Gaspain

Pantoprazole
Antiulcerant

Gaspain

Description

Composition:

GaspainTablet 20 mg : Each enteric coated tablet contains Pantoprazole Sodium Sesquihydrate BP equivalent to Pantoprazole 20 mg.
GaspainTablet 40 mg : Each enteric coated tablet contains Pantoprazole Sodium Sesquihydrate BP equivalent to Pantoprazole 40 mg.

Pharmacology:

Pantoprazole is a specific inhibitor of the gastric proton pump (H+/K+- ATPase) in the parietal cell. It inhibits acid secretion by binding to the H+/K+- ATPase enzyme.

Indications:

Pantoprazole (Gaspain) is indicated where suppression of acid secretion is of therapeutic benefit. Pantoprazole (Gaspain) is registered for the following indications: –

1. Peptic ulcer diseases (PUD)

2. Gastro esophageal reflux diseases (GERD)

3. Treatment of ulcer resistant to H2 receptor antagonists (H2RAs)

4. Treatment of ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs)

5. Gastrointestinal (GI) bleeding from stress or acid peptic diseases

6. Eradication of Helicobacter pylori (in combination with antibiotics)

7. Zollinger-Ellison syndrome

8. Prophylaxis for acid aspiration syndrome during induction of anaesthesia

 

Dosage & Administration:

GaspainTablet : The usual starting dose is 40 mg once daily & maintenance dose is 20 mg once daily to be taken 30 minutes before breakfast. Duodenal ulcer : 40 mg daily in the morning for two weeks, continued for further two weeks if not fully healed. Gastric ulcer : 40 mg dally in the morning for four weeks, continued for further four weeks if not fully healed. Gastro-esophageal reflux disease : 40 mg daily in the morning for four weeks, continued for further four weeks if not fully healed; may be continued at 20 mg daily (long-term management), increased to 40 mg daily if symptoms return. Duodenal ulcer associated with Helicobacter pylori : 40 mg twice daily associated with appropriate antibiotic regimen. Ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs): Pantoprazole 40 mg daily in the morning has been used to prevent the formation of gastroduodenal lesions in patients receiving continuous treatment with NSAIDs. Gastro-intestinal bleeding from stress or acid peptic diseases : The usual adult oral dose is 40 mg once daily, preferably in the morning with or without food, if required dose may be increased.

 

Contraindication:

In patients with known hypersensitivity to Pantoprazole Sodium Sesquihydrate or any excipient of the formulation.

 

Warning & Precaution:

Proton pump inhibitors should be used with caution in patients with liver disease, in pregnancy and breast feeding, before treatment the presence of gastric malignancy should be excluded. No problem with Pantoprazole has been encountered in clinical use in elderly patients. No dosage adjustment of Pantoprazole is required in patients with renal impairment but prolongation of metabolism leading to a slight rise in peak plasma levels occurs in hepatic cirrhosis and it is recommended that the dosing is reduced to every other day.

 

Side Effects:

Side effects of the proton pump inhibitors include gastro-intestinal disturbances (including diarrhoea, nausea and vomiting, constipation, flatulence, abdominal pain), headache hypersensitivity reactions (including rash, urticaria, angioedema, bronchospasm), pruritus, dizziness, peripheral edema, muscle and joint pain, malaise, blurred vision, depression and dry mouth.

 

Pregnancy and Lactation:

Pregnant women: USFDA pregnancy category B. Studies using animals hav not found any risk to fetus.
Neonates & Children: No data are available on administration of Pantoprazole.

 

Drug interaction:

Pantoprazole does not react with the cytochrome P-450 system. No drug interaction has been reported in a large series of studies examining reactions with contraceptives, diazepam. diclofenac, ethanol, caffeine, metoprolol, theophylline, digoxin, phenytoin, nifedipine and warfarin.

 

Packing:

Gaspain Tablet 20 mg : Box containing 50’s tablets in alu-alu blister pack.
Gaspain Tablet 40 mg : Box containing 50’s tablets in alu-alu blister pack.