Vonoprazan 20 is indicated for:
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Xevon 20 is a potassium-competitive acid blocker (P-CAB) and does not require activation by acid. It inhibits H+, K+-ATPase in a reversible and potassium-competitive manner. Vonoprazan has a strong basicity and resides on the acid production site of gastric parietal cells for a long time, thereby inhibiting gastric acid production. Vonoprazan exerts a strong inhibitory effect on the formation of mucosal damage in the upper part of the gastrointestinal tract.
- 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 increased 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.
Vonoprazan can be taken without regard to food or timing of food.
The following side effects have been reported with the use of Xevon: Diarrhea, constipation, drug hypersensitivity (including anaphylactic shock), drug eruption, urticaria, hepatotoxicity, jaundice, rash, nausea, abdominal distension, increased gamma-glutamyl transferase, increased AST, abnormal liver function test, ALT increased, ALP increased, LDH, increased y-GPT, edema, and eosinophilia
Since the physiological functions, such as hepatic or renal function, are decreased in elderly patients in general, Xevon should be carefully administered.
The safety and efficacy of Xevon in children and adolescents have not been established. Therefore, the administration of Xevon is not recommended in children and adolescents below 18 years of age.
No dose adjustment of Xevon is recommended in patients with mild hepatic impairment (Child-Pugh A). Avoid the use of Xevon in patients with moderate to severe hepatic impairment (Child-Pugh B or C).
No dose adjustment of Xevon is recommended in patients with mild to moderate renal impairment (eGFR 30 to 89 mL/min). Avoid the use of Xevon in patients with severe renal impairment (eGFR < 30 mL/min)
Vonoprazan should be used in pregnant women or women having possibility of being pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk. It is advisable to avoid the administration of Vonoprazan to nursing mothers. However, when the administration is indispensable, nursing should be discontinued.
During the treatment, the course of the disease should be closely observed, and the minimum therapeutic necessity should be used according to the disease condition. In the long-term, treatment with Xevon, close observation by such means as endoscopy should be made.
In the maintenance of healing of reflux esophagitis, Xevon should be administered only to patients who experience repeated recurrence and recrudescence of the condition. Administration to the patients who do not necessitate maintenance of healing should be avoided.
When the healing is maintained over a long period and when there is no risk of recurrence, the dose reduction to a dose of 10mg from a dose of 20mg, or suspension of administration, should be considered.
Store below 30°C, in a cool and dry place. Keep away from light. Keep all the medicine out of the reach of children.
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