Indication
Pantoprazole (Pantogut®) is indicated where suppression of acid secretion is of therapeutic benefit. Pantoprazole (Pantogut®) is registered for the following indications:
- Peptic ulcer diseases (PUD)
- Gastro esophageal reflux disease (GERD)
- Treatment of ulcer resistant to H2 receptor antagonists (H2RAs)
- Treatment of ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs)
- Gastrointestinal (GI) bleeding from stress or acid peptic diseases
- Eradication of Helicobacter pylori (in combination with antibiotics)
- Zollinger-Ellison Syndrome
- Prophylaxis for acid aspiration during induction of anaesthesia
Dosage & Administration
|
Dosage Form |
|
Conditions |
|
Dose |
|
Frequency |
|
Duration |
|
20 & 40 mg Tablet |
|
Usually recommended |
|
40 mg |
|
Once daily |
|
2-8 weeks |
|
|
|
Duodenal Ulcer |
|
40 mg |
|
Once daily |
|
2-4 weeks |
|
|
|
Gastric Ulcer |
|
40 mg |
|
Once daily |
|
4-8 weeks |
|
|
|
Reflux esophagitis |
|
40 mg |
|
Once daily |
|
4-8 weeks |
|
|
|
In resistant ulcers |
|
40 mg |
|
Once daily |
|
8 weeks |
|
|
|
Eradication of |
|
40 mg |
|
Twice daily in |
|
1 week |
|
|
|
Zollinger-Ellison |
|
20 mg |
|
Maximum 8 |
|
Up to control acid |
|
|
|
Prophylaxis for acid |
|
20 mg |
|
Given at the evening |
|
- |
|
|
|
Maintenance therapy |
|
20 mg |
|
Once daily |
|
- |
|
40 mg IV injection |
|
Usually recommended |
|
40 mg |
|
Once daily |
|
- |
|
|
|
Duodenal ulcer |
|
2-4 weeks |
||||
|
|
|
Gastric ulcer |
|
4-8 weeks |
||||
|
|
|
Gastro-esophageal |
|
4 weeks |
Method of Administration
Injection: Pantogut® IV Injection 40 mg should be given as a slow intravenous injection. The
solution for IV injection is obtained by adding to the vial 10 ml of the solvent provided. After
reconstitution the injection should be given slowly over a period of at least 2.5 minutes at a
maximum rate of 4 ml per minute.
Infusion: For IV infusion reconstitute one sterile single dose vial of Pantogut® injection with
10 ml 0.9% Sodium Chloride to make 10 ml solution containing 4 mg/ml of Pantoprazole
approximately. Subsequently add 10 ml of reconstituted solution containing 4 mg/ml of
Pantoprazole approximately, to 90 ml 0.9% Sodium Chloride Solution or 90 ml of 5%
dextrose solution to make 100 ml solution of 0.4 mg/ml of Pantoprazole approximately. The
resultant infusion should be given intravenously over a period of 2-15 minutes. Do not dilute
to < 0.4 mg/ml. Reconstitute solution and further diluted solution is stable for 6 hours only.
Do not mix with other drugs/ solution.
Precautions
Patients should be cautioned that Pantogut® tablet should not be split or crushed. Neonates and children: No data are available on administration of Pantoprazole (Pantogut®) to neonates and children. In patients with renal disfunction and geriatric patients the daily dose should not exceed 40 mg. Patients with serious hepatic dysfunction a daily dose should not exceed 20 mg.
Use in Pregnancy
During pregnancy Pantoprazole should not be used unless the benefit exceeds the potential risk.
Use in Lactation
There is no information about the safety of Pantoprazole during breast feeding in human. It should only be used during nursing if considered essential.
