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:

Bryant Ranch Prepack

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 hydrochloride tablets have 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-acetylmethadol)]. - 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

Product summary:

Product: 71335-1480 NDC: 71335-1480-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-1480-2 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-1480-3 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-1480-4 45 TABLET, FILM COATED in a BOTTLE NDC: 71335-1480-5 120 TABLET, FILM COATED in a BOTTLE NDC: 71335-1480-6 15 TABLET, FILM COATED in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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NALTREXONE HYDROCHLORIDE TABLETS USP
50 MG
RX ONLY
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.
Naltrexone hydrochloride has the chemical name of
17-(cyclopropylmethyl)-4,5α-epoxy-
3,14-dihydroxymorphinan-6-one hydrochloride.
It has the following structural formula:
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
USP for oral administration are available as film coated tablets,
containing 50 mg of
naltrexone hydrochloride.
In addition, each tablet contains the following inactive ingredients:
crospovidone,
hydroxypropyl methylcellulose, lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
silicon dioxide, titanium
dioxide, yellow iron oxide and red iron oxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC ACTIONS
Naltrexone 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.
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.
Clinical studies indicate that 50 mg of naltrexone hydroch