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:

Avera McKennan Hospital

SNN (starptautisko nepatentēto nosaukumu):

Naltrexone Hydrochloride

Kompozīcija:

Naltrexone Hydrochloride 50 mg

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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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 symptomatolo