HYDROXYZINE HYDROCHLORIDE- hydroxyzine hydrochloride tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

REMEDYREPACK INC.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as 10/32", Green round biconvex film-coated tablets debossed “Є” above “160” on one side and plain on the other side, Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6617-61 Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6618-61 Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as 11/32", Yellow round biconvex film-coated tablets, debossed “Є” above “161” on one side and plain on the other side, packaged in bottles of 100’s, 500’s and 1000’s. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Refer to package label for Distributor's NDC Number Revised October 2016 MF159REV10/16 OE1518

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
REMEDYREPACK INC.
----------
HYDROXYZINE HYDROCHLORIDE TABLETS USP, FILM-COATED
RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(
_p_-Chloro-α-phenylbenzyl)-1-
piperazinyl]ethoxy]ethanol dihydrochloride.
C
H
CIN
O
·2HCl
M.W. 447.83
Hydroxyzine hydrochloride, USP 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 hydrochloride, USP.
Inactive ingredients include carnauba wax, colloidal silicon dioxide,
crospovidone, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, D&C
Yellow #10 Aluminum Lake (25 mg
and 50 mg), FD&C Blue #2 Aluminum Lake (25 mg), FD&C Red #40 Aluminum
Lake (50 mg), FD&C
Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene
glycol 3350, polyvinyl
alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10
mg).
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.
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27
2
2
INDICATIONS AND USAGE
For symptomatic relief of anxiety and tension associated with