Meclizine: uses, appearance and warnings

Meclizine hydrochloride tablets, USP are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets, USP are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults (1).

Tablets 50 mg: Pink mottled, oval shaped, biconvex tablets, debossed with ‘943’ on one side and plain on the other side. Tablets: 50 mg (3).

16.1 How Supplied Tablets Meclizine Hydrochloride Tablets, USP, 50 mg : Pink mottled, oval shaped, biconvex tablets, debossed with ‘943’ on one side and plain on the other side. Bottles of 100 NDC 23155-943-01 Bottles of 1,000 NDC 23155-943-10 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

Meclizine hydrochloride tablets, USP are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions (6) and Description (11)]. Meclizine hydrochloride tablets, USP are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients (4).

May cause drowsiness: Use caution when driving a car or operating dangerous machinery (5.1). Potential anticholinergic action: this drug should be prescribed with care to patients with a history of asthma, glaucoma, or enlargement of the prostate gland (5.2). 5.1 Drowsiness Since drowsiness may occur with use of meclizine hydrochloride tablets, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking meclizine hydrochloride tablets [see Drug Interactions (7.1)]. 5.2 Concurrent Medical Conditions Because of its potential anticholinergic action, meclizine hydrochloride tablets should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

The following adverse reactions associated with the use of meclizine hydrochloride tablets were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported. Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported (6). To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Coadministration of meclizine hydrochloride tablets with other CNS depressants, including alcohol, may result in increased CNS depression (7.1). CYP2D6 inhibitors: As meclizine is metabolized by CYP2D6, there is a potential for drug-drug interactions between meclizine hydrochloride tablets and CYP2D6 inhibitors (7.2). 7.1 CNS Depressants There may be increased CNS depression when meclizine hydrochloride tablets are administered concurrently with other CNS depressants, including alcohol [see Warnings and Precautions (5.1)]. 7.2 CYP2D6 Inhibitor Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore, there is a possibility for a drug interaction between meclizine hydrochloride tablets and CYP2D6 inhibitors. Therefore, monitor for adverse reactions and clinical effect accordingly.