HYDROXYZINE HYDROCHLORIDE tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

HYDROXYZINE HYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)

Доступна с:

Contract Pharmacy Services-PA

ИНН (Международная Имя):

HYDROXYZINE HYDROCHLORIDE

состав:

HYDROXYZINE HYDROCHLORIDE 50 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 are available as follows: 50 mg tablets: round, film coated white tablets. Debossed H over 502 on one side and plain on the reverse side. They are available as follows: NDC 67046-279-07 blisterpacks of 7 NDC 67046-279-14 blisterpacks of 14 NDC 67046-279-15 blisterpacks of 15 NDC 67046-279-20 blisterpacks of 20 NDC 67046-279-21 blisterpacks of 21 NDC 67046-279-28 blisterpacks of 28 NDC 67046-279-30 blisterpacks of 30 NDC 67046-279-60 blisterpacks of 60 Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) 51U000000193US06 Revised: 10/2016

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET
CONTRACT PHARMACY SERVICES-PA
----------
279 HYDROXYZINE 50 MG
RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride, USP has the chemical name of (±)-2-[2-[4-(
_p_-Chloro-α-phenylbenzyl)-1-
piperazinyl]ethoxy]ethanol dihydrochloride.
Molecular Formula: C
H
ClN
O
· 2HCl Molecular Weight: 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 anhydrous lactose, colloidal silicon
dioxide, crospovidone, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
polysorbate and titanium dioxide.
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.
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 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