OMLINK (Omeprazole 20mg)
Omeprazole inhibits the secretion of gastric acid by irreversibly blocking the enzyme system of H
+/K+ATPase of the gastric parietal cell.
Orally omeprazole is well absorbed from small intestine completely within 3-6 hours with 95% plasma proteins bound & T ½ is 30 to 90 minutes with total body clearance is 500-600mL/min. Inactive metabolites are excreted 80% in urine & 2% via faeces
Omeprazole is indicated for the treatment of Oesophageal reflux disease, dyspepsia, duodenal and benign gastric ulcers, ulcers related to Helicobacter pylori
In patients with history to Omeprazole or to any of excipients of this product.
Special precautions and warnings
- Relief of symptoms does not preclude the presence of a gastric malignancy.
- Use of Omeprazole capsules may increase risk of GI infection (e.g. Salmonella, Campylobacter).
- Bioavailability of Omeprazole may be increased in patients with hepatic dysfunction; consider dosage reductions, especially for maintenance healing of erosive esophagitis.
- Use during pregnancy & lactation, if potential benefit to mother outweighs possible risk to fetus.
Dosage and directions for use
Duodenal ulcer: 20mg once daily for two to four weeks
Prevention of relapse of duodenal ulcer: 10mg/daily, can be increased to 20-40mg/day
Gastric ulcer and reflux oesophagitis: 20-40 mg once daily for four to eight weeks
NSAID-associated gastric and duodenal ulcers: 20mg once daily
Symptomatic gastroesophageal reflux disease: 10 to 20mg daily
Zollinger-Ellison syndrome: 60mg once daily
H.pylori eradication for duodenal ulcer recurrence: 20mg with antibiotics as a triple therapy.
For GERD & to maintain erosive esophagitis healing, 5mg/day for 5<10kg, 10mg/day for 10<20 kg, 20mg/day for >20kg
Dosage should be adjusted individually & treatment continued as long as clinically indicated.
Commonly observed adverse events are headache, abdominal pain, nausea, constipation, diarrhoea, flatulence, nausea/vomiting. Other adverse effects are acid regurgitation, upper respiratory infection, constipation, dizziness, rash, asthenia, back-pain and cough.
Reduced absorption of ketoconazole or itraconazole with omeprazole treatment. Omeprazole may increase serum concentration of tacrolimus, Vitamin K antagonists and benzodiazepines. Increase in digoxin bioavailability with omeprazole. Omeprazole may decrease the serum concentration of Atazanavir. Concomitant administration of Omeprazole & CYP2C19 and CYP3A4 inhibitor, voriconazole resulted in doubling of omeprazole exposure