HYDROXYZINE- hydroxyzine hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROXYZINE HYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)

Available from:

Major Pharmaceuticals

INN (International Name):

HYDROXYZINE HYDROCHLORIDE

Composition:

HYDROXYZINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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 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. Hydroxyzine, when administered

Product summary:

Hydroxyzine hydrochloride tablets, USP are available as follows: Hydroxyzine hydrochloride tablets, USP 10 mg are supplied as white, round, film coated, biconvex tablets debossed “K10” on one side and plain on the other sid in bottles of 100. NDC 0904-0357-60.   Hydroxyzine hydrochloride tablets, USP 25 mg are supplied as white, round, film coated, biconvex tablets debossed “K11” on one side and plain on the other side in bottles of 100, NDC 0904-0358-60.  Bottles of 1000, NDC 0904-0358-80. Hydroxyzine hydrochloride tablets, USP 50 mg are supplied as white, round, film coated, biconvex tablets debossed “K12” on one side and plain on the other side in bottles of 100. NDC 0904-0359-60.  Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20o to 25oC with excursions permitted between 15o to 30oC (59o to 86oF) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED
MAJOR PHARMACEUTICALS
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HYDROXYZINE HYDROCHLORIDE TABLETS, USP RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride has the chemical name of
2-[2-[4-(_p_-Chloro-α-phenylbenzyl)- 1-
piperazinyl]ethoxy] ethanol dihydrochloride. C21H27CIN2O2•2HCl M.W.
447.83 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
hydrochloride. Inactive ingredients include
carnauba wax, colloidal silicon dioxide, crospovidone, lactose
monohydrate, macrogol/polyethylene
glycol 3350, magnesium stearate, microcrystalline cellulose, polyvinyl
alcohol - part. hydrolyzed, talc
and titanium dioxide.
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.
CLINICAL STUDIES
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 an