HYDROXYZINE HYDROCHLORIDE tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

Hydroxyzine Dihydrochloride (UNII: 76755771U3) (hydroxyzine - UNII:30S50YM8OG)

Fáanlegur frá:

Northstar RxLLC

INN (Alþjóðlegt nafn):

HydrOXYzine Hydrochloride

Samsetning:

HydrOXYzine Hydrochloride 10 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

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 100 tablets          NDC 16714-081-10 Bottles of 500 tablets          NDC 16714-081-11 25 mg- White, biconvex, circular, coated tablets with 'N004' debossed on one face and plain on the other face. Bottles of 100 tablets          NDC 16714-082-10 Bottles of 500 tablets          NDC 16714-082-11 Bottles of 1000 tablets        NDC 16714-082-12 50 mg- White, biconvex, circular, coated tablets with 'N006' debossed on one face and plain on the other face. Bottles of 100 tablets          NDC 16714-083-10 Bottles of 500 tablets          NDC 16714-083-11 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 Number: 1-800-206-7821   Manufactured by: Piramal Pharma Limited, Plot No. 67-70, Sector-2, Pithampur 454 775, Dist.: Dhar, Madhya Pradesh, INDIA. October 2020

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

HYDROXYZINE HYDROCHLORIDE - HYDROXYZINE HYDROCHLORIDE TABLET
NORTHSTAR RXLLC
----------
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 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