HYDROXYZINE HYDROCHLORIDE tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Dispensing Solutions, Inc.

INN (الاسم الدولي):

HYDROXYZINE HYDROCHLORIDE

تركيب:

HYDROXYZINE HYDROCHLORIDE 25 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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. Hydroxyzine, when administered

ملخص المنتج:

Hydroxyzine Hydrochloride Tablets, USP are available as: 10 mg – orange, round tablets debossed "3615" on one side and debossed "V" on the reverse side. Supplied in bottles of: 25 mg – green, round tablets debossed "3616" on one side and debossed "V" on the reverse side. Supplied in bottles of: 50 mg – light orange, round tablets debossed "3617" on one side and debossed "V" on the reverse side. Supplied in bottles of:

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
DISPENSING SOLUTIONS, INC.
----------
HYDROXYZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride has the chemical name of
2-[2-[4-(_p_-Chloro-α-phenylbenzyl)-1-
piperazinyl]ethoxy]ethanol dihydrochloride.
Hydroxyzine hydrochloride 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 HCl. Inactive
ingredients include colloidal silicon dioxide, dibasic calcium
phosphate, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, povidone, sodium
starch glycolate, and titanium dioxide.
The 10 mg tablet also contains FD&C Red #40 Aluminum Lake and FD&C
Yellow #6 Aluminum Lake.
The 25 mg tablet also contains D&C Yellow #10 Aluminum Lake and FD&C
Blue #1 Aluminum Lake.
The 50 mg tablet also contains FD&C Red #40 Aluminum Lake and FD&C
Yellow #5 Aluminum Lake.
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 associate