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HYDROXYZINE HYDROCHLORIDE tablet, film coated
[Heritage Pharmaceuticals Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

DESCRIPTION

HydrOXYzine hydrochloride  has the chemical name of 2-[2-[4-  (p-Chloro-α-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride.

31945055-figure-01

C21H27CIN202.2HCI

HydrOXYzine hydrochloride 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 HCl.  Inactive ingredients include: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, polyethylene glycol, polysorbate 80, and titanium dioxide.

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, 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 it.

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 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.

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.

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: Oral hydroxyzine hydrochloride is associated with fixed drug eruptions in postmarketing reports.

OVERDOSAGE

The most common manifestation of hydrOXYzine overdosage is hypersedation.  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.

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, 50-100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50-100 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, 50-100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50-100 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,

10 mg - Round, white, film-coated tablet, debossed “H/105”, supplied in bottles of 100, 500, and 1000.

Bottles of 100 NDC 23155-105-01

Bottles of 500 NDC 23155-105-05

Bottles of 1000 NDC 23155-105-10

25 mg - Round, white, film-coated tablet, debossed “H/106”, supplied in bottles of 100, 500, and 1000.

Bottles of 100 NDC 23155-106-01

Bottles of 500 NDC 23155-106-05

Bottles of 1000 NDC 23155-106-10

50 mg- Round, white, film-coated tablet, debossed “H/107”, supplied in bottles of 100, 500, and 1000.

Bottles of 100 NDC 23155-107-01

Bottles of 500 NDC 23155-107-05

Bottles of 1000 NDC 23155-107-10

Dispense in a tight container as defined in the USP.

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

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for:

Heritage Pharmaceuticals Inc.

Eatontown, NJ 07724

1-866-901-DRUG (3784)

Iss.06/14

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydroxyzine Hydrochloride Tablets, USP

10 mg, 100 count

10mg-100ct

Hydroxyzine Hydrochloride Tablets, USP

25 mg, 100 count

25mg-100ct

Hydroxyzine Hydrochloride Tablets, USP

50 mg, 100 count

50mg-100ct
HYDROXYZINE HYDROCHLORIDE 
hydroxyzine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:23155-105
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
SILICON DIOXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint Code H;105
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23155-105-01100 in 1 BOTTLE
2NDC:23155-105-05500 in 1 BOTTLE
3NDC:23155-105-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04080406/30/2008
HYDROXYZINE HYDROCHLORIDE 
hydroxyzine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:23155-106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
SILICON DIOXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code H;106
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23155-106-01100 in 1 BOTTLE
2NDC:23155-106-05500 in 1 BOTTLE
3NDC:23155-106-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04080406/30/2008
HYDROXYZINE HYDROCHLORIDE 
hydroxyzine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:23155-107
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
SILICON DIOXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize9mm
FlavorImprint Code H;107
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23155-107-01100 in 1 BOTTLE
2NDC:23155-107-05500 in 1 BOTTLE
3NDC:23155-107-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04080406/30/2008
Labeler - Heritage Pharmaceuticals Inc. (780779901)
Establishment
NameAddressID/FEIBusiness Operations
ANDAPharm LLC152284449MANUFACTURE(23155-105, 23155-106, 23155-107)

Revised: 7/2014
 
Heritage Pharmaceuticals Inc.

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