HYDROXYZINE HYDROCHLORIDE tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

Hydroxyzine Dihydrochloride (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)

Доступна с:

Major Pharmaceuticals

ИНН (Международная Имя):

HYDROXYZINE HYDROCHLORIDE

состав:

HYDROXYZINE HYDROCHLORIDE 25 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient. Oral hydroxyzine h

Обзор продуктов:

Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as 10/32", Green round biconvex film-coated tablets debossed “Є” above “160” on one side and plain on the other side, Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6617-61 Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as 11/32", Yellow round biconvex film-coated tablets, debossed “Є” above “161” on one side and plain on the other side, Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6618-61 . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Distributed By: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Refer to package label for Distributor's NDC Number Revised October 2016 MF159REV10/16 OE1518

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
MAJOR PHARMACEUTICALS
----------
HYDROXYZINE HYDROCHLORIDE TABLETS USP, FILM-COATED
RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(
_p_-Chloro-α-
phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride.
C
H
CIN O ·2HCl
M.W. 447.83
Hydroxyzine hydrochloride, USP occurs as a white, odorless powder
which is very
soluble in water.
Each tablet for oral administration contains 10 mg, 25 mg or 50 mg
hydroxyzine
hydrochloride, USP. Inactive ingredients include carnauba wax,
colloidal silicon dioxide,
crospovidone, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
D&C Yellow #10 Aluminum Lake (25 mg and 50 mg), FD&C Blue #2 Aluminum
Lake (25
mg), FD&C Red #40 Aluminum Lake (50 mg), FD&C Yellow #6 Aluminum Lake
(10 mg
and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl alcohol,
talc, titanium
dioxide, triacetin and yellow iron oxide (10 mg).
CLINICAL PHARMACOLOGY
Hydroxyzine hydrochloride is unrelated chemically to the
phenothiazines, reserpine,
meprobamate or the benzodiazepines. Hydroxyzine is not a cortical
depressant, but its
action may be due to a suppression of activity in certain key regions
of the subcortical
area of the central nervous system.
21
27
2
2
Primary skeletal muscle relaxation has been demonstrated
experimentally.
Bronchodilator activity, and antihistaminic and analgesic effects have
been
demonstrated experimentally and confirmed clinically. An antiemetic
effect, both by the
apomorphine test and the veriloid test, has been demonstrated.
Pharmacological and clinical studies indicate that hydroxyzine in
therapeutic dosage
does not increase gastric secretion or acidity and in most cases has
mild antisecretory
activity.
Hydroxyzine is rapidly absorbed from the gastrointestinal tract and
hydroxyzine’s
clinical effects are usually noted within 15 to 30 minutes after oral
administration.
INDICATIONS AND USAGE
For symptomatic relief of anxiety and tension associated