MECLIZINE HYDROCHLORIDE- meclizine hydrocloride tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

PD-Rx Pharmaceuticals, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data H

Produkt oversigt:

25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.) Bottles of 10 NDC 43063-899-10 Bottles of 15 NDC 43063-899-15 Bottles of 30 NDC 43063-899-30 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] . Dispense in a tight, light-resistant container (USP).

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCLORIDE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
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
RX ONLY
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).
DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg, and 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 JUBILANT CADISTA
PHARMACEUTICALS INC.
AT 1-800313-4623 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).
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Instruc