HYDROXYZINE HYDROCHLORIDE syrup

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Hydroxyzine Hydrochloride (UNII: 76755771U3) (Hydroxyzine - UNII:30S50YM8OG)

Dostopno od:

Pharmaceutical Associates, Inc.

INN (mednarodno ime):

Hydroxyzine Hydrochloride

Sestava:

Hydroxyzine Hydrochloride 10 mg in 5 mL

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 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 hydrochloride i

Povzetek izdelek:

Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in the following oral dosage forms: NDC 0121-4822-12 (unit dose cups of 12.5 mL) and NDC 0121-4822-25 (unit dose cups of 25 mL). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM FREEZING PROTECT FROM LIGHT

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE SYRUP
PHARMACEUTICAL ASSOCIATES, INC.
----------
HYDROXYZINE
HYDROCHLORIDE
SYRUP USP
RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride is designated chemically as
(±)-2-[2-[4-(_p_-Chloro-α-phenylbenzyl)-1-
piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is
as follows:
INACTIVE INGREDIENTS for Hydroxyzine Hydrochloride Syrup are: alcohol
0.5%; liquid sugar;
methylparaben; peppermint oil; propylene glycol; propylparaben;
purified water and spearmint oil.
IT MAY ALSO CONTAIN citric acid anhydrous or sodium citrate dihydrate
for pH adjustment. The pH range
is between 2.0 and 4.3.
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 its 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 a sedative when used as premedication and following general
anesthesia, HYDROXYZINE MAY
POTENTIATE