NALTREXONE HYDROCHLORIDE TABLETS USP

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NALTREXONE HYDROCHLORIDE

Available from:

STERINOVA INC.

ATC code:

N07BB04

INN (International Name):

NALTREXONE

Dosage:

50MG

Pharmaceutical form:

TABLET

Composition:

NALTREXONE HYDROCHLORIDE 50MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

OPIATE ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0118591001; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-02-11

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR N
ALTREXONE H
YDROCHLORIDE T
ABLETS USP
50MG
OPIOID ANTAGONIST
STERINOVA INC.
3005 Avenue José-Maria-Rosell
St-Hyacinthe, Québec J2S 0J9
Canada
Date of Preparation:
February 05, 2016
Control #: 185075
2
PRODUCT MONOGRAPH
PR N
ALTREXONE H
YDROCHLORIDE T
ABLETS USP
50MG
THERAPEUTIC CLASSIFICATION
Opioid Antagonist
ACTION AND CLINICALPHARMACOLOGY
PHARMACODYNAMIC ACTIONS
Naltrexone Hydrochloride Tablets USP (naltrexone hydrochloride) is a
pure opioid antagonist. It
markedly attenuates or
completely blocks, reversibly, the subjective effects of intravenously
administered opioids. [In
this context, the term opioid is used to describe 1) classic morphine-
like agonists and 2)
analgesics possessing agonist and antagonist activity (eg,
butorphanol,
nalbuphine and
pentazocine)].
When co-administered with morphine, on a chronic basis, naltrexone
hydrochloride blocks the
physical
dependence to morphine and presumably 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.
While the mechanism of action is not fully understood, the
preponderance of evidence suggests
that naltrexone hydrochloride blocks the effects of opioids by
competitive binding (ie, analogous
to competitive inhibition of enzymes) at opioid receptors. This makes
the blockade produced
potentially surmountable, but overcoming full naltrexone blockade by
administration of very high
doses of
opiates has resulted in excessive symptoms of histamine release in
experimental
subjects.
The mechanism of action of naltrexone hydrochloride in the treatment
of alcoholism is not
understood; however,
involvement of the endogenous opioid system is suggested by
preclinical
data. Naltrexone hydrochloride, an opioid
receptor antagonist, competitively binds to such
receptors and may block the effects of
endogenous opioids. Opioid antagonists have been
shown to reduce alcohol consumption by
animals, and naltrexone hydro