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:

Clinical Solutions Wholsesale

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 hydr

製品概要:

Hydroxyzine Pamoate Capsules USP for oral administration are available as: 25 mg: (equivalent to 25 mg hydroxyzine hydrochloride) are light green/dark green capsules imprinted “ E 613” and supplied as: NDC 58118-0025-08 blister packs of 30 50 mg: (equivalent to 50 mg hydroxyzine hydrochloride) are dark green/white capsules imprinted “ E 615” and supplied as: NDC 58118-0615-08 blister packs of 30 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 Rev. 09/09 Repackaged By CLINICAL SOLUTIONS WHOLESALE Franklin, TN 37067

認証ステータス:

Abbreviated New Drug Application

製品の特徴

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
CLINICAL SOLUTIONS WHOLSESALE
----------
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
21
27
2
2
23
16
6
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.
INDICATIONS
For symptomatic relief of anxie