Imprint Code ANI;841 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62559-841-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 2 NDC:62559-841-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA084657 12/27/2021 MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-842 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) 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 Marketing Start Date Marketing End Date 1 NDC:62559-842-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 2 NDC:62559-842-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA084657 12/27/2021 Labeler - ANI Pharmaceuticals, Inc. (145588013)