ESOMEPRAZOLE GxP esomeprazole (as magnesium) 20mg tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

esomeprazole magnesium

Sẵn có từ:

Generic Partners Pty Ltd

INN (Tên quốc tế):

Esomeprazole magnesium

Tình trạng ủy quyền:

Registered

Tờ rơi thông tin

ESOMEPRAZOLE GXP® TABS and ESOMEPRAZOLE GXP® CAPS
1
ESOMEPRAZOLE
GXP®
_contains the active ingredient Esomeprazole (as magnesium) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Esomeprazole GxP. It does not
contain all the information that is
known about Esomeprazole GxP.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
Esomeprazole GxP against the
benefits they expect it will have for
you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT ESOMEPRAZOLE
GXP IS USED FOR
_REFLUX OESOPHAGITIS _
Esomeprazole GxP is taken to treat
reflux oesophagitis. This can be
caused by "washing back" (reflux) of
food and acid from the stomach into
the food pipe (oesophagus).
Reflux can cause a burning sensation
in the chest rising up to the throat,
also known as heartburn.
Esomeprazole GxP is also taken to
help stop reflux oesophagitis coming
back or relapsing.
Upper gastrointestinal symptoms
associated with non-steroidal anti-
inflammatory drugs (NSAIDs)
therapy
Esomeprazole GxP is taken to treat
the symptoms of pain or discomfort,
in the stomach caused by NSAIDs, a
type of medicine for pain or
inflammation.
Esomeprazole GxP is also taken to
help heal and prevent ulcers caused
by NSAIDs
Peptic Ulcers Associated with
Helicobacter pylori Infection
Most people who have a peptic
(gastric and duodenal) ulcer also
have a bacterium called Helicobacter
pylori in their stomach.
Depending on the position of the
ulcer it is called a gastric or duodenal
ulcer. A gastric ulcer occurs in the
stomach. A duodenal ulcer occurs in
the duodenum which is the tube
leading out from the stomach.
If you have a peptic ulcer, your
doctor will prescribe Esomeprazole
GxP with antibiotics. When
Esomeprazole GxP and antibiotics
are taken together, they work to kill
th

Đặc tính sản phẩm

ESOMPERAZOLE GXP
_Esomeprazole (as magnesium) _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient
:
esomeprazole magnesium
Chemical name
:
di-(_S_)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1_H_-
benzimidazole magnesium salt
Structural formula
:
Molecular formula
:
C
34
H
36
N
6
O
6
S
2
Mg
Molecular weight
:
713.12 (anhydrous)
CAS Registry no.
:
161973-10-0
DESCRIPTION
Esomeprazole magnesium is an off white to slight coloured powder,
soluble in N,N-Dimethly formamide.
Esomeprazole GxP 20mg and 40mg tablets are comprised of enteric coated
pellets containing esomeprazole
magnesium as the active ingredient as well as the following inactive
(excipient) ingredients: Non-pareil seeds 40-
50 (ARTG 108808), hyprolose, crospovidone, sucrose and maize starch,
magnesium oxide light, purified talc,
macrogol
6000,
methacrylic
acid
-
ethyl
acrylate
copolymer
(1:1),
glyceryl
monostearate,
macrogol
400,
polysorbate
80,
hypromellose
phthalate,
acetone,
microcrystalline
cellulose,
iron
oxide
red,
povidone,
pregelatinised
maize
starch,
silicon
dioxide,
lactose
monohydrate,
OPADRY
complete
film
coating
system
03B84893 PINK (ARTG 108603) (20mg), OPADRY complete film coating
system 03B54193 PINK (ARTG
108604) (40mg).
PHARMACOLOGY
Esomeprazole magnesium reversibly reduces gastric acid secretion by
specifically inhibiting the gastric enzyme
H
+
,
K
+
-ATPase
proton
pump
in
the
parietal
cell.
Both
the
R-
and
S-isomer
of
omeprazole
have
similar
pharmacodynamic activity. In humans, acid control with esomeprazole is
dose dependent and is significantly
greater, more sustained and less variable compared to that obtained
with equal doses of omeprazole.
Esomeprazole
is
a
weak
base
and
is
concentrated
and
converted
to
the
active
form
in
the
highly
acidic
environment of the secretory canaliculi of the parietal cell, where it
inhibits the enzyme H
+
, K
+
-ATPase (the acid
pump) and inhibits both basal and stimulated acid secretion.
Esomeprazole GXP– PRODUCT INFORMATION
2
% GORD patients with intragastric pH >4