HYDROXYZINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

HYDROXYZINE HYDROCHLORIDE

Composition:

HYDROXYZINE HYDROCHLORIDE 25 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. Oral hydroxyzine hydrochloride

Product summary:

Hydroxyzine Hydrochloride Tablets, USP are available as follows: 25 mg tablets: round, film coated white tablets. Debossed H over 501 on one side and plain on the reverse side. They are available as follows: NDC 63629-1856-1: 30 TABLET in a BOTTLE NDC 63629-1856-2: 60 TABLET in a BOTTLE NDC 63629-1856-3: 20 TABLET in a BOTTLE NDC 63629-1856-4: 100 TABLET in a BOTTLE NDC 63629-1856-5: 15 TABLET in a BOTTLE NDC 63629-1856-6: 90 TABLET in a BOTTLE NDC 63629-1856-7: 19 TABLET in a BOTTLE NDC 63629-1856-8: 10 TABLET in a BOTTLE 50 mg tablets: round, film coated white tablets. Debossed H over 502 on one side and plain on the reverse side. They are available as follows: NDC 63629-4929-1: 120 TABLET in a BOTTLE NDC 63629-4929-2: 20 TABLET in a BOTTLE NDC 63629-4929-3: 30 TABLET in a BOTTLE NDC 63629-4929-4: 60 TABLET in a BOTTLE NDC 63629-4929-5: 90 TABLET in a BOTTLE 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
BRYANT RANCH PREPACK
----------
RX ONLY
DESCRIPTION
Hydroxyzine hydrochloride, USP has the chemical name of
(±)-2-[2-[4-(_p_-Chloro-α-
phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride.
Molecular Formula: C
H
ClN O · 2HCl Molecular Weight: 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,
colloidal silicon
dioxide, crospovidone, hypromellose, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polysorbate 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.
21
27
2
2
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.