Hydroxyzine Pamoate

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

• 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.
• 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 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, droperidol).
• 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.
• Geriatric Use A determination has not been made whether controlled clinical studies of hydroxyzine pamoate included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects.

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 most common manifestation of overdosage of hydroxyzine pamoate is hypersedation.
• Other reported signs and symptoms were convulsions, stupor, nausea and vomiting.
• 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 vasopressors (
• do not use epinephrine as hydroxyzine counteracts its pressor action. ) Caffeine and Sodium Benzoate Injection, USP, may be used to counteract central nervous system depressant effects.
• Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes.
• ECG monitoring is recommended in cases 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.
• There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.
• DOSAGE 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 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.