Tramille Capsule 50mg

国: マレーシア

言語: 英語

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

有効成分:

TRAMADOL HYDROCHLORIDE

から入手可能:

MILRIN PHARMACEUTICAL CO. (M) SDN BHD

INN（国際名）:

TRAMADOL HYDROCHLORIDE

パッケージ内のユニット:

500capsule Capsules; 100capsule Capsules

製:

PT NOVELL PHARMACEUTICAL LABORATORIES.

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TRAMILLE CAPSULE 50MG
Tramadol HCl 50mg
1
WHAT IS IN THIS LEAFLET
1.
What is Tramille used for
2.
How Tramille works
3.
Before you take Tramille
4.
How to take Tramille
5.
While you are using it
6.
Possible side-effects
7.
Storage and disposal of Tramille
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT IS TRAMILLE USED FOR
Tramille
contains
the
active
ingredient Tramadol Hydrochloride.
It
is
used
for
the
treatment
of
moderate to severe pain.
HOW DOES TRAMILLE WORK
Tramille is a painkiller belonging to
the class of the opioids that acts on
the central nervous system. It relieves
pain by acting on specific nerve cells
of the spinal cord and brain.
BEFORE YOU TAKE TRAMILLE
_When you must NOT take it _
_ _
Do not take Tramille if you:

are less than 12 years old.

have
shallow
breathing
or
other
breathing problems

are pregnant or breastfeeding

have
known
hypersensitivity
to
tramadol hydrochloride or to any
of
the
ingredients
in
this
preparation.

are
taking
alcohol,
hypnotics,
analgesic
or
other
drugs
that
influence
the
central
nervous
system.

are on monoamine oxidase (MAO)
inhibitor treatment for depression.
Do not take this medicine if any of
the above applies to you. If you are
not
sure,
talk
to
your
doctor
or
pharmacist before taking Tramille.
_Before taking Tramille _
_ _
Tell your doctor or pharmacist if you:

have a head injury or brain disease

have difficulty in breathing

suffer from consciousness disorder

suffer
from
a
liver
or
kidney
disease

think that you are addicted to other
pain relievers

are,
or
suspect
that
you
are
pregnant

have
tendency
of
developing
seizures
_Taking other medicines _
Before you consume Tramille, do tell
your doctor or pharmacist if you have
recently taken, are taking or intend to
take any other medications
Tramille
may
interact
with
the
following medications:

a
MAO
inhibitor
for
depression.
Potential
serious
consequences
affecting th

製品の特徴

TRAMILLE CAPSULE 50MG
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each capsule contains:
Tramadol Hydrochloride 50 mg
PRODUCT DESCRIPTION
White granule, capsule no.2, cap colored pink opaque and body
colored maroon opaque.
INDICATIONS
Treatment of moderate to severe pain.
PHARMACODYNAMICS
Tramadol is a centrally acting synthetic analgesic compound. It is
a
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
inhibition of neuronal reuptake of noradrenaline (norepineph.
rine) and enhancement of serotonin release.
Tramadol opioid activity derives from low affinity binding of the
parent compound to mu-opioid receptors and higher affinity
binding
of
the
active
metabolite,
O-
desmethyl
tramadol.
Compared to morphine, tramadol does not show respiratory
depression when given within the analgesic dosage interval. The
effect
of
tramadol
is
considered
1/10
to
1/6
the
effect
of
morphine. The gastrointestinal motility is not affected. There is
minimal effect on the cardiovascular system. The contribution to
human analgesia of tramadol relative to the active metabolite is
unknown.
Tramadol has an antitussive effect. Animal studies have revealed
a reduced dependence potential compared with morphine and a
very slight tolerance potential.
PHARMACOKINETICS
ABSORPTION
Racemic tramadol is rapidly and almost completely absorbed
after oral administration. The mean absolute bioavailability of a
100 mg oral dose is approximately 75%. The mean peak plasma
concentration of racemic tramadol and M1 occurs at 2 and 3
hours,
respectively,
after
administration
in
healthy
adults.
DISTRIBUTION
The volume of distribution of tramadol was 2.6 and 2.9 liters/kg in
male
and
female
subjects,
respectively,
following
a
100
mg
intravenous dose. The binding of tramadol to human plasma
proteins is approximately 20%.
METABOLISM
Tramadol is extensively metabolized by a number of pathways,
including CYP2D6 and CYP3A4, as well as by conjugatio