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:

Precision Dose 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 are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone has 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 LAAM (levo- alpha-acetyl-methadol)]. - 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. - Any individual with acute hepatitis or liver failure. Naltrexone is a pure opioid antagonist. It does not lead to physical or p

leaflet_short:

Naltrexone Hydrochloride Tablets, USP 50 mg are yellow, round film-coated tablets, bisected on one side, debossed with "EL" on one side of the bisect and "15" on the other side of the bisect. NDC 68094-853-62 Thirty (30) unit dose 50 mg tablets per carton Store at 20° to 25° C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
PRECISION DOSE INC.
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NALTREXONE HYDROCHLORIDE TABLETS USP, FILM COATED
RX ONLY
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, (5a)-. The structural formula is as follows:
C
H
NO ∙HCl
Molecular Weight: 377.87
Naltrexone hydrochloride is a white, crystalline compound. The
hydrochloride salt is
soluble in water to the extent of about 100 mg/ml. Each film-coated
tablet, for oral
administration, contains 50 mg of naltrexone hydrochloride. In
addition each film-coated
tablet contains the following inactive ingredients: carnauba wax
powder, colloidal silicon
dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose,
lactose
anhydrous, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, titanium
dioxide and yellow iron oxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC ACTIONS
Naltrexone hydrochloride is a pure opioid antagonist. It markedly
attenuates or
20
23
4
completely blocks, reversibly, the subjective effects of intravenously
administered
opioids.
When co-administered 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.