CELECOXIB AN Celecoxib 200 mg capsule blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

celecoxib

Disponível em:

Amneal Pharma Australia Pty Ltd

DCI (Denominação Comum Internacional):

Celecoxib

Status de autorização:

Registered

Folheto informativo - Bula

CELECOXIB AN CMI v2.0
1
CELECOXIB AN
_celecoxib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CELECOXIB AN. 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 AN 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 CELECOXIB AN AND
KEEP IT WITH THE MEDICINE.
You may need to read it again.
WHAT CELECOXIB
AN IS USED FOR
CELECOXIB AN 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 AN also provides
short-
term pain relief in conditions
such as:
•
menstrual cramps or period pain
•
after surgery
•
muscle and joint injuries.
CELECOXIB AN belongs to a
group of medicines called Coxibs
which are used to relieve pain
and inflammation in number of
conditions.
Although CELECOXIB AN can
relieve the symptoms of pain and
inflammation, it will not cure your
condition.
Your doctor, however, may have
prescribed CELECOXIB AN for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CELECOXIB
AN HAS BEEN PRESCRIBED FOR YOU.
CELECOXIB AN 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
CELECOXIB AN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CELECOXIB AN 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
•

Características técnicas

Celecoxib AN PI v4.1
Page 1 of 31
Celecoxib is a diaryl substituted pyrazo
formula:
CELECOXIB AN
PRODUCT INFORMATION
NAME OF THE MEDICINE
Celecoxib 100 mg
Celecoxib 200 mg
le and has the following chemical structure and
C
17
H
14
F
3
N
3
O
2
S
M.W. = 381.38
4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1- yl]
benzenesulfonamide
CAS registry no: 169590-42-5
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.
DESCRIPTION
100 mg capsules: Opaque, white capsules with 2 blue bands and marked
“100” on the body.
200 mg capsules: Opaque, white capsules with 2 gold bands and marked
“200” on the body.
CELECOXIB AN 100 mg and 200 mg capsules contain 100 mg or 200 mg of
celecoxib. The capsules
also contain lactose monohydrate, sodium lauryl sulfate,
croscarmellose sodium, povidone and
magnesium
Celecoxib AN PI v4.1
Page 2 of 31
stearate. The capsule shell contains gelatin, titanium dioxide, sodium
lauryl sulfate and the inks -
TekPrint
TM
SB-6018 Blue Ink (ARTG 2653) [_for 100 mg capsules_] and TekPrint
TM
SB-3002 Gold Ink
(ARTG 3426) [_for 200 mg capsules_]
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,
analgesi