OMEPRAZOLE AN omeprazole 20 mg enteric-coated tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

omeprazole, Quantity: 20 mg

제공처:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Omeprazole

약제 형태:

Tablet, enteric coated

구성:

Excipient Ingredients: iron oxide black; microcrystalline cellulose; povidone; iron oxide red; crospovidone; purified talc; lactose monohydrate; hypromellose phthalate; magnesium stearate; triacetin; ascorbyl palmitate

관리 경로:

Oral

패키지 단위:

5 tablets, 30 tablets, 10 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Omeprazole Tablets are indicated for: A. Gastro-Oesophageal Reflux Disease (GORD): 1. Symptomatic GORD: The relief of heartburn and other symptoms associated with GORD. 2. Erosive Oesophagitis: The treatment and prevention of relapse. B. Peptic Ulcers: 1. The treatment of duodenal and gastric ulcer. 2. Combination therapy for the treatment of peptic ulcer disease associated with Heliobacter pylori infection. 3. The treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. The prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. Long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be Heliobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. C. Zollinger-Ellison Syndrome: The treatment of Zollinger-Ellison Syndrome.

제품 요약:

Visual Identification: Red brown, oblong, enteric coated tablets.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2009-05-12

환자 정보 전단

_Omeprazole AN tablets – Consumer Medicine Information _
_ _
_Doc ID: 83.AN.M.1.0 _
_ _
_ _
_Page 1 _
OMEPRAZOLE AN TABLETS
_Omeprazole _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Omeprazole AN.
It
does
not
contain
all
of
the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the
risks
of
you
taking
Omeprazole
AN
against
the
benefits they expect it will have
for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
YOUR
MEDICINE.
You may need to read it again.
WHAT OMEPRAZOLE AN
IS USED FOR
_Peptic Ulcers _
Omeprazole AN is used to treat
peptic ulcers. 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.
These ulcers can be caused by
too much acid being made in the
stomach.
Omeprazole AN is also used to
help
stop
peptic
or
duodenal
ulcers coming back.
_Peptic _
_Ulcers _
_Associated _
_with _
_Helicobacter pylori Infection _
Most peptic ulcers are caused by
an infection with the bacterium
Helicobacter
pylori
in
the
stomach.
_H. _
_pylorus_
weakens
the
protective mucous coating of the
stomach and duodenum, which
allows acid to get through to the
sensitive
lining
beneath.
Both
the acid and the bacteria irritate
the lining and cause a sore, or
ulcer.
When Omeprazole AN is taken
together with an antibiotic, the
combination will kill _H. pylori_ and
let your peptic ulcer heal.
_Peptic _
_Ulcers _
_Associated _
_with _
_Non-Steroidal _
_Anti-Inflammatory _
_Drugs (NSAID’s) _
Some peptic ulcers are caused
by
medicines
called
non-
steroidal
anti-
inflammatory
drugs.
These
medicines
are
commonly
taken
to
treat
joint
disease or arthritis.
Omeprazole AN is also used to
heal
and
prevent
ulcers
associated with NSAIDs.
_Reflux Oesophagitis _
Omepraz

제품 특성 요약

_Omeprazole AN tablets Product Information _
_ _
_ _
_ Scentia Pharmaceuticals Pty Ltd _
Doc ID: 83.AN.P.1.2
Page 1 of 12
OMEPRAZOLE AN
_ _
_(OMEPRAZOLE TABLETS) _
_ _
PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
The name of the medicine is omeprazole.
CHEMICAL NAME:
5-methoxy-2-[(_RS_)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]-
sulphinyl]-1_H_-
benzimidazole
MOLECULAR FORMULA: C
17
H
19
N
3
O
3
S
MOLECULAR WEIGHT: 345.4
CAS REGISTRY NUMBER: _[73590-58-6] _
DESCRIPTION
Omeprazole is a white or almost white powder, very slightly soluble in
water, soluble in
methylene chloride, sparingly soluble in alcohol and in methanol. It
dissolves in dilute
solutions
of alkali hydroxides.
Each tablet contains 20 mg of omeprazole and the following excipients:
ascorbyl palmitate,
-
microcrystalline cellulose, crospovidone, magnesium stearate,
povidone, lactose, purified
talc,
hypromellose phthalate, glycerol triacetate, iron oxide red, iron
oxide black.
PHARMACOLOGY
Omeprazole
reversibly
reduces
gastric
acid
secretion
by
specifically
inhibiting
the
gastric
enzyme H+, K+-ATPase, the proton pump, in the acid environment of the
intracellular canaliculi
within the parietal cell. This effect of omeprazole on the final
step of the gastric acid formation
process is dose dependent and effectively inhibits both
basal acid secretion and stimulated acid
secretion, irrespective of the stimulus to acid
production.
Omeprazole
has
no
effect
on
acetylcholine
or
histamine
receptors.
No
clinically
significant
pharmacodynamic effects, other than those explained by the effect on
acid
secretion, have been
observed.
_EFFECT ON GASTRIC ACID SECRETION: _Oral dosing with omeprazole 20 mg
once daily provides
rapid
and effective reduction of gastric acid secretion. After a single dose
the onset of
_Omeprazole AN tablets Product Information _
_ _
_ _
_ Scentia Pharmaceuticals Pty Ltd _
Doc ID: 83.AN.P.1.2
Page 2 of 12
antisecretory
effect occurs within one hour and is maximal within two hours. With
repeated once daily dosing
the maximum effect is usuall