Hydroxyzine

What is hydroxyzine?

• hydroxyzine (Atarax; Hypam; Orgatrax; Vistaril) is a first generation antihistamine that is used largely for symptoms of itching, nausea, anxiety and tension.

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hydroxyzine

hydroxyzine

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hydroxyzine-3d-sticks

What are the uses of this medicine?

hydroxyzine (Atarax; Hypam; Orgatrax; Vistaril) is used:

• For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
• in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus.
• along with other medications in adults and children as a sedative before and after general anesthesia for surgery.

Limitations of use:

• 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.

How does this medicine work?

• hydroxyzine (hye drox' i zeen) is a first generation antihistamine that is used mostly to treat itching and nausea. Because of its sedating effects, hydroxyzine is also used for anxiety, tension and as a mild sleeping aid.
• hydroxyzine belongs to the piperazine class of antihistamines (with cyclizine and meclizine) which are more commonly used for itching, nausea and anxiety than for their effects on symptoms of allergic rhinitis or coryza.
• hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines.

hydroxyzine 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.
• hydroxyzine is rapidly absorbed from the gastrointestinal tract and hydroxyzine's clinical effects are usually noted within 15 to 30 minutes after oral administration.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride
• with a prolonged QT interval.
• in early pregnancy.
• who have shown a previous hypersensitivity to any component of this medication.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• antihistamines
• azithromycin (Zithromax, ZMax), certain antidepressants such as citalopram (Celexa) and fluoxetine (Prozac, Sarafem, Selfemra)
• medications for anxiety
• certain medications for arrhythmias such as amiodarone (Cordarone, Nexterone, Pacerone, ), procainamide, quinidine (in Nuedexta), and sotalol (Betapace, Sorine, Sotylize)
• barbiturates
• clarithromycin (Biaxin, in Prevpac)
• droperidol (Inapsine)
• erythromycin (Eryc, Ery-Tab, PCE, others)
• gatifloxacin
• certain medications for mental illness such as chlorpromazine, clozapine (Clozaril, Fazaclo ODT, Versacloz), iloperidone (Fanapt), quetiapine (Seroquel), and ziprasidone (Geodon)
• meperidine (Demerol)
• methadone (Dolophine, Methadose)
• moxifloxacin (Avelox)
• medications for pain
• ondansetron (Zofran, Zuplenz)
• pentamidine (Nebupent, Pentam)
• medications for seizures, sedatives, sleeping pills
• tranquilizers

Is this medicine FDA approved?

• hydroxyzine was approved for use in the United States in 1957 and continues to be widely used.
• It is available as tablets or capsules of 10, 25, 50 and 100 mg in multiple generic forms and under the trade names Atarax and Vistaril. hydroxyzine is also available as an oral suspension or syrup and as a liquid for injection.

How should this medicine be used?

Recommended dosage: For symptomatic relief of anxiety and tension:

• Adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses.

For use in the management of 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 to 100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia:

• 50 to 100 mg for adults and 0.6 mg/kg of body weight in children.

Administration:

• hydroxyzine comes as capsules, tablets, a syrup, and suspension to take by mouth.
• It usually is taken three or four times a day.
• ake hydroxyzine exactly as directed.
• Do not take more or less of it or take it more often than prescribed by your doctor.
• Shake the suspension well before each use to mix the medication evenly.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As capsules, tablets, a syrup, and suspension

This medicine is available in fallowing brand namesː

• Atarax; Hypam; Orgatrax; Vistaril

What side effects can this medication cause?

The most common side effects of this medicine include:

• Dry mouth
• Drowsiness
• tremor
• convulsions
• respiratory depression
• QT prolongation
• Torsade de Pointes
• allergic reaction
• headache
• hallucination
• Acute Generalized Exanthematous Pustulosis (AGEP)
• Pruritus
• rash
• urticaria

What special precautions should I follow?

• When central nervous system depressants are administered concomitantly with hydroxyzine their dosage should be reduced.
• Cases of QT prolongation and Torsade de Pointes have been reported. Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.
• Caution is recommended during the concomitant use of drugs known to prolong the QT interval.
• 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.
• Patients should also be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effects of alcohol may be increased.
• 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.
• hydroxyzine may rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin reaction characterized by fever and numerous small, superficial, non-follicular, sterile pustules, arising within large areas of edematous erythema. Avoid cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions with hydroxyzine, due to the risk of cross-sensitivity.
• 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.
• hydroxyzine has not been linked to instances of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• convulsions, stupor, nausea and vomiting
• hydroxyzine overdose may cause QT prolongation and Torsade de Pointes.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• 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.
• ECG monitoring is recommended incases 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.

Can this medicine be used in pregnancy?

• hydroxyzine is contraindicated in early pregnancy.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• hydroxyzine hydrochloride

Inactive ingredients:

• acacia
• carnauba wax
• dibasic calcium phosphate
• gelatin
• lactose
• magnesium stearate
• precipitated calcium carbonate
• shellac
• sucrose
• talc
• white wax
• sodium hydroxide
• starch
• titanium dioxide
• Yellow 6 Lake

Who manufactures and distributes this medicine?

Distributed by:

• Caraco Pharmaceutical Laboratories, Ltd.
• Detroit, MI

Manufactured by:

• Sun Pharmaceutical Industries, Inc.
• Cranbury, New Jersey

What should I know about storage and disposal of this medication?

• Dispense in a tight container as defined in the USP.
• Store at 20 - 25°C (68 - 77°F).

First Generation Antihistamines

• Brompheniramine
• Carbinoxamine
• Chlorcyclizine
• Chlorpheniramine
• Clemastine
• Cyclizine
• Cyproheptadine
• Dexbrompheniramine
• Dexchlorpheniramine
• Dimenhydrinate
• Diphenhydramine
• Doxylamine
• Hydroxyzine
• Meclizine
• Phenyltoloxamine
• Promethazine
• Triprolidine

Second Generation Antihistamines

• Acrivastine
• Cetirizine
• Fexofenadine
• Levocetirizine
• Loratadine
• Desloratadine

• Dailymed label info on Hydroxyzine
• FDA Hydroxyzine

Hydroxyzine Resources
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