NALTREXONE HYDROCHLORIDE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

American Health Packaging

INN (Tarptautinis Pavadinimas):

NALTREXONE HYDROCHLORIDE

Sudėtis:

NALTREXONE HYDROCHLORIDE 50 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions. Naltrexone 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 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 is a pure opioid antagonist. It does not lead to physical or psychological dependence.

Produkto santrauka:

Naltrexone Hydrochloride Tablets USP 50 mg are available as a yellow film coated capsule-shaped tablet with a convex surface, debossed with a number “50” and a full bisect in between the 5 and 0 on one side and “1170” on the other side. Unit dose packages of 30 (3 x 10) NDC 68084-291-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2022 Mallinckrodt. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Mallinckrodt Pharmaceuticals as follows: (50 mg / 30 UD) NDC 68084-291-21 packaged from NDC 0406-1170 Distributed by: American Health Packaging Columbus, OH 43217 8229121/0223

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
NALTREXONE HYDROCHLORIDE TABLETS USP
RX ONLY
8229121/0223
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.
naltrexone hydrochloride
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
USP are available as film coated tablets, containing 50 mg of
naltrexone hydrochloride.
Naltrexone hydrochloride tablets also contain: crospovidone,
hydroxypropyl
methylcellulose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polysorbate 80, silicon dioxide, titanium
dioxide, yellow iron oxide
and red iron oxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC ACTIONS
Naltrexone 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
blocks the physical
dependence to morphine, heroin and other opioids.
Naltrexone 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 is not associated with the
development of tolerance or
dependence. In subjects physically dependent on opioids, naltrexone
will precipitate
withdrawal symptomatology.
Clinical studies indicate that 50 mg of naltrexone hydrochloride will
block the
pharmacologic effects of 25 mg of intravenously administered heroin
for periods as long
as 24 hours. Other data suggest that doubling the dose of naltrexone
hydr