HYDROXYZINE PAMOATE- 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:

AvKARE, 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

Product summary:

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 90 NDC 42291-322-90, bottles of 500 NDC 42291-322-50. 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 90 NDC 42291-323-90, bottles of 500 NDC 42291-323-50. Store below 30°C (86°F) [See USP]. Dispense in a tight, light resistant container as defined in USP/NF.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
AVKARE, 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 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 as an adjunct in
organic dis