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:

State of Florida DOH Central Pharmacy

INN (Nome Internazionale):

HYDROXYZINE PAMOATE

Composizione:

HYDROXYZINE PAMOATE 25 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 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,

Dettagli prodotto:

Hydroxyzine Pamoate Capsules, USP (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride) are supplied as follows: 25 mg capsules: Dark green opaque cap/light green opaque body filled with yellow powder. Imprinted in black ink WATSON over 800 on the cap and 25 mg on the body, in bottles of 100 and 500. 50 mg capsules: Dark green opaque cap/white opaque body filled with yellow powder. Imprinted in black ink WATSON over 801 on the cap and 50 mg on the body, in bottles of 100 and 500. They are supplied by State of Florida DOH Central Pharmacy as follows: Store below 30° C (86° F) [see USP]. Dispense in a tight, light-resistant container as defined in USP/NF. BIBLIOGRAPHY Available on request. Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45215 USA For: Watson Laboratories, Inc. Corona, CA 92880 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HYDROXYZINE PAMOATE - HYDROXYZINE PAMOATE CAPSULE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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, FD&C blue #1, gelatin,
magnesium stearate, pregelatinized
starch, sodium lauryl sulfate, and titanium dioxide. The imprinting
ink on the capsules contains synthetic
black iron oxide.
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 within 15 to 30
minutes after oral administration.
21
27
2
2
23
16
6
INDICATIONS AND USAGE
For sympto