MECLIZINE HYDROCHLORIDE tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

DIRECT RX

ИНН (Международная Имя):

MECLIZINE HYDROCHLORIDE

состав:

MECLIZINE HYDROCHLORIDE 25 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

Meclizine HCI Tablets, USP are available in the following strengths and package sizes: 12.5 mg (Blue, oval-shaped, scored, debossed with TL122) Bottles of 100           NDC 59746-122-06 Bottles of 1000         NDC 59746-122-10 25 mg (Yellow, oval-shaped, scored, debossed with TL121) Bottles of 100            NDC 59746-121-06 Bottles of 1000          NDC 59746-121-10 Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 03/11

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
DIRECT RX
----------
MECLIZINE HYDROCHLORIDE
DESCRIPTION SECTION
Chemically, Meclizine HCl is
1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine
dihydrochloride monohydrate.
Meclizine HCI 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 HCI Tablets USP, 12.5 mg contains FD&C Blue
#1 Aluminum
Lake (11-13%) and Meclizine HCI Tablets USP, 25 mg contains D&C Yellow
#10
Aluminum Lake (15-20%).
CLINICAL PHARMACOLOGY SECTION
Meclizine Hydrochloride is an antihistamine which 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.
INDICATIONS & USAGE SECTION
Meclizine Hydrochloride is contraindicated in individuals who have
shown a previous
hypersensitivity to it
CONTRAINDICATIONS SECTION
Meclizine Hydrochloride is contraindicated in individuals who have
shown a previous
hypersensitivity to it
WARNINGS SECTION
Since drowsiness may, on occasion, occur with use of this drug,
patients should be
warned of this possibility and cautioned against driving a car or
operating dangerous
machinery.
Patients should avoid alcoholic beverages while taking this drug.
Due to its potential anticholinergic action, this drug should be used
with caution in
patients with asthma, glaucoma or enlargement of the prostate gland.
PRECAUTIONS SECTION
PREGNANCY, Teratogenic Effects
Pregnancy Category B. Reproduction studies in rats have shown cleft
palates at 25-50
times the human dose. Epidemiological studies in pregnant women,
however, do not
indic