HYDROXYZINE PAMOATE capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

HYDROXYZINE PAMOATE (UNII: M20215MUFR) (HYDROXYZINE - UNII:30S50YM8OG)

から入手可能:

Teva Pharmaceuticals USA, Inc.

INN（国際名）:

HYDROXYZINE PAMOATE

構図:

HYDROXYZINE HYDROCHLORIDE 25 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 (Demerol® ) 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 a

製品概要:

Hydroxyzine pamoate capsules, USP (hydroxyzine pamoate, USP equivalent to hydroxyzine hydrochloride), 25 mg are available as light yellow opaque cap and pink opaque body filled with yellow powder, imprinted in black ink stylized “barr” over “323” on one piece and “25” on the other piece, packaged in bottles of 100 (NDC 0555-0323-02)  and 500 (NDC 0555-0323-04) capsules. Hydroxyzine pamoate capsules, USP (hydroxyzine pamoate, USP equivalent to hydroxyzine hydrochloride), 50 mg are available as light yellow opaque cap and maroon opaque body filled with yellow powder, imprinted in black ink stylized “barr” over “302” on one piece and “50” on the other piece, packaged in bottles of 100 (NDC 0555-0302-02) and 500 (NDC 0555-0302-04) capsules. Hydroxyzine pamoate capsules, USP (hydroxyzine pamoate, USP equivalent to hydroxyzine hydrochloride), 100 mg are available as light yellow opaque cap and pink opaque body filled with yellow powder, imprinted in black ink stylized “barr” over “324” on one piece and “100” on the other piece, packaged in bottles of 100 (NDC 0555-0324-02) capsules. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. F 10/2022

認証ステータス:

Abbreviated New Drug Application

製品の特徴

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
TEVA PHARMACEUTICALS USA, INC.
----------
HYDROXYZINE PAMOATE CAPSULES, USP
RX ONLY
DESCRIPTION
Hydroxyzine pamoate, USP is designated chemically as
1-(p-chlorobenzhydryl) 4-[2-(2-
hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis
(2 hydroxy-3-
naphthalene carboxylic acid). It has the following structural formula:
C
H CLN O •C
H O M.W. 763.27
Hydroxyzine pamoate capsules, USP are administered in doses equivalent
to 25 mg, 50
mg or 100 mg of hydroxyzine hydrochloride. In addition, each capsule
contains the
following inactive ingredients: croscarmellose sodium, magnesium
stearate, and
pregelatinized corn starch. The 25 mg also contains anhydrous lactose.
The 50 mg and
100 mg also contain lactose monohydrate. The capsule shell ingredients
for the 25 mg
capsule are D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C
Red No. 40,
FD&C Yellow No. 6, gelatin, and titanium dioxide. The 50 mg capsule
shell contains D&C
Red No. 33, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and
titanium dioxide. The
100 mg capsule shell contains D&C Red No. 28, D&C Red No. 33, D&C
Yellow No. 10,
FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide.
The edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules
contains black iron
oxide, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake,
FD&C Blue No.
2 aluminum lake, FD&C Red No. 40 aluminum lake, propylene glycol, and
shellac glaze.
CLINICAL PHARMACOLOGY
Hydroxyzine pamoate is unrelated chemically to the phenothiazines,
reserpine,
meprobamate, or the benzodiazepines.
Hydroxyzine pamoate is not a cortical depressant, but its action may
be due to a
21
27
2
2
23
16
6
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,