COMPOSITION
Each enteric coated tablet contains Pantoprazole INN 40 mg (as Pantoprazole Sodium Sesquihydrate).
PHARMACOLOGY
Nixpan (Pantoprazole) is a proton pump inhibitor that suppresses the final step in gastric acid production by covalently binding to the H+/K+ATPase enzyme system at the surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus that persists longer than 24 hours.
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.
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. Safety and effectiveness in case of children have not been established.
CONTRAINDICATION
It is contraindicated in patients with known hypersensitivity to the active drug or any other components of the formulation.
WARNING AND 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.
SIDE EFFECTS
Nixpan (Pantoprazole) is well tolerated in both short term and long term treatment. Headache and diarrhea are the most common side effects and rarely included abdominal pain, flatulence, rash, eructation, insomnia, and hyperglycemia.
USE IN PREGNANCY AND LACTATION
There are no adequate and well-controlled studies in pregnant women, the drug should be used during pregnancy only if clearly needed. Nixpan (Pantoprazole) excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. 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.
DRUG INTERACTION
Nixpan (Pantoprazole) may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (eg, ketoconazole, ampicillin esters, and iron salts).
STORAGE
Store in a cool and dry place below 300C. Protect from light and moisture. Keep out of the reach of the children.
PACKING
Box containing 10 x 3’s enteric coated tablets in alu-alu pack.
