TRUPAN Tablet

Pantoprazole is contraindicated in patients with known hypersensitivity to the active drug or any other components of the formulation.

Pantoprazole is well tolerated in both short term and long term treatment. Headache and diarrhoea are the most common side effects and rarely included abdominal pain, flatulence, rash, insomnia and hyperglycemia.

Pantoprazole is metabolized through the CYP system, primarily the CYP2C19 and CYP3A4 isozymes and subsequently undergoes PhaseⅡconjugation. Based on studies evaluating possible interactions of Pantoprazole with other drugs, no dosage adjustment is needed with concomitant use of the following: theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam (and its active metabolite, desmethyldiazepam), diclofenac, naproxen, piroxicam, digoxin, ethanol, glyburide, oral contraceptive (levonorgestrel/ethinyl estradiol), metoprolol, nifedipine, phenytoin, warfarin, midazolam, clarithromycin, metronidazole or amoxicillin. Because of profound and long lasting inhibition of gastric acid secretion, Pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (e.g. ketoconazole, ampicillin ester and iron salts).

Teratology studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Pantoprazole. There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40mg oral dose. The clinical relevance of this finding is not known. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

Patients should be cautioned that Pantoprazole tablet should not be split, crushed or chewed. The tablet should be swallowed whole, with or without food in the stomach. Concomitant administration of antacid does not affect the absorption of Pantoprazole.

Pantoprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. Pantoprazole inhibits secretion of gastric acid by blocking the hydrogen-potassium-adenosine triphosphatase enzyme system, the so called ‘Proton Pump’ of the gastric parietal cell. Absorption of Pantoprazole begins only after the tablet leaves the stomach. Cmax and AUC increase in a manner proportional to oral dose from 10mg to 80mg. Pantoprazole does not accumulate and its pharmacokinetics are unaltered with multiple daily dosing. Following oral administration, the serum concentration of Pantoprazole declines biexponentially with a terminal elimination half-life of approximately one hour. The absorption of Pantoprazole is rapid, with a Cmax of 2.5mcg/mL, which occurs approximately 2.5 hours after single or multiple oral 40mg doses. Pantoprazole is well absorbed. It undergoes little first-pass metabolism resulting in an absolute bioavailability of approximately 77%. Administration of Pantoprazole with food may delay its absorption up to 2 hours or longer. However, the Cmax and the extent of Pantoprazole absorption (AUC) are not altered. Thus, Pantoprazole may be taken without regard to timing of meals. The serum protein binding of Pantoprazole is about 98%, primarily to albumin. Pantoprazole is extensively metabolized in the liver through the CYP system. After a single oral dose of 14C-labeled Pantoprazole to healthy, normal metabolizer volunteers, approximately 71% of the dose was excreted in the urine with 18% excreted in the faces through biliary excretion. There was no renal excretion of unchanged Pantoprazole