TRAMOX CAPSULE 50MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TRAMADOL HYDROCHLORIDE

Boleh didapati daripada:

APEX PHARMACY MARKETING SDN. BHD.

INN (Nama Antarabangsa):

TRAMADOL HYDROCHLORIDE

Unit dalam pakej:

100Capsule Capsules

Dikeluarkan oleh:

DELORBIS PHARMACEUTICALS LTD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
TRAMOX CAPSULE
Tramadol hydrochloride 50mg
1
WHAT IS IN THIS LEAFLET:
1.
What Tramox capsule
is used for
2.
How Tramox capsule works
3.
Before you use
Tramox capsule
4.
How to use Tramox capsule
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Tramox capsule
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT TRAMOX CAPSULE IS USED
FOR
Tramadol hydrochloride is the
active substance in Tramox
capsule. It is a painkiller
belonging to the class of opioids
that acts on the central nervous
system (nervous system
consisting of brain and spinal
cord). Tramox capsule is used for
the treatment of moderate to
severe pain.
HOW TRAMOX CAPSULE WORKS
Tramox capsule relieves pain
by acting on specific nerve
cells of the spinal cord and
brain.
BEFORE YOU USE TRAMOX
CAPSULE
-
_When you must not use it_
Do
not
take
Tramox
capsule if you have any of
the
following
medical
conditions:
• if you are allergic
(hypersensitive) to
Tramadol
hydrochloride or any of
the other ingredients of
Tramox capsule
• in acute poisoning with
alcohol, sleeping pills,
pain relievers or other
psychotropic medicines
(medicines that affect
mood and emotions);
• if you are also taking
Monoamine oxidase
inhibitors (MAOIs)
(certain medicines used
for treatment of
depression) or have
taken them in the last 14
days before treatment
with Tramox capsule
(see “
_Taking other _
_medicines_
”);
Do not take Tramox if:
‐
you are less than 12 years
old
‐
you have slow or shallow
breathing, or other
breathing problems
‐
you are pregnant
‐
you are breastfeeding
-
_Before you start to use it _
Tell your doctor or
pharmacist:
• if you think that you are
addicted to other pain
relievers (opioids);
• if you suffer from
consciousness disorders (if
you feel that you are going
to faint);
• if you are in a state of shock;
• if you suffer from increased
pressure in the brain
(possibly after a head injury
or brain disease

Ciri produk

COMPOSITION
Tramadol hydrochloride 50mg
PRODUCT DESCRIPTION
Buff, hard gelatine capsule, size 3, containing
white to off-white granular powder.
PHARMACODYNAMICS
Tramadol hydrochloride is a centrally acting
analgesic. It is non selective pure agonist at mu,
delta and kappa opioid receptors with a higher
affinity for the mu receptor. Other mechanisms
which may contribute to its analgesic effect are
inhibitor of neuronal reuptake of noradrenaline
and enhancement of serotonin release.
PHARMACOKINETICS
After oral administration, tramadol is almost
completely
absorbed.
Mean
absolute
bioavailability is approximately 70% following a
single dose and increases to approximately 90%
at
steady
state.
Plasma
protein
binding
of
tramadol
is
approximately
20%.
When
C14
labelled tramadol was administered to humans,
approximately 90% was excreted via the kidneys
with the remaining 10% appearing in the faeces.
Tramadol has a linear pharmacokinetic profile
within the therapeutic dosage range. The half life
of the terminal elimination phase (t½β) was
6.0±1.5
h
in
young
volunteers.
Tramadol
pharmacokinetics show little age dependence in
volunteers up to the age of 75 years. In volunteers
aged over 75 years, t½β was 7.0±1.6 h on oral
administration.
Following a single oral dose administration of
tramadol 100mg as capsules or tablets to young
healthy volunteers, plasma concentrations were
detectable within approximately 15-45 minutes
with a mean Cmax of 280 to 308 mcg/L and
Tmax of 1.6 to 2h.
Tramadol is metabolized by the cytochrome P450
iso-enzyme
CYP2D6.
It
undergoes
biotransformation to a number of metabolites
mainly by means of N- and O-demethylation. O-
desmethyl
tramadol
appears
to
be
the
most
pharmacologically active metabolite, showing
analgesic activity in rodents. As humans excrete a
higher percentage of unchanged tramadol than
animals it is believed that the contribution made
by this metabolite to analgesic activity is likely to
be less in humans than animals. In humans the
plasma concentration of this metabolite is abo