HYDROXYZINE HYDROCHLORIDE- hydroxyzine hydrochloride tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

HydrOXYzine Hydrochloride (UNII: 76755771U3) (hydrOXYzine - UNII:30S50YM8OG)

Verfügbar ab:

QPharma Inc

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Hydroxyzine Hydrochloride Tablets, USP are supplied as: 10 mg - White, biconvex, circular, coated tablets with '112' debossed on one face and 'N' on the other face. Bottles of 12 tablets          NDC 42708-060-12 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. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Toll Free : 1-800-206-7821 Manufactured by: Piramal Enterprises Limited, Plot No. 67-70, Sector-2, Pithampur 454 775, Dist.: Dhar, Madhya Pradesh, INDIA. October 2016

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

HYDROXYZINE HYDROCHLORIDE- HYDROXYZINE HYDROCHLORIDE TABLET
QPHARMA INC
----------
RX ONLY
DESCRIPTION
HydrOXYzine hydrochloride, USP 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 very soluble in water;
soluble in chloroform; slightly soluble in acetone; practically
insoluble in ether.
Each tablet for oral administration contains 10 mg, 25 mg or 50 mg
hydrOXYzine hydrochloride USP.
Inactive ingredients for 10 mg include anhydrous lactose, colloidal
silicon dioxide, crospovidone,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
pregelatinized starch and titanium dioxide.
Inactive ingredients for 25 mg include anhydrous lactose, colloidal
silicon dioxide, crospovidone,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
pregelatinized starch, sodium starch glycolate and titanium dioxide.
Inactive ingredients for 50 mg include anhydrous lactose, colloidal
silicon dioxide, crospovidone,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
pregelatinized starch, sodium starch glycolate 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
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 studi