HYDROXYZINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

Hydroxyzine Hydrochloride

Composition:

Hydroxyzine Hydrochloride 50 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 pa

Product summary:

Storage Condition: Store at 20° to 25°C (68° to 7JOF); 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 MG #7842

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE- HYDROXYZINE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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HYDROXYZINE HCL 50 MG/ML INJECTION, USP 1ML SINGLE DOSE VIAL
DESCRIPTION
Hydroxyzine hydrochloride has the chemical name of
(±)-2-[2-[4-(p-Chloro-a­
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:
Molecular Formula: C21H27CIN202•2HCI Molecular Weight:
447.83
Hydroxyzine Hydrochloride Injection, USP is a sterile aqueous solution
intended for
intramuscular administration.
Each mL contains: Hydroxyzine HCI 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