MECLIZINE HYDROCHLORIDE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

NuCare Pharmaceuticals, Inc.

ІПН (Міжнародна Ім'я):

MECLIZINE HYDROCHLORIDE

Склад:

MECLIZINE HYDROCHLORIDE 25 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications as follows: Effective: Management of nausea and vomiting, and dizziness associated with motion sickness. Final classification of the less than effective indications requires further investigation. Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

Огляд продуктів:

Meclizine Hydrochloride Tablets USP are available as: 25 mg, white, modified oval-shaped tablets, de-bossed “ Є14 ” on one side and plain on the other side. They are supplied as follows: NDC 66267-801-04 in bottles of 4 NDC 66267-801-06 in bottles of 6 Store at 20º to 25ºC (68 to 77ºF) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Revised January 2016 MF012REV01/16 OE1035

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
MECLIZINE HYDROCHLORIDE TABLETS USP, 12.5 MG AND 25 MG
RX ONLY
DESCRIPTION
Chemically, meclizine hydrochloride is 1-(
_p_-chloro-α-phenylbenzyl)-4-( _m_-methylbenzyl) piperazine
dihydrochloride monohydrate.
C
H
CIN
·2HCl·H
0 M.W. 481.89
Meclizine hydrochloride tablets, USP are available in two different
strengths, 12.5 mg and 25 mg.
Inactive ingredients: microcrystalline cellulose, lactose monohydrate,
croscarmellose sodium and
magnesium stearate. The 12.5 mg tablet also contains FD&C Blue #1
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 using human
25
27
2
2
max
hepatic microsome and recombinant CYP enzyme, CYP 2D6 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 5-6 hours in
humans.
INDICATIONS
Based on a