HYDROXYZINE PAMOATE- hydroxyzine pamoate capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NuCare Pharmaceuticals, Inc.

INN (Nome Internazionale):

HYDROXYZINE PAMOATE

Composizione:

HYDROXYZINE HYDROCHLORIDE 50 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

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 68071-3158-6 bottles of 6 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. 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. 50 mg Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 46114010 Rev. October 2016 MF0674REV10/16 OS7127 Rev. October 2016 MF0674REV10/16

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
NUCARE PHARMACEUTICALS, INC.
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HYDROXYZINE PAMOATE CAPSULES, USP
25 MG AND 50 MG
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,
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, 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.
21
27
2
2
23
16
6
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