Vonozest-Trio Kit
Vonoprazan 20 mg + Clarithromycin 500 mg + Amoxycillin 500 mg Combikit — PCD Pharma Franchise, Wholesale Supply & Third Party Manufacturing
| Composition | Vonoprazan 20 mg (2 Tablets) + Clarithromycin 500 mg (2 Tablets) + Amoxycillin 500 mg (4 Capsules) |
|---|---|
| Dosage Form | Combikit (Tablets + Capsules) |
| Pack Type | Combikit Blister |
| Pack Size | 1 Day Combikit — 2 Tablets + 2 Tablets + 4 Capsules (8 units) |
| MRP | On request — contact for PTR/PTS |
| Therapy | Gastroenterology — P-CAB based Triple Therapy — H. pylori Eradication Kit |
| Storage | Store below 30 °C in a dry place, protected from light and moisture. Keep the kit in its original blister until use. Keep out of reach of children. Dispense strictly on a registered medical practitioner's prescription. |
📱 WhatsApp Enquiry📞 Call: +919041677932
About Vonozest-Trio Kit
Vonoprazan 20 mg + Clarithromycin 500 mg + Amoxycillin 500 mg is a vonoprazan-based triple therapy combikit for the eradication of Helicobacter pylori infection. Trumac Healthcare is a WHO-GMP certified manufacturer and supplier of H. pylori eradication kits in India, offering this combination on monopoly PCD pharma franchise, wholesale distribution and third party / contract manufacturing basis. Marketed under the brand name Vonozest-Trio.
Each combikit provides one full day of therapy: 2 tablets of Vonoprazan 20 mg (one twice daily), 2 tablets of Clarithromycin 500 mg (one twice daily) and 4 capsules of Amoxycillin 500 mg (two twice daily) — delivering the standard regimen of Vonoprazan 20 mg BD + Clarithromycin 500 mg BD + Amoxycillin 1000 mg BD. The usual course is 14 days.
What differentiates this kit from conventional PPI-based triple therapy is Vonoprazan, a potassium-competitive acid blocker (P-CAB) rather than a proton pump inhibitor. Vonoprazan does not require acid activation, so it delivers full acid suppression from the very first dose instead of taking several days to reach steady state. Its effect is also largely independent of CYP2C19 genotype — a meaningful advantage in Indian and East Asian populations, where a high proportion of rapid CYP2C19 metabolisers has historically reduced the efficacy of PPI-based regimens. The sustained, round-the-clock rise in intragastric pH both protects the acid-labile antibiotics from degradation and drives H. pylori into an actively replicating state, in which it is far more susceptible to amoxycillin.
Trumac Healthcare supplies H. pylori eradication combikits pan-India to PCD franchise partners, distributors, wholesalers and hospital chains, with full QC documentation and batch Certificate of Analysis. Third party contract manufacturing under your own brand name is available on request. We also supply the single-molecule Vonozest Vonoprazan 20 mg Tablet — see the Vonoprazan 20 mg molecule page for the full range. Connect with us on WhatsApp at +91 90416 77932 for net rates, pack configuration and monopoly territory availability.
