HYDROXYZINE PAMOATE capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Apotheca Inc.

INN (इंटरनेशनल नाम):

HYDROXYZINE PAMOATE

रचना:

HYDROXYZINE HYDROCHLORIDE 50 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

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 0185-0674-01 bottles of 100 NDC 0185-0674-05 bottles of 500 NDC 0185-0674-10 bottles of 1000 50 mg: (equivalent to 50 mg hydroxyzine hydrochloride) are dark green/white capsules imprinted “ E 615” and supplied as: NDC 0185-0615-01 bottles of 100 NDC 0185-0615-05 bottles of 500 NDC 0185-0615-10 bottles of 1000 Storage 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. 25 mg Manufactured by Sandoz Inc. Princeton, NJ 08540 46114010 Rev. 07/14 50 mg Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 OS7127 Rev. 07/14 MF0674REV07/14 MG# 16920

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
APOTHECA INC.
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HYDROXYZINEPAMOATE CAPSULES USP
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,
hydroxypropyl cellulose, lactose monohydrate, magnesium stearate,
sodium starch glycolate (potato),
and sodium lauryl sulfate.
The capsule shell contains the following ingredients: D&C Yellow #10,
FD&C Green #3, FD&C
Yellow #6, gelatin, and titanium dioxide.
The edible imprinting ink contains the following ingredients: black
iron oxide, D&C Yellow #10,
FD&C Blue #1, FD&C Blue #2, FD&C Red #40, 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 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 cli