Meclizine

DESCRIPTION

Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless.

The chemical name is 1-(r-chloro-alpha-phenylben-zyl)-4-(m-methyl-benzyl)-piperazine dihydrochloride monohydrate.

Meclizine Hydrochloride Tablets are multiple-layered tablets (MLT) available in 12.5 mg, 25 mg*, and 50 mg* strengths for oral administration.

*Contains FD&C Yellow #5 (See PRECAUTIONS).

Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, stearic acid and other ingredients. In addition, the 12.5 mg tablet contains FD&C Blue #1; the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5; and the 50 mg tablet contains D&C Yellow #10 FD&C Blue #1 and FD&C Yellow #5.

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

For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

DOSAGE AND ADMINISTRATION

Motion Sickness: The initial dose of 25 to 50 mg meclizine hydrochloride, 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 12.5 mg - debossed with "Par 034'', oval shape, blue/white multiple-layered tablet (MLT), and are supplied in bottles of 100 (NDC 49884-034-01) and 1000 (NDC 49884-034-10).

Meclizine Hydrochloride Tablets 25 mg - debossed with ''Par 035'', pumpkin seed shape, yellow/white multiple-layered tablet (MLT), and are supplied in bottles of 100 (NDC 49884-035-01) and 1000 (NDC 49884-035-10).

Meclizine Hydrochloride Tablets 50 mg - debossed with ''Par 015'', oval shape, scored, yellow/blue multiple-layered tablet (MLT), and are supplied in bottles of 100 ( NDC 49884-015-01) and 500 (NDC 49884-015-05).

Dispense in tight, light-resistant containers as defined in the USP.

Store at controlled room temperature 15°-30°C (59°-86° F).

CAUTION: Federal law prohibits dispensing without prescription.

SIDE EFFECTS

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

DRUG INTERACTIONS

No information provided.

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. Do not give to children under 12 years of age unless directed by a doctor.

PRECAUTIONS

The Meclizine Hydrochloride Tablets, 25 mg and 50 mg contain FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow #5 (tartrazine) sensitivity in the general population is low it is frequently seen in patients who also have aspirin hypersensitivity.

Usage In Children

Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended under 12 years of age.

Usage In Pregnancy

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. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine hydrochloride, or any other medication should be used during pregnancy only if clearly necessary.