DESCRIPTION

Hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-(p- Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride.

      

M.W. 447.83

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

Hydroxyzine Hydrochloride Tablets USP, 10 mg, 25 mg and 50 mg contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Hydroxyzine Hydrochloride Tablets USP, 25 mg and 50 mg also contain D&C Yellow No. 10 and FD&C Blue No. 2.

CLINICAL PHARMACOLOGY

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

PRECAUTIONS

THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NONNARCOTIC 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 hydrochloride. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

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 the 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 hydrochloride 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 norepinephrine or metaraminol. Do not use epinephrine as hydroxyzine hydrochloride 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: in adults, 50-100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses and 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: 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, 50-100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50-100 mg in 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 medications, the dosage should be adjusted according to the patient’s response to therapy.

HOW SUPPLIED

Hydroxyzine Hydrochloride Tablets USP, 10 mg are 7/32”, unscored, round, orange, film-coated tablets imprinted DAN and 5522 supplied in bottles of 100 and 500.

Hydroxyzine Hydrochloride Tablets USP, 25 mg are 7/32”, unscored, round, green, film-coated tablets imprinted DAN and 5523 supplied in bottles of 100, 500 and 1000.

Hydroxyzine Hydrochloride Tablets USP, 50 mg are 10/32”, unscored, round, yellow, film-coated tablets imprinted DAN and 5565 supplied in bottles of 100, 500 and 1000.

Dispense in a tight container with child-resistant closure.

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

Manufactured by:
Watson Laboratories, Inc
Corona, CA 92880 USA

Distributed by:
Watson Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: October 2014

PRINCIPAL DISPLAY PANEL

NDC 0591-5522-01
HydrOXYzine
Hydrochloride
Tablets USP

10mg
100 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0591-5523-01
HydrOXYzine
Hydrochloride
Tablets USP

25 mg
100 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0591-3423-01
HydrOXYzine
Hydrochloride
Tablets USP

50 mg
100 Tablets