HYDROXYZINE HYDROCHLORIDE- hydroxyzine hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

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 a 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 hydrochlor

Product summary:

HydrOXYzine Hydrochloride Tablets, USP, 50 mg- Round, white, film-coated tablet, debossed “H/107”, supplied in bottles of 15, 20, 30, 60 and 90.. Dispense in a tight container as defined in the USP. Store at controlled room temperature 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1-866-901-DRUG (3784) Iss.06/14 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
PROFICIENT RX LP
----------
HYDROXYZINE HYDROCHLORIDE
TABLETS, USP
RX ONLY
DESCRIPTION
HydrOXYzine hydrochloride has the chemical name of 2-[2-[4-
(p-Chloro-α-phenylbenzyl)-1-
piperazinyl] ethoxy] ethanol dihydrochloride.
C21H27CIN202.2HCI
HydrOXYzine hydrochloride occurs as a white, odorless powder which is
very soluble in water.
Each tablet for oral administration contains 10 mg, 25 mg or 50 mg
hydrOXYzine HCl. Inactive
ingredients include: lactose monohydrate, colloidal silicon dioxide,
hypromellose, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate, stearic acid,
polyethylene glycol, polysorbate 80,
and titanium dioxide.
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
hydrOXYzine’s 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