Celebrex

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

Celecoxib

Disponible desde:

Pfizer Australia Pty Ltd

clase:

Medicine Registered

Información para el usuario

CELEBREX
®

_celecoxib_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CELEBREX. 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 CELEBREX
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
YOU START CELEBREX AND KEEP IT
WITH THE MEDICINE.
You may need to read it again.
WHAT CELEBREX IS
USED FOR
CELEBREX 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.
CELEBREX also provides short-
term pain relief in conditions such as:
•
menstrual cramps or period pain
•
after surgery
•
muscle and joint injuries.
CELEBREX belongs to a group of
medicines called Coxibs which are
used to relieve pain and
inflammation in a number of
conditions.
Although CELEBREX can relieve
the symptoms of pain and
inflammation, it will not cure your
condition.
Your doctor, however, may have
prescribed CELEBREX for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CELEBREX
HAS BEEN PRESCRIBED FOR YOU.
CELEBREX is not recommended for
use in children or adolescents under
18 years of age.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE
CELEBREX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CELEBREX IF:
•
YOUR DOCTOR HAS TOLD YOU THAT
YOU HAVE SEVERE HEART OR BLOOD
VESSEL DISEASE AFFECTING THE
CIRCULATION IN YOUR BRAIN OR
LIMBS
•
YOU HAVE SEVERE LIVER PROBLEMS
 Your doctor will decide if your
condition is too severe to take this
medicine.
•
YOU HAVE PROBLEMS WITH YOUR
KIDNEY FUNCTION
•
YOU HAVE HAD AN ATTACK OF
ASTHMA, HIVES, ITCHING, SKIN RA

Ficha técnica

Version: pfpcelec10413 
Supersedes: pfpcelec10912 

Page 1 of 34

PRODUCT INFORMATION 
CELEBREX
® 
(CELECOXIB) 
NAME OF THE MEDICINE 
CELEBREX (celecoxib) 100 mg, 200 mg and 400 mg capsules. 
Celecoxib  is  a  diaryl  substituted  pyrazole  and  has  the  following  chemical  structure  and 
formula: 
CH
3
N
N
CF
3
S
NH
2
O
O

Chemical name 
4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] 
benzenesulfonamide 
Molecular formula: 

C
17
H
14
F
3
N
3
O
2
S 
Molecular weight 

381.38 
CAS Registry Number: 
169590-42-5. 
DESCRIPTION 
Celecoxib is weakly acidic with a pKa in water of 11.1 and is practically insoluble in water.

Celecoxib  is  chemically  unrelated  to  anti-inflammatory  agents  of  steroidal  or  non-steroidal 
nature.  Celecoxib does not contain a chiral centre. 
CELEBREX  100 mg,  200 mg  and  400 mg  capsules  contain  lactose,  sodium  lauryl  sulfate, 
povidone,  croscarmellose  sodium,  and  magnesium  stearate.    The  capsule  shells  contain 
gelatin,  titanium  dioxide  and  the  inks  contain:  iron

oxide  yellow  CI  77492  (200 mg  and 
400 mg  capsule);  indigo  carmine  CI  73015  (100 mg  capsule);  brilliant  blue  FCF  CI  42090 
aluminium lake (400 mg capsule). 
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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  (NSAIDs)  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,  primaril