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:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride is 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 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Human Data Epidemiological studies

Product summary:

Tablets Meclizine hydrochloride 25 mg tablets are oval shaped, biconvex, two-layered tablet, one yellow to pale yellow layer debossed with “49” and one white to off white layer debossed with “L”. Bottles of 10                   NDC 71205-786-10 Bottles of 20                   NDC 71205-786-20 Bottles of 30                   NDC 71205-786-30 Bottles of 60                   NDC 71205-786-60 Bottles of 90                   NDC 71205-786-90 Store at 20o C to 25o C (68o F to 77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MECLIZINE
HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR MECLIZINE
HYDROCHLORIDE.
MECLIZINE HYDROCHLORIDE TABLETS, FOR ORAL USE
MECLIZINE HYDROCHLORIDE CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1957
INDICATIONS AND USAGE
Meclizine hydrochloride is 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 is 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 RISING PHARMACEUTICALS, INC. AT
1-866-562-4597
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Instructions
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).
Tablets: 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 with other CNS
depressants, including alcohol, may result
in increased CNS depression (7.1).
CYP2D6 inhibitors: As meclizine is metabolized by