Pantoprazole in Pantospey is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific action on the proton pumps of the parietal cells.
Each vial contains: pantoprazole Sodium USP eq. to pantoprazole – 40 mg
Intravenous administration of Pantospey is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, treatment with Pantospey IV should be discontinued and 40 mg pantoprazole p.o. should be administered instead.
Gastric and duodenal ulcer, reflux oesophagitis:
The recommended intravenous dose is 1 vial of Pantospey (40 mg pantoprazole) per day.
Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions:
For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg Pantospey. Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.
In case a rapid acid control is required, a starting dose of 2 x 80 mg Pantospey is sufficient to manage a decrease of acid output into the target range (<10 mEq/h) within one hour in the majority of patients.
Paediatric population:
The experience in children is limited. Therefore, Pantospey is not recommended for use in patients below 18 years of age until further data become available.
Hepatic Impairment:
A daily dose of 20 mg Pantospey (half a vial of 40 mg Pantospey) should not be exceeded in patients with severe liver impairment.
Renal Impairment:
No dose adjustment is necessary in patients with impaired renal function.
Elderly:
No dose adjustment is necessary in elderly patients.
Method of administration:
A ready-to-use solution is prepared in 10 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection. For instructions for preparation of the medicinal product before administration. The prepared solution may be administered directly or may be administered after mixing it with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 55 mg/ml (5 %) solution for injection.
After preparation the solution must be used within 12 hours.
The medicinal product should be administered intravenously over 2 – 15 minutes.
