MECLIZINE HYDROCHLORIDE- meclizine hydrocloride tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

DOH CENTRAL PHARMACY

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system. Meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

Обзор продуктов:

Meclizine hydrochloride tablets, USP are available in the following strengths: 12.5 mg (Blue, oval shaped tablets, debossed with “TL 122” with score on one side and plain on the other side.) 25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.) They are supplied by DOH CENTRAL PHARMACY as follows: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA This Product was Repackaged By: DOH CENTRAL PHARMACY 104 HAMILTON PARK DR # 2 TALLAHASSEE, FL 32304 USA

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

MECLIZINE HYDROCHLORIDE - MECLIZINE HYDROCLORIDE TABLET
DOH CENTRAL PHARMACY
----------
MECLIZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Chemically, Meclizine HCl is
1-(_p_-chloro-α-phenylbenzyl)-4-(_m_-methylbenzyl) piperazine
dihydrochloride monohydrate.
C
H ClN • 2HCl•H O Molecular Weight 481.88
Meclizine hydrochloride tablets, USP are available in two different
strengths: 12.5 mg and 25 mg. In
addition each tablet contains the following inactive ingredients:
Colloidal Silicon Dioxide,
Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate,
Microcrystalline Cellulose. Also,
Meclizine hydrochloride tablets USP, 12.5 mg contains FD&C Blue #1
Aluminum Lake (11-13%) and
Meclizine hydrochloride tablets USP, 25 mg contains D&C Yellow #10
Aluminum Lake (15-20%).
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 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 ultra-rapid
25
27
2
2
max
metabolizer phenotypes could contribute