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Omeprazole Ranbaxy CMI V2 Jun 2009
OMEPRAZOLE
RANBAXY
OMEPRAZOLE TABLETS
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
OMEPRAZOLE RANBAXY. 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
OMEPRAZOLE RANBAXY against
the benefits it is expected to
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 OMEPRAZOLE RANBAXY
IS USED FOR
_Peptic Ulcers _
OMEPRAZOLE RANBAXY 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 RANBAXY 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 RANBAXY 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 (NSAIDs) _
Some peptic ulcers are caused
by medicines called non-
steroidal anti-inflammatory
drugs. These medicines are
co
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OMEPRAZOLE RBX PI V2 Jun09
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OMEPRAZOLE RANBAXY
_PRODUCT INFORMATION _
OMEPRAZOLE RANBAXY (omeprazole) 20 mg tablets
DESCRIPTION
Chemical name: 5-methoxy-2-[(_RS_)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]-sulphinyl]-1_H_-
benzimidazole. 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,
cellulose- microcrystalline, crospovidone, magnesium stearate, povidone, lactose, talc purified,
hypromellose phthalate, glycerol triacetate, iron oxide red
(CI77491), iron oxide black (CI77499).
Omeprazole has the empirical formula of C
17
H
19
N
3
O
3
S, a molecular weight of 345.4 and CAS
number 73590-58-6.
Structurally it is represented as:
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 antisecretory
effect occurs within one hour and is
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