HYDROXYZINE
HYDROCHLORIDE
TABLETS USP
Rev. B 4/2014
5060
5061
5062
only
DESCRIPTION
Hydroxyzine hydrochloride, USP has the chemical name
of 2-[2-[4-(p-Chloro--phenylbenzyl)-1-piperazinyl]ethoxy]
ethanol dihydrochloride.
• 2HCl
Cl
N
NOOH
C21H27ClN2O2 • 2HCl M.W. 447.83
Hydroxyzine hydrochloride, USP 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 hydrochloride, USP. Inactive ingredients
include: anhydrous lactose, carnauba wax, colloidal silicon
dioxide, crospovidone, hypromellose, magnesium stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
sodium starch glycolate, titanium dioxide, and triacetin.
CLINICAL PHARMACOLOGY
Hydroxyzine hydrochloride is unrelated chemically
to the phenothiazines, reserpine, meprobamate or the
benzodiazepines. Hydroxyzine 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 antihistaminic
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 hydroxyzine’s clinical effects are usually noted
within 15 to 30 minutes after oral administration.
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.
CONTRAINDICATIONS
Oral hydroxyzine hydrochloride is contraindicated in patients
with known hypersensitivity to hydroxyzine hydrochloride
products, and in patients with known hypersensitivity to
cetirizine hydrochloride or levocetirizine hydrochloride.
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 for patients who have
shown a previous hypersensitivity to any component of
this medication.
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.
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. Patients should also be advised against
the simultaneous use of other CNS depressant drugs, and
cautioned that the effects of alcohol may be increased.
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
Skin and Appendages: Oral hydroxyzine hydrochloride
is associated with fixed drug eruptions in postmarketing
reports.
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 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.
In postmarketing experience, the following additional
undesirable effects have been reported:
Body as a Whole: Allergic reaction.
Nervous System: Headache.
Psychiatric: Hallucination.
Skin and Appendages: Pruritus, rash, urticaria.
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.
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 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 to 100 mg
q.i.d.; children under 6 years, 50 mg daily in divided doses;
children over 6 years, 50 to 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 to 100 mg daily
in divided doses.
As a sedative when used as a premedication and following
general anesthesia: 50 to 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.
HOW SUPPLIED
Hydroxyzine Hydrochloride Tablets USP, 10 mg are available
as white, round, film-coated, convex tablets, debossed with
“TV” on one side and “307” on the other side, containing
10 mg hydroxyzine hydrochloride, USP packaged in bottles
of 100, 500, and 1000 tablets.
Hydroxyzine Hydrochloride Tablets USP, 25 mg are available
as white, round, film-coated, convex tablets, debossed with
“TV” on one side and “308” on the other side, containing
25 mg hydroxyzine hydrochloride, USP packaged in bottles
of 100, 500 and 1000 tablets.
Hydroxyzine Hydrochloride Tablets USP, 50 mg are available
as white, round, film-coated, convex tablets, debossed with
“TV” on one side and “309” on the other side, containing
50 mg hydroxyzine hydrochloride, USP packaged in bottles
of 100, 500 and 1000 tablets.
Dispense in a tight container as defined in the USP, with a
child-resistant closure (as required).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled
Room Temperature].
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH
OF CHILDREN.
Manufactured In Croatia By:
PLIVA HRVATSKA d.o.o.
Zagreb, Croatia
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. B 4/2014
Reference ID: 3510120Reference ID: 3519087
