VOCINTI Film-coated tablet Ref.[50552] Active ingredients: Vonoprazan

Dosage

Adults

• Gastric ulcer

The usual dose is 20 mg of vonoprazan once a day. Administration should be limited to 8 weeks.

• Duodenal ulcer

The usual dose is 20 mg of vonoprazan once a day. Administration should be limited to 6 weeks.

• Reflux esophagitis (erosive esophagitis)

The usual dose is 20 mg of vonoprazan once a day. Administration should be limited to 4 weeks. However, when the effect is insufficient, treatment may be continued for up to 8 weeks.

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

The usual dose is 10 mg of vonoprazan once a day.

• Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration

The usual dose is 10 mg of vonoprazan once a day.

• Adjunct to Helicobacter pylori eradication

Usually, the following 3 drugs are orally administered at the same time twice daily for 7 days: 20 mg vonoprazan, 750 mg amoxicillin hydrate, and 200 mg clarithromycin. The dose of clarithromycin may be appropriately increased as required, however, the upper limit is 400 mg twice daily or physician judgement.

When Helicobacter pylori eradication treatment with 3 drugs consisting of a proton pump inhibitor, amoxicillin hydrate, and clarithromycin fails, alternative treatment with the following 3 drugs is recommended; 20 mg vonoprazan, 750 mg amoxicillin hydrate, and 250 mg metronidazole, orally administered at the same time twice daily for 7 days. The doses of antibiotic should follow the respective label recommendations for H. pylori eradication.

Method of Administration

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

Special Patient Populations

Elderly Patients

Since the physiological functions such as hepatic or renal function are decreased in elderly patients in general, vonoprazan should be carefully administered (See Impaired Renal Function and Impaired Hepatic Function sections below).

Pediatric Patients

Vonoprazan has not been studied in patients under 18 years of age.

Impaired Renal Function

Vonoprazan should be administered with care in patients with renal disorders as a delay in the excretion of vonoprazan may occur, which may result in an increase in the concentration of vonoprazan in the blood (See Section 5.2).

Impaired Hepatic Function

Vonoprazan should be administered with care in patients with hepatic disorders as a delay in the metabolism and excretion of vonoprazan may occur, which may result in an increase in the concentration of vonoprazan in the blood (See Section 5.2).

There is no experience of overdose with vonoprazan.

Vonoprazan is not removed from the circulation by hemodialysis. If overdose occurs, treatment should be symptomatic and supportive.

Drug Abuse and Dependence

Vonoprazan has no known potential for abuse or dependence.

Store below 30°C.

Polyvinyl chloride (PVC) film/Aluminum foil blister, one blister contains 10 tablets.