HYDROXYZINE HYDROCHLORIDE- 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:

Mylan Institutional Inc.

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 hydrochloride tablets 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 hydrochloride tablets are 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 hydrochloride tablets 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 t

Product summary:

Hydroxyzine Hydrochloride Tablets, USP are available containing 10 mg, 25 mg or 50 mg of hydroxyzine hydrochloride, USP. The 10 mg tablets are light blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and H10 on the other side. They are available as follows: NDC 51079-796-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 25 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and H25 on the other side. They are available as follows: NDC 51079-806-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 50 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and H50 on the other side. They are available as follows: NDC 51079-816-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-10796 R4 12/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
MYLAN INSTITUTIONAL INC.
----------
DESCRIPTION
Hydroxyzine hydrochloride has the chemical name of (±)-2-[2-[4-(
_p_-Chloro-α-phenylbenzyl)-1-
piperazinyl]ethoxy]ethanol dihydrochloride.
Hydroxyzine hydrochloride, USP occurs as a white, odorless powder
which is freely soluble in water.
Each tablet for oral administration contains 10 mg, 25 mg or 50 mg
hydroxyzine hydrochloride. Inactive
ingredients include: anhydrous lactose, colloidal silicon dioxide,
crospovidone, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,
sodium lauryl sulfate, talc and
titanium dioxide. In addition, the 10 mg tablets also contain FD&C
Blue No. 1 Aluminum Lake and the 25
mg and 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.
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
a