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:

A-S Medication Solutions

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 (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 administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy. Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine pamoate is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication. Hydroxyzine is contraindicated in patients with known hypersensitivity to hydroxyzine products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.

Resumo do produto:

Product: 50090-4471 NDC: 50090-4471-1 20 CAPSULE in a BOTTLE NDC: 50090-4471-0 12 CAPSULE in a BOTTLE

Status de autorização:

Abbreviated New Drug Application

Características técnicas

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
A-S MEDICATION SOLUTIONS
----------
HYDROXYZINE PAMOATE CAPSULES, USP
(25 MG AND 50 MG)
RX ONLY
DESCRIPTION
Hydroxyzine pamoate, USP 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,
USP 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, 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
21
27
2
2
23
16
6
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.
INDICATIONS
For symptomat