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:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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. Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

পণ্য সারাংশ:

Meclizine Hydrochloride Tablets, USP 12.5 mg, are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. They are available as follows: Bottles of 30:               NDC 65162-441-03 Bottles of 100:             NDC 65162-441-10 Bottles of 500:             NDC 65162-441-50 Bottles of 1000:           NDC 65162-441-11 Blister packs:               NDC 65162-441-60 (Packages of 100 unit doses, 10 cards of 10 tablets each) Meclizine Hydrochloride Tablets, USP 25 mg, are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. They are available as follows: Bottles of 30:               NDC 65162-442-03 Bottles of 100:             NDC 65162-442-10 Bottles of 500:             NDC 65162-442-50 Bottles of 1000:           NDC 65162-442-11 Blister packs:               NDC 65162-442-60 (Packages of 100 unit doses, 10 cards of 10 tablets each) Meclizine Hydrochloride Tablets, USP 50 mg, are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side. They are available as follows: Bottles of 30:               NDC 65162-444-03 Bottles of 100:             NDC 65162-444-10 Bottles of 500:             NDC 65162-444-50 Bottles of 1000:           NDC 65162-444-11 Blister packs:               NDC 65162-444-60 (Packages of 100 unit doses, 10 cards of 10 tablets each) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Rx only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 04-2018-01

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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MECLIZINE HYDROCHLORIDE TABLETS, USP
DESCRIPTION
Chemically, meclizine hydrochloride, USP is 1-(
_p_-chloro-α-phenylbenzyl)-4-( _m_-
methylbenzyl) piperazine dihydrochloride monohydrate.
Inactive ingredients for the tablets are: colloidal silicon dioxide,
lactose monohydrate,
magnesium stearate, microcrystalline cellulose, sodium starch
glycolate and talc. The
12.5 mg tablets also contain FD&C Blue #1 Aluminum Lake. The 25 mg
tablets also
contain D&C Yellow #10 Aluminum Lake.
CLINICAL PHARMACOLOGY
Meclizine hydrochloride is an antihistamine that shows marked
protective activity against
nebulized histamine and lethal doses of intravenously injected
histamine in guinea pigs. It
has a marked effect in blocking the vasodepressor response to
histamine, but only a
slight blocking action against acetylcholine. Its activity is
relatively weak in inhibiting the
spasmogenic action of histamine on isolated guinea pig ileum.
PHARMACOKINETICS
The available pharmacokinetic information for meclizine following oral
administration has
been summarized from published literature.
ABSORPTION
Meclizine is absorbed after oral administration with maximum plasma
concentrations
reaching at a median T
value of 3 hours post-dose (range: 1.5 to 6 hours) for the
tablet dosage form.
DISTRIBUTION
Drug distribution characteristics for meclizine in humans are unknown.
METABOLISM
The metabolic fate of meclizine in humans is unknown. In an _in vitro_
metabolic study
max
using human hepatic microsome and recombinant CYP enzyme, CYP2D6 was
found to
be the dominant enzyme for metabolism of meclizine.
The genetic polymorphism of CYP2D6 that results in extensive-, poor-,
intermediate- and
ultrarapid metabolizer phenotypes could contribute to large
inter-individual variability in
meclizine exposure.
ELIMINATION
Meclizine has a plasma elimination half-life of about 5 to 6 hours in
humans.
INDICATIONS AND USAGE
Meclizine hydrochloride table