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:

Quality Care Products, LLC

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 12.5 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “34” and one white to off white layer debossed with “L”. 55700-919-30 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”. Meclizine hydrochloride 50 mg tablets are oval shaped, biconvex, two-layered tablet, one blue to pale blue layer debossed with “50” and one yellow to pale yellow layer and debossed with “L”. Chewable Tablets Meclizine hydrochloride 25 mg chewable tablets are pink colored round tablets debossed with “M 25” on one side and break line on other side. 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
QUALITY CARE PRODUCTS, LLC
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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
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
Meclizine hydrochloride 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 RISING PHARMACEUTICALS,
INC. AT 1-866-
562-4597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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 CYP2D6, there is a
potential for drug-drug
interactions between meclizine hydrochloride and CYP2D6 inhibitors
(7.2).
REVISED: 9/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 I