País: Filipines
Idioma: anglès
Font: FDA (Food And Drug Administration)
Vonoprazan (as fumarate)
Japan; Importer: N/A; Distributor: Takeda Healthcare Philippines, Inc.
Vonoprazan (as fumarate)
10 mg
Film-Coated Tablet
PVC/Aluminum Blister Pack x 10's (Box of 30's), PVC/Aluminum blister by 10’s (Box of 30's)
Takeda Pharmaceutical Company Limited (Hikari Plant)
2023-03-23
PRODUCT DESCRIPTION: 10 mg tablets: pale yellow, oval, biconvex, film-coated tablets with " B217" printed on one side ( : Takeda logo) 20 mg tablets: pale red, oval, biconvex, film-coated tablets with score on both sides and " B218" printed on one side ( : Takeda logo) FORMULATION Each tablet contains 10mg or 20mg Vonoprazan (as fumarate). INDICATION ● Gastric ulcer, duodenal ulcer, reflux esophagitis, prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration, or prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration ● Adjunct to _Helicobacter pylori_ eradication in the followings Gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early stage gastric cancer, or Helicobacter pylori gastritis PRECAUTIONS FOR INDICATIONS _Prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration_ This drug should be administered to the patients who are under continuous administration of low- dose aspirin for prevention of blood clots and emboli formation. History of gastric ulcer or duodenal ulcer should be confirmed before starting administration. _Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration_ This drug should be administered to the patients who are under continuous administration of NSAIDs for purpose such as pain management of rheumatoid arthritis or osteoarthritis, etc. History of gastric ulcer or duodenal ulcer should be confirmed before starting administration. ADJUNCT TO _HELICOBACTER PYLORI_ ERADICATION (1) The efficacy of _Helicobacter pylori_ eradication in the advanced stage of gastric MALT lymphoma has not been established. (2) _Helicobacter pylori_ eradication should be conducted in the idiopathic thrombocytopenic purpura patients only if _Helicobacter pylori_ eradication is considered appropriate with referring to the guidelines etc. (3) The efficacy on the prevention o Llegiu el document complet