Clinical Information
Gen. Code and Des.
4734 meclizine HCl ORAL TABLET 50 MG
GCN and Des.
18303 meclizine HCl ORAL TABLET 50 MG
Strength
50MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
56220800 ANTIHISTAMINES (GI DRUGS)
4041600 PIPERAZINE DERIVATIVES
Active Ingredients
3400 meclizine HCl 31884772
Inactive Ingredients
10138 blue dye
10143 yellow dye
2598 sucrose 57501
These highlights do not include all the information needed to use ANTIVERT® safely and effectively. See full prescribing information for ANTIVERT®.
ANTIVERT® (meclizine HCl) tablets, for oral use
ANTIVERT® (meclizine HCl) chewable tablets, for oral use
Initial U.S. Approval: 1957
INDICATIONS AND USAGE
ANTIVERT® is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults (1).
DOSAGE AND ADMINISTRATION
• Recommended dosage: 25 mg to 100 mg daily, in divided doses (2.1).
• Tablets: Swallow whole (2.2).
• Chewable Tablets: Must be chewed or crushed before swallowing; do not swallow whole (2.2).
DOSAGE FORMS AND STRENGTHS
• Tablets: 12.5 mg, 25 mg, and 50 mg (3).
• Chewable Tablets: 25 mg (3).
CONTRAINDICATIONS
ANTIVERT® is contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients (4).
WARNINGS AND 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).
ADVERSE REACTIONS
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 Casper Pharma LLC at 1-844�"5�"CASPER (1-844-522-7737) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
• Coadministration of ANTIVERT® 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 ANTIVERT® and CYP2D6 inhibitors (7.2).
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 10/2022
