PPI – Dhaka Rx

Omeprazole

GASTROINTESTINAL

INDICATION

Benign gastric and duodenal ulcer, heartburn, NSAID-associated complications, peptic ulcer associated with Helicobacter pylori, gastro-esophageal reflux disease, Zollinger-Ellison syndrome, prevention of acid aspiration syndrome, acid-related dyspepsia and other hyper acidic complications.

DOSAGE AND ADMINISTRATION

Adults:

Capsule: PPI (Omeprazole) should be taken before meal.

Benign gastric and duodenal ulcers: 20 mg once daily for 4 weeks in duodenal ulceration or 8 weeks in gastric ulceration; in severe or recurrent cases increase to 40 mg daily; maintenance for recurrent duodenal ulcer, 20 mg once daily.

prevention of relapse in duodenal ulcer: 10 to 20 mg once daily if symptoms return.

Heartburn: 20 mg once daily for 14 days.

NSAID-associated complications: NSAID-associated duodenal or gastric ulcer & gastroduodenal erosions, 20 mg once daily for 4 weeks, followed by a further 4 weeks if not fully healed; prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers, gastroduodenal lesions, or dyspeptic symptoms who require continued NSAID treatment, 20 mg once daily.

For Peptic ulcer associated with Helicobacter pylori:

Age	Dose
Omeprazole (PPI) 20 mg twice daily.Amoxicillin (MOXILIN) 1 g twice daily.Clarithromycin (CLARICIN) 500 mg twice daily.	01-02 weeks
Omeprazole (PPI) 20 mg twice daily.Clarithromycin (CLARICIN) 500 mg twice daily.Metronidazole (DIROZYL) 400 mg twice daily.	01 week
Omeprazole (PPI) 20 mg twice daily.Amoxicillin (MOXILIN) 1 g twice daily.Metronidazole (DIROZYL) 400 mg twice daily.	01-02 weeks

Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, followed by a further 4-8 weeks if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease refractory to other treatment; may be continued at 20 mg once daily.

Maintenance therapy: 10-20 mg once daily.

Zollinger-Ellison syndrome: Initially 60 mg (40+20 mg) once daily; usual range 20-120 mg daily (above 80 mg in 2 divided doses).

Gastric acid reduction during general anesthesia (prophylaxis of acid aspiration): 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.

Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks according to response.

Injection: Benign gastric ulcer, duodenal ulcer and gastro-esophageal reflux disease, 40 mg once daily until oral administration is possible, prophylaxis of acid aspiration, 40 mg completed 1 hour before surgery. In patients with Zollinger-Ellison syndrome the recommended initial dose is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily.

Method of Administration

Injection: The solution for IV injection is prepared by 10 ml of WFI (provided) adding to the vial. After reconstitution, the injection should be given over 5 minutes or at least by 2.5 minutes at a maximum rate of 4 ml per minute. The solution should be used within 4 hours of reconstitution when stored in original vial in a cool place. The reconstituted solution should not be used if it contains visible particulate matter.

Infusion: PPI IV infusion 40 mg should be given as an intravenous infusion (over a period of 20-30 minutes or more). The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% dextrose solution for infusion. The solution should be used within 12 hours when omeprazole is dissolved in saline and within 6 hours when dissolved in 5% dextrose solution. The constituted solution should not be mixed or co-administered in the same infusion set with any other drug.

Use in children

Capsule: Child over 2 years : Severe ulcerating reflux esophagitis, 0.7-1.4 mg/kg daily for 4-12 weeks; maximum 40 mg daily (to be initiated by hospital physician under close supervision).

Injection: There is limited experience of use in children.

Elderly: Dose adjustment is not required in the elderly. Impaired renal or hepatic function: Dose adjustment is not required in renal impairment. Patients with severe liver disease should not require more than 20 mg Omeprazole daily. OR, AS DIRECTED BY PHYSICIAN.