Hydroxyzine Hydrochloride

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 mg to 100 mg four times daily (q.i.d.); children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 mg 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 three times daily (t.i.d.) or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 mg to100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50 mg 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.

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 is contraindicated in patients with a prolonged QT interval. 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.

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 has been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System: QT prolongation, Torsade de Pointes. 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 Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports. Pruritus, rash, urticaria. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 CIN 2 O 2 ·2HCl M.W. 447.83 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 carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, D&C Yellow #10 Aluminum Lake (25 mg and 50 mg), FD&C Blue #2 Aluminum Lake (25 mg), FD&C Red #40 Aluminum Lake (50 mg), FD&C Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10 mg). Structural Formula

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. Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose. 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.

HOW SUPPLIED 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. NDC 71335-0246-1: 120 Tablets in a BOTTLE NDC 71335-0246-2: 20 Tablets in a BOTTLE NDC 71335-0246-3: 30 Tablets in a BOTTLE NDC 71335-0246-4: 60 Tablets in a BOTTLE NDC 71335-0246-5: 90 Tablets in a BOTTLE 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. NDC 71335-0935-1: 30 Tablets in a BOTTLE NDC 71335-0935-2: 60 Tablets in a BOTTLE NDC 71335-0935-3: 20 Tablets in a BOTTLE NDC 71335-0935-4: 100 Tablets in a BOTTLE NDC 71335-0935-5: 15 Tablets in a BOTTLE NDC 71335-0935-6: 90 Tablets in a BOTTLE NDC 71335-0935-7: 19 Tablets in a BOTTLE NDC 71335-0935-8: 10 Tablets in a BOTTLE 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. NDC 71335-0961-1: 30 Tablets in a BOTTLE NDC 71335-0961-2: 100 Tablets in a BOTTLE NDC 71335-0961-3: 20 Tablets in a BOTTLE NDC 71335-0961-4: 90 Tablets in a BOTTLE NDC 71335-0961-5: 15 Tablets in a BOTTLE NDC 71335-0961-6: 60 Tablets in a BOTTLE NDC 71335-0961-7: 120 Tablets in a BOTTLE NDC 71335-0961-8: 10 Tablets in a BOTTLE 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504