Vono 10 mg is indicated for:

• Gastric ulcer, duodenal ulcer, reflux esophagitis, prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin therapy, and prevention of recurrence of gastric or duodenal ulcer during NSAID therapy.
• Adjunct treatment for Helicobacter pylori eradication in conditions such as gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphatic tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, post-endoscopic resection of early gastric cancer, and Helicobacter pylori-associated gastritis.

Vonoprazan is a potassium-competitive acid blocker (P-CAB) that does not require activation by acid. It reversibly and competitively inhibits H+, K+-ATPase. Due to its strong basicity, Vonoprazan accumulates for a prolonged period at the acid-secreting site of gastric parietal cells, thereby suppressing gastric acid secretion effectively. Vonoprazan also exhibits a potent inhibitory effect against mucosal damage formation in the upper 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 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.

Administration

Vonoprazan can be taken without regard to food or timing of food.

Vonoprazan is contraindicated in:

• Patients with hypersensitivity to Vonoprazan or any excipient of this preparation.
• Patients receiving atazanavir sulfate, nelfinavir, or rilpivirine hydrochloride.

The following adverse effects have been reported with Vonoprazan therapy: diarrhea, constipation, hypersensitivity reactions (including anaphylactic shock), drug eruption, urticaria, hepatotoxicity, jaundice, rash, nausea, abdominal distension, increased gamma-glutamyl transferase, elevated AST, abnormal liver function tests, increased ALT, elevated ALP, increased LDH, elevated γ-GTP, edema, and eosinophilia.

Vonoprazan should be used during pregnancy or in women who may become pregnant only if the expected therapeutic benefits outweigh the potential risks. Administration of Vonoprazan to nursing mothers should preferably be avoided. If treatment is considered essential, breastfeeding should be discontinued.

During treatment with Vonoprazan, the course of the disease should be carefully monitored, and the minimum effective therapeutic dose should be used according to the patient's condition. During long-term therapy, close monitoring, including endoscopic evaluation, is recommended.

For maintenance therapy in reflux esophagitis, Vonoprazan should be administered only in patients with recurrent or relapsing disease. Use in patients who do not require maintenance therapy should be avoided.

When healing is maintained for an extended period and the risk of recurrence is low, dose reduction from 20 mg to 10 mg or discontinuation of therapy should be considered.

Use in the elderly: Since hepatic and renal functions are generally reduced in elderly patients, Vonoprazan should be administered with caution.

Use in children below 18 years of age: The safety and efficacy of Vonoprazan in children and adolescents have not been established. Therefore, its use is not recommended in patients below 18 years of age.

Patients with renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment (eGFR 30 to 89 mL/min). Use of Vonoprazan should be avoided in patients with severe renal impairment (eGFR <30 mL/min).

Patients with hepatic impairment: No dose adjustment is necessary in mild hepatic impairment (Child-Pugh A). Avoid use in moderate to severe hepatic impairment (Child-Pugh B or C).

There is limited experience regarding overdose with Vonoprazan. Vonoprazan is not removed from circulation by hemodialysis. In cases of overdose, treatment should be symptomatic and supportive.

Potassium competitive acid blocker

Store below 30°C in a cool and dry place, protected from light. Keep out of the reach of children.