HYDROXYZINE PAMOATE capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Bryant Ranch Prepack

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 ad

Каталог на резюме:

NDC: 63629-8183-1: 30 Capsules in a BOTTLE

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
BRYANT RANCH PREPACK
----------
RX ONLY
DESCRIPTION
Hydroxyzine pamoate is a light yellow 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) and can be structurally represented as
follows:
Chemical Formula: C
H
ClN O .C
H
O
Molecular Weight: 763.29
Inert ingredients for the capsule formulations are: hard gelatin
capsules (which contain
gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40, D&C Yellow
#10), printing ink
which contains shellac glaze ~45% (20% esterified) in Ethanol, iron
oxide black, n-butyl
alcohol, isopropyl alcohol, propylene glycol and ammonium hydroxide
28%); magnesium
stearate, microcrystalline cellulose, pregelatinized starch, sodium
lauryl sulfate, sodium
starch glycolate.
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's clinical effects are usually noted within 15 to 30 minutes
after oral
21
27
2
2
23
16
6
administration.
INDICATIONS
For symptomatic relief of anxiety and tension associated with
psychoneurosis and a