MECLIZINE HYDROCHLORIDE tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Epic Pharma LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 Epidemiological

পণ্য সারাংশ:

Meclizine Hydrochloride Tablets, USP are available as follows: 12.5 mg, blue, modified oval-shaped tablets, de-bossed with “Є12” on one side, and plain on the other side. They are supplied as follows: NDC 42806-012-01 in bottles of 100 NDC 42806-012-10 in bottles of 1000 25 mg, white, modified oval-shaped tablets, de-bossed with “Є14” on one side, and plain on the other side. They are supplied as follows: NDC 42806-014-01 in bottles of 100 NDC 42806-014-10 in bottles of 1000 16.2 Storage and Handling 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).

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
EPIC PHARMA LLC
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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 EPIC PHARMA, LLC AT
1-888-374-2791 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2.1 RECOMMENDED DOSAGE
2.2 ADMINISTRATION INSTRUCTIONS
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5.1 DROWSINESS
5.2 CONCURRENT MEDICAL CONDITIONS
6 ADVERSE REACTIONS
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