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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 such patients.

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 useful alternative.

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 metronidazole-sensitive patients).

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 indicated.

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 myalgia.
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 gastrointestinal candidiasis.
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 children.
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.

Drug Interaction(s):
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 excluded.
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 are anticipated.

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.

Storage Condition(s):
Keep in a tight container. Store at temperature below 25C. Protect from light and

Product Description & Packing(s):
A size #2 pale brown cap and pink body hard gelatin capsule, containing milky white
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.











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