Indications
- Eradication of Helicobacter pylori infection in adults
- H. pylori-associated duodenal ulcer and gastric ulcer
- H. pylori-associated chronic gastritis
- Prevention of peptic ulcer recurrence following successful H. pylori eradication
- H. pylori eradication in low-grade gastric MALT lymphoma, as an adjunct
- First-line eradication therapy where clarithromycin resistance is not known to be high, and as an alternative where PPI-based triple therapy has been suboptimal
Mechanism of Action
This kit combines three agents that act synergistically against Helicobacter pylori. VONOPRAZAN is a potassium-competitive acid blocker (P-CAB). Unlike proton pump inhibitors, which are prodrugs requiring accumulation in the acidic canaliculus and covalent binding to activated H+/K+-ATPase, vonoprazan binds the enzyme reversibly and competitively at the potassium-binding site, independent of acid activation. This gives three practical advantages: full acid inhibition from the first dose rather than after three to five days; a long plasma half-life producing sustained suppression across the 24-hour period including nocturnal acid breakthrough; and metabolism principally via CYP3A4 rather than CYP2C19, so efficacy is not diminished in rapid CYP2C19 metabolisers, a genotype common in Indian and East Asian populations. AMOXYCILLIN is a beta-lactam that inhibits bacterial cell wall synthesis by binding penicillin-binding proteins, preventing peptidoglycan cross-linking and causing lysis. Critically, amoxycillin is bactericidal only against actively dividing organisms — and H. pylori only replicates at higher intragastric pH — so the profound acid suppression from vonoprazan directly potentiates amoxycillin activity. Resistance to amoxycillin remains rare. CLARITHROMYCIN is a macrolide that binds the 50S ribosomal subunit and blocks bacterial protein synthesis; it is the most potent single agent against H. pylori but is also the component most vulnerable to acquired resistance, which is the principal cause of eradication failure worldwide. Both antibiotics are acid-labile and degrade rapidly at low pH, so raising and holding gastric pH improves their stability, mucosal concentration and therefore their bactericidal effect. The combination of a potent P-CAB with two antibiotics of differing mechanism attacks the organism on multiple fronts while suppressing the emergence of resistant sub-populations, and clinical studies of vonoprazan-based triple therapy have demonstrated eradication rates superior to PPI-based triple therapy, with the advantage most pronounced in clarithromycin-resistant strains.
Dosage & Administration
PRESCRIPTION-ONLY — to be prescribed and supervised by a registered medical practitioner.
ADULTS — standard regimen: the contents of ONE combikit taken across the day, divided into two doses.
MORNING DOSE: 1 tablet Vonoprazan 20 mg + 1 tablet Clarithromycin 500 mg + 2 capsules Amoxycillin 500 mg.
EVENING DOSE: 1 tablet Vonoprazan 20 mg + 1 tablet Clarithromycin 500 mg + 2 capsules Amoxycillin 500 mg.
This delivers Vonoprazan 20 mg BD, Clarithromycin 500 mg BD and Amoxycillin 1000 mg BD.
DURATION: 14 days is the standard course. Shorter courses are associated with lower eradication rates and should not be used unless specifically directed.
ADMINISTRATION: swallow whole with water. May be taken with or without food, though taking with food improves gastrointestinal tolerability. Doses should be spaced approximately 12 hours apart and taken at consistent times.
COMPLETION IS ESSENTIAL: the full 14-day course must be completed even if symptoms resolve early. Incomplete therapy is a leading cause of eradication failure and of acquired clarithromycin resistance.
CONFIRMATION OF ERADICATION: test-of-cure by urea breath test or stool antigen test is recommended, performed at least 4 weeks after completing therapy and at least 2 weeks after stopping any acid-suppressing drug, to avoid false-negative results.
RENAL / HEPATIC IMPAIRMENT: dose reduction of clarithromycin and amoxycillin may be required in significant renal impairment; use with caution in hepatic impairment.
NOT RECOMMENDED in children, or in pregnancy and lactation, unless specifically directed by a specialist.
Side Effects
Most adverse effects are gastrointestinal, mild to moderate, and settle after the course is completed.
COMMON: diarrhoea, nausea, abdominal discomfort, bloating; taste disturbance — a persistent metallic or bitter taste is very characteristic of clarithromycin and is a common reason for patients stopping early; headache; dizziness.
LESS COMMON: skin rash and hypersensitivity reactions (usually attributable to amoxycillin), oral or vaginal candidiasis following broad-spectrum antibiotic exposure, transient elevation of liver enzymes, and raised serum gastrin with acid suppression.
IMPORTANT BUT UNCOMMON: Clostridioides difficile-associated diarrhoea and pseudomembranous colitis — any severe, persistent or bloody diarrhoea during or after therapy must be reported and investigated rather than treated with antimotility agents. QT-interval prolongation and ventricular arrhythmia including torsades de pointes, attributable to clarithromycin, particularly in patients with existing QT prolongation, electrolyte disturbance or on other QT-prolonging drugs. Cholestatic hepatitis. Severe cutaneous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare). Anaphylaxis in penicillin-allergic individuals.
