MECLIZINE HYDROCHLORIDE tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

A-S Medication Solutions

INN (Isem Internazzjonali):

MECLIZINE HYDROCHLORIDE

Kompożizzjoni:

MECLIZINE HYDROCHLORIDE 25 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 Epidemiologic

Sommarju tal-prodott:

Product: 50090-0107 NDC: 50090-0107-2 12 TABLET in a BOTTLE

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
A-S MEDICATION SOLUTIONS
----------
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
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, 25 mg, and 50 mg (3).
CONTRAINDICATIONS
Meclizine hydrochloride tablets are 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 AMNEAL PHARMACEUTICALS
AT 1-877-835-5472 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Co-administration 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: 1/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Instructions
3