HYDROXYZINE HYDROCHLORIDE TABLETS, USP

Rx only Rev. 11/08

DESCRIPTION: HydrOXYzine hydrochloride has the chemicalname of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride.

C21H27ClN202•2HCI M.W. 447.83

HydrOXYzine hydrochloride occurs as a white, odorlesspowder which is very soluble in water.

Each tablet for oral administration contains 10 mg, 25 mgor 50 mg hydrOXYzine HCl. Inactive ingredients includeanhydrous lactose, carnauba wax, colloidal silicon dioxide,crospovidone, hypromellose, magnesium stearate, micro-crystalline cellulose, polydextrose, polyethylene glycol, sodiumstarch glycolate, titanium dioxide, and triacetin.

CLINICAL PHARMACOLOGY: HydrOXYzine hydrochloride isunrelated chemically to the phenothiazines, reserpine,meprobamate or the benzodiazepines. HydrOXYzine is not acortical depressant, but its action may be due to a suppressionof activity in certain key regions of the subcortical area ofthe central nervous system.

Primary skeletal muscle relaxation has been demonstratedexperimentally. Bronchodilator activity, and antihistaminicand analgesic effects have been demonstrated experimentallyand confirmed clinically. An antiemetic effect, both by theapomorphine test and the veriloid test, has been demon-strated.

Pharmacological and clinical studies indicate thathydrOXYzine in therapeutic dosage does not increase gastricsecretion or acidity and in most cases has mild antisecretoryactivity.

HydrOXYzine is rapidly absorbed from the gastrointestinaltract and HydrOXYzine’s clinical effects are usually notedwithin 15 to 30 minutes after oral administration.

INDICATIONS AND USAGE: For symptomatic relief of anxi-ety and tension associated with psychoneurosis and as anadjunct in organic disease states in which anxiety is mani-fested.

Useful in the management of pruritus due to allergicconditions such as chronic urticaria and atopic and contact

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dermatoses and in histamine-mediated pruritus.

As a sedative when used as a premedication and follow-ing general anesthesia, hydrOXYzine may potentiatemeperidine and barbiturates, so their use in pre-anestheticadjunctive therapy should be modified on an individualbasis. Atropine and other belladonna alkaloids are notaffected by the drug. HydrOXYzine is not known to interferewith the action of digitalis in any way and it may be usedconcurrently with this agent.

The effectiveness of hydrOXYzine as an antianxiety agentfor long term use, that is more than 4 months, has not beenassessed by systematic clinical studies. The physicianshould reassess periodically the usefulness of the drug forthe individual patient.

CONTRAINDICATIONS: HydrOXYzine, when administered tothe pregnant mouse, rat, and rabbit induced fetal abnormalitiesin the rat and mouse at doses substantially above thehuman therapeutic range. Clinical data in human beings areinadequate to establish safety in early pregnancy. Until suchdata are available, hydrOXYzine is contraindicated in earlypregnancy.

HydrOXYzine is contraindicated for patients who haveshown a previous hypersensitivity to it.

WARNINGS: Nursing Mothers: It is not known whether thisdrug is excreted in human milk. Since many drugs are soexcreted, hydrOXYzine should not be given to nursingmothers.

PRECAUTIONS: THE POTENTIATING ACTION OF HYDROX-YZINE MUST BE CONSIDERED WHEN THE DRUG IS USEDIN CONJUNCTION WITH CENTRAL NERVOUS SYSTEMDEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTICANALGESICS AND BARBITURATES. Therefore, when centralnervous system depressants are administered concomitant-ly with hydrOXYzine their dosage should be reduced.

Since drowsiness may occur with use of this drug,patients should be warned of this possibility and cautionedagainst driving a car or operating dangerous machinerywhile taking hydrOXYzine. Patients should also be advisedagainst the simultaneous use of other CNS depressantdrugs, and cautioned that the effects of alcohol may beincreased.

