FDA Label for Meclizine Hydrochloride

Description

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

     C₂₅H₂₇ClN₂• 2HCl•H₂O                                        Molecular Weight 481.88

Meclizine hydrochloride 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 hydrochloride tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine hydrochloride tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%).

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.

Indications And Usage

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

Contraindications

Meclizine hydrochloride tablets are 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.

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 Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage And Administration

For the treatment of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 to 100 mg daily, in divided dosage, depending upon clinical response.

How Supplied

Meclizine hydrochloride tablets, USP are available in the following strengths:

12.5 mg (Blue, oval shaped tablets, debossed with “TL 122” with score on one side and plain on the other side.)

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

They are supplied by DOH CENTRAL PHARMACY as follows:

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

Manufactured By:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA

This Product was Repackaged By:

DOH CENTRAL PHARMACY
104 HAMILTON PARK DR # 2
TALLAHASSEE, FL 32304
USA

Package Label

Label Image for 53808-1116
25mg