Each capsule contains: Omeprazole 20mg
Pharmacology (Summary of Pharmacodynamic and Pharmacokinetics):
Omeprazole reduces gastric acid secretion through a unique mechanism of
action. It is a specific inhibitor of the gastric acid pump in the parietal
cell. It is rapidly-acting and produces reversible control of gastric
secretion with once daily dosing.
Omeprazole is a weak base and is concentrated and converted to the active
form in the acid environment of the intracellulas canaliculi within the
parietal cell, where it inhibits the enzyme H+, K+-ATPase, the acid pump.
This effect on the final step of the gastric acid formation process is
dose-dependent and provides for effective inhibition of both basal acid
secretion and stimulated acid secretion irrespective of the secretagogue.
Omeprazole has no effect on acetylcholine or histamine receptors and no
clinically significant pharmacodynamic effects have been observed other than
those explained by the effect of omeprazole on acid secretion.
Helicobacter pylori is associated with acid peptic disease including
duodenal ulcer and gastric ulcer in which about 95% and 80% of patients,
respectively are infected with this agent. It is implicated as major
contributing factor in the development of gastritis and ulcer recurrence in
Recent evidence also suggests a causative link between Helicobacter pylori
and gastric carcinoma.
Clinical evidence has shown that the combination of omeprazole with
amoxicillin eradicates in excess of 50% of Helicobacter pylori isolates
irrespective of metronidazole sensitivity, and that clarithromycin may be a
Other antibiotics which have been used in combination with omeprazole in
clinical trials showing a useful effect on Helicobacter pylori include
tetracycline and metronidazole. One study using omeprazole 40mg daily,
amoxycycline 1500mg daily and metronidazole 1200mg daily for 14 days
achieved on overall Helicobacter pylori eradication rate of 89% (96% in
Oral dosing with 20mg omeprazole once daily provides rapid and effective
inhibition of gastric acid secretion with maximum effect being within 4 days
of treatment. In duodenal ulcer patients, a mean decrease of approximately
80% in 24-hr intragastric acidity is then maintained, with the mean decrease
in peak acid output after pentagastrin stimulation being about 70%, 24 hrs
after dosing with omeprazole. The inhibition of acid secretion is directly
related to the area under the plasma concentration-time curve (AUC) but not
to the plasma concentration at any given time.
Treatment of duodenal and benign gastric ulcers including those complicating
NSAID therapy. Treatment of reflux oesophagitis. Zollinger-Ellision
syndrome. Eradication of Helicobacter pylori. Long term treatment for
recurrent duodenal ulcer.
Dosage and Administration:
Duodenal and benign gastric ulcers: 20mg once daily for 4 weeks in duodenal
ulceration or 8 weeks in gastric ulceration; in severe or recurrent cases
increase to 40mg daily.
Maintenance for recurrent
duodenal ulcer: 20mg once daily.
Reflux oesophagitis: 20mg once daily for 4 - 8 weeks
Zollinger-Ellison syndrome: Initially 60mg once daily; usual range
20-120mg daily (above 80mg in 2 divided doses), for as long as is clinically
H. pylori eradication:
Triple therapy regimens: Omelon 20mg, amoxicillin 1g and
clarithromycin 500mg, all twice a day for 1 week; or Omelon 20mg,
clarithromycin 250mg and metronidazole 400mg, all twice a day for I week; or
Omelon 40mg once daily with amoxicillin 500mg and metronidazole 400mg, both
3 times a day for 1 week.
Dual therapy regimens: Omelon 40mg daily with amoxicillin 1.5g daily
in divided doses for 2 weeks.
Renal and hepatic impairment: No dosage adjustment necessary.
Known hypersensitivity to omeprazole.
Side Effect(s) / Adverse Reaction(s):
1.Omeprazole is well tolerated and adverse reactions have generally been
mild and reversible.
2. Skin: Rarely, rash and/or pruritus. In isolated cases, photosensitivity,
bullous eruption, erythema multiforme and alopecia.
