FDA Label for Meclizine Hydrochloride

Description

Chemically, Meclizine HCl is 1-( p-chloro-α-phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate.

Structure of Meclizine HCl - structuremeclizinehcl

                          C ₂₅H ₂₇ClN ₂. 2HCl . H ₂O                                                                                        M .W . 481 .88

Meclizine HCI Tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose. Also, Meclizine HCI Tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine HCI Tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%).

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

For the 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 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.

Precautions

PREGNANCY, Teratogenic Effects
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 medicine 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. 

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.

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 of Meclizine HCI 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 HCI Tablets, USP are available in the following strengths and package sizes:

25 mg (Yellow, oval shaped tablets, debossed with "TL 121" with score on one side and plain on the other side.)

Bottles of 10            NDC 43063-899-10
Bottles of 15          NDC 43063-899-15
Bottles of 30 NDC 43063-899-30

Store at 20 to 25°C (68 to 77°F) (See USP Controlled Room Temperature].

Principal Display Panel

Meclizine Hydrochloride Tablets, USP 25 mg

Rx Only

Each tablet Contains 25 mg of meclizine HCl

DOSAGE AND USE

See accompanying prescribing information

MOTION SICKNESS: 25 mg to 50 mg daily.

Dispense in tight, light-resistant containers (USP).

Store at 20-25°C (68-77°F)

[See USP Controlled Room Temperature].

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