Axcel Etoricoxib-60mg Tablet

国家: 马来西亚

语言: 英文

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

有效成分:

ETORICOXIB

可用日期:

KOTRA PHARMA (M) SDN. BHD.

INN（国际名称）:

ETORICOXIB

每包单位数:

100 Tablets; 3x10tablet Tablets

厂商:

KOTRA PHARMA (M) SDN. BHD.

资料单张

AXCEL ETORICOXIB-60MG TABLET
_Etoricoxib 60mg _
_ _
_ _
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Axcel
Etoricoxib-60mg
Tablet is used for.
2.
How
Axcel
Etoricoxib-60mg
Tablet works.
3.
Before
you
use
Axcel
Etoricoxib-60mg Tablet.
4.
How
to
use
Axcel
Etoricoxib-
60mg Tablet.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Etoricoxib-60mg Tablet.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT
AXCEL
ETORICOXIB-60MG
TABLET IS USED FOR
It
helps
to
reduce
the
pain
and
swelling (inflammation) in the joints
and
muscles
of
people
with
osteoarthritis,
rheumatoid
arthritis,
ankylosing spondylitis and gout. It is
also use for the treatment of acute
pain,
including
that
related
to
menstrual
pain
and
minor
dental
procedures.
_What is osteoarthritis? _
Osteoarthritis
is
a
disease
of
the
joints.
It
results
from
the
gradual
breakdown of cartilage that cushions
the ends of the bones. This causes
swelling
(inflammation),
pain,
tenderness, stiffness and disability.
_What is rheumatoid arthritis? _
Rheumatoid arthritis is a long term
inflammatory disease of the joints. It
causes pain, stiffness, swelling, and
increasing loss of movement in the
joints it affects. It may also cause
inflammation in other areas of the
body.
_What is gout? _
Gout is a disease of sudden, recurring
attacks of very painful inflammation
and redness in the joints. It is caused
by deposits of mineral crystals in the
joint.
_What is ankylosing spondylitis? _
Ankylosing
spondylitis
is
an
inflammatory
disease
of
the
spine
and large joints.
HOW AXCEL ETORICOXIB-60MG TABLET
WORKS
Etoricoxib
is
one
of
a
group
of
medicines
called
selective
COX-2
inhibitors. These belong to a family
of
medicines
called
non-steroidal
anti-inflammatory
drugs
(NSAIDs),
that
exhibits
anti-inflammatory,
analgesic, and antipyretic activities.
BEFORE YOU USE AXCEL ETORICOXIB-
60MG TABLET
_When you must not use it _
You must not use Axcel Etoricoxib-
60mg Tablet if you:

产品特点

_ACUTE PAIN _
In the following acute painful conditions, Etoricoxib should be
used only for the acute symptomatic period, limited to a
maximum of 8 days treatment:
_Acute Gouty Arthritis_
The recommended dose is 120 mg once daily.
_Primary Dysmenorrhea _
The recommended dose is 120 mg once daily.
_Minor Dental Procedures _
The recommended dose is 90 mg once daily.
Doses greater than those recommended for each indication
have either not demonstrated additional efficacy or have not
been studied. Therefore:
The dose for osteoarthritis should not exceed 60 mg daily.
The dose for rheumatoid arthritis should not exceed 90 mg
daily.
The dose for ankylosing spondylitis should not exceed 90 mg
daily.
The dose for acute gout should not exceed 120 mg daily.
The dose for acute pain and primary dysmenorrhea should
not exceed 120 mg daily.
The dose for minor dental procedures should not exceed 90
mg daily.
As the cardiovascular risks of selective COX-2 inhibitors may
increase with dose and duration of exposure, the shortest
duration possible and the lowest effective daily dose should
be used. The patient's need for symptomatic relief and
response to therapy should be re-evaluated periodically.
_ELDERLY, GENDER, RACE_
No dosage adjustment in Etoricoxib is necessary for the
elderly or based on gender or race.
_HEPATIC INSUFFICIENCY _
In patients with mild hepatic insufficiency (Child-Pugh score
5-6), a dose of 60 mg once daily should not be exceeded. In
patients
with
moderate
hepatic
insufficiency
(Child-Pugh
score 7-9), the dose should be reduced; a dose of 60 mg
every other day should not be exceeded, administration of 30
mg once daily can also be considered. There are no clinical
or pharmacokinetic data in patients with severe hepatic
insufficiency (Child-Pugh score >9).
_RENAL INSUFFICIENCY _
In patients with advanced renal disease (creatinine clearance
<30 mL/min), treatment with Etoricoxib is not recommended.
No dosage adjustment is necessary for patients with lesser
degrees of renal insufficiency (creatinine clearance ≥