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BPA-PANTOPRAZOLE (Beximco Pharmaceuticals Australia Pty Ltd)

Product name
BPA-PANTOPRAZOLE
Date registered
Evaluation commenced
Decision date
Approval time
167 working days (255)
Active ingredients
Pantoprazole (as sodium sesquihydrate)
Registration type
New generic medicine
Indication

BPA-PANTOPRAZOLE (Tablets) is indicated for the treatment of:

Adults
  1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:
    • Duodenal ulcer
    • Gastric ulcer
    • Gastro-oesophageal reflux disease (GORD)
    • Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD
    • Reflux oesophagitis
    • Gastrointestinal lesions refractory to H2 blockers
    • Zollinger-Ellison Syndrome

      Patients whose gastric or duodenal ulceration is not associated with ingestion of non- steroidal anti-inflammatory drugs (NSAIDs) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.

  2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis
  3. For eradication of Helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics:
    • Clarithromycin and amoxicillin or Clarithomycin and metronidazole or Amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism.
  4. Pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of Helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism.
  5. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment.
Children aged from 5 to 17 years

Gastro-oesophageal reflux disease (GORD):

  • Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD
  • Reflux oesophagitis

The treatment duration should not exceed 8 weeks.

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