DESCRIPTION

Chemically, meclizine hydrochloride is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate.

Inactive ingredients include: 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 tablet also contains D&C Yellow #10.

CLINICAL PHARMACOLOGY

Meclizine hydrochloride is an antihistamine which 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.

INDICATIONS AND USAGE

Management of nausea and vomiting, and dizziness associated with motion sickness.

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 the 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 under 12 years of age.

Pregnancy Use

Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine hydrochloride increases the risk of abnormalities when administered during pregnancy. however, do not indicate that meclizine increases the risk of abnormalities when administered during preganancy. 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.

ADVERSE REACTIONS

Drowsiness, dry mouth, and on rare occasions, blurred vision have been reported.

DOSAGE AND ADMINISTRATION

Motion Sickness

The initial dose of 25 to 50 mg Meclizine Hydrochloride Tablets should be taken one hour prior to travel for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

HOW SUPPLIED:

Meclizine Hydrochloride Tablets, USP 12.5 mg are light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. Tablets may contain characteristic dye spots. They are available as follows:

Unit dose packages of 100 (10 x 10) NDC 68084-490-01.

Meclizine Hydrochloride Tablets, USP 25 mg are light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. Tablets may contain characteristic dye spots. They are available as follows:

Unit dose packages of 100 (10 x 10) NDC 68084-491-01.

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788

Distributed by:
Amneal Pharmaceuticals

Glasgow, KY 42141

Repackaged by:

American Health Packaging

Columbus, OH 43217

8249001/1210

Principal Display Panel - 12.5 mg

Principal Display Panel - 25 mg