Vonoprazan


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO GERD 20 mg once daily for 4 weeks, may be followed by a further 4 weeks if needed. Maintenance of healing for recurrent reflux oesophagitis: 10 mg once daily, may increase to 20 mg once daily, as necessary. Peptic ulcer 20 mg once daily for 8 weeks in gastric ulcer and 6 weeks in duodenal ulcer. Prophylaxis of NSAID-induced ulcers 10 mg once daily including. Eradication of H. pylori associated with peptic ulcer disease 20 mg bid for 7 days, given as triple therapy in combination with amoxicillin and clarithromycin or with amoxicillin and metronidazole.
Dosage Details
Oral
Gastro-oesophageal reflux disease
Adult: 20 mg once daily for 4 weeks, may be followed by a further 4 weeks if needed. Maintenance of healing for recurrent reflux oesophagitis: 10 mg once daily, may increase to 20 mg once daily, as necessary.

Oral
Peptic ulcer
Adult: 20 mg once daily for 8 weeks in gastric ulcer and 6 weeks in duodenal ulcer.

Oral
Prophylaxis of NSAID-induced ulcers
Adult: 10 mg once daily.

Oral
Eradication of H. pylori associated with peptic ulcer disease
Adult: 20 mg bid for 7 days, given as triple therapy in combination with amoxicillin and clarithromycin. Alternatively, 20 mg bid for 7 days with amoxicillin and metronidazole.
Administration
Film-Coated Tab: May be taken with or without food.
Contraindications
Lactation. Concomitant use with drugs which depend on acidic gastric pH for absorption (e.g. atazanavir, rilpivirine, nelfinavir).
Special Precautions
May mask symptoms of gastric cancer; rule out malignancy prior to initiation of therapy. Renal and hepatic impairment. Pregnancy.
Adverse Reactions
Significant: Hepatotoxicity including liver injury, pseudomembranous colitis (in combination with antibiotics), benign gastric polyp (prolonged use).
Gastrointestinal disorders: Diarrhoea, constipation, nausea, abdominal distention, taste abnormality, stomatitis.
Hepatobiliary disorders: Jaundice.
Immune system disorders: Hypersensitivity including anaphylactic shock, urticaria.
Investigations: Increased AST, ALT, gamma-glutamyl transferase,
Skin and subcutaneous tissue disorders: Rash, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, drug eruption.
Drug Interactions
Increased blood concentration with CYP3A4 inhibitors (e.g. clarithromycin) and with amoxicillin in triple treatment for eradication of H. pylori. May decrease the effects of itraconazole and tyrosine kinase inhibitors (e.g. gefitinib, nilotinib). Vonoprazan may increase the effects of digoxin.
Potentially Fatal: May significantly reduce the bioavailability of atazanavir, rilpivirine and nelfinavir.
Action
Description: Vonoprazan is a potassium-competitive acid blocker (PCAB). It inhibits the binding of K ions to hydrogen/potassium adenosine triphosphate (H+/K+ ATPase) enzyme system which is the proton pump of the gastric parietal cell thereby increasing gastric pH and inhibiting gastric acid production.
Onset: Rapid.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Time to peak plasma concentrations: Within 2 hours.
Distribution: Plasma protein-binding: Approx 85-88%.
Metabolism: Metabolised in the liver mainly by CYP3A4 and partially by CYP2B6, CYP2C19 and CYP2D6 to inactive metabolites.
Excretion: Via urine (approx 67%, mainly as metabolites), faeces (31%). Elimination half-life: Approx 6-8.8 hours.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store below 30°C.
Disclaimer: This information is independently developed by MIMS based on Vonoprazan from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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