HYDROXYZINE HYDROCHLORIDE- hydroxyzine hydrochloride tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Caraco Pharmaceutical Laboratories, Ltd.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 preanesthetic 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. HydrOXYzine, when administered t

Produktsammanfattning:

HydrOXYzine hydrochloride tablets, USP contains 10 mg, 25 mg, or 50 mg of hydrOXYzine hydrochloride, USP and are supplied as follows: 10 mg: White to off-white, round, biconvex, bevel edge, film-coated tablets debossed with ‘112’ on one side and plain on the other side. NDC 57664-112-83          Bottles of 30        CRC NDC 57664-112-88          Bottles of 100      CRC NDC 57664-112-08          Bottles of 100      NCRC NDC 57664-112-13          Bottles of 500      NCRC NDC 57664-112-18          Bottles of 1000    NCRC 25 mg: White to off-white, round, biconvex, bevel edge, film-coated tablets debossed with‘113’ on one side and plain on the other side. NDC 57664-113-83          Bottles of 30        CRC NDC 57664-113-88          Bottles of 100      CRC NDC 57664-113-08          Bottles of 100      NCRC NDC 57664-113-13          Bottles of 500      NCRC NDC 57664-113-18          Bottles of 1000    NCRC 50 mg: White to off-white, round, biconvex, bevel edge, film-coated tablets debossed with ‘114’ on one side and plain on the other. NDC 57664-114-83          Bottles of 30        CRC NDC 57664-114-88          Bottles of 100      CRC NDC 57664-114-08          Bottles of 100      NCRC NDC 57664-114-13          Bottles of 500      NCRC NDC 57664-114-18          Bottles of 1000    NCRC Dispense in a tight container as defined in the USP. Store at 20 - 25°C (68 - 77°F). (See USP Controlled Room Temperature). Distributed by:          Caraco Pharmaceutical Laboratories, Ltd.                                           Detroit, MI 48202 Manufactured by:     Sun Pharmaceutical Industries, Inc.                                          Cranbury, New Jersey 08512 Issued: November 2008 Stock No. 6033T01

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

HYDROXYZINE HYDROCHLORIDE - HYDROXYZINE HYDROCHLORIDE TABLET
CARACO PHARMACEUTICAL LABORATORIES, LTD.
----------
DESCRIPTION
HydrOXYzine hydrochloride has the chemical name of
2-[2-[4-(_p_-Chloro-α-phenylbenzyl)-1-
piperazinyl]ethoxy]ethanol dihydrochloride.
HydrOXYzine hydrochloride occurs as a white, odorless powder which is
very soluble in water.
Each film-coated tablet for oral administration contains 10 mg, 25 mg,
or 50 mg hydrOXYzine
hydrochloride, USP. Inactive ingredients include anhydrous lactose,
colloidal silicon dioxide,
crospovidone, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polyvinyl alcohol,
sodium starch glycolate, talc 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 when used as a premedication and foll