hydroxyzine hydrochloride- Hydroxyzine hydrochloride tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
19-01-2007

Aktīvā sastāvdaļa:

Hydroxyzine hydrochloride (UNII: 76755771U3) (Hydroxyzine - UNII:30S50YM8OG)

Pieejams no:

Mutual Pharmaceutical Company, Inc.

SNN (starptautisko nepatentēto nosaukumu):

Hydroxyzine hydrochloride

Zāļu forma:

TABLET, FILM COATED

Kompozīcija:

10 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 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. HydrOXYzine, when administered t

Produktu pārskats:

HydrOXYzine hydrochloride tablets, USP are supplied as follows: HydrOXYzine hydrochloride tablets, 10 mg, lavender, round, film-coated, debossed MP 3 Bottles of 100          NDC 53489-126-01 Bottles of 500          NDC 53489-126-05 Bottles of 1000        NDC 53489-126-10 HydrOXYzine hydrochloride tablets, 25 mg, purple, round, film-coated, debossed MP 7 Bottles of 100          NDC 53489-127-01 Bottles of 500          NDC 53489-127-05 Bottles of 1000        NDC 53489-127-10 HydrOXYine hydrochloride tablets, 50 mg, purple, round, film-coated, debossed MP 13 Bottles of 100          NDC 53489-128-01 Bottles of 500          NDC 53489-128-05 Bottles of 1000        NDC 53489-128-10 HydrOXYine hydrochloride tablets, 25 mg, pink, round, film-coated, debossed MP 7 Bottles of 100          NDC 53489-594-01 Bottles of 500          NDC 53489-594-05 Bottles of 1000        NDC 53489-594-10 HydrOXYine hydrochloride tablets, 50 mg, pink, round, film-coated, debossed MP 13 Bottles of 100          NDC 53489-595-01 Bottles of 500          NDC 53489-595-05 Bottles of 1000        NDC 53489-595-10 Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Produkta apraksts

                                HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
MUTUAL PHARMACEUTICAL COMPANY, INC.
----------
HYDROXYZINE HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
HydrOXYzine hydrochloride is designated chemically as
1-(p-chlorobenzhydryl) 4-[2-(2-hydroxy-
ethoxy)-ethyl] piperazine dihydrochloride.
Each tablet, for oral administration, contains 10 mg, 25 mg, or 50 mg
of hydrOXYzine hydrochloride.
Inactive ingredients: anhydrous lactose, colloidal silicon dioxide,
croscarmellose sodium, FD&C Blue
No. 2 Aluminum lake (not contained in the 25 mg or 50 mg pink
tablets), hypromellose, magnesium
stearate, polyethylene glycol, and titanium dioxide. The 25 mg
includes hydroxypropyl cellulose; and
the 50 mg includes polysorbate 80. The lavender 10 mg includes D&C Red
No. 27 Aluminum lake;
FD&C Red No. 40 Aluminum lake; FD&C Yellow No. 6 Aluminum lake;
polydextrose and triacetin.
The 25 mg and 50 mg include D&C Red No. 7 Calcium lake.
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 hydrochloride clinical effects
are usually noted within 15 to 30
minutes after oral administration.
INDICATIONS
For symptomatic relief of anxiety and tension associated with
psychoneurosis and as an adjunct in
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