HYDROXYZINE HYDROCHLORIDE- hydroxyzine tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Golden State Medical Supply

INN (שם בינלאומי):

HYDROXYZINE HYDROCHLORIDE

הרכב:

HYDROXYZINE HYDROCHLORIDE 10 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 hydrochloride i

leaflet_short:

Hydroxyzine Hydrochloride Tablets, USP are white, round, film coated, biconvex tablets containing 10 mg, 25 mg, or 50 mg of Hydroxyzine Hydrochloride, and supplied as: 10 mg Tablets: Debossed ‘75’ on one side and ‘A’ on the other NDC 60429-223-01 Bottles of 100 NDC 60429-223-10 Bottles of 1000 25 mg Tablets: Debossed ‘71’ on one side and ‘AN’ on the other NDC 60429-224-01 Bottles of 100 NDC 60429-224-10 Bottles of 1000 50 mg Tablets: Debossed ‘77’ on one side and ‘AN’ on the other NDC 60429-225-01 Bottles of 100 NDC 60429-225-05 Bottles of 500 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (if required) and in a tight container as defined in the USP. Manufactured for: HARRIS Pharmaceutical, Inc. Fort Myers, FL 33908 877-RX4-DERM • www.HarrisPharmaceutical.com Manufactured by: Amneal Pharmaceuticals Paterson, NJ 07504 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012 Rev: 10-2016-03

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY
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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.
C
H CLN 0 •2HCI
M.W. 447.83
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 anhydrous lactose, carnauba wax,
colloidal silicon dioxide,
crospovidone, hypromellose, magnesium stearate, microcrystalline
cellulose,
polydextrose, polyethylene glycol, sodium starch glycolate, titanium
dioxide and triacetin.
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
21
27
2 2
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 histami