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
adult oral dose

 

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
Helicobacter pylori

 

40 mg

 

Twice daily in
combination
with appropriate
antibiotic

 

1 week

 

 

Zollinger-Ellison
syndrome

 

20 mg

 

Maximum 8
capsules per day

 

Up to control acid
secretion. Then the
dose reduced to
normal

 

 

Prophylaxis for acid
aspiration syndrome
during Induction of
anaesthesia

 

20 mg

 

Given at the evening
before surgery and
repeated again in the
morning of surgery

 

-

 

 

Maintenance therapy

 

20 mg

 

Once daily

 

-

40 mg IV injection

 

Usually recommended
adult dose

 

40 mg

 

Once daily

 

-

 

 

Duodenal ulcer

 

       

2-4 weeks

 

 

Gastric ulcer

 

       

4-8 weeks

 

 

Gastro-esophageal
reflux disease

 

       

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.


Product Details


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