Branch of Imexpharm Corporation - Binh Duong Hi-Tech Plant

Imexpharm Pharmaceutical Joint Stock Company

Pantoprazol (as Pantoprazol sodium sesquihydrat)

40mg

24 months

Lyophilized powder for injection

Box of 10 vials

VD-35195-21

23/06/2021

Gastro-Intestinal

Pantoprazole is used for short-term treatment to improve symptoms and promote healing in gastrointestinal diseases that require reduction of acid secretion:
- Reflux oesophagitis
- Gastric and duodenal ulcer
- Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions
- Treatment of bleeding gastric ulcers.

Gastric and duodenal ulcer, reflux oesophagitis
The recommended dose: 40 mg pantoprazole per day.
Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions
Initial dose: 80 mg pantoprazole per day.
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 of pantoprazole is possible but should not be applied longer than required for adequate acid control.
In case rapid acid control is required, a starting dose of 80 mg pantoprazole, 2 times per day, is sufficient to manage a decrease of acid output into the target range (<10 mEq/h) within one hour in the majority of patients.
Switch to oral pantoprazole as soon as clinical signs allow.
Treatment of upper gastrointestinal bleeding (in combination with endoscopic therapy):
Slow intravenous injection of 80 mg pantoprazole, followed by an infusion of 8 mg pantoprazole/hour for 72 hours is recommended.
Special populations
Paediatric population
The safety and efficacy of pantoprazol 40 mg powder for solution for injection in children aged under 18 years have not been established. Therefore, pantoprazole 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age.
Patients with hepatic impairment
A daily dose of 20 mg pantoprazole (half a vial of 40 mg pantoprazole) should not be exceeded in patients with severe liver impairment.
Patients with renal impairment
No dose adjustment is necessary in patients with impaired renal function.
Elderly people
No dose adjustment is necessary in older patients.