HYDROXYZINE PAMOATE- hydroxyzine pamoate capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYDROXYZINE PAMOATE (UNII: M20215MUFR) (HYDROXYZINE - UNII:30S50YM8OG)
Available from:
A-S Medication Solutions
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 a
Product summary:
Product: 50090-4471 NDC: 50090-4471-1 20 CAPSULE in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
50090-4471-1

HYDROXYZINE PAMOATE- hydroxyzine pamoate capsule

A-S Medication Solutions

----------

Hydroxyzine Pamoate Capsules, USP

(25 mg and 50 mg)

Rx only

DESCRIPTION

Hydroxyzine pamoate, USP 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 (2

hydroxy-3-naphthalene carboxylic acid) and can be structurally represented as follows:

Chemical Formula: C

H ClN O C

Molecular Weight: 763.29

Each capsule, for oral administration, contains hydroxyzine pamoate, USP 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 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.

CONTRAINDICATIONS

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.

WARNINGS

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Since many drugs are so excreted,

hydroxyzine should not be given to nursing mothers.

PRECAUTIONS

THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE

DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS

SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore,

when central nervous system depressants are administered concomitantly with hydroxyzine, their dosage

should be reduced. Since drowsiness may occur with use of the drug, patients should be warned of this

possibility and cautioned against driving a car or operating dangerous machinery while taking

hydroxyzine pamoate. Patients should be advised against the simultaneous use of other CNS depressant

drugs, and cautioned that the effect of alcohol may be increased.

QT Prolongation/Torsade de Pointes (TdP): Cases of QT prolongation and Torsade de Pointes have

been reported during post-marketing use of hydroxyzine. The majority of reports occurred in patients

with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or

concomitant arrhythmogenic drug use). Therefore, hydroxyzine should be used with caution in patients

with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT

syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as

recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.

®

Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These

include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics,

certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain

antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin,

clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron,

droperidol).

Acute Generalized Exanthematous Pustulosis (AGEP): Hydroxyzine may rarely cause acute

generalized exanthematous pustulosis (AGEP), a serious skin reaction characterized by fever and

numerous small, superficial, non-follicular, sterile pustules, arising within large areas of edematous

erythema. Inform patients about the signs of AGEP, and discontinue hydroxyzine at the first appearance

of a skin rash, worsening of pre-existing skin reactions which hydroxyzine may be used to treat, or any

other sign of hypersensitivity. If signs or symptoms suggest AGEP, use of hydroxyzine should not be

resumed and alternative therapy should be considered. Avoid cetirizine or levocetirizine in patients who

have experienced AGEP or other hypersensitivity reactions with hydroxyzine, due to the risk of cross-

sensitivity.

Geriatric Use: A determination has not been made whether controlled clinical studies of hydroxyzine

pamoate included sufficient numbers of subjects aged 65 and over to define a difference in response

from younger subjects. Other reported clinical experience has not identified differences in responses

between the elderly and younger patients. In general, dose selection for an elderly patient should be

cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of

decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

The extent of renal excretion of hydroxyzine pamoate has not been determined. Because elderly patients

are more likely to have decreased renal function, care should be taken in dose selections. Sedating

drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started

on low doses of hydroxyzine pamoate and observed closely.

ADVERSE REACTIONS

Side effects reported with the administration of hydroxyzine pamoate are usually mild and transitory in

nature.

Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized

Exanthematous Pustulosis (AGEP) and fixed drug eruptions in post-marketing reports.

Anticholinergic: Dry mouth.

Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of

continued therapy or upon reduction of the dose. Involuntary motor activity, including rare instances of

tremor and convulsions, has been reported, usually with doses considerably higher than those

recommended. Clinically significant respiratory depression has not been reported at recommended

doses.

Cardiac System: QT prolongation, Torsade de Pointes.

In post-marketing experience, the following additional undesirable effects have been reported:

Body as a Whole: allergic reaction,

Nervous System: headache,

Psychiatric: hallucination,

Skin and Appendages: pruritus, rash, urticaria.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-

835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

The most common manifestation of overdosage of hydroxyzine pamoate is hypersedation. Other

reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of

overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also

recommended. General supportive care, including frequent monitoring of the vital signs and close

observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with

intravenous fluids and vasopressors (do not use epinephrine as hydroxyzine counteracts its pressor

action). Caffeine and Sodium Benzoate Injection, USP, may be used to counteract central nervous

system depressant effects.

Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is

recommended in cases of hydroxyzine overdose.

There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of

overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested

concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in

body fluids or tissue after its ingestion or administration.

DOSAGE

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in

organic disease states in which anxiety is manifested: in adults, 50 mg to 100 mg q.i.d.; children under 6

years, 50 mg daily in divided doses; and over 6 years, 50 mg to 100 mg daily in divided doses.

For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and

contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6

years, 50 mg daily in divided doses; and over 6 years, 50 mg to 100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50 mg to 100 mg in

adults, and 0.6 mg/kg in children. When treatment is initiated by the intramuscular route of administration,

subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient's response to therapy.

HOW SUPPLIED

Product: 50090-4471

NDC: 50090-4471-1 20 CAPSULE in a BOTTLE

BIBLIOGRAPHY

Available on request.

Brands listed are the trademarks of their respective owners.

Manufactured by:

Patheon Pharmaceuticals Inc.

Cincinnati, OH 45237 USA

Manufactured for:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

70037762

Revised: 12-2018-00

Storage

Store below 30°C (86°F) [see USP]. Dispense in a tight, light resistant container as defined in USP/NF.

Hydroxyzine Pamoate

HYDROXYZINE PAMOATE

hydroxyzine pamoate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:50 0 9 0 -4471(NDC:0 115-18 0 4)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO XYZINE PAMO ATE (UNII: M20 215MUFR) (HYDROXYZINE -

UNII:30 S50 YM8 OG)

HYDROXYZINE

HYDROCHLORIDE

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

A-S Medication Solutions

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

Product Characteristics

Color

GREEN (o paque dark green) , WHITE (o paque white)

S core

no sco re

S hap e

CAPSULE

S iz e

19 mm

Flavor

Imprint Code

IX;6 58

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 0 9 0 -4471-1

20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /19 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 156

0 6 /15/19 9 6

Labeler -

A-S Medication Solutions (830016429)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A-S Medicatio n So lutio ns

8 30 0 16 429

RELABEL(50 0 9 0 -4471) , REPACK(50 0 9 0 -4471)

Revised: 8/2019

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