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.
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. Therefore,
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.
QT Prolongation/Torsade De Pointes (TdP)
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,
Acute Generalized Exanthematous Pustulosis (AGEP)
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. Inform patients about the signs of AGEP, and discontinue
hydroxyzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which
hydroxyzine may be used to treat, or any other sign of hypersensitivity. If signs or symptoms suggest
AGEP, use of hydroxyzine should not be resumed and alternative therapy should be considered. Avoid
cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions
with hydroxyzine, due to the risk of cross-sensitivity.
A determination has not been made whether controlled clinical studies of VISTARIL 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 VISTARIL 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 VISTARIL and observed closely.