OXYCONTIN TABLET (EXTENDED-RELEASE)

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

OXYCODONE HYDROCHLORIDE

Fáanlegur frá:

PURDUE PHARMA

ATC númer:

N02AA05

INN (Alþjóðlegt nafn):

OXYCODONE

Skammtar:

15MG

Lyfjaform:

TABLET (EXTENDED-RELEASE)

Samsetning:

OXYCODONE HYDROCHLORIDE 15MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

50/100

Gerð lyfseðils:

Narcotic (CDSA I)

Lækningarsvæði:

OPIATE AGONISTS

Vörulýsing:

Active ingredient group (AIG) number: 0107552007; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2012-09-26

Vara einkenni

_Page 1 of 49_
PRODUCT MONOGRAPH
N
OXYCONTIN
®
OXYCODONE HYDROCHLORIDE CONTROLLED RELEASE TABLETS
5, 10, 15, 20, 30, 40, 60, 80, 120 AND 160 MG
PURDUE PHARMA STD.
OPIOID ANALGESIC
Purdue Pharma
575 Granite Court
Pickering, Ontario
L1W 3W8
DATE OF REVISION:
Control No.: 148343
November 8, 2011
®
Purdue Pharma, owner of the registered trademark OxyContin
_Page 2 of 49_
PRODUCT MONOGRAPH
NAME OF DRUG
N
OXYCONTIN
®
Oxycodone Hydrochloride Controlled Release Tablets
5, 10, 15, 20, 30, 40, 60, 80, 120 and 160 mg
Purdue Pharma Std.
PHARMACOLOGICAL CLASSIFICATION
Opioid Analgesic
ACTIONS
Oxycodone is a semi-synthetic opioid analgesic which exerts an agonist
effect at specific,
saturable opioid receptors in the CNS and other tissues. In man,
oxycodone produces a variety
of effects including analgesia, constipation from decreased
gastrointestinal motility, suppression
of the cough reflex, respiratory depression from reduced
responsiveness of the respiratory center
to CO
2
, nausea and vomiting via stimulation of the chemoreceptor trigger
zone, changes in mood
including euphoria and dysphoria, sedation, mental clouding, and
alterations of the endocrine
and autonomic nervous systems.
PHARMACODYNAMICS
Oxycodone retains at least one-half of its analgesic activity when
administered orally and with
acute dosing is approximately twice as potent as orally administered
morphine.
There is no intrinsic limit to the analgesic effect of oxycodone; like
morphine, adequate doses
will relieve even the most severe pain. Clinically, however, dosage
limitations are imposed by
OXYCONTIN
® (OXYCODONE HCL CR TABLETS) PRODUCT MONOGRAPH
_Page 3 of 49_
the adverse effects, primarily respiratory depression, nausea and
vomiting, which can result
from high doses.
Studies with
OXYCONTIN
®
(oxycodone hydrochloride controlled release tablets) and immediate
release
oxycodone
hydrochloride
tablets
(Oxy•IR
®
)
in
normal
volunteers
and
patients
demonstrate
a
consistent
relationship
between
oxycodone
dosage
and
plasma
oxycodone
concentrations as well