NALTREXONE HYDROCHLORIDE- naltrexone hydrochloride tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Preferred Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

NALTREXONE HYDROCHLORIDE

Σύνθεση:

NALTREXONE HYDROCHLORIDE 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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.

Περίληψη προϊόντος:

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: 20 Tablets       NDC 68788-7084-2 30 Tablets       NDC 68788-7084-3 60 Tablets       NDC 68788-7084-6 90 Tablets       NDC 68788-7084-9 100 Tablets       NDC 68788-7084-1 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight container. Manufactured For: Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA Manufactured By: Intas Pharmaceuticals Limited, Plot No : 457, 458, Village – Matoda, Bavla Road, Ta.- Sanand, Dist.- Ahmedabad – 382 210. India. 10 4003 2 652187 Issued February 2014 Repackaged by: Preferred Pharmaceuticals Inc.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS 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