HYDROXYZINE HYDROCHLORIDE- hydroxyzine hydrochloride tablet, film coated

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

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Active ingredient:
HYDROXYZINE HYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)
Available from:
REMEDYREPACK INC.
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 a premedication and following general anesthesia, hydroxyzine may potentiate meperidine 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. Oral hydroxyzine hydrochloride
Product summary:
Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as 10/32", Green round biconvex film-coated tablets debossed “Є” above “160” on one side and plain on the other side, Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6617-61 Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6618-61 Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as 11/32", Yellow round biconvex film-coated tablets, debossed “Є” above “161” on one side and plain on the other side, packaged in bottles of 100’s, 500’s and 1000’s. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Refer to package label for Distributor's NDC Number Revised October 2016 MF159REV10/16 OE1518
Authorization status:
Abbreviated New Drug Application
Authorization number:
70518-2240-0

HYDROXYZINE HYDROCHLORIDE- hydroxyzine hydrochloride tablet, film coated

REMEDYREPACK INC.

----------

Hydroxyzine Hydrochloride Tablets USP, Film-Coated

Rx Only

DESCRIPTION

Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-

piperazinyl]ethoxy]ethanol dihydrochloride.

·2HCl

M.W. 447.83

Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water.

Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP.

Inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose

monohydrate, magnesium stearate, microcrystalline cellulose, D&C Yellow #10 Aluminum Lake (25 mg

and 50 mg), FD&C Blue #2 Aluminum Lake (25 mg), FD&C Red #40 Aluminum Lake (50 mg), FD&C

Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl

alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10 mg).

CLINICAL PHARMACOLOGY

Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or

the benzodiazepines. Hydroxyzine 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’s clinical effects are

usually noted within 15 to 30 minutes after oral administration.

INDICATIONS AND USAGE

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 a premedication and following general anesthesia, hydroxyzine may

potentiate meperidine 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

Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to

hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine

hydrochloride or levocetirizine hydrochloride.

Hydroxyzine is contraindicated in patients with a prolonged QT interval.

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 for patients who have shown a previous hypersensitivity to any

component of this medication.

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.

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).

Since drowsiness may occur with use of this drug, patients should be warned of this possibility and

cautioned against driving a car or operating dangerous machinery while taking hydroxyzine. Patients

should also be advised against the simultaneous use of other CNS depressant drugs, and cautioned that

the effects of alcohol may be increased.

Geriatric Use

A determination has not been made whether controlled clinical studies of hydroxyzine 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 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 and observed closely.

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.

ADVERSE REACTIONS

Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and

transitory in nature.

Anticholinergic: Dry mouth.

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

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

tremor and convulsions have 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 postmarketing experience, the following additional undesirable effects have been reported:

Body as a Whole: Allergic reaction.

Nervous System: Headache.

Psychiatric: Hallucination.

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

Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports.

Pruritus, rash, urticaria.

OVERDOSAGE

The most common manifestation of hydroxyzine overdosage 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 levarterenol or metaraminol. Do not use epinephrine as hydroxyzine counteracts

its pressor action.

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 AND ADMINISTRATION

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

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

50 mg daily in divided doses; children over 6 years, 50 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: adults, 25 mg t.i.d. or q.i.d.; children under 6

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

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

and 0.6 mg/kg of body weight in children.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be

administered orally.

As with all potent medication, the dosage should be adjusted according to the patient's response to

therapy.

HOW SUPPLIED

Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as 10/32", Green round biconvex film-

coated tablets debossed “Є” above “160” on one side and plain on the other side,

Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6617-61

Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6618-61

Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as 11/32", Yellow round biconvex film-

coated tablets, debossed “Є” above “161” on one side and plain on the other side, packaged in bottles

of 100’s, 500’s and 1000’s.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as

required.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured by:

Epic Pharma, LLC

Laurelton, NY 11413

Manufactured in USA

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Refer to package label for Distributor's NDC Number

Revised October 2016

MF159REV10/16

OE1518

PRINCIPAL DISPLAY PANEL

DRUG: Hydroxyzine Hydrochloride

GENERIC: Hydroxyzine Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-2240-0

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 9 mm

IMPRINT: E161

PACKAGING: 90 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

HYDROXYZINE HYDROCHLORIDE 50mg in 1

INACTIVE INGREDIENT(S):

D&C YELLOW NO. 10

FD&C YELLOW NO. 6

TITANIUM DIOXIDE

LACTOSE MONOHYDRATE

FD&C RED NO. 40

HYPROMELLOSE, UNSPECIFIED

TALC

POLYETHYLENE GLYCOL, UNSPECIFIED

CROSPOVIDONE (15 MPA.S AT 5%)

MICROCRYSTALLINE CELLULOSE

POLYVINYL ALCOHOL, UNSPECIFIED

SILICON DIOXIDE

CARNAUBA WAX

MAGNESIUM STEARATE

TRIACETIN

HYDROXYZINE HYDROCHLORIDE

hydroxyzine hydrochloride tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:70 518 -2240 (NDC:0 9 0 4-6 6 18 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO XYZINE HYDRO CHLO RIDE (UNII: 76 755771U3) (HYDROXYZINE -

UNII:30 S50 YM8 OG)

HYDROXYZINE

HYDROCHLORIDE

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

REMEDYREPACK INC.

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

TALC (UNII: 7SEV7J4R1U)

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

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

ye llo w

S core

no sco re

S hap e

ROUND (bico nvex)

S iz e

9 mm

Flavor

Imprint Code

E16 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 518 -2240 -

9 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/31/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 6 0 4

0 7/31/20 19

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 7/2019

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