HYDROXYZINE HYDROCHLORIDE syrup

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Compre agora

Ingredientes ativos:

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

Disponível em:

Pharmaceutical Associates, Inc.

DCI (Denominação Comum Internacional):

Hydroxyzine Hydrochloride

Composição:

Hydroxyzine Hydrochloride 10 mg in 5 mL

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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 de autorização:

Abbreviated New Drug Application

Características técnicas

                                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
                                
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