HYDROXYZINE HYDROCHLORIDE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Life Line Home Care Services, Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 histaminemediated pruritus. As a sedative when used as 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 to

Tuoteyhteenveto:

Hydroxyzine Hydrochloride Tablets, USP are available as follows: Hydroxyzine hydrochloride tablets, USP 10 mg are supplied as white, round, film coated, biconvex tablets debossed “K10” on one side and plain on the other side. Bottle of 100, NDC 10702-010-01 Bottle of 500, NDC 10702-010-50 Bottle of 1000, NDC 10702-010-10 Hydroxyzine hydrochloride tablets, USP 25 mg are supplied as white, round, film coated, biconvex tablets debossed “K11” on one side and plain on the other side. Bottle of 100, NDC 10702-011-01 Bottle of 500, NDC 10702-011-50 Bottle of 1000, NDC 10702-011-10 Hydroxyzine hydrochloride tablets, USP 50 mg are supplied as white, round, film coated, biconvex tablets debossed “K12” on one side and plain on the other side. Bottle of 100, NDC 10702-012-01 Bottle of 500, NDC 10702-012-50 Bottle of 1000, NDC 10702-012-10 Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by: KVK-TECH, INC. 110 Terry Dr. Suite 200 Newtown, PA 18940

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

HYDROXYZINE HYDROCHLORIDE - HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
LIFE LINE HOME CARE SERVICES, INC.
----------
HYDROXYZINE HYDROCHLORIDE TABLETS, USP
8225301/0610
RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride is designated chemically as
(±)-2-[2-[4-(_p_- Chloro-α-phenylbenzyl)-1-
piperazinyl]ethoxy]ethanol dihydrochloride.
M.W. 447.83
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 hydrochloride. Inactive
ingredients include carnauba wax_, _colloidal silicon dioxide,
crospovidone, lactose monohydrate,
macrogol/polyethylene glycol 3350, magnesium stearate,
microcrystalline cellulose, polyvinyl alcohol
- part. hydrolyzed, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
Hydroxyzine hydrochloride is unrelated chemically to the
phenothiazines, reserpine, meprobamate, or
the benzodiazepines. Hydroxyzine hydrochloride 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 hydrochloride’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 urti