Vonoprazan: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
Reflux oesophagitis

Adult: 20 mg once daily for 4 weeks, may be followed by a further 4 weeks if necessary. Maintenance therapy of healing in patients with repeat recurrence or relapse: 10 mg once daily, may be increased to 20 mg once daily if needed.

Oral
Gastric ulcer

Adult: 20 mg once daily for 8 weeks.

Oral
Prophylaxis of NSAID-induced ulcers

Adult: Including cases that occur during low-dose aspirin therapy: 10 mg once daily.

Oral
Duodenal ulcer

Adult: 20 mg once daily for 6 weeks.

Oral
Eradication of H. pylori associated with peptic ulcer disease

Adult: Adjunct in the triple therapy regimen with antibiotics: 20 mg bid for 7 days in combination with amoxicillin and clarithromycin. Alternatively, 20 mg bid may be given for 7 days in combination with amoxicillin and metronidazole.

Administration

film-coated tab: May be taken with or without food.

Contraindications

Lactation. Concomitant use with atazanavir and rilpivirine.

Special Precautions

May mask symptoms of gastric malignancy. Renal and hepatic impairment. Pregnancy.

Adverse Reactions

Significant: Clostridioides difficile-associated infection, pseudomembranous colitis, increased intragastric pH, benign gastric polyps (prolonged use); increased risk of hip, spine, or wrist osteoporosis-related fractures (long-term use or high doses); hepatic function abnormalities, including liver injury. Rarely, hypomagnesaemia (prolonged use).
Gastrointestinal disorders: Diarrhoea, constipation, nausea, abdominal distention or discomfort, stomatitis, taste abnormality.
Hepatobiliary disorders: Jaundice.
Immune system disorders: Hypersensitivity reactions (e.g. urticaria, anaphylactic shock).
Investigations: Increased AST, ALT, and gamma-glutamyl transferase.
Skin and subcutaneous tissue disorders: Rash, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, drug eruption.

Monitoring Parameters

Evaluate the type of ulcer to rule out gastric malignancy before treatment initiation. Monitor Mg levels.

Drug Interactions

May increase blood concentration with CYP3A4 inhibitors (e.g. clarithromycin) and amoxicillin in the triple treatment for H. pylori eradication. May enhance the effects of digoxin and methyldigoxin. May diminish the effects of nelfinavir, itraconazole, and tyrosine kinase inhibitors (e.g. gefitinib, nilotinib).
Potentially Fatal: May significantly decrease the blood concentrations of atazanavir and rilpivirine.

Action

Description: Vonoprazan is a potassium-competitive acid blocker (PCAB). It competitively inhibits the binding of K ions to hydrogen/potassium-adenosine triphosphate (H⁺/K⁺-ATPase) enzyme system that acts as the proton pump of the gastric parietal cell, thereby inhibiting gastric acid production.
Onset: Rapid.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Time to peak plasma concentration: 1-3 hours (fasted state); 1-4 hours (after meal).
Distribution: Plasma protein-binding: 85.2-88%.
Metabolism: Metabolised in the liver mainly by CYP3A4 isoenzyme and partially by CYP2B6, CYP2C19 and CYP2D6 isoenzymes to inactive metabolites.
Excretion: Via urine (67.4%); faeces (31.1%). Elimination half-life: 7.7 ± 1 hours (fasted state); 7.7 ± 1.2 hours (after meal).

Chemical Structure

Storage

Store below 30°C.

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).

References

Anon. Vonoprazan. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/02/2022.

Buckingham R (ed). Vonoprazan. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/02/2022.

Vocinti 10 mg and 20 mg Film-Coated Tablet (Takeda Healthcare Philippines, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 03/02/2022.

Vocinti Film-Coated Tablet 10 mg and 20 mg (Takeda Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 03/02/2022.

Vocinti Film-Coated Tablet 10 mg and 20 mg (Takeda Pharmaceuticals [Asia Pacific] Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 03/02/2022.

Vocinti Tablet 10 mg and 20 mg (Takeda [Thailand] Ltd.). MIMS Thailand. http://www.mims.com/thailand. Accessed 03/02/2022.

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