PROTON-P

Pantoprazole

Description:

Proton-P, preparation of Pantoprazole, is a proton pump inhibitor indicated for the treatment of acid-peptic diseases. Proton-P causes long-lasting inhibition of acid secretion by inactivating the parietal cell H⁺/K⁺-ATPase.

Composition:

Proton-P 20: Each tablet contains Pantoprazole sodium sesquihydrate INN equivalent to pantoprazole 20 mg.

Proton-P 40: Each tablet contains Pantoprazole sodium sesquihydrate INN equivalent to pantoprazole 40 mg.

Indications:

Proton-P is indicated for the following purposes:

Duodenal ulcer, benign gastric ulcer, esophagitis, Zollinger-Ellision syndrome, resistant ulcer, eradication of Helicobacter pylori in the treatment of peptic ulcer (in combination with antibiotics) and in the treatment of ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs).

Dosage & administration:

The usual recommended adult oral dose is 40 mg once daily, preferably in the morning with or without food.

Duodenal ulcer: 40 mg daily in the morning for two weeks, continued for further two weeks if not fully healed.

Gastric ulcer: 40 mg daily in the morning for two 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.

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 has been used to prevent the formation of gastroduodenal lesion 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.

Contraindications:

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

Side-effects:

Side effects of the proton pump inhibitor include gastro-intestinal disturbances (including diarrhoea, nausea and vomiting, constipation, flatulence, abdominal pain), headache, hypersensitivity reactions (including rash, urticaria, angioedema, bronchospasm), pruritus, dizziness, peripheral oedema, muscle and joint pain, malaise, blurred vision, depression and dry mouth. Proton pump inhibitors decrease gastric acidity and may increase the risk of gastro-intestinal infections.

Cautions:

Proton pump inhibitor should be used with caution in patients liver diseases, 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 slight rise in peak plasma levels occurs in hepatic cirrhosis and it is recommended that the dosing is reduced to every other day.

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. The absence of drug interactions may therefore be regarded as an advantage for pantoprazole.

Storage:

§         Store in a cool and dry place, protected from light.

§         Keep out of the reach of the children.

Packing:

Proton-P Tablet 20: Box containing 5 x 10's tablets in alu/alu blister pack.

Proton-P Tablet 40: Box containing 5 x 10's tablets in alu/alu blister pack.