NALTREXONE HYDROCHLORIDE tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Sun Pharmaceutical Industries, Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride 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 o

Produktu pārskats:

Naltrexone Hydrochloride Tablets, USP are available as follows: 50 mg: Yellow, round, biconvex, film-coated tablets debossed with “326” on one side and scored on other side. Bottles of 30’s with Child Resistant Cap……………..NDC 47335-326-83 Bottles of 100’s with Child Resistant Cap…................NDC 47335-326-88 Bottles of 100’s with Non Child Resistant Cap…........NDC 47335-326-08 Bottles of 1000’s with Non Child Resistant Cap……..NDC 47335-326-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
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NALTREXONE HYDROCHLORIDE TABLETS, USP
OPIOID ANTAGONIST
DESCRIPTION
Naltrexone hydrochloride, an opioid antagonist, is a synthetic
congener of oxymorphone
with no opioid agonist properties. Naltrexone hydrochloride 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, (5 )-. 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 is available
in scored film-coated tablets containing 50 mg of naltrexone
hydrochloride, USP.
Naltrexone hydrochloride tablets, USP also contain: lactose
monohydrate,
microcrystalline cellulose, colloidal silicon dioxide, crospovidone,
magnesium stearate,
hypromellose, titanium dioxide, polyethylene glycol, iron oxide
yellow, polysorbate 80
and iron oxide red. test
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 symptomatolog