HYDROXYZINE PAMOATE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Aphena Pharma Solutions - Tennessee, LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 a

Povzetek izdelek:

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 "IX" on the capsule cap and "657" on the capsule body, in bottles of 100 (NDC 0115-1803-01) and 500 (NDC 0115-1803-02). 50 mg capsules: Dark green opaque cap/white opaque body filled with yellow powder. Imprinted in black "IX" on the capsule cap and "658" on the capsule body, in bottles of 100 (NDC 0115-1804-01) and 500 (NDC 0115-1804-02). Store below 30°C (86°F) [See USP]. Dispense in a tight, light resistant container as defined in USP/NF.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 (2hydroxy-3-naphthalene carboxylic acid) and can be
structurally
represented as follows:
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, 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 administration.
INDICATIONS
For symptomatic relief of anxiety and tension associated with
psychoneurosis and