Pantoprazole Tablets 40mg
Each enteric coated tablet contains:
Pantoprazole Sodium Sesquihydrate
Equivalent to Pantoprazole 40mg
Colour: Iron oxide yellow
Pantoprazole is proton pump Inhibitor ,i.e, it inhibits specifically and dose proportionally H+,K+-ATPase the enzyme which is responsible for gastric acid secretion in the parietal cells of the stomach.
Concomitant intake of food has no influence on the bioavailability
Pantoprazole may reduce or increase the absorption of drugs whose bioavailability is Ph-dependent e.g.ketoconazole.
Studies in humans reveal no interaction with the cytochrome P450-system of the liver. There was no induction of the cytochrome P450-system after chronic administration as shown with marker antipyrine and no interactions were observed after concomitant administration of Pantoprazole with either antiphyrine, diazepam, theophylline, digoxin, oralconraceptiveshenytoin, nifedipine, carbamazepine, diclofenac, metoprolol, glibenclamide, ethanol and caffeine. Concomitant administration of warfarin or phenprocoumon has no influence on its effect on coagulation factors.
Antacid do not interact with Pantoprazole.
Pantoprazole 40 is indicated for the short-term treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis. If the duodenal ulcer has been demonstrated to be associated with Helicobacter pylori infection.
Pantoprazole 40used in combination with appropriate antibiotic may be useful.
Hypersensitivity to Pantoprazole.
Safety in pregnancy and during lactation has not been established. Safety and efficacy in children have not been established. Safety and efficacy in children have not been established. Severely impaired liver function.
DOSAGE AND DIRECTIONS FOR USE
The recommended once daily dosage of Pantoprazole should be taken in the morning. Panzo40 should be swallowed whole with a little water either before or during breakfast.
Duodenal ulcer: The recommended oral dosage is 40mg Pantoprazole once daily in the morning for 2 to 4 weeks. If the duodenal ulcer has been demonstrated to be associated with Helicobacter pylori infection, Panzo 40 used in combination with appropriate antibiotics may be useful.
Gastric ulcer: The recommended oral dosage is 40mg Pantoprazole once daily in the morning for 4 to 8 weeks. In case of a suspected gastric ulcer, malignancy of the ulcer should be excluded, as treatment could conceal the symptoms and may delay diagnosis.
Reflux oesophagitis: The recommended oral dosage is 40mg Pantoprazole once daily in the morning for 4 to 8 weeks.
No dosage adjustment is necessary in the elderly.
Impaired renal and liver function
No dosage adjustment is required in the presence of impaired renal and liver function.
ADVERSE EFFECTS AND SPECIAL PRECAUTIONS
Headache and gastro-intestinal complaints such as upper abdominal pain, diarrhea, constipation or flatulence have been reported. With contained treatment complaints usually diminish.
There have been less frequent reports of nausea, dizziness or disturbances in vision (blurred-vision). Peripheral edema, depression, fever or myalgia has been reported in individual cases.
Pantoprazole is not indicated for mild gastro-intestinal complaints such as nervous dyspepsia.
Diagnosis of reflux oesophagitis should be confirmed by endoscopy.
Blister pack of 10 tablets.