Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Meclizine Hydrochloride Tablets, USP are available as follows: 12.5 mg, blue, modified oval-shaped tablets, de-bossed with “Є12” on one side, and plain on the other side. They are supplied as follows: NDC 42806-012-01 in bottles of 100 NDC 42806-012-10 in bottles of 1000 25 mg, white, modified oval-shaped tablets, de-bossed with “Є14” on one side, and plain on the other side. They are supplied as follows: NDC 42806-014-01 in bottles of 100 NDC 42806-014-10 in bottles of 1000 16.2 Storage and Handling Store at 20 o C to 25 o C (68 o F to 77 o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Meclizine Hydrochloride Tablets, USP 12.5 mg 100 Tablets 12.5 mg 100ct; Package/Label Display Panel Meclizine Hydrochloride Tablets, USP 25 mg 100 Tablets 25 mg 100ct
- 16 HOW SUPPLIED/STORAGE AND HANDLING Meclizine Hydrochloride Tablets, USP are available as follows: 12.5 mg, blue, modified oval-shaped tablets, de-bossed with “Є12” on one side, and plain on the other side. They are supplied as follows: NDC 42806-012-01 in bottles of 100 NDC 42806-012-10 in bottles of 1000 25 mg, white, modified oval-shaped tablets, de-bossed with “Є14” on one side, and plain on the other side. They are supplied as follows: NDC 42806-014-01 in bottles of 100 NDC 42806-014-10 in bottles of 1000 16.2 Storage and Handling Store at 20 o C to 25 o C (68 o F to 77 o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Meclizine Hydrochloride Tablets, USP 12.5 mg 100 Tablets 12.5 mg 100ct
- Package/Label Display Panel Meclizine Hydrochloride Tablets, USP 25 mg 100 Tablets 25 mg 100ct
Overview
Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula: Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg. Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate. The 12.5 mg tablet also contains FD&C Blue #1 Aluminum Lake. structure
Indications & Usage
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).
Dosage & Administration
• Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ). • Tablets: Swallow whole ( 2.2 ).
Warnings & Precautions
• 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 ).
Contraindications
Meclizine hydrochloride tablets 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 are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients ( 4 ).
Adverse Reactions
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 Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
• 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 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 Inhibitors Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore, there is a possibility for a drug interaction between meclizine and CYP2D6 inhibitors. Therefore, monitor for adverse reactions and clinical effect accordingly
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