Vistaril 50 MG Oral Capsule
WARNINGS
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.
OVERDOSAGE
The most common manifestation of overdosage of Vistaril 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.
DESCRIPTION
Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4- [2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy- 3-naphthalene carboxylic acid).
Inert ingredients for the capsule formulations are: hard gelatin capsules (which may contain Yellow 10, Green 3, Yellow 6, Red 33, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.
Inert ingredients for the oral suspension formulation are: carboxymethylcellulose sodium; lemon flavor; propylene glycol; sorbic acid; sorbitol solution; water.
HOW SUPPLIED
Vistaril Capsules (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride) 25 mg: 100’s (NDC 0069-5410-66), two-tone green capsules 50 mg: 100’s (NDC 0069-5420-66), green and white capsules Vistaril Oral Suspension (hydroxyzine pamoate equivalent to 25 mg hydroxyzine hydrochloride per teaspoonful-5 mL): 1 pint (473 mL) bottles (NDC 0069-5440-93) and 4 ounce (120 mL) bottles (NDC 0069-5440-97) in packages of 4.
Shake vigorously until product is completely resuspended.
GERIATRIC USE
Geriatric Use 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.
INDICATIONS AND USAGE
INDICATIONS 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 (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.
NUSRING MOTHERS
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.
DOSAGE AND 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.