MECLIZINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)

Available from:

ANI Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. 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)] . Risk Summary Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data Epidemi

Product summary:

Meclizine Hydrochloride Tablets USP 12.5 mg are blue and light blue double layered, oval tablets, debossed “ANI” on the blue side and “841” on the light blue side. Bottles of 100           NDC 62559-841-01 Bottles of 1000         NDC 62559-841-10 Meclizine Hydrochloride Tablets USP 25 mg are yellow and light yellow double layered, oval tablets, debossed “ANI” on the yellow side and “842” on the light yellow side. Bottles of 100           NDC 62559-842-01 Bottles of 1000         NDC 62559-842-10 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
ANI PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MECLIZINE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MECLIZINE HYDROCHLORIDE TABLETS.
MECLIZINE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1957
INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment of
vertigo associated with diseases
affecting the vestibular system in adults (1).
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Meclizine hydrochloride tablets are contraindicated in patients with
hypersensitivity to meclizine or any of
the inactive ingredients (4).
WARNINGS AND PRECAUTIONS
•
•
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 ANI PHARMACEUTICALS,
INC. AT 1-800-308-
6755 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
Recommended dosage: 25 mg to 100 mg daily, in divided doses (2.1).
Tablets: Swallow whole (2.2).
Tablets: 12.5 mg and 25 mg (3).
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).
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 be