NALTREXONE HYDROCHLORIDE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Bryant Ranch Prepack

INN (Nama Antarabangsa):

NALTREXONE HYDROCHLORIDE

Komposisi:

NALTREXONE HYDROCHLORIDE 50 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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. Product: 71335-0014 NDC: 71335-0014-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0014-2 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-0014-3 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-0014-4 45 TABLET, FILM COATED in a BOTTLE NDC: 71335-0014-5 120 TABLET, FILM COATED in a BOTTLE NDC: 71335-0014-6 15 TABLET, FILM COATED in a BOTTLE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight container. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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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 symptomat