DESCRIPTION.
Hydroxyzine hydrochloride is designated chemically as
2-[2-[4-(p-chlorobenzhydryl)-1-piperazinyl]ethoxy]ethanol
dihydrochloride.
Hydroxyzine hydrochloride occurs as a white, odorless powder
which is very soluble in water. Hyroxyzine Hydrocholoride
Tablets USP, 10 mg, 25 mg, and 50mg contain the following
inactive ingredients: anhydrous lactose, colloidal silicon
dioxide, croscarmellose sodium, FD&C Yellow No. 6, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol, ploysorbate 80 and titanium dioxide.
Hydroxyzine Hydrochloride Tablets USP, 25 mg and 50 mg
also contain FD&C Blue No. 2 and D&C Yellow No.
10.
CLINICAL PHARMACOLOGY
Atarax is unrelated chemically to the phenothiazines,
reserpine, meprobamate, or the benzodiazepines.
Atarax is not a cortical depressant, but its action may
be due to a suppression of activity in certain key regions
of the subcortical area of the central nervous system.
Primary skeletal muscle relaxation has been demonstrated
experimentally. Bronchodilator activity, and anti-histaminic
and analgesic effects have been demonstrated experimentally
and confirmed clinically, An antiemetic effect, both by
the apomorphine test and the veriloid test, has been demonstrated.
Pharmacological and clinical studies indicate that hydroxyzine
in therapeutic dosage does not increase gastric secretion
or acidity and in most cases has mild antisecretory activity.
Hydroxyzine is rapidly absorbed from the gastrointestinal
tract and Atarax's clinical effects are usually noted within
15 to 30 minutes after oral administration.
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 pre-medication and following
general anesthesia, Hydroxyzine may potentiate meperidine
(Demerols®) and barbiturates, so their use in pre-anesthetic
adjunctive therapy should be modified on an individual
basis. Atropine and other bella-donna 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.
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: 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 pre-medication 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.
HOW SUPPLIED
Hydroxyzine Hydrocholoride Tablets USP, 10 mg are 7/32",
unscored, round, orange, film-coated tablets imprinted "DAN" and "5522" supplied
in bottles of 100 and 500.
Hydroxyzine Hydrochloride Tablets USP, 25 mg are 7/32",
unscored, round, green, film-coated tablets imprinted "DAN" and "5523" supplied
in bottles of 100, 500 and 1000.
Hydroxyzine Hydrochloride Tablets USP, 50 mg are 10/32",
unscored, round, yellow, film-coated tablets imprinted "DAN" and "5565" supplied
in bottles of 100 and 500.
Dispense in a tight container with child-resistant closure.
Store at controlled room temperature 15°-30°C (59°-86°F)
SIDE EFFECTS
Side effects reported with the administration of Atarax
(hydroxyzine hydrochloride) are usually mild and transitory
in nature.
Anticholinergic: Dry mouth.
Central Nervous System: Drowsiness is usually transitory
and may disappear in a few days of continued therapy or
upon reduction of the dose. Involuntary motor activity
including rare instances of tremor and convulsions have
been reported, usually with doses considerably higher than
those recommended. Clinically significant respiratory depression
has not been reported at recommended doses.
DRUG INTERACTIONS
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 this drug, patients
should be warned of this possibility and cautioned against
driving a car or operating dangerous machinery while taking
Atarax. Patients should be advised against the simultaneous
use of other CNS depressant drugs, and cautioned that the
effect of alcohol may be increased.
WARNINGS
No Information Provided.
PRECAUTIONS
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 this drug, patients
should be warned of this possibility and cautioned against
driving a car or operating dangerous machinery while taking
hydroxyzine hydrochloride. Patients should be advised against
the simultaneous use of other CNS depressant drugs, and
cautioned that the effect of alcohol may be increased.
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.
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.
ADVERSE REACTIONS
Side effects reported with the administration of hydroxyzine
hydrochloride are usually mild and transitory in nature.
Anticholinergic: Dry mouth.
Central Nervous System: Drowsiness is usually transitory
and may disappear in a few days of continued therapy or
upon reduction of the dose. Involuntary motor activity
including rare instances of tremor and convulsions have
been reported, usually with doses considerably higher than
those recommended. Clinically significant respiratory depression
has not been reported at recommended doses.
OVERDOSE
The most common manifestation of Atarax overdosage is
hypersedation. As in the management of over-dosage 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 Levophed® (levarterenol),
or Aramine® (metaraminol). Do not use epinephrine as
Atarax counteracts its pressor action.
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.
CONTRAINDICATIONS
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, hydroxyine is contraindicated in early pregnancy.
Hydroxyzine is contraindicated for patients who have shown
a previous hypersensitivity to it
