HYDROXYZINE- hydroxyzine hydrochloride solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Preferred Pharmaceuticals, Inc.

Designació comuna internacional (DCI):

Hydroxyzine Hydrochloride

Composición:

Hydroxyzine Hydrochloride 10 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 in premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol® ) 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 hyd

Resumen del producto:

Hydroxyzine Hydrochloride Syrup (Hydroxyzine Hydrochloride Oral Solution, USP) 10 mg per 5 mL (teaspoonful) is a slightly yellow peppermint flavored liquid, supplied in 473 mL (16 fl. oz.) amber plastic bottles. NDC 68788-9466-4 Store at Controlled Room Temperature 15° to 30°C (59° to 86°F). [See USP controlled room temperature]. Dispense in a tight, light-resistant container with child-resistant closure as defined in the USP. Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 Rev. 01/18 10-1114 Relabeled By: Preferred Pharmaceuticals Inc.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

HYDROXYZINE- HYDROXYZINE HYDROCHLORIDE SOLUTION
PREFERRED PHARMACEUTICALS, INC.
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HYDROXYZINE HYDROCHLORIDE SYRUP
(HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP)
10 MG PER 5 ML
RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride is designated chemically as
(±)-2-[2-[4-(_p_-Chloro-α-phenylbenzyl)-1-
piperazinyl]ethoxy]ethanol dihydrochloride.
Inert ingredients: citric acid, peppermint flavor, sodium benzoate,
sucrose and water. Citric acid and/or
sodium citrate may be used to adjust the pH when necessary.
CLINICAL PHARMACOLOGY
Hydroxyzine hydrochloride is unrelated chemically to the
phenothiazines, reserpine, meprobamate, or
the benzodiazepines.
Hydroxyzine hydrochloride is not a cortical depressant, but its action
may be due to 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 in premedication and following general
anesthesia, HYDROXYZINE MAY
POTENTIATE MEPERIDINE (Demerol
) and barbiturates, so their use in pre-anesthetic adjunctive therapy
®
should be modified on an individ