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:

TAGI Pharma Inc.

INN (International Name):

Naltrexone Hydrochloride

Composition:

Naltrexone Hydrochloride 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naltrexone Hydrochloride Tablets USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone Hydrochloride Tablets USP have 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

Product summary:

Naltrexone Hydrochloride Tablets, USP are available as: 50 mg; 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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
TAGI PHARMA INC.
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NALTREXONE HYDROCHLORIDE TABLETS, USP
50 MG
Opioid Antagonist
RX ONLY
DESCRIPTION
Naltrexone hydrochloride, an opioid antagonist, are 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, (5a)-. The structural formula is as follows:
C
H NO ·HCl
Molecular Weight: 377.86
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
are available in scored film-
coated tablets containing 50 mg of naltrexone hydrochloride.
Naltrexone Hydrochloride Tablets USP
also contain: 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
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
hydrochlor