HYDROXYZINE PAMOATE capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Preferred Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

HYDROXYZINE PAMOATE

Composição:

HYDROXYZINE HYDROCHLORIDE 25 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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: Bottle of 15 - 68788-9696-5 Bottle of 20 - 68788-9696-2 Bottle of 30 - 68788-9696-3 Bottle of 60 - 68788-9696-6 Bottle of 90 - 68788-9696-9 Bottle of 100 - 68788-9696-1 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. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. D 11/2016 Repackaged By: Preferred Pharmaceuticals Inc

Status de autorização:

Abbreviated New Drug Application

Características técnicas

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
PREFERRED PHARMACEUTICALS, 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 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 apomorphi