NALTREXONE HYDROCHLORIDE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

NALTREXONE HYDROCHLORIDE (UNII: Z6375YW9SF) (NALTREXONE - UNII:5S6W795CQM)

זמין מ:

Accord Healthcare, Inc.

INN (שם בינלאומי):

NALTREXONE HYDROCHLORIDE

הרכב:

NALTREXONE HYDROCHLORIDE 50 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Naltrexone hydrochloride tablets USP 50 mg is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets USP 50 mg has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions. Naltrexone hydrochloride is contraindicated in - Patients receiving opioid analgesics. - Patients currently dependent on opioids, including those currently maintained on opiate agonists (e.g., methadone ) or partial agonists (e.g., buprenorphine) - Patients in acute opioid withdrawal (see WARNINGS ). - Any individual who has failed the naloxone challenge test or who has a positive urine screen for opioids. - Any individual with a history of sensitivity to naltrexone hydrochloride or any other components of this product.It is not known if there is any cross-sensitivity with naloxone or the phenanthrene containing opioids. Naltrexone hydrochloride is a pure opioid antagonist. It does not lead to physical or psychological dependence. Tolerance to the opioid antagonist effect is not known to occur.

leaflet_short:

Naltrexone hydrochloride tablets USP 50 mg yellow coloured, oval, biconvex, film-coated tablets with breakline on one side and '50' debossed on the other side. Available in bottles of: 30 Tablets with a child-resistant closure       NDC 16729-081-10 100 Tablets with a child-resistant closure     NDC 16729-081-01 500 Tablets                                                     NDC 16729-081-16 1000 Tablets                                                   NDC 16729-081-17 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight container. For more information, go to www.accordhealthcare.us or call Accord Healthcare at 1-866-941-7875. Manufactured For: Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA. Manufactured By: Intas Pharmaceuticals Limited, Plot No : 457, 458, Village – Matoda, Bavla Road, Ta.- Sanand, Dist.- Ahmedabad – 382 210. India. 10 6947 0 6025148 Issued October 2023

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
ACCORD HEALTHCARE, INC.
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NALTREXONE HYDROCHLORIDE TABLETS USP 50 MG
OPIOID ANTAGONIST
DESCRIPTION
Naltrexone hydrochloride, an opioid antagonist, is a synthetic
congener of oxymorphone
with no opioid agonist properties. Naltrexone differs in structure
from oxymorphone in
that the methyl group on the nitrogen atom is replaced by a
cyclopropylmethyl group.
Naltrexone hydrochloride is also related to the potent opioid
antagonist, naloxone, or n-
allylnoroxymorphone.
The chemical name for naltrexone hydrochloride is Morphinan-6-one, 17-
(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, hydrochloride, (5α)-.
The structural
formula is as follows:
Naltrexone hydrochloride is a white, crystalline compound. The
hydrochloride salt is
soluble in water to the extent of about 100 mg/mL. Naltrexone
hydrochloride tablets,50
mg is available in film coated tablets, containing 50 mg of naltrexone
hydrochloride USP.
Naltrexone hydrochloride tablets 50 mg also contain: colloidal
anhydrous silica,
crospovidone, hydroxypropyl methylcellulose, lactose monohydrate,
magnesium
stearate, microcrystalline cellulose, polyethylene glycol 400,
polysorbate 80, iron oxide
red, iron oxide yellow and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC ACTIONS
Naltrexone hydrochloride is a pure opioid antagonist. It markedly
attenuates or
completely blocks, reversibly, the subjective effects of intravenously
administered
opioids.
When coadministered with morphine, on a chronic basis, naltrexone
hydrochloride
blocks the physical dependence to morphine, heroin and other opioids.
Naltrexone hydrochloride has few, if any, intrinsic actions besides
its opioid blocking
properties. However, it does produce some pupillary constriction, by
an unknown
mechanism.
The administration of naltrexone hydrochloride is not associated with
the development
of tolerance or dependence. In subjects physically dependent on
opioids, naltrexone
hydrochloride will precipitate withdrawal sympto