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Vistaril

Generic Name: Hydroxyzine Pamoate
Drug Category: Antihistamine
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 2 years old for a maximum duration of 4 months.

Approved Uses

Indicated for:

Anxiety and Tension:

• Symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Pruritus:

• Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

Sedative as Premedication and Following General Anesthesia:

• As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol) 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.

Hydroxyzine is contraindicated in patients with a prolonged QT interval.

The potentiating action of Hydroxyzine must be considered when the drug is used in conjunction with central nervous system depressants such as narcotics, non-narcotic analgesics and barbiturates. When central nervous system depressants are administered concomitantly with hydroxyzine, their dosage should be reduced. Since drowsiness may occur with use of the drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Vistaril (hydroxyzine pamoate). Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

Cases of QT prolongation and Torsade de Pointes have been reported during post-marketing use of hydroxyzine. The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use). 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. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).

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.

Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.

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.

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Off-label Uses

• Use in patients under the age of 2. GoToSource

• Obsessive-compulsive disorder and panic disorder. GoToSource

• Management of restless legs syndrome perioperatively. GoToSource 

• Bruxism. GoToSource 

• Pain management in labour. GoToSource 

• Chronic idiopathic urticaria. GoToSource 

• Symptoms of multiple sclerosis. GoToSource

Adverse Events

Urticaria (hives), angioedema (swelling), contact dermatitis, anaphylaxis (severe allergic reaction) and fixed drug eruption. GoToSource 

QT prolongation. GoToSource 

Catatonia (movement and behavior abnormality). GoToSource 

Supraventricular tachycardia (abnormally fast heart rhythm). GoToSource

Dysrhythmias and sudden death. GoToSource

Acute generalized exanthematous pustulosis (skin eruption). GoToSource

Litigation

Lawsuits filed for arrhythmias. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated April 26, 2024