HYDROXYZINE HYDROCHLORIDE injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

American Regent, Inc.

INN (International namn):

HYDROXYZINE HYDROCHLORIDE

Sammansättning:

HYDROXYZINE HYDROCHLORIDE 25 mg in 1 mL

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy. Hydroxyzine has been found to be particularly useful for this latter phase of therapy in its ability to render the disturbed patient more amenable to psychotherapy in long term treatment of the psychoneurotic and psychotic, although it should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression. Hydroxyzine is also useful in alleviating the manifestations of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. It has also been recommended for the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma, chronic urticaria, and pruritus. Hydroxyzine hydrochloride intramuscular solution is useful in treating the following types of pati

Produktsammanfattning:

Storage Condition: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Protect from light. Discard unused portion of the single dose vial. AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN4201 Rev. 10/16

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE INJECTION,
SOLUTION
AMERICAN REGENT, INC.
----------
HYDROXYZINE HYDROCHLORIDE INJECTION, USP
(FOR INTRAMUSCULAR USE ONLY)
RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride has the chemical name of
(±)-2-[2-[4-(_p_-Chloro-α-phenylbenzyl)-1-
piperazinyl]ethoxy]ethanol dihydrochloride and occurs as a white,
odorless powder which is very
soluble in water.
It has the following structural formula:
Hydroxyzine Hydrochloride Injection, USP is a sterile aqueous solution
intended for intramuscular
administration.
Each mL contains: Hydroxyzine HCl 25 mg or 50 mg, Benzyl Alcohol 0.9%,
and Water for Injection
q.s. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid.
CLINICAL PHARMACOLOGY
Hydroxyzine hydrochloride is unrelated chemically to phenothiazine,
reserpine, and meprobamate.
Hydroxyzine has demonstrated its clinical effectiveness in the
chemotherapeutic aspect of the total
management of neuroses and emotional disturbances manifested by
anxiety, tension, agitation,
apprehension or confusion.
Hydroxyzine has been shown clinically to be a rapid-acting true
ataraxic with a wide margin of safety. It
induces a calming effect in anxious, tense, psychoneurotic adults and
also in anxious, hyperkinetic
children without impairing mental alertness. It 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.
Hydroxyzine has been shown experimentally to have antispasmodic
properties, apparently mediated
through interference with the mechanism that responds to spasmogenic
agents such as serotonin,
acetylcholine, and histamine.
Antihistaminic 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