Indications & Dose:

INDICATIONS:

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 non-steroidal anti-inflammatory drug (NSAID) administration.

Adjunct to Helicobacter pylori eradication in the following settings: 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

Gastric ulcer and duodenal ulcer The usual adult dosage for oral use is 20mg 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 20mg 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 20mg of (Vonoprazan) once daily. Prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin administration The usual adult dosage is one tablet of 10mg 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 dosage is one tablet of 10mg 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: 20mg of (Vonoprazan), 750mg of amoxicillin hydrate and 200mg of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage should not exceed 400mg 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: 20mg of (Vonoprazan), 750mg of amoxicillin hydrate and 250mg of metronidazole.

Contraindications:

CONTRAINDICATIONS

Patients with hypersensitivity to Vonoprazan or to any excipient of the product.

Patients receiving atazanavir sulphate, nelfinavir or rilpivirine hydrochloride.

Cautions:

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Precautions:

General At the treatment, the course of the disease should closely be observed and the minimum therapeutic necessity should be used according to the disease condition. In the long-term, treatment with Vonoprazan, close observation by such means as endoscopy should be made. In the maintenance of healing of reflux esophagitis, Vonoprazan should be administered only to the patients who repeat 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 20mg, or suspension of administration should be considered. 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. 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. Hepatic function abnormalities including liver injury have been reported. Discontinuation of Vonoprazan is recommended in patients who have evidence of liver function abnormalities or if they develop signs or symptoms suggestive of liver dysfunction. Elevation of intragastric pH Administration of Vonoprazan results in elevation of intragastric pH and is therefore not recommended to be taken with drugs for which absorption is dependent on acidic intragastric pH. Symptomatic response to Vonoprazan does not preclude the presence of gastric malignancy. It is therefore, necessary to ascertain the ulcer is not of a malignant nature before initiating the administration of this drug. Clostridium difficile, serious colitis, including pseudomembranous colitis There is an increased risk of gastrointestinal infection caused by Clostridium difficile. Serious colitis accompanied with bloody stools, such as pseudomembranous colitis, may occur due to amoxicillin hydrate or clarithromycin being used for Helicobacter pylori eradication, in combination with Vonoprazan. If abdominal pain and frequent diarrhea occur, appropriate measures, such as immediate discontinuation of the treatment, should be taken. Benign gastric polyps Benign gastric polyp has been observed in patient on long-term administration of PPIs. Fractures An increased risk for osteoporosis-related fractures of the hip, wrist or spine have been reported in patients under treatment with proton pump inhibitors. The risk of fracture was especially increased in the patients receiving high dose or long term (a year or longer) treatment. Hypomagnesemia Severe hypomagnesemia has been reported in patients on prolonged treatment with PPIs for at least three months and in most cases for a year. Use in elderly Since the physiological functions such as hepatic or renal function are decreased in elderly patients in general, Vonoprazan should be carefully administered. Use in children less than 18 years of age Vonoprazan has not been studied in patients under 18 years of age. Pregnancy Vonoprazan should be used in pregnant women or women having possibilities of being pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk. Nursing Mothers It is advisable to avoid the administration of Vonoprazan to nursing mothers. However, when the administration is indispensable, nursing should be discontinued.

Interaction:

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Warnings:

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Adverse Effects:

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Lactations:

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Special Precautions:

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Counselling:

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Side Effects Or Adverse Reactions:

Diarrhea, constipation, drug hypersensitivity (including anaphylactic shock), drug eruption, urticaria, hepatotoxicity, jaundice, rash, nausea, abdominal distension, gamma-glutamyl transferase increased, AST increased, Liver function test abnormal, ALT increased.

Patient And Carer Advice:

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