MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet
Epic Pharma LLC
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
Meclizine hydrochloride tablets are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients (4).
WARNINGS AND PRECAUTIONS
See 17 for PATIENT COUNSELING INFORMATION.
FULL PRESCRIBING INFORMATION: CONTENTS*
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.
The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response.
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)].
Because of its potential anticholinergic action, meclizine hydrochloride tablets should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.
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.
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)].
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 and any potential adverse effects on the breastfed infant from meclizine or from the underlying maternal condition.
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.
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 meclizine. Treatment with meclizine hydrochloride tablets should be administered with caution in patients with hepatic 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.
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, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula:
Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.
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.
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 5-6 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.
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.
Meclizine Hydrochloride Tablets, USP are available as follows:
12.5 mg, blue, modified oval-shaped tablets, de-bossed with “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 with “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
16.2 Storage and Handling
Store at 20o C to 25o C (68o F to 77o F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container (USP).
Advise patients that the tablets must be swallowed whole [see DOSAGE AND ADMINISTRATION (2.1)].
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 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)].
Epic Pharma, LLC
Laurelton, NY 11413
meclizine hydrochloride tablet
meclizine hydrochloride tablet
|Labeler - Epic Pharma LLC (827915443)|
|Registrant - Epic Pharm LLC (827915443)|
|Epic Pharma LLC||827915443||MANUFACTURE(42806-012, 42806-014)|