Vocinti

Vocinti

vonoprazan

Manufacturer:

Takeda

Distributor:

Zuellig
Concise Prescribing Info
Contents
Vonoprazan fumarate
Indications/Uses
Gastric & duodenal ulcer, reflux esophagitis, prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin or NSAIDs administration. Adjunct to H. pylori eradication in gastric & duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early stage gastric cancer, or H. pylori gastritis.
Dosage/Direction for Use
Adult Gastric & duodenal ulcer 20 mg once daily, up to 8 wk for gastric ulcer & up to 6 wk for duodenal ulcer. Reflux esophagitis 20 mg once daily for up to 4 wk or if necessary, up to 8 wk. Recurrent & relapsing reflux esophagitis 10 mg once daily, may be increased to 20 mg once daily if necessary. Prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin or NSAIDs administration 10 mg once daily. Adjunct to H. pylori eradication 20 mg vonoprazan + 750 mg amoxicillin hydrate + 200 mg clarithromycin bid for 7 days. May properly increase clarithromycin dose up to max 400 mg bid as the occasion demands. Alternatively, 20 mg vonoprazan + 750 mg amoxicillin hydrate + 250 mg metronidazole bid for 7 days may be used if the other treatment fails.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients receiving atazanavir sulphate or rilpivirine HCl.
Special Precautions
Confirm history of gastric or duodenal ulcer before starting administration. Close observation by endoscopy should be made during long-term treatment. Administer only in patients who repeat recurrence & recrudescence of reflux esophagitis. Benign gastric polyp in long-term administration. May mask symptoms of gastric cancer. Increased risk for osteoporosis-related fractures of the hip, wrist or spine; especially increased in patients receiving high dose or long term (≥1 yr) treatment. Increased risk of GI infection caused by Clostridium difficile in patients receiving PPI. Renal & hepatic impairment. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Constipation, diarrhea, feeling of enlarged abdomen, nausea; rash; increased AST, ALT, AL-P, LDH, γ-GPT; edema, eosinophilia. Taste abnormality, stomatitis, feeling of abdominal discomfort.
Drug Interactions
May promote or inhibit absorption of concomitant drugs which absorption is dependent on acidic intragastric pH. May diminish effects of atazanavir sulfate & rilpivirine HCl; itraconazole, tyrosine kinase inhibitors (eg, gefitinib, nilotinib, erlotinib), nelfinavir mesylate. May increase blood conc w/ CYP3A4 inhibitors eg, clarithromycin. May enhance effects of digoxin & methyldigoxin.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC08 - vonoprazan ; Belongs to the class of potassium-competitive acid blocker. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Vocinti FC tab 10 mg
Packing/Price
30's
Form
Vocinti FC tab 20 mg
Packing/Price
30's
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