3. Musculoskeletal: In isolated cases arthralgia, muscular weakness and
4. Central and Peripheral Nervous System: Headache. Rarely, dizziness,
paraesthesia, somnolence, insomnia and vertigo. In isolated cases,
reversible mental confusion, agitation, depression and hallucinations,
predominantly in severely ill patients.
5. Gastrointestinal: Diarrhoea, constipation, abdominal pain,
nausea/vomiting and flatulence. In isolated cases dry mouth, stomatitis and
6. Hepatic: Rarely, increased liver enzymes. In isolated cases,
encephalopathy in patients with preexisting severe liver disease; hepatitis
with or without jaundice, hepatic failure.
7. Endocrine: In isolated cases, gynoecomastia.
8. Haematological: In isolated cases, leucopenia, thrombocytopena,
agranulocytosis and pancytopenia.
9. Others: Rarely, malaise. Hypersensitivity reactions, e.g. urticaria
(rarely) and in isolated cases angioedema, fever, bronchospasm, interstitial
nephritis and anaphylactic shock, in isolated cases increased sweating,
peripheral oedema, blurred vision, taste disturbance.
Precaution(s) / Warning(s):
1. Use in pregnancy & lactation: There is no evidence on the safety of
omeprazole in human pregnancy. Animal studies have revealed reduced litter
weights. Avoid in pregnancy unless there is no safer alternative. There is
no information available on the passage of omeprazole into milk or its
effects on the neonate. Breastfeeding should therefore be discontinued if
the use of omeprazole is considered essential.
2. Use in children: There is no experience on the use of omeprazole in
3. Use in elderly: Dose adjustment is not required in the elderly.
4. Impaired renal or hepatic function: Dose adjustment is not required in
patients with impaired renal or hepatic function. Patients with severe liver
disease should not require >20mg of omeprazole daily.
5. When gastric ulcer is suspected, the possibility of malignancy should be
excluded before treatment with omeprazole is instituted, as treatment may
alleviate symptoms and delay diagnosis.
1. Omeprazole can delay the elimination of diazepam, phenytoin and drugs
that are metabolized by oxidation in the liver. Monitoring of patients
receiving warfarin or phenytoin is recommended and a reduction of warfarin
or phenytoin is recommended and a reduction of warfarin or phenyotin dose
may be necessary when omeprazole is added to treatment. However, concomitant
treatment with omeprazole 20mg did not change the blood concentration of
phenytoin in patients on continuous treatment with phenytoin. Similarly,
concomitant treatment with omeprazole 20mg did change coagulation time in
patients on continuous treatment with warfarin.
2. There is no evidence of an interaction with theophylline, propranolol,
metoprolol, lidocaine, quinidine, amoxycilin or antacids, but interaction
with other drugs also metabolized via cytochrome P-450 system cannot be
3. The absorption of omeprazole is not affected by alcohol or food.
4. Simultaneous treatment with omeprazole and digoxin in healthy subjects
lead to a 10% increase in the bioavailability of digoxin as a consequence of
the increased intragastric pH.
5. The absorption of some drugs might be altered due to the decreased
intragatric acidity. Thus, it can be predicted that the absorption of
ketoconazole will decrease during omeprazole treatment, as it does during
treatment with other acid secretion inhibitors or antacids.
6. Plasma concentrations of omeprazole and clarithromycin are increased
during concomitant administration.
Symptoms and Treatment for Overdosage, and Antidote(s):
There is no information available on the effects of overdosage in man.
However, omeprazole is very specific in action and no particular problems
Symptomatic and supportive therapy should be given as appropriate. Single
oral doses of up to 160mg and total oral doses of up to 300mg/day have been
given without adverse effects.
2 years from the date of manufacture.
Keep in a tight container. Store at temperature below 25°C. Protect from
Product Description & Packing(s):
A size #2 pale brown cap and pink body hard gelatin capsule, containing
pellets, and both cap and body impressed with a mark " YSP".
Plastic bottle of 300's. OMCp
Blister packing 10's x 10, 7's x 2, 7's x 4, 14's x 10 and 7's x 50.