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ENTOCORT(R)
1
ENTOCORT(R)
_Budesonide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Entocort.
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 Entocort
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING ENTOCORT, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
ENTOCORT.
You may need to read it again.
WHAT ENTOCORT IS FOR
Entocort is used in the treatment of
Crohn's disease. It can be used to
treat acute attacks.
Crohn's disease is an inflammatory
disease of the bowel. It mainly
affects the small bowel and the first
part of the large bowel and causes
symptoms such as stomach pain,
diarrhoea and fever.
Entocort contains budesonide. This
belongs to the group of medicines
called corticosteroids, which are used
to help reduce inflammation in many
parts of the body.
Entocort capsules are designed to
release their contents in the small
bowel and the first part of the large
bowel.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ENTOCORT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Entocort is not addictive.
Entocort is available only with a
doctor's prescription.
BEFORE YOU TAKE
ENTOCORT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ENTOCORT IF YOU HAVE
AN ALLERGY TO:
*
any medicine containing
budesonide
*
any ingredients listed at the end
of this leaflet.
Some of the symptoms of an allergic
reaction may include:
-
rash, itching or hives on the skin
-
shortness of breath, wheezing or
difficulty breathing
-
swelling of the face, lips, tongue
or other parts of the body.
DO NOT GIVE ENTOCORT TO CHILDREN.
There is no information available on
its use in children.
DO NOT
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产品特点
Entocort
®
Capsules Product Information
1 (9)
ENTOCORT
®
PRODUCT INFORMATION
(Budesonide controlled ileal release capsules)
NAME OF THE DRUG
The active ingredient in ENTOCORT is budesonide.
The CAS Registry Number for budesonide (11
β, 16α) is 51333-22-3.
The Australian Approved Name is budesonide.
The chemical structure for budesonide is
O
CH
3
HO
CH
3
C=O
CH
2
OH
O
O
C
CH
2
CH
2
CH
3
H
(22)
DESCRIPTION
The active ingredient, budesonide, is a non-halogenated glucocorticoid
structurally
related to 16
α hydroxyprednisolone. The chemical name is 16α,17α-22R,
S-propylmethylenedioxy-pregna-1,4-diene-11
β, 21-diol-3, 20-dione.
Budesonide is a white to off-white powder, freely soluble in
chloroform, sparingly
soluble in ethanol and practically insoluble in water and heptane.
Budesonide is a
mixture of two epimeric forms, epimer A and epimer B, in a 50:50
ratio. The epimer
mixture melts with decomposition between 224°C and 231.5°C.
ENTOCORT is a hard gelatine capsule filled with gastric
acid-resistant, prolonged
release granules for oral use. The granules are practically
insoluble in gastric juice
and have prolonged release properties adjusted to release budesonide
in the ileum
and the ascending colon.
In addition to budesonide, ENTOCORT capsules contain ethylcellulose,
tributyl
acetylcitrate, methacrylic acid copolymer, triethyl citrate,
dimethicone, Polysorbate
80, purified talc and sugar spheres. The capsule shell is made from
gelatin, with the
colouring agents titanium dioxide and iron oxide.
2009-Jan-29_Entocort PI.doc
Entocort
®
Capsules Product Information
2 (9)
PHARMACOLOGY
Studies in animals and humans have shown an advantageous ratio between
topical
anti-inflammatory activity and systemic glucocorticoid effect over a
wide dose range.
This is explained by the extensive first-pass hepatic degradation of
budesonide after
systemic absorption, approximately 8
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