HYDROXYZINE PAMOATE capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Contract Pharmacy Services-PA

DCI (Denominação Comum Internacional):

HYDROXYZINE PAMOATE

Composição:

HYDROXYZINE HYDROCHLORIDE 25 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 and barbiturates, therefore use of these agents 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 anti-anxiety 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,

Resumo do produto:

Hydroxyzine Pamoate Capsules, USP (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride) are supplied as follows: 25 mg capsules: Light green/dark green capsules imprinted "E 613". 50 mg capsules: Dark green/white capsules imprinted "E 615". Store below 30° C (86° F) [see USP]. Dispense in a tight, light-resistant container as defined in USP/NF. BIBLIOGRAPHY Available on request. Sandoz Inc. Princeton, NJ 08540 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW

Status de autorização:

Abbreviated New Drug Application

Características técnicas

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
CONTRACT PHARMACY SERVICES-PA
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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 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:
Chemical Formula:
C
H ClN O . C
H O
Molecular Weight: 763.29
Each capsule, for oral administration, contains hydroxyzine pamoate
equivalent to 25 mg or 50 mg of
hydroxyzine hydrochloride. In addition, each capsule contains the
following inactive ingredients:
colloidal silicon dioxide, D&C yellow #10, D&C yellow #10 Aluminum
Lake, FD&C Blue #1
Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40
Aluminum Lake,
FD&C Yellow #6, gelatin, hydroxypropyl cellulose, lactose monohydrate,
magnesium sterate, sodium
lauryl sulfate, sodium starch glycolate and titanium dioxide.
CLINICAL PHARMACOLOGY
Hydroxyzine pamoate is unrelated chemically to the phenothiazines,
reserpine, meprobamate, or the
benzodiazepines.
Hydroxyzine pamoate is not a cortical depressant, although 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’s clinical effects
are usually noted withi