HYDROXYZINE PAMOATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

HYDROXYZINE PAMOATE

Composition:

HYDROXYZINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Hydroxyzine Pamoate Capsules, USP, for oral administration, are available as 25 mg (equivalent to 25 mg hydroxyzine hydrochloride) are light green/dark green capsules imprinted “E613” and supplied as: NDC: 70518-0209-00 NDC: 70518-0209-01 NDC: 70518-0209-02 NDC: 70518-0209-03 PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 100 in 1 BOTTLE PLASTIC Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. KEEP OUT OF THE REACH OF CHILDREN. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
REMEDYREPACK INC.
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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
(±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol
4,4’-
methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be
structurally
represented as follows:
C
H
CIN
O
•C
H
O
M.W. 763.27
Each capsule, for oral administration, contains hydroxyzine pamoate
equivalent to
hydroxyzine hydrochloride 25 mg or 50 mg.
In addition, each capsule contains the following inactive ingredients:
colloidal silicon
dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium
stearate, sodium
starch glycolate (potato), and sodium lauryl sulfate.
The capsule shell contains the following ingredients: D&C Yellow #10,
FD&C Green #3,
FD&C Yellow #6, gelatin, and titanium dioxide.
The edible imprinting ink contains the following ingredients: black
iron oxide, D&C Yellow
#10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and
shellac glaze.
CLINICAL PHARMACOLOGY
Hydroxyzine pamoate is unrelated chemically to the phenothiazines,
reserpine,
meprobamate, or the benzodiazepines.
21
27
2
2
23
16
6
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 gas