HYDROXYZINE HYDROCHLORIDE- hydroxyzine tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

HARRIS Pharmaceutical, Inc.

Designació comuna internacional (DCI):

HYDROXYZINE HYDROCHLORIDE

Composición:

HYDROXYZINE HYDROCHLORIDE 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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 67405-575-10                Bottles of 100 NDC 67405-575-50                Bottles of 500 NDC 67405-575-96                Bottles of 1000 25 mg Tablets: Debossed ‘71’ on one side and ‘AN’ on the other NDC 67405-671-10                Bottles of 100 NDC 67405-671-50                Bottles of 500 NDC 67405-671-96                Bottles of 1000 50 mg Tablets: Debossed ‘77’ on one side and ‘AN’ on the other NDC 67405-577-10                Bottles of 100 NDC 67405-577-50                Bottles of 500 NDC 67405-577-96                Bottles of 1000 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 Rev: 10-2016-03

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE TABLET, FILM COATED
HARRIS PHARMACEUTICAL, INC.
----------
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 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
21
27
2
2
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