HYDROXYZINE HYDROCHLORIDE solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Physicians Total Care, Inc.

INN (nume internaţional):

HYDROXYZINE HYDROCHLORIDE

Compoziție:

HYDROXYZINE HYDROCHLORIDE 10 mg in 5 mL

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 (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. Hydroxyzin

Rezumat produs:

Hydroxyzine Hydrochloride Oral Solution, USP 10 mg per 5 mL (teaspoonful) NDC 54868-2032-0 is a slightly yellow peppermint flavored liquid supplied in 1 pint amber plastic bottles. Alcohol content: alcohol 0.5% v/v. Store at controlled room temperature 15° - 30°C (59° - 86°F). Dispense in tight, light-resistant containers as defined in the USP. Manufactured by: HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Rev. 796:03 8/09 Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK     74146

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

HYDROXYZINE HYDROCHLORIDE - HYDROXYZINE HYDROCHLORIDE SOLUTION
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Hydroxyzine hydrochloride is designated chemically as
1-(p-chlorobenzhydryl) 4-[2-(2-
hydroxyethoxy)-ethyl] piperazine dihydrochloride, with the following
structure:
Each 5 mL (teaspoonful), for oral administration, contains 10 mg of
hydroxyzine hydrochloride.
The inactive ingredients for the oral solution are alcohol 0.5% v/v,
corn syrup, methylparaben,
peppermint flavor, propylene glycol, purified water, sodium benzoate,
and sucrose. Sodium hydroxide
and/or hydrochloric acid 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 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
potenti