NALTREXONE HYDROCHLORIDE tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Bryant Ranch Prepack

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

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 30:  NDC 63629-1046-1 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.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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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
20
23
4
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, naltrexon