REVIA TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NALTREXONE HYDROCHLORIDE

Available from:

TEVA CANADA LIMITED

ATC code:

N07BB04

INN (International Name):

NALTREXONE

Dosage:

50MG

Pharmaceutical form:

TABLET

Composition:

NALTREXONE HYDROCHLORIDE 50MG

Administration route:

ORAL

Units in package:

50

Prescription type:

Prescription

Therapeutic area:

OPIATE ANTAGONISTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2015-05-05

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
REVIA
TM
(NALTREXONE
HYDROCHLORIDE)
TABLETS, 50
MG
Teva Standard
OPIOID ANTAGONIST
Teva Canada Limited
30 Novopharm Court
Toronto, ON M1B 2K9
Canada
www.tevacanada.com
Date of
Revision:
July 16, 2020
Control #: 234458
1
PRODUCT
MONOGRAPH
PR
REVIA
TM
(NALTREXONE HYDROCHLORIDE)
Tablets,
50
mg
THERAPEUTIC
CLASSIFICATION
Opioid
Antagonist
ACTION AND CLINICAL
PHARMACOLOGY
PHARMACODYNAMIC ACTIONS
REVIA (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, REVIA blocks
the
physical
dependence to morphine and presumably other opioids. REVIA 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 REVIA 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 REVIA in the treatment of alcoholism is not
understood;
however,
involvement of the endogenous opioid system is suggested by
preclinical data. REVIA,
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 REVIA has been shown to reduce alcohol consumption in
clinical
studies.
REVIA is not aversive therapy and does not cause