Detonix-20

Pantoprazole BP 20mg


Description
Detonix-20 Tablet: Each enteric coated tablet is a preparation of Pantoprazole, which is a proton pump inhibitor indicated for the treatment of acid-peptic diseases. Like other proton pump inhibitors Detonix-20 causes long-lasting inhibition of acid secretion by inactivating the parietal cell H+-K+ ATPase.

Composition
Detonix-20 Tablet: Each tablet contains Pantoprazole Sodium Sesquihydrate BP equivalent to Pantoprazole 20 mg.

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Indications
Pantoprazole (Detonix-20) is indicated where suppression of acid secretion is of therapeutic benefit. Detonix-20 is indicated for the following purposes:

w Duodenal ulcer w benign gastric ulcer w esophagitis/ulceration
w Zollinger-Ellision syndrome w resistant ulcers w eradication of Helicobacter pylon in the treatment of peptic ulcer (in combination with antibiotics) and in the treatment of ulcers induced by non-steroidal antiinflammatory drugs (NSAIDs).

Dosage & Administration
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 daliy in the morning for four weeks, continued for further four weeks if not fully healed.

Gastro-oesophageal 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.

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

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 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 inhibitors should be used with caution in patients with liver disease, in pregnancy and breast feeding: before treatment the presence of gastric malignancy should he 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. 

Drug Interactions
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.

Packing
Detonix-20 Tablet: Box containing 3x10's, 5x10's & 10x10's tablets in alu/alu blister pack.