Hydroxyzine (Hydroxyzine Hydrochloride) - Indications and Dosage

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.

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,

50 mg - Round, white, film-coated tablet, debossed "H/107", supplied in bottles of 24,30,60,90,100.

Bottles of 24 NDC: 35356-701-24

Bottles of 30 NDC: 35356-701-30

Bottles of 60 NDC: 35356-701-60

Bottles of 90 NDC: 35356-701-90

Bottles of 100 NDC: 35356-701-00

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.
Edison, NJ 08837
1.866.901.DRUG (3784)

Manufactured by:
ANDAPharm,LLC
Ft. Lauderdale, FL 33309
Iss. 06/09