Geriatric Use: A determination has not been made whethercontrolled clinical studies of hydrOXYzine included sufficientnumbers of subjects aged 65 and over to define a differencein response from younger subjects. Other reported clinicalexperience has not identified differences in responsesbetween the elderly and younger patients. In general, doseselection for an elderly patient should be cautious, usuallystarting at the low end of the dosing range, reflecting thegreater frequency of decreased hepatic, renal or cardiac

Amneal Hydroxyzine HCl Tabs Size: 6-3/4 x 10-1/8 Fold: 1-1/8 x 1-1/8 Type: 9 pt. Page 1 11-19-08 JB

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function, and of concomitant disease or other drug therapy.

The extent of renal excretion of hydrOXYzine has notbeen determined. Because elderly patients are more likely tohave decreased renal function, care should be taken in doseselections.

Sedating drugs may cause confusion and over sedationin the elderly; elderly patients generally should be started onlow doses of hydrOXYzine and observed closely.

ADVERSE REACTIONS: Side effects reported with theadministration of hydrOXYzine hydrochloride are usuallymild and transitory in nature.

Anticholinergic: Dry mouth.

Central Nervous System: Drowsiness is usually transitoryand may disappear in a few days of continued therapy orupon reduction of dose. Involuntary motor activity includingrare instances of tremor and convulsions have been reported,usually with doses considerably higher than those recom-mended. Clinically significant respiratory depression has notbeen reported at recommended doses.

OVERDOSAGE: The most common manifestation ofhydrOXYzine overdosage is hypersedation. As in the man-agement of overdosage with any drug, it should be borne inmind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should beinduced. Immediate gastric lavage is also recommended.General supportive care, including frequent monitoring ofthe vital signs and close observation of the patient, isindicated. Hypotension, though unlikely, may be controlledwith intravenous fluids and levarterenol or metaraminol. Donot use epinephrine as hydrOXYzine counteracts its pressoraction.

There is no specific antidote. It is doubtful thathemodialysis would be of any value in the treatment of over-dosage with hydrOXYzine. However, if other agents such asbarbiturates have been ingested concomitantly, hemodialysismay be indicated. There is no practical method to quantitatehydrOXYzine in body fluids or tissue after its ingestion oradministration.

DOSAGE AND ADMINISTRATION: For symptomatic relief ofanxiety and tension associated with psychoneurosis and asan adjunct in organic disease states in which anxiety ismanifested: Adults, 50-100 mg q.i.d.; children under 6years, 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 allergicconditions such as chronic urticaria and atopic and contactdermatoses and in histamine-mediated pruritus: adults, 25 mgt.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 divideddoses.

As a sedative when used as a premedication and followinggeneral anesthesia: 50-100 mg for adults and 0.6 mg/kg ofbody weight in children.

When treatment is initiated by the intramuscular route ofadministration, subsequent doses may be administeredorally.

As with all potent medication, the dosage should beadjusted according to the patient's response to therapy.

HOW SUPPLIED: HydrOXYzine Hydrochloride Tablets, USPare white, round, film coated, biconvex tablets containing10 mg, 25 mg, or 50 mg of HydrOXYzine Hydrochloride,and supplied as:

10 mg Tablets: Debossed ‘75’ on one side and ‘A’ on theother

NDC 67405-575-10 Bottles of 100NDC 67405-575-50 Bottles of 500NDC 67405-575-96 Bottles of 1000

25 mg Tablets: Debossed ‘71’ on one side and ‘AN’ on theother

NDC 67405-671-10 Bottles of 100NDC 67405-671-50 Bottles of 500NDC 67405-671-96 Bottles of 1000

50 mg Tablets: Debossed ‘77’ on one side and ‘AN’ on theother

NDC 67405-577-10 Bottles of 100NDC 67405-577-50 Bottles of 500NDC 67405-577-96 Bottles of 1000

STORAGE

Store at 20°C to 25°C (68°F to 77°F). [See USP ControlledRoom Temperature]. Dispense contents with a child-resis-tant closure (if required) and in a tight container as definedin the USP.

Manufactured for:HARRIS Pharmaceutical, Inc.Fort Myers, FL 33908877-RX4-DERM • www.HarrisPharmaceutical.com

By: Amneal PharmaceuticalsPaterson, NJ 07504

Rev: 11/08

Amneal Hydroxyzine HCl Tabs Size: 6-3/4 x 10-1/8 Fold: 1-1/8 x 1-1/8 Type: pt. Page 2 11-19-08 JB