HYDROXYZINE HYDROCHLORIDE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Morton Grove Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Hydroxyzine Hydrochloride Oral Solution, USP (Syrup) 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) and Pint (473 mL) bottles. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING PROTECT FROM LIGHT Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure. Rx Only Product No.: 8150 Manufactured For: Wockhardt USA, LLC Parsippany, NJ 07054 Manufactured By: Morton Grove Pharmaceuticals, Inc. Morton Grove, IL 60053 A50-8150-16 REV.07-18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE SYRUP
MORTON GROVE PHARMACEUTICALS, INC.
----------
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP (SYRUP)
10 MG/5 ML
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 Oral Solution, USP
(Syrup) are: alcohol 0.5%
(v/v); 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
Useful in the management of pruritus due to allergic conditions such
as chronic urticaria and atop