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, NSAID-associated benign gastric ulcers and gastroduodenal erosion in patients continued NSAID treatment. Prophylaxis of acid aspiration and Zollinger-Ellison syndrome.
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