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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

HYDROXYZINE PAMOATE

Composition:

HYDROXYZINE 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. Hydroxyz

Product summary:

Hydroxyzine Pamoate Capsules (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride)are available as:  25 mg capsules:  two-tone green capsules, cap and body imprinted EP136 in black ink. They are supplied as follows: Bottles of 100: NDC 60429-294-01 Bottles of 500: NDC 60429-294-05  50 mg capsules: green and white capsules, cap and body imprinted EP112 in black ink. They are supplied as follows: Bottles of 100: NDC 60429-295-01 Bottles of 500: NDC 60429-295-05 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in tight, light resistant containers (USP). Manufactureed by: Emcure Pharmaceuticals, USA East Brunswick, New Jersey, 08816 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Marketed and Packaged by: GSMS, Inc. Camarillo, CA 93012 USA MF# 0334-03 Rev. 02/2014

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE PAMOATE- HYDROXYZINE PAMOATE CAPSULE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HYDROXYZINE PAMOATE CAPSULES 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) 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 administration.
INDICATIONS
For symptomatic relief of anxiety and