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Hydroxyzine Tablets

Pronunciation

Generic Name: hydroxyzine hydrochloride
Dosage Form: tablet, film coated

HYDROXYZINE HYDROCHLORIDE
TABLETS USP

5060

5061

5062

Rx only

Hydroxyzine Tablets Description

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

C 21 H 27 ClN 2 O 2 · 2HCl M.W. 447.83

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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: anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin.

Hydroxyzine Tablets - 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 Hydroxyzine Tablets

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 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.

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 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 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.

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.

Hydroxyzine Tablets 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 is Hydroxyzine Tablets Supplied

Hydroxyzine Hydrochloride Tablets USP, 10 mg are available as white, round, film-coated, convex tablets, debossed with “TV” on one side and “307” on the other side, containing 10 mg hydroxyzine hydrochloride, USP packaged in bottles of 100, 500, and 1000 tablets.

Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as white, round, film-coated, convex tablets, debossed with “TV” on one side and “308” on the other side, containing 25 mg hydroxyzine hydrochloride, USP packaged in bottles of 100, 500 and 1000 tablets.

Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as white, round, film-coated, convex tablets, debossed with “TV” on one side and “309” on the other side, containing 50 mg hydroxyzine hydrochloride, USP packaged in bottles of 100, 500 and 1000 tablets.

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

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

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

Manufactured In Croatia By:

PLIVA HRVATSKA d.o.o.

Zagreb, Croatia

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. C 6/2014

Package/Label Display Panel

Hydroxyzine Hydrochloride Tablets USP 10 mg 100s Label Text

NDC 0093-5060-01

HydrOXYzine
HYDROCHLORIDE
Tablets USP
10 mg

Rx only

100 TABLETS

TEVA

Package/Label Display Panel

Hydroxyzine Hydrochloride Tablets USP 25 mg 100s Label Text

NDC 0093-5061-01

HydrOXYzine
HYDROCHLORIDE
Tablets USP
25 mg

Rx only

100 TABLETS

TEVA

Package/Label Display Panel

Hydroxyzine Hydrochloride Tablets USP 50 mg 100s Label Text

NDC 0093-5062-01

HydrOXYzine
HYDROCHLORIDE
Tablets USP
50 mg

Rx only

100 TABLETS

TEVA

HYDROXYZINE HYDROCHLORIDE 
hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0093-5060
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
CARNAUBA WAX  
SILICON DIOXIDE  
CROSPOVIDONE  
HYPROMELLOSE 2910 (3 MPA.S)  
HYPROMELLOSE 2910 (6 MPA.S)  
HYPROMELLOSE 2910 (50 MPA.S)  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYDEXTROSE  
POLYETHYLENE GLYCOL 8000  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code TV;307
Contains         
Packaging
# Item Code Package Description
1 NDC:0093-5060-01 100 TABLET, FILM COATED in 1 BOTTLE
2 NDC:0093-5060-05 500 TABLET, FILM COATED in 1 BOTTLE
3 NDC:0093-5060-10 1000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088617 02/19/2013
HYDROXYZINE HYDROCHLORIDE 
hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0093-5061
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
CARNAUBA WAX  
SILICON DIOXIDE  
CROSPOVIDONE  
HYPROMELLOSE 2910 (3 MPA.S)  
HYPROMELLOSE 2910 (6 MPA.S)  
HYPROMELLOSE 2910 (50 MPA.S)  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYDEXTROSE  
POLYETHYLENE GLYCOL 8000  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code TV;308
Contains         
Packaging
# Item Code Package Description
1 NDC:0093-5061-01 100 TABLET, FILM COATED in 1 BOTTLE
2 NDC:0093-5061-05 500 TABLET, FILM COATED in 1 BOTTLE
3 NDC:0093-5061-10 1000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088618 10/09/2012
HYDROXYZINE HYDROCHLORIDE 
hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0093-5062
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
CARNAUBA WAX  
SILICON DIOXIDE  
CROSPOVIDONE  
HYPROMELLOSE 2910 (3 MPA.S)  
HYPROMELLOSE 2910 (6 MPA.S)  
HYPROMELLOSE 2910 (50 MPA.S)  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYDEXTROSE  
POLYETHYLENE GLYCOL 8000  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code TV;309
Contains         
Packaging
# Item Code Package Description
1 NDC:0093-5062-01 100 TABLET, FILM COATED in 1 BOTTLE
2 NDC:0093-5062-05 500 TABLET, FILM COATED in 1 BOTTLE
3 NDC:0093-5062-10 1000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088619 10/22/2012
Labeler - Teva Pharmaceuticals USA Inc (001627975)
Revised: 05/2015
 
Teva Pharmaceuticals USA Inc
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