This combination is used as a standard triple therapy regimen for the eradication of H. pylori infection in active chronic gastritis, duodenal ulcer, and gastric ulcer.

Each Vonokit, Vonocab Trio, Helicon V, and Vonocab Trio blister strip contains:

• One Vonoprazan 20 mg tablet (as Vonoprazan Fumarate INN)
• Two Amoxicillin 500 mg capsules (as Amoxicillin Trihydrate BP)
• One Clarithromycin 500 mg tablet (as Clarithromycin USP)

Each Vonolend kit contains:

• Two Vonoprazan 20 mg tablets (Each film-coated tablet contains Vonoprazan Fumarate INN equivalent to Vonoprazan 20 mg)
• Four Amoxicillin 500 mg capsules (Each capsule contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 500 mg)
• Two Clarithromycin 500 mg tablets (Each film-coated tablet contains Clarithromycin USP 500 mg)

Helicobacter pylori (H. pylori) plays an important role in the development of gastritis and peptic ulcer disease. The standard triple therapy regimen containing Vonoprazan 20 mg, Amoxicillin 500 mg, and Clarithromycin 500 mg for oral administration is effective in eradicating H. pylori infection.

Vonoprazan suppresses both basal and stimulated gastric acid secretion by inhibiting the H+, K+-ATPase enzyme system on the secretory surface of gastric parietal cells through potassium-competitive inhibition. Since this enzyme functions as the acid (proton) pump of the parietal cell, Vonoprazan is categorized as a gastric proton pump inhibitor that blocks the final step of acid production. Vonoprazan does not require acid activation and may selectively accumulate in gastric parietal cells during both resting and stimulated states. It binds reversibly and noncovalently to active proton pumps. Amoxicillin is a penicillin-class antibacterial drug, while Clarithromycin is a macrolide antimicrobial agent. Suppression of gastric acid enhances the replication of H. pylori bacteria and improves the stability and efficacy of antimicrobial agents in the treatment of H. pylori infection.

The recommended dosage regimen is-

• Vonoprazan 20 mg
• Amoxicillin 1000 mg
• Clarithromycin 500 mg

Each given twice daily (morning and evening, 12 hours apart), with or without food, for 14 days.

Geriatrics: The standard triple therapy regimen increased risk of torsade de pointes due to the clarithromycin component.

Renal Impairment: Avoid use in severe renal impairment.

Hepatic Impairment: Avoid use in moderate and severe hepatic impairment.

The triple therapy regimen should be administered cautiously when used together with the following medications: tacrolimus, cyclosporine, clopidogrel, citalopram, cilostazol, probenecid, allopurinol, itraconazole, ketoconazole, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, saquinavir, ritonavir, etravirine, rilpivirine-containing products, atazanavir, and nelfinavir.

This standard triple therapy regimen is contraindicated in patients with known hypersensitivity to Vonoprazan, Amoxicillin or other beta-lactam antibiotics, Clarithromycin, or other macrolide antimicrobial agents.

The most commonly reported adverse reactions (>2%) include dysgeusia, diarrhea, vulvovaginal candidiasis, headache, abdominal pain, hypertension, and nasopharyngitis.

Based on findings from animal studies and observational studies involving pregnant women treated with clarithromycin, use of this triple therapy pack is not recommended during pregnancy except in situations where no suitable alternative treatment is available. There are no adequate data regarding the presence of Vonoprazan in human breast milk, its effects on breastfed infants, or its effect on milk production. Vonoprazan and its metabolites have been detected in rat milk.

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, have been reported with components of this therapy pack. If hypersensitivity reactions occur, discontinue treatment immediately and initiate appropriate management.

Severe Cutaneous Adverse Reactions (SCAR): Discontinue this therapy at the first appearance of SCAR symptoms or other hypersensitivity signs and consider further evaluation.

Clostridioides difficile-associated diarrhea (CDAD): Evaluate patients if diarrhea develops during treatment with this therapy pack.

Due to the Clarithromycin component:

QT Prolongation: Avoid use in patients with known QT prolongation, ventricular arrhythmia (including torsades de pointes), hypokalemia/hypomagnesemia, significant bradycardia, or in those receiving Class IA or III antiarrhythmic agents.

Hepatotoxicity: Discontinue treatment if signs or symptoms of hepatitis occur.

Serious adverse reactions due to concomitant use with other drugs: Serious adverse effects may occur because of interactions between clarithromycin and drugs such as colchicine, certain lipid-lowering agents, calcium channel blockers, and other medications.

Embryo-Fetal Toxicity: Based on animal and human observational studies with clarithromycin, this therapy should not be used during pregnancy unless no suitable alternative treatment exists.

Myasthenia Gravis: Exacerbation of myasthenia gravis may occur in patients receiving clarithromycin-containing therapy.

If overdose occurs, consult a physician immediately.

Anti H. pylori drugs

Do not store above 30°C. Store in a dry place, protected from light, and keep out of the reach of children.