Class: Gastrointestinal System
Dosage Form: Tablets
Description: Proton pump inhibitor for the treatment of peptic ulcer
Manufacturer: Delta Pharma
Pantoprazole sodium sesquihydrate………….. 22.56 mg (equivalent to 20 mg Pantoprazole)
Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production. This effect is dose-related and leads to inhibition of both hasal and stimulated gastric acid secretion irrespective of the stimulus. The duration of antisecretory effect of Pantoprazole persists longer than 24 hours.
For the symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:
- Duodenal ulcer
- Gastric ulcer
- Gastroesophageal reflux disease (GERD)
- For the treatment of mild reflux disease and associated symptoms (e.g. heartburn, acid rcgurgitation, pain on swallowing)
- Zollinger-Ellison Syndrome
- Chronic hyperacidity
- Eradication of Helicobacter pylori
- Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment
Delpanto E.C. Tablets are contraindicated in patients with known hypersensitivity to any component of the formulation.
Pantoprazole is metabolized through the cytochrome P450 system, primarily the CYP2C19 & CYP3A4 isozymes, and subsequently undergoes phase II conjugation. Based on studies evaluating possible interactions of pantoprazole with other drugs metabolized by the cytochrome P450 system, no dosage adjustment is needed with concomitant use of the following drugs: theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam, diclofenac, glyburide, oral contraceptives (levonorgestrel/ estradiol), metoprolol, nifedipine, phenytoin or warfarin.
Clinically relevant interactions of pantoprazole with other drugs with the same pathways are not expected . Therefore, when co-administered with pantoprazole, adjustment of the dosage of the of pantoprazole or of such drugs may not be necessary. There was also no interaction with concomitantly administered antacids.
Because of profound ard long lasting inhibition of gastric acid secretion, it is theoretically possible that pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavilability (e.g. ketokonazole, ampicillin esters, and iron salts).
In general pantoprazole is well tolerated in both short-term and long term usage.
With doses of 20 or 40 mg for up to 8 weeks, there were no dose-related effects on the incidence of adverse events.
The most frequent adverse events reported were: headache, diarrhea, flatulence, abdominal pain, rash, insomnia and hyperglycemia.
Dosage and Administration:
The recommended adult oral dose is 20- to 40-mg given once daily for up to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course treatment may be considered.
No dosage adjustment is necessary in patients with renal impairment, hepatic impairment, or for elderly patients. No dosage adjustment is necessary in patients undergoing hemodialysis.
Delpanto E.C. Tablets should be swallowed whole, with or without food in the stomach . concomitant administration of antacids does not affect the absorption of Delpanto.
Patients should, be cautioned that Delpanto E.C. Tablets should not be split, chewed or crushed.
During treatment with Pantoprazote a dose related elevation ofj^erumj^strm levels usually occurs. However, following healing of gastric or duodenal ulcers with pantoprazole treatment, elevated gastrin levels return to normal by at least 3 months.
Long term treatment with Pantoprazole for up to 5 years might results in a moderate increase in enterochromaffin-like ECL-cell density.
Pack of 2 strips of 7 tablets each.
Store at room temperature, below 25°C.