OxyContin Controlled-Release Tablets 40mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

OXYCODONE HYDROCHLORIDE

Boleh didapati daripada:

MUNDIPHARMA PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

OXYCODONE HYDROCHLORIDE

Unit dalam pakej:

30tablet Tablets; 20tablet Tablets

Dikeluarkan oleh:

Purdue Pharmaceuticals L.P.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
OXYCONTIN
® CONTROLLED-RELEASE
TABLETS
Oxycodone hydrochloride (10mg, 20mg, 40mg, 80mg)
WHAT IS IN THIS LEAFLET
1.
What OxyContin® is used for
2.
How OxyContin®works
3.
Before you use OxyContin®
4.
How to use OxyContin®
5.
While you are taking it
6.
Side effects
7.
Storage and Disposal of
OxyContin®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT OXYCONTIN® IS USED FOR
These tablets have been prescribed for
you by your doctor to relieve moderate
to severe pain that require daily around-
the-clock, long-term treatment with an
opioid, when other pain treatments such
as non-opioid pain medicines or
immediate-release opioids medicines do
not treat your pain well enough or you
cannot tolerate them.
A long-acting (extended-release) opioid
pain medicine that can put you at risk
for overdose and death. Even if you
take your dose correctly as prescribed
you are at risk for opioid addiction,
abuse, and misuse that can lead to
death.
Not for use to treat pain that is not
around-the-clock.
HOW
OXYCONTIN®
WORKS
Oxycodone is a full opioid agonist with
no antagonist properties. It has an
affinity for kappa, mu and delta opiate
receptors in the brain and spinal cord.
Oxycodone is similar to morphine in its
action.
The therapeutic effect is mainly
analgesic, antianxiety and sedative.
BEFORE YOU TAKE OXYCONTIN®
_-When you must not use it _
Do not take OxyContin
®
tablets if
-
are allergic (hypersensitive) to
oxycodone
-
severe asthma, trouble breathing or
other lung problems
-
a bowel blockage or have narrowing
of the stomach or intestines
_-Before you start take it _
Before treatment with these tablets tell
your doctor or pharmacist if you:
-
have low blood pressure
(hypotension) including from having
low blood volume
-
have head injury
-
have liver or kidney problem
-
have adrenal gland problems, such
as Addison’s disease
-
have convulsions or seizures
-
have alcoholism
-
have hallunications or othe

Ciri produk

For Hospital Use Only
PRODUCT INFORMATION
_OXYCONTIN_
® CONTROLLED RELEASE TABLETS (10 MG, 20 MG, 40 MG, 80 MG)
CAUTION:
THISPREPARATION
MAYBEHABITFORMINGONPROLONGEDUSE
NAME OF THE MEDICINE
Non-proprietary name:Oxycodone hydrochloride
Chemical name
:4,5
α
-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
hydrochloride
CAS No.
:124-90-3
Molecular formula (anhydrous form): C
18
H
21
NO
4
.HCl
Molecular weight (anhydrous form):
351.83
Molecular formula (monohydrate form): C
18
H
21
NO
4
.HCl.H
2
0
Molecular weight (monohydrate
form): 369.84
Structural formula (anhydrous form):
DESCRIPTION
Oxycodone hydrochloride is a white, crystalline, odourless powder
readily soluble in water,
sparingly soluble in ethanol and nearly insoluble in ether.
_OxyContin _
tablets are modified release tablets designed to provide delivery of
oxycodone over
12 hours.
_OxyContin _
10 mg, 20 mg, 40 mg, and 80 mg tablets have been reformulated, and
comprise a
matrix formulation with a hydrogelling property (i.e. particles or
whole tablets become highly
viscous (gel-like) in water), intended to be crush-deterrent and to
reduce the rapid release of
oxycodone upon accidental or intentional misuse. The tablets have been
heat-treated to increase
the mechanical strength of the tablet.
The physical properties of the reformulated
_OxyContin _
tablets were examined following an
extensive
battery
of
physical
manipulations.
Beyond
demonstrating
that
the
reformulated
_OxyContin _
tablets are harder to crush than another controlled release oxycodone
formulation,
testing over the range of the reformulated
_OxyContin _
tablets fragment sizes showed that some of
the controlled release properties were still retained. Hydrogelling
properties continued to be
demonstrated.
The inactive ingredients in the reformulated
_OxyContin _
10 to 80 mg tablets are: polyethylene
oxide, butylated hydroxytoluene (BHT) and magnesium stearate. The
tablets’ film coating also
contain: Opadry Y-5-18024-A White (US version) (ARPING No. 3548)
(10mg), Opadry YS- 1-
14518-A Pink