HYDROXYZINE HYDROCHLORIDE tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Aurobindo Pharma Limited

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

Hydroxyzine Hydrochloride Tablets USP, 10 mg are lavender, round, biconvex, film- coated tablets debossed with "1" on one side and plain on other side. They are supplied as follows:                 Bottles of 100                                                 NDC 59651-499-01                 Bottles of 500                                                 NDC 59651-499-05                 Bottles of 1,000                                              NDC 59651-499-99                 Blister of 10x10 Unit-Dose Tablets                  NDC 59651-499-78 Hydroxyzine Hydrochloride Tablets USP, 25 mg are lavender, round, biconvex, film- coated tablets debossed with "2" on one side and plain on other side. They are supplied as follows:                   Bottles of 100                              NDC 59651-500-01                   Bottles of 500                              NDC 59651-500-05                   Bottles of 1,000                           NDC 59651-500-99 Hydroxyzine Hydrochloride Tablets USP, 50 mg are purple, round, biconvex, film-coated tablets debossed with "7" on one side and plain on other side. They are supplied as follows:                 Bottles of 100                              NDC 59651-501-01                 Bottles of 500                              NDC 59651-501-05                 Bottles of 1,000                           NDC 59651-501-99 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 10/2021

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

HYDROXYZINE HYDROCHLORIDE - HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
AUROBINDO PHARMA LIMITED
----------
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. C
H CLN O •2HCL MOLECULAR WEIGHT 447.83
Hydroxyzine hydrochloride USP occurs as a white 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 FD&C blue #2 aluminum
lake,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polysorbate 80, pregelatinized starch (corn), and
titanium dioxide. In
addition, 10 mg contains D&C red #30 aluminum lake, 25 mg and 50 mg
contains D&C
red #7 calcium 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
21
27
2
2
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 o