CELECOXIB RBX celecoxib 100 mg capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
14-02-2017
Summary of Product characteristics
(SPC)
14-02-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
Celecoxib
Available from:
Sun Pharma ANZ Pty Ltd
INN (International Name):
Celecoxib
Patient Information leaflet
CELECOXIB RBX CMI Version 1
Page 1 of 8
CELECOXIB RBX
CELECOXIB
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CELECOXIB RBX. It
does not contain
all the available information. It does not take the place of talking
to your doctor or
pharmacist. All medicines have risks and benefits. Your doctor has
weighed the risks of you
taking CELECOXIB RBX against the benefits it is expected to have for
you.
This leaflet was last updated on the date at the end of this leaflet.
More recent information
may be available. The latest Consumer Medicine Information is
available from
https://www.ebs.tga.gov.au/ and may contain important information
about the medicine and
its use of which you should be aware.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE YOU START CELECOXIB RBX AND KEEP IT
WITH THE
MEDICINE.
You may need to read it again.
WHAT CELECOXIB RBX IS USED FOR
CELECOXIB RBX is used to relieve the symptoms of joint pain,
tenderness, swelling and
stiffness in:
•
osteoarthritis
•
rheumatoid arthritis and
•
ankylosing spondylitis, a chronic inflammatory rheumatic disorder that
primarily
affects, but is not limited to, the spine.
CELECOXIB RBX also provides short-term pain relief in conditions such
as:
•
menstrual cramps or period pain
•
after surgery
•
muscle and joint injuries.
CELECOXIB RBX belongs to a group of medicines called Coxibs which are
used to relieve
pain and inflammation in a number of conditions.
Although CELECOXIB RBX can relieve the symptoms of pain and
inflammation, it will not
cure your condition.
Your doctor, however, may have prescribed CELECOXIB RBX for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CELECOXIB RBX HAS
BEEN
PRESCRIBED FOR YOU.
CELECOXIB RBX is not recommended for use in children or adolescents
under 18 years of
age. This medicine is only available with a doctor's prescription.
CELECOXIB RBX CMI Version 1
Page 2 of 8
BEFORE YOU TA
Read the complete document
Summary of Product characteristics
CELECOXIB RBX PI Version 6
Page 1 of 34
PRODUCT INFORMATION
CELECOXIB RBX
CELECOXIB 100 / 200 MG CAPSULES
NAME OF THE MEDICINE
Celecoxib
Celecoxib is a diaryl substituted pyrazole.
Structural formula:
Molecular formula: C
17
H
14
F
3
N
3
O
2
S
Chemical name:
4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1_H_-pyrazol-1-yl]
benzenesulfonamide
Molecular weight: 381.38
CAS number: 169590-42-5
DESCRIPTION
Celecoxib is weakly acidic with a pKa in water of 11.1 and is
practically insoluble in
water, freely soluble to soluble in anhydrous ethanol and soluble in
methylene chloride.
Celecoxib is chemically unrelated to anti-inflammatory agents of
steroidal or non-
steroidal nature. Celecoxib does not contain a chiral centre.
CELECOXIB
RBX
capsules
contain
100
mg
or
200
mg
of
celecoxib,
lactose,
povidone, colloidal anhydrous silica, sodium lauryl sulfate,
croscarmellose sodium and
magnesium stearate. The capsule shells contain gelatin, titanium
dioxide, sodium lauryl
CELECOXIB RBX PI Version 6
Page 2 of 34
sulfate and TekPrint SW-9008 Black Ink (Proprietary ingredient #
2328).
PHARMACOLOGY
PHARMACODYNAMICS
_PHARMACOTHERAPEUTIC GROUP: M01AH COXIBS_
Celecoxib is a cyclooxygenase-2 (COX-2) specific inhibitor, a member
of a larger
class
of
non-steroidal
anti-inflammatory
drugs
that
exhibits
anti-inflammatory,
analgesic, and antipyretic activities in animal models. The mechanism
of action of
celecoxib is believed to be due to inhibition of prostaglandin
synthesis, primarily by
inhibition of COX-2. At therapeutic concentrations in humans celecoxib
does not
inhibit cyclooxygenase-1 (COX-1). COX-2 is induced in response to
inflammatory
stimuli. This leads to the synthesis and accumulation of inflammatory
prostanoids, in
particular
prostaglandin
E2,
causing
inflammation,
oedema
and
pain.
In
animal
models, celecoxib acts as an anti-inflammatory, analgesic, and
antipyretic agent by
blocking the production of inflammatory prostanoids via COX-2
inhibition. In animal
colon tumour models, celecoxib reduced the incidence and multiplicity
of tu
Read the complete document
