NALTREXONE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

NALTREXONE HYDROCHLORIDE

Composition:

NALTREXONE HYDROCHLORIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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. They are available in bottles of: 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
NUCARE PHARMACEUTICLS, 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 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.
20
23
4
The administration of naltrexone is not associated with the
development of tolerance or dependence. In
subjects physically dependent on opioids, naltrexone will precipitate
withdrawal symptoma