INDICATIONS

ATARAX is indicated in the management of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. Also used in the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma.

ATARAX is useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses.

ATARAX is also useful in the control of nausea and vomiting, excluding nausea and vomiting of pregnancy (see CONTRAINDICATIONS section).

CONTRAINDICATIONS

ATARAX is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride and any component of this medication.

Use in Pregnancy
Hydroxyzine hydrochloride, 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, ATARAX is contraindicated in early pregnancy.

WARNINGS
Nursing Mothers: It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, ATARAX should not be given to nursing mothers.

PRECAUTIONS

The potentiating action of hydroxyzine hydrochloride must be considered when the drug is used in conjunction with central nervous system (CNS) depressants such as narcotics, non-narcotic analgesics, hypnotics, sedatives, psychotherapeutic agents, barbiturates or alcohol. Therefore when central nervous system depressants are administered concomitantly with ATARAX (hydroxyzine hydrochloride) their dosage should be reduced.

Administer ATARAX cautiously to epileptic patients.

Since drowsiness may occur with use of this drug, patients should be cautioned against driving a car or operating dangerous machinery while taking ATARAX.

ADVERSE REACTIONS

Side effects reported with the administration of ATARAX are usually mild and transitory in nature.

Anticholinergic: Dry mouth may be encountered at higher dosages.

Central Nervous System: Drowsiness.

Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended.
In post-marketing experience, the following undesirable effects have been reported: Body as a Whole:allergic reaction, Nervous System: headache, Psychiatric: hallucination, Skin and Appendages: pruritus, rash, urticaria.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

The most common manifestation of ATARAX 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.
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 (such as norepinephrine). Do not use epinephrine as ATARAX 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.

DOSAGE AND ADMINISTRATION

The dosage is dependent upon the intensity of the emotional disturbance rather than upon the weight of the patient.

Usual Oral Dosage

Adults: 25 mg to 100 mg three or four times daily.
Children: under 6 years of age: 30 to 50 mg daily in divided doses;
                over 6 years of age: 50 to 100 mg daily in divided doses.

DOSAGE FORMS

Availability:

Pr ATARAX Syrup: Each 5 mL of mint-flavored syrup contains: hydroxyzine hydrochloride 10 mg, sodium benzoate 1.5 mg. Also contains sucrose, water, alcohol, menthol, spearmint oil, peppermint oil and hydrochloric acid (for pH adjustment). Energy: 67 kJ (16 kcal). Tartazine-free.

Available in bottles of 473 mL.