Contraindications & Precautions
ABSOLUTE CONTRAINDICATIONS: known hypersensitivity to vonoprazan, clarithromycin or any macrolide, and — critically — to penicillins or any beta-lactam, given the amoxycillin component. A clear penicillin-allergy history must be taken before dispensing; anaphylaxis risk is real. Also contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with previous clarithromycin use, in patients with a history of QT prolongation or ventricular arrhythmia including torsades de pointes, and in uncorrected hypokalaemia or hypomagnesaemia.
CONTRAINDICATED DRUG COMBINATIONS: clarithromycin is a potent CYP3A4 inhibitor and must not be co-administered with ergot alkaloids (ergotamine, dihydroergotamine — risk of acute ergot toxicity), pimozide, cisapride, terfenadine, astemizole, lomitapide, ticagrelor or ranolazine, or with the HMG-CoA reductase inhibitors simvastatin and lovastatin (risk of rhabdomyolysis). Colchicine co-administration is contraindicated in patients with renal or hepatic impairment and requires dose reduction in all others. Vonoprazan must not be given with rilpivirine. Concomitant use with midazolam, calcium channel blockers, quetiapine, tacrolimus, ciclosporin, digoxin, theophylline, carbamazepine, phenytoin, warfarin and direct oral anticoagulants requires monitoring or dose adjustment.
PRECAUTIONS: acid suppression reduces absorption of drugs requiring an acidic environment — including atazanavir, nelfinavir, ketoconazole, itraconazole, erlotinib and gefitinib — so co-administration should be reviewed. Use with caution in significant renal or hepatic impairment, in myasthenia gravis (macrolides may exacerbate), and in the elderly. Not established as safe in pregnancy — clarithromycin in particular should be avoided in the first trimester unless there is no alternative — nor in lactation or in children. Prolonged or repeated acid suppression has been associated with hypomagnesaemia, vitamin B12 deficiency, enteric infection and, with long-term use, fracture risk; a 14-day eradication course carries minimal such risk, but repeated courses should be reviewed. Infectious mononucleosis should be excluded before giving amoxycillin, as a florid maculopapular rash frequently follows.
Storage
Store below 30 °C in a dry place, protected from light and moisture. Keep the kit in its original blister until use. Keep out of reach of children. Dispense strictly on a registered medical practitioner's prescription.
Vonozest-Trio Kit is available for monopoly-based PCD pharma franchise across India and for third-party manufacturing under your brand. WHO-GMP certified, with full visual-aid and promotional support. Become a Trumac franchise partner →
Frequently Asked Questions
What is Vonozest-Trio Kit used for?
Vonozest-Trio is a combikit containing Vonoprazan 20 mg (2 tablets), Clarithromycin 500 mg (2 tablets) and Amoxycillin 500 mg (4 capsules) — one full day of vonoprazan-based triple therapy for eradicating Helicobacter pylori. It is prescribed for H. pylori-associated duodenal and gastric ulcers, chronic gastritis, prevention of ulcer recurrence after eradication, and as an adjunct in low-grade gastric MALT lymphoma.
How is the kit taken?
The contents of one kit are split into two doses about 12 hours apart. Morning: 1 Vonoprazan tablet + 1 Clarithromycin tablet + 2 Amoxycillin capsules. Evening: the same again. That delivers Vonoprazan 20 mg twice daily, Clarithromycin 500 mg twice daily and Amoxycillin 1000 mg twice daily. The standard course is 14 days, and it must be completed in full even if symptoms settle earlier.
How is Vonoprazan different from a PPI like pantoprazole or esomeprazole?
