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:

Glenmark Pharmaceuticals Inc., USA

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 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 i

Product summary:

HydrOXYzine Hydrochloride Tablets, USP 10 mg, 25 mg and 50 mg are supplied as follows: 10 mg Tablets: Beige, film coated, round, biconvex tablets debossed with ‘IG ’ on one side and ‘275 ’ on other. Bottles of 100 NDC # 68462-352-01 Bottles of 500 NDC # 68462-352-05 25 mg Tablets: Beige, film coated, round, biconvex tablets debossed with ‘IG ’ on one side and ‘276 ’ on other. Bottles of 100 NDC # 68462-353-01 Bottles of 500 NDC # 68462-353-05 50 mg Tablets: Beige, film coated, round, biconvex tablets debossed with ‘IG ’ on one side and ‘277 ’ on other. Bottles of 100 NDC # 68462-354-01 Bottles of 500 NDC # 68462-354-05 Dispense in a tight container as defined in the USP. 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. Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma.com/usa Rev: 10/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET, FILM
COATED
GLENMARK PHARMACEUTICALS INC., USA
----------
HYDROXYZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
HydrOXYzine hydrochloride has the chemical name of
2-[2-[4-(_p_-Chloro- -phenylbenzyl)-1-
piperazinyl] ethoxy] ethanol dihydrochloride.
HydrOXYzine hydrochloride occurs as a white, odorless powder which is
very soluble in water.
Each tablet for oral administration contains 10 mg, 25 mg and 50 mg
hydrOXYzine HCl. Inactive
ingredients include colloidal silicon dioxide, crospovidone, dibasic
calcium phosphate anhydrous,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
sodium starch glycolate and
Opadry Beige (Hypromellose, Titanium dioxide, Iron oxide yellow, PEG
400, Iron oxide red, and
Polysorbate 80).
CLINICAL PHARMACOLOGY
HydrOXYzine hydrochloride is unrelated chemically to the
phenothiazines, reserpine, meprobamate, or
the benzodiazepines. HydrOXYzine hydrochloride 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 hydrochloride’s
clinical effects are usually noted within 15 to 30 minutes after oral
administration.
INDICATIONS AND USAGE
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 a