HYDROXYZINE PAMOATE capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Aidarex Pharmaceuticals LLC

INN (שם בינלאומי):

HYDROXYZINE PAMOATE

הרכב:

HYDROXYZINE HYDROCHLORIDE 50 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Hydroxyzine Pamoate Capsules USP for oral administration are available as: 50 mg: (equivalent to 50 mg hydroxyzine hydrochloride) are dark green/white capsules imprinted “E 615” and supplied as: NDC 33261-0858-30 bottles of 30 NDC 33261-0858-60 bottles of 60 NDC 33261-0858-02 bottles of 120 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Rev. 09/09 MF0613REV09/09 OS7127 Sandoz Inc. Princeton, NJ 08540 OS8905 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Rev. 09/09

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
AIDAREX PHARMACEUTICALS LLC
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HYDROXYZINE PAMOATE CAPSULES USP
RX ONLY
DESCRIPTION
Hydroxyzine pamoate is a light yellow, practically odorless powder
practically insoluble in water and
methanol and freely soluble in dimethylformamide. It is chemically
designated as (±)-2-[2-[4-(_p_-Chloro-
α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol
4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-
75-0] and can be structurally represented as follows:
C
H CIN O •C
H O
M.W. 763.27
Each capsule, for oral administration, contains hydroxyzine pamoate
equivalent to hydroxyzine
hydrochloride 25 mg or 50 mg. In addition, each capsule contains the
following inactive ingredients:
colloidal silicon dioxide, D&C yellow No. 10, FD&C green No. 3, FD&C
yellow No. 6, gelatin,
hydroxypropyl cellulose, lactose monohydrate, magnesium stearate,
propylene glycol, sodium lauryl
sulfate, sodium starch glycolate and titanium dioxide.
CLINICAL PHARMACOLOGY
Hydroxyzine pamoate capsules are unrelated chemically to the
phenothiazines, reserpine, meprobamate
or the benzodiazepines.
Hydroxyzine pamoate capsules are not a cortical depressant, but their
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 pamoate capsules
clinical effects are usually noted within 15 to 30 minutes after oral
administration.
21
27
2
2
23
16
6
INDICATIONS
For symptomatic relief of anxiety