HYDROXYZINE HYDROCHLORIDE- hydroxyzine tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Amneal Pharmaceuticals LLC

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. Hydroxyzine is contraindicated in patients with a prolonged QT interval. 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 it.

उत्पाद समीक्षा:

Hydroxyzine Hydrochloride Tablets, USP are white, round, film-coated, biconvex tablets containing 10 mg, 25 mg, or 50 mg of Hydroxyzine Hydrochloride, and supplied as: 10 mg Tablets: Debossed ‘75’ on one side and ‘A’ on the other NDC 65162-575-10                Bottles of 100 NDC 65162-575-50                Bottles of 500 NDC 65162-575-11                Bottles of 1000 25 mg Tablets: Debossed ‘71’ on one side and ‘AN’ on the other NDC 65162-671-10                Bottles of 100 NDC 65162-671-50                Bottles of 500 NDC 65162-671-11                Bottles of 1000 50 mg Tablets: Debossed ‘77’ on one side and ‘AN’ on the other NDC 65162-577-10                Bottles of 100 NDC 65162-577-50                Bottles of 500 NDC 65162-577-11                Bottles of 1000 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (if required) and in a tight container as defined in the USP. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev: 10-2016-00

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS LLC
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HYDROXYZINE HYDROCHLORIDE TABLETS, USPRX ONLY
DESCRIPTION
Hydroxyzine hydrochloride, USP has the chemical name of
2-[2-[4-(p-Chloro-α-
phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride.
C
H CLN 0 •2HCI
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 HCl,
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
21
27
2 2
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 a