Meclizine Hydrochloride

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 AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CONTRAINDICATIONS Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

DESCRIPTION Chemically, meclizinehydrochloride, USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. 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. Image1

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.

INDICATIONS AND USAGE Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system.

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.

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.

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Meclizine Hydrochloride Meclizine SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC FD&C BLUE NO. 1 MECLIZINE HYDROCHLORIDE MECLIZINE Light AN;441 Meclizine Hydrochloride Meclizine Hydrochloride SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC D&C YELLOW NO. 10 MECLIZINE HYDROCHLORIDE MECLIZINE Light AN;442

ANDA201451

Meclizine Hydrochloride

Meclizine Hydrochloride

50268-523

HUMAN PRESCRIPTION DRUG

ORAL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5mg 25mg

Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 04-2018-01 AV Rev. 12/18 (P) AvPAK

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: 10 Tablets per card, 5 cards per carton: NDC 50268-522-15 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: 10 Tablets per card, 5 cards per carton: NDC 50268-523-15 Meclizine Hydrochloride Tablets, USP 50 mg, are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side. 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]. Dispensed in Unit Dose package. For Institutional Use Only. Rx only Keep out of reach of children

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.