HYDROXYZINE HYDROCHLORIDE tablet, film coated HYDROXYZINE HYDROCHLORIDE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

KVK-Tech, Inc.

INN (nemzetközi neve):

HYDROXYZINE HYDROCHLORIDE

Összetétel:

HYDROXYZINE HYDROCHLORIDE 10 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

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 Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). 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 Drive Newtown, PA 18940 Item ID # 6015/12   11/2018 Manufacturer’s Code: 10702

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
KVK-TECH, 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
hydrochloride. Inactive ingredients include colloidal silicon dioxide,
crospovidone,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol/macrogol and titanium dioxide.
This product complies with USP dissolution test 2.
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 pruritus.
As