Indication

? Gastric & Duodenal Ulcer

? Gastroesophageal Reflux Disease

? Maintenance Therapy for Recurrence and Recrudescence of Reflux Esophagitis

? Prevention of Recurrence of Gastric or Duodenal Ulcer During Low-dose Aspirin or Non-steroidal Anti-inflammatory Drug (NSAID) Administration

? Adjunct to Helicobacter pylori eradication


Dosage & Administration

Gastric and Duodenal Ulcer: The usual adult dosage for oral use is Vonomax 20 administered orally once daily an 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer.

Gastroesophageal Reflux Disease (GERD): The usual adult dosage for oral use is Vonomax 20 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 GERD showing recurrence and recrudescence, the maximum dose for oral use is Vonomax 20 once daily.

Maintenance Therapy for Recurrence and Recrudescence of Reflux Esophagitis: Vonomax 10 once daily. However, when the efficacy is inadequate, the dosage may be increased to Vonomax 20 once daily.

Prevention of Recurrence of Gastric or Duodenal Ulcer During Low-dose Aspirin or Non-steroidal Anti-inflammatory Drug (NSAID) Administration: The usual adult dosage is Vonomax 10 once daily.

Adjunct to Helicobacter pylori eradication: Dual Therapy: The recommended dosage regimen is Vonomax 20 twice daily (morning and evening) plus Amoxicillin 1,000 mg, three times a day (morning, mid-day, and evening), with or without food, for 14 days. Triple Therapy: The recommended dosage regimen is Vonomax 20 mg plus Amoxicillin 1,000 mg & Clarithromycin 500 mg, twice daily (morning and evening, 12 hours apart), with or without food, for 14 days.


Precautions

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.

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.


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