Vonoprazan/amoxicillin/clarithromycin

What is Vonoprazan/amoxicillin/clarithromycin?

• Vonoprazan/amoxicillin/clarithromycin (Voquezna Triple Pak) is a co-packaged product containing vonoprazan, a potassium-competitive acid blocker (PCAB), amoxicillin, a penicillin class antibacterial, and clarithromycin, a macrolide antimicrobial used to treat Helicobacter pylori infection.

Vonoprazan structure

Amoxicillin

Clarithromycin structure

What are the uses of this medicine?

• Vonoprazan/amoxicillin/clarithromycin (Voquezna Triple Pak) is used for the treatment of Helicobacter pylori (H. pylori) infection in adults.

How does this medicine work?

Vonoprazan:

• Vonoprazan suppresses basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H+, K+-ATPase enzyme system in a potassium competitive manner. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, vonoprazan has been characterized as a type of gastric proton-pump inhibitor, in that it blocks
• the final step of acid production.
• Vonoprazan does not require activation by acid.

Amoxicillin:

• Amoxicillin is an antibacterial drug.

Clarithromycin:

• Clarithromycin is a macrolide antimicrobial drug used widely to treat mild-to-moderate bacterial infections caused by sensitive agents. Clarithromycin, like other macrolide antibiotics such such as eythromycin and azithromycin, is bacteriostatic against many gram positive bacteria.
• Macrolide antibiotics act by inhibiting protein synthesis of bacteria by binding to the 50S ribosomal element.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity to vonoprazan, amoxicillin or any other betalactams, clarithromycin or any other macrolide antimicrobial or any component of Voquezna Triple Pak.
• Rilpivirine-containing products
• Pimozide
• Lomitapide, lovastatin, and simvastatin
• Ergot alkaloids (ergotamine or dihydroergotamine)
• Colchicine in renal or hepatic impairment
• History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin

What drug interactions can this medicine cause?

• Avoid concomitant use of Voquezna Triple Pak with Strong or Moderate CYP3A Inducers.
• Avoid concomitant use of Voquezna Triple Pak with Probenecid.
• Discontinue allopurinol at the first appearance of skin rash when used concomitantly with Voquezna Triple Pak.
• Avoid concomitant use of Voquezna Triple Pak with omeprazole.
• Use of Voquezna Triple Pak with antivirals that are CYP3A substrates, inducers, or CYP3A inhibitors may potentially lead to bi-directional drug interactions.
• Vonoprazan reduces intragastric acidity , which may alter the absorption of antiretroviral drugs leading to changes in their safety and/or effectiveness.

This medicine is contraindicated to use with:

• Rilpivirine-containing products
• Pimozide
• Lomitapide, lovastatin, and simvastatin
• Ergot alkaloids (ergotamine or dihydroergotamine)
• Colchicine in renal or hepatic impairment

Is this medicine FDA approved?

• It was approved for medical use in Japan in 2016, and in the United States in May 2022.

How should this medicine be used?

Recommended dosage and Administration:

• vonoprazan 20 mg plus amoxicillin 1,000 mg plus clarithromycin 500 mg, each given twice daily (morning and evening, 12 hours apart), with or without food, for 14 days.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: Vonoprazan 20 mg
• Tablets: Clarithromycin 500 mg
• Capsules: Amoxicillin 500 mg

This medicine is available in fallowing brand namesː

• Voquezna Triple Pak

What side effects can this medication cause?

The most common side effects of this medicine include:

• dysgeusia
• diarrhea
• vulvovaginal candidiasis
• headache
• abdominal pain
• hypertension

What special precautions should I follow?

• Serious and occasionally fatal reactions (e.g., anaphylaxis) have been reported with components of Voquezna Triple Pak . If hypersensitivity reactions occur, discontinue Voquezna Triple Pak and institute immediate therapy (e.g., anaphylaxis management).
• Voquezna Triple Pak at the first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation.
• Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of acid suppressing therapies and nearly all antibacterial agents, including amoxicillin and clarithromycin , and may range in severity from mild diarrhea to fatal colitis.
• Avoid Voquezna Triple Pak in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia (torsades de pointes), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics.
• Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported with clarithromycin (a component of Voquezna Triple Pak).Discontinue if signs and symptoms of hepatitis occur with Voquezna Triple Pak.
• Serious adverse reactions can occur with Voquezna Triple Pak due to drug interactions of clarithromycin with colchicine, some lipid lowering agents, some calcium channel blockers, and other drugs.
• Based on the findings from animal studies and human observational studies in pregnant women treated with clarithromycin, Voquezna Triple Pak is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate.
• Exacerbation of myasthenia gravis can occur with Voquezna Triple Pak since it has been reported in patients receiving clarithromycin tablets.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No information is available on accidental overdosage of Voquezna Triple Pak in humans.
• Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin
• overdosage in adult and pediatric patients.
• Overdosage of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea.

Management of overdosage: In case of an overdose, patients should contact a physician, poison control center, or emergency room.

The available overdosage information for each of the individual components as below:

Vonoprazan:

• Vonoprazan is not removed from the circulation by hemodialysis. If overdose occurs, treatment should be symptomatic and supportive.

Amoxicillin :

• In case of amoxicillin overdosage, discontinue medication, treat symptomatically and institute supportive measures as needed.
• In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.
• Amoxicillin can be removed from circulation by hemodialysis.

Clarithromycin:

• As with other macrolides, clarithromycin serum concentrations are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.

Can this medicine be used in pregnancy?

• There are no adequate and wellcontrolled studies of Voquezna Triple Pak in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
• If Voquezna Triple Pak is used during pregnancy, advise pregnant women of the potential risk to a fetus.

Can this medicine be used in children?

• Safety and effectiveness of Voquezna Triple Pak in pediatric patients have not been established.

Who manufactures and distributes this medicine?

• Vonoprazan Tablets are manufactured for Phathom Pharmaceuticals, Inc., Buffalo Grove, IL,U.S.A.

What should I know about storage and disposal of this medication?

• Store between 20°C and 25°C (68°F and 77°F).
• Brief exposure to 15°C to 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature).
• Protect from light.

• Dailymed label info on Vonoprazan/amoxicillin/clarithromycin
• FDA Vonoprazan/amoxicillin/clarithromycin

Vonoprazan/amoxicillin/clarithromycin Resources
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