HYDROXYZINE PAMOATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug Inc.

INN (International Name):

HYDROXYZINE PAMOATE

Composition:

HYDROXYZINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Hydroxyzine Pamoate Capsules USP (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride) 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 Light yellow opaque cap and maroon opaque body filled with yellow powder. 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 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 Sellersville, PA 18960 11001678 Iss. 6/2010

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE PAMOATE - HYDROXYZINE PAMOATE CAPSULE
REDPHARM DRUG INC.
----------
HYDROXYZINE PAMOATE CAPSULES USP
0323
0302
0324
Iss. 6/2010
11001678
RX ONLY
DESCRIPTION
Hydroxyzine pamoate 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) and can be
structurally represented as follows:
C H CLN O •C
H O MOLECULAR WEIG HT: 763.27
Hydroxyzine Pamoate Capsules USP are administered in doses equivalent
to 25 mg, 50 mg or 100 mg of
hydroxyzine HCl.
INACTIVE INGREDIENTS
Croscarmellose sodium, magnesium stearate, and pregelatinized 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
21
27
2
2
23
16
6
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 apomorphine test an