Hydroxyzine Hydrochloride 50 MG Oral Tablet
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 hydroxyzine overdosage 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 levarterenol, or metaraminol.
Do not use epinephrine as hydroxyzine counteracts its pressor action.
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 hydrochloride has the chemical name of 2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride.
Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water.
Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine HCl.
Inactive ingredients include colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.
The 10 mg tablet also contains FD&C Red #40 Aluminum Lake and FD&C Yellow #6 Aluminum Lake.
The 25 mg tablet also contains D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake.
The 50 mg tablet also contains FD&C Red #40 Aluminum Lake and FD&C Yellow #5 Aluminum Lake.
This is an image of the structural formula for hydroxyzine.
HOW SUPPLIED
Hydroxyzine Hydrochloride Tablets, USP are available as: 50 mg – light orange, round tablets debossed “3617” on one side and debossed “V” on the reverse side.
Supplied in bottles of: Bottles of 12, 17, 20, 30 and 1000.
GERIATRIC USE
Geriatric Use: A determination has not been made whether controlled clinical studies of hydroxyzine 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 hydroxyzine 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 hydroxyzine and observed closely.
INDICATIONS AND USAGE
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 a premedication and following general anesthesia, hydroxyzine may potentiate meperidine 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
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: Adults, 50–100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children 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: adults, 25 mg t.i.d.
or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50–100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50–100 mg for adults and 0.6 mg/kg of body weight in children.
When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.
As with all potent medication, the dosage should be adjusted according to the patient’s response to therapy.