Manufacturer: Affordable HealthCare manufactures Pantoprazole.
The uses of Pantoprazole include:
1. For the symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:
-Gastro-oesophageal reflux disease (GORD)
*For the treatment of mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing)
2. Eradication of Helicobacter pylori (hereinafter referred to as H. pylori) in combination with
-clarithromycin and amoxycillin or
-clarithromycin and metronidazole or
-amoxycillin and metronidazole
(see Dosage and Administration) in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism.
The NIH have recommended that regimens to eradicate H. pylori in patients with PUD should contain both anti-secretory agents and anti-microbial agents (to which H. pylori has been demonstrated to be sensitive in vivo). A trial by Bardhan in patients with gastritis, florid duodenal ulcer or history of duodenal ulcer has demonstrated that pantoprazole 40 mg twice daily in the combination with tinidazole 500 mg twice daily and clarithromycin 250 mg twice daily for 10 days is effective in eradicating H. pylori in 86% of cases. Following combination therapy the DU healing rate was 100% after 1 month.
3. Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment.
Pantoprazole tablets are indicated for maintenance treatment of reflux oesophagitis, duodenal ulcer, gastric ulcer and Zollinger-Ellison syndrome. Prolonged treatment should be considered:
-in patients who have recurrent peptic ulceration where the pathogenesis of the ulcer is not related to H. pylori infection; or
-where repeated eradication therapy is unsuccessful; or
who have a past history of perforation or bleeding from an ulcer.
Dosage and Administration
The recommended oral dosage is one gastro-resistant 40 mg pantoprazole tablet per day. A duodenal ulcer generally heals within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks.
The recommended oral dosage is one gastro-resistant 40 mg pantoprazole tablet per day.
A 4-week period is usually required for the treatment of gastric ulcers. If this is not sufficient, healing will usually be achieved within a further 4 weeks.
For mild reflux disease and the associated symptoms, the recommended dosage is one pantoprazole 20 mg tablet per day. Symptom relief is generally accomplished within 2-4 weeks. If symptom control has not been achieved after four weeks treatment with pantoprazole 20 mg tablets daily, further investigation is recommended.
For treatment of reflux oesophagitis, the recommended oral dosage is one pantoprazole 40 mg tablet per day. A 4-week period is usually required for treatment of reflux oesophagitis, however if this is not sufficient, healing will usually be achieved within a further 4 weeks.
The recommended oral dosage is one gastro-resistant pantoprazole tablet 40 mg per day.
Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment.
The recommended oral dosage is one gastro-resistant pantoprazole tablet 20 mg per day.
Duodenal and Gastric Ulcer, and Zollinger-Ellison Syndrome:
For long-term management, a maintenance dose of one gastro-resistant pantoprazole tablet 40 mg per day is recommended.
A maintenance dose of one pantoprazole tablet 20 mg per day is recommended, increasing to 40 mg per day if relapse occurs. After healing of the relapse the dosage can be reduced again to 20 mg.
Experience with long-term administration in man over several years is available in a limited number of patients. Therefore, long-term treatment exceeding 1 year may be considered after careful evaluation of the risk benefit ratio. Patients should then be kept under regular surveillance.
Use in children
There are no data currently available on the use of pantoprazole in children.
Use in the elderly
The daily dose of 20 mg or 40 mg can be given. An exception is combination therapy for eradication of H. pylori, where also elderly patients should receive the usual pantoprazole dose (2 x 40 mg/day) during 1-week treatment.
Impaired Renal Function
The daily dose of 20 mg or 40 mg can be given.
Impaired Liver Function
In patients with severe liver impairment the dose has to be reduced to 20 mg pantoprazole per day.