Indication: Benign gastric ulcer, duodenal ulcer, Gastroesophageal reflux disease (GERD), NSAID induced peptic ulcer, acid hypersecretory conditions including Zollinger-Ellison syndrome, eradication of Helicobacter pylori in combination with Antibiotics), ulcer resistant to H2-receptor antagonists.
Composition: Prilosec 20 Tablet: Each enteric coated tablet contains Pantoprazole Sodium Sesquihydrate BP 22.55 mg equivalent to Pantoprazole 20 mg. Prilosec 40 Tablet: Each enteric coated tablet contains Pantoprazole Sodium Sesquihydrate BP 45.10 mg equivalent to Pantoprazole 40 mg.
Therapeutic Class: Anti-Ulcerant
Generic Name: Pantoprazole Sodium BP
Pharmacology: Pantoprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. Pantoprazole is well absorbed it undergoes little first- pass metabolism of approximately 77%. The serum protein binding of pantoprazole is about 98%, primarily to albumin. Pantoprazole is extensively metabolizer in the liver through the cytochrome P450 (CYP) system.
Pantoprazole inhibits secretion of gastric acid by blocking the hydrogen-potassiumadenosine triphosphatase enzyme system, the so called ‘Proton Pump’ of the gastric parietal cell. Absorption of Pantoprazole begins only after the tablet leaves the stomach.
Dose and Administration: Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks if not fully healed. Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed. GERD: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks if not fully healed. NSAIDs induced peptic ulcer: 20 mg daily. Acid hypersecretory conditions including Zollinger-Ellison syndrome: Initially 80 mg once daily adjusted according to response (Elderly – max. 40 mg daily), daily doses above 80 mg given in two divided doses. Eradication of Helicobacter pylori: 40 mg twice daily by triple therapy with antibiotics. Ulcer resistant to H2-receptor antagonists: 40 mg once daily for 8 weeks. Maintenance therapy: 20 mg daily, increased to 40 mg daily if symptoms return.
Contraindication: Pantoprazole is contraindicated in patients with known hypersensitivity to the active drug or any other components of the formulation.
Warning & Precaution: Patients should be cautioned that this tablet should not be split, crushed or chewed. The tablet should be swallowed whole, with or without food in the stomach.
a) Common: Pantoprazole is well tolerated in both short term and long term treatment. Headache and diarrhea are the most common side effects.
b) Rare: Side effects that may be seen very rarely include abdominal pain, flatulence, rash, insomnia, hyperglycemia.
Use in pregnancy and lactation: 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, however, 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 40 mg 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.
Use in children & adolescents: Safety and effectiveness have not been established.
a) With medicine: Pantoprazole interactions with following drugs: theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam (and its active metabolite, desmethyldiazepam), diclofenac, naproxen, piroxicam, digoxin, ethanol, glyburide, an oral contraceptive (levonorgestrel/ethinyl estradiol), metoprolol, nifedipine, phenytoin, warfarin, ketoconazole, 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 (eg, ampicillin esters, and iron salts).
b) With Food and others: 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.
Overdose: There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein bound, it is not removed by hemodialysis. In case of overdose, treatment should be symptomatic and supportive.
Storage: Store below 30°C, protected from light & moisture. Keep away from the reach of the children.
Prilosec 20 Tablet: Box containing 5 x10’s tablets in Alu-Alu blister pack.
Prilosec 40 Tablet: Box containing 3 x10’s tablets in Alu-Alu blister pack.
20 mg, 40 mg