INDICATIONS

1. Gastric ulcer, duodenal ulcer, reflux esophagitis, prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin administration, prevention of recurrence of gastric or duodenal ulcer during NSAID administration.

2. Adjunct to Helicobacter pylori eradication in the following: Gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphatic tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early-stage gastric cancer or Helicobacter pylori gastritis.

DOSAGE AND ADMINISTRATION

Gastric ulcer and duodenal ulcer

The usual adult dose for oral use is 20 mg of Vonoprazan administered orally once daily an 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer.

Reflux esophagitis

The usual adult dose for oral use is 20 mg of Vonoprazan administered once daily for a total of 4 weeks of treatment. If that dosing proves insufficient, the administration should be extended, but for no longer than 8 weeks of treatment.

For the maintenance therapy of reflux esophagitis showing recurrence and recrudescence, the dose for oral use is 10mg of Vonoprazan once daily. However, when the efficacy is inadequate, the dosage may be increase up to 20 mg of Vonoprazan once daily.

Prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin administration

The usual adult dose is one tablet of 10 mg of Vonoprazan administered orally once daily.

Prevention of recurrence of gastric or duodenal ulcer during non-steroidal anti-inflammatory drug (NSAID) administration

The usual adult dose is one tablet of 10 mg of Vonoprazan administered orally once daily

Adjunct to Helicobacter pylori eradication

For adults, the following three-drug regimen should be administered orally at the same time twice daily for seven days: 20 mg of Vonoprazan, 750 mg of amoxicillin hydrate and 200 mg of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage should not exceed 400 mg twice daily.

If Helicobacter pylori eradication with a three-drug regimen comprising a proton pump inhibitor, amoxicillin hydrate and clarithromycin has been unsuccessful, as an alternative treatment, adults should be administered the following three drugs orally twice daily for seven days: 20 mg of Vonoprazan, 750 mg of amoxicillin hydrate and 250 mg of metronidazole. 

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