Medication info

Bosintide 10 mg (BonoPrazan Fumarate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Vonoprazan Fumarate›13.36mg / 1 tablet
Manufacturer / importer
Takeda Pharmaceuticals Korea CO., Ltd.
Appearance
Pale yellow oval film-coated tablet
Packaging
100 tablets (10 tablets/PTP packaging x 10)/box 30 tablets (10 tablets/PTP packaging x 3)/box
Approval status
Approval withdrawn

MFDS item code 201901917 · Approved 2019.03.29

This product's status changed to Approval withdrawn on 2024.12.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and maintenance of erosive reflux disease; treatment of gastric ulcers; prevention of recurrence of NSAID-induced ulcers
Who takes it
Adults
Adult dose
Gastric ulcer Administer vonoprazan 20mg orally once daily to adults. For gastric ulcers, treatment is generally given for up to 8 weeks. Treatment of erosive gastroesophageal reflux disease and maintenance therapy after treatment Administer vonoprazan 20mg orally once daily to adults for up to 4 weeks. If the effect is insufficient, treatment may be continued for up to 8 weeks. For maintenance therapy after treatment of erosive gastroesophageal reflux disease, administer 10mg orally once daily; if the effect is insufficient, 20mg may be administered orally once daily. Prevention of recurrence of gastric or duodenal ulcers during administration of nonsteroidal anti-inflammatory drugs (NSAIDs) Administer vonoprazan 10mg orally once daily to adults.

Ingredients

Importer
Takeda Pharmaceuticals Korea CO., Ltd.

Efficacy & effects

Treatment and maintenance of erosive reflux disease; treatment of gastric ulcers; prevention of recurrence of NSAID-induced ulcers

  • Peptic ulcer
  • erosive gastroesophageal reflux disease
  • duodenal ulcer
View approved original text

This medicine is used for the treatment and maintenance of peptic ulcers and erosive gastroesophageal reflux disease. It also helps prevent the recurrence of gastric ulcers or duodenal ulcers that may occur with non-steroidal anti-inflammatory drugs (NSAIDs). With these effects, it effectively protects digestive health and improves symptoms.

How to take

Adult dose

Gastric ulcer Administer vonoprazan 20mg orally once daily to adults. For gastric ulcers, treatment is generally given for up to 8 weeks. Treatment of erosive gastroesophageal reflux disease and maintenance therapy after treatment Administer vonoprazan 20mg orally once daily to adults for up to 4 weeks. If the effect is insufficient, treatment may be continued for up to 8 weeks. For maintenance therapy after treatment of erosive gastroesophageal reflux disease, administer 10mg orally once daily; if the effect is insufficient, 20mg may be administered orally once daily. Prevention of recurrence of gastric or duodenal ulcers during administration of nonsteroidal anti-inflammatory drugs (NSAIDs) Administer vonoprazan 10mg orally once daily to adults.

Precautions

This medication should not be used in certain patients. Patients who are allergic to this drug or have experienced hypersensitivity reactions should not take it. Additionally, patients currently taking specific medications containing Atazanavir, Nelfinavir, or Rilpivirine should not use this drug. Patients with liver or kidney function problems should be cautious as the metabolism or excretion of this drug may be delayed, resulting in increased blood concentration. Elderly patients should also be administered with caution. Using this medication may result in gastrointestinal adverse reactions such as constipation, diarrhea, abdominal distension, or nausea. Rarely, symptoms like skin rash, liver dysfunction, or edema may occur; if any abnormal symptoms arise, notify healthcare personnel immediately. Liver dysfunction or hepatotoxicity has been reported; if liver function issues occur or symptoms appear, it is recommended to discontinue the use of this medication. Also, long-term users should have their condition monitored through endoscopy, and it is advisable not to use it for maintenance therapy in patients with a low risk of recurrence. This medication suppresses gastric acid secretion to help treat gastrointestinal diseases but may interact with certain drugs. In particular, it should not be taken in combination with Atazanavir, Nelfinavir, or Rilpivirine, as efficacy may be reduced. Moreover, this drug may inhibit specific enzymes or affect metabolism, leading to changes in the concentration and effects of other medications; thus, it is essential to consult a doctor or pharmacist if taking other drugs. Women who are pregnant or nursing should not use this medication as its safety has not been established, and if unavoidable, breastfeeding should be discontinued. Finally, safety has not been verified in children or neonates, and it is advisable not to use this drug. Lastly, this medication is provided in PTP packaging, and care should be taken not to swallow the packaging sheet. The packaging sheet could cause injury to the esophagus and lead to severe complications, so it must be removed from the packaging before use.

Side effects

  • Constipation
  • diarrhea
  • abdominal distension
  • nausea
  • rash
  • increased AST (GOT)
  • increased ALT (GPT)
  • increased AL-P
  • increased LDH
  • increased γ-GTP
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  • edema
  • eosinophilia
  • drug hypersensitivity
  • drug rash
  • urticaria
  • pancytopenia
  • agranulocytosis
  • leukopenia
  • thrombocytopenia
  • hepatotoxicity
  • jaundice
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • erythema multiforme

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or humidity. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)/box 30 tablets (10 tablets/PTP packaging x 3)/box

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.