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

C₂₁H₂₇CIN₂0₂•2HCI         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.

Last updated on RxList: 11/13/2007

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.

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.

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 controlled room temperature 15°-30°C (59°-86°F).

Watson Laboratories, Inc, Corona, CA 92880 USA. Revised: September 2004. FDA rev date:

Last updated on RxList: 11/13/2007

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.

No information provided.

Last updated on RxList: 11/13/2007

No information provided.

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.

Nursing mothers

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

Geriatric use

A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

The extent of renal excretion of hydroxyzine has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely.

Last updated on RxList: 11/13/2007

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.

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.

Last updated on RxList: 11/13/2007

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.

Last updated on RxList: 11/13/2007

No information provided. Please refer to the PRECAUTIONS section.

Last updated on RxList: 11/13/2007

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

HYDROXYZINE HYDROCHLORIDE - ORAL

(hye-DROX-i-zeen hye-droe-KLOR-ide)

COMMON BRAND NAME(S): Atarax

USES: Hydroxyzine is used for the short-term treatment of nervousness and tension that may occur with certain mental/mood disorders (e.g., anxiety, dementia). It is also used to treat itching from allergies and other causes (e.g., reactions to certain drugs). It may also be used to help you feel calmer before/after surgery, or to help certain narcotic pain relievers (e.g., meperidine) work better.

Hydroxyzine belongs to a class of medications called antihistamines. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its other effects (e.g., calming, pain relief) may work by affecting other natural substances (e.g., acetylcholine, serotonin) or by acting directly on certain parts of the brain.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to prevent/treat motion sickness, nausea, and vomiting related to certain conditions (e.g., traveling, after surgery).

HOW TO USE: Take this medication by mouth as needed, usually three or four times daily or as directed by your doctor. If you are taking the syrup, measure the dose carefully using a special medication spoon or a kitchen measuring spoon.

Dosage is based on your age, medical condition, and response to therapy. In children, dosage may also be based on body weight. Take this medication as directed. Do not take more medication or take it more often than prescribed.

Inform your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Drowsiness, dizziness, blurred vision, dry mouth, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: mental/mood changes (e.g., worsening anxiety, confusion, hallucinations), shaking (tremor), decreased/painful urination, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: pounding/irregular heartbeat, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking hydroxyzine, tell your doctor or pharmacist if you are allergic to it; or to cetirizine; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., emphysema, asthma), a certain eye problem (glaucoma), heart problems, high blood pressure, kidney problems, liver problems, seizures, stomach/intestine problems (e.g., ulcer, blockage), overactive thyroid (hyperthyroidism), problems urinating (e.g., due to enlarged prostate, bladder blockage).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Liquid forms of this medication may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about the safe use of this product.

Caution is advised when using this drug in children because they may be more sensitive to its effects. This drug can often cause excitement in young children instead of drowsiness.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially drowsiness and confusion.

This medication should be used only when clearly needed during the last six months of pregnancy. It is not recommended for use during the first three months of pregnancy due to possible harm to the unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately.

It is not known if this medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antispasmodics (e.g., atropine, belladonna alkaloids), epinephrine, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), drugs for Parkinson's disease (e.g., anticholinergics such as benztropine, trihexyphenidyl), scopolamine, tricyclic antidepressants (e.g., amitriptyline).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products, allergy products, sleep medications) because they may contain drowsiness-causing ingredients or other antihistamines (e.g., diphenhydramine). Ask your pharmacist about the safe use of those products.

This medication may interfere with certain laboratory tests (allergy skin tests, urine corticosteroids), possibly causing false test results. Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe/prolonged drowsiness.

NOTES: Do not share this medication with others.

MISSED DOSE: If you are taking this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.