Vonoprazan is a potassium-competitive acid blocker (P-CAB), not a proton pump inhibitor. PPIs are prodrugs that need stomach acid to activate and take three to five days to reach full effect. Vonoprazan works from the very first dose, suppresses acid for the full 24 hours including overnight, and is metabolised mainly by CYP3A4 rather than CYP2C19. That last point matters in India — a substantial proportion of the population are rapid CYP2C19 metabolisers, in whom PPIs are cleared quickly and work less well. Vonoprazan sidesteps that variability.
Why does stronger acid suppression improve H. pylori eradication?
Two reasons. First, both amoxycillin and clarithromycin are acid-labile and degrade quickly at low gastric pH, so raising pH keeps more active antibiotic at the site of infection. Second, H. pylori only actively divides at higher pH — and amoxycillin, which works by disrupting cell wall synthesis, only kills dividing bacteria. Holding the stomach at a higher pH therefore both preserves the antibiotics and pushes the organism into the replicating state where it is vulnerable.
Who must NOT take this kit?
Anyone allergic to penicillins or beta-lactams must not take it, because of the amoxycillin component — this is the single most important check before dispensing. It is also contraindicated in macrolide allergy, in previous clarithromycin-associated cholestatic jaundice, in patients with QT prolongation or a history of ventricular arrhythmia, and in uncorrected low potassium or magnesium. It must not be combined with ergot alkaloids, pimozide, cisapride, lomitapide, ticagrelor, simvastatin, lovastatin or rilpivirine.
What are the common side effects?
Diarrhoea, nausea and abdominal discomfort are the most frequent. A persistent metallic or bitter taste from clarithromycin is very characteristic and is one of the commonest reasons patients abandon the course early — warning them in advance improves completion rates. Headache and mild dizziness also occur. Severe, persistent or bloody diarrhoea during or after the course should be reported immediately rather than self-treated, as it may indicate C. difficile colitis.
How is successful eradication confirmed?
By a urea breath test or stool antigen test, done at least 4 weeks after finishing the course and at least 2 weeks after stopping any acid-suppressing medication. Testing earlier risks a false negative. Serology is not suitable for confirming cure, as antibodies persist long after the organism has been cleared.
Who manufactures Vonoprazan Clarithromycin Amoxycillin kits in India?
Trumac Healthcare is a WHO-GMP certified manufacturer and supplier of H. pylori eradication combikits in India, marketed as Vonozest-Trio. We supply pan-India to PCD franchise partners, wholesalers, distributors and hospital chains, with full QC documentation and batch Certificate of Analysis. Contact +91 90416 77932 for net rates and availability.
Is this combikit available for PCD pharma franchise on monopoly basis?
Yes. The Vonoprazan + Clarithromycin + Amoxycillin combikit is available from Trumac Healthcare for monopoly PCD (Propaganda Cum Distribution) pharma franchise across India, with monopoly rights granted at district or state level. Partners receive promotional support, territory protection, competitive net rates with healthy PTR/PTS margins, and dedicated backend support for billing and despatch.
Do you offer this kit for third party or contract manufacturing?
Yes. Trumac Healthcare undertakes third party manufacturing and contract manufacturing of H. pylori eradication combikits under your own brand name, subject to minimum order quantity and valid drug licence and GST documentation. Custom combikit blister layout, carton design and artwork are supported. Share your projected monthly volumes on WhatsApp for a quotation.
Can the kit be supplied on wholesale or distributor basis?
Yes. Beyond PCD franchise, the combikit is supplied to wholesalers, stockists and distributors at wholesale rates against a valid drug licence and GST registration. Bulk and institutional supply is available on request.
Do you also supply plain Vonoprazan tablets?
Yes. Alongside this combikit, Trumac Healthcare supplies single-molecule Vonoprazan 20 mg Tablets under the Vonozest brand for acid-peptic disorders including GERD, erosive oesophagitis and peptic ulcer maintenance. Both the combikit and the plain tablet are available for PCD franchise and third party manufacturing.
How quickly can Trumac Healthcare dispatch a PCD order?
Routine PCD orders are dispatched within 48 hours of payment realisation, subject to stock availability and your distance from our depot. For monopoly partners we maintain buffer stock against forecasted monthly off-take.