Usual Adult Dose for Helicobacter pylori Infection

Amoxicillin: 1000 mg orally twice a day
Clarithromycin: 500 mg orally twice a day
Vonoprazan: 20 mg orally twice a day

Duration of therapy: 14 days

Use: For the treatment of Helicobacter pylori infection

Renal Dose Adjustments

Mild to moderate renal dysfunction (estimated GFR 30 to 89 mL/min): No adjustment recommended.
Severe renal dysfunction (estimated GFR less than 30 mL/min): Not recommended.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate to severe liver dysfunction (Child-Pugh B or C): Not recommended.

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to an active component: amoxicillin (or other beta-lactam antibacterials [e.g., penicillins, cephalosporins]), clarithromycin (or other macrolide antibacterials [e.g., erythromycin]), or vonoprazan
• Coadministration with rilpivirine-containing products, pimozide, lomitapide, simvastatin, lovastatin, ergotamine, dihydroergotamine, colchicine (in patients with renal or liver dysfunction)
• History of cholestatic jaundice or liver dysfunction associated with prior use of clarithromycin

Dialysis

Data not available

Comments:

• Amoxicillin can be removed from circulation by hemodialysis.
• Clarithromycin serum levels are not expected to be significantly affected by hemodialysis or peritoneal dialysis.
• Vonoprazan is not removed from circulation by hemodialysis.

Other Comments

Administration advice:

• Administer in the morning and evening (12 hours apart).
• Administer with or without food.

• Store between 20C and 25C (68F and 77F); brief exposure to 15C to 30C (59F to 86F) permitted.
• Protect from light.

• This co-packaged product contains amoxicillin capsules, clarithromycin tablets, and vonoprazan tablets.
• There have been postmarketing reports of drug interactions when clarithromycin was coadministered with pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, torsades de pointes) most likely due to inhibition of metabolism of these drugs by clarithromycin; fatalities have been reported.
• To reduce the development of drug-resistant organisms and maintain effective therapy, this product should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.

• Nervous System: For symptoms of myasthenia gravis
• Renal: Renal function in elderly patients

• Avoid missing doses and complete the entire course of therapy.
• If a dose is missed within 4 hours of the usual time taken, administer the missed dose as soon as possible; if a dose is missed by more than 4 hours, skip the missed dose and administer the next dose at the regularly scheduled time; continue the normal dosing schedule until therapy is completed.
• Contact health care provider immediately if a new rash, urticaria, drug eruptions, swelling of the face, difficulty in breathing, or other symptoms of allergic reactions develop.
• Stop taking this product immediately and promptly report the first signs/symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Contact health care provider at once if watery and bloody stools (with or without stomach cramps and fever) develop.
• If exposed to this product during pregnancy, contact Phathom Pharmaceuticals at 1-888-775-7428.
• Dizziness, vertigo, confusion, and disorientation reported with clarithromycin; may affect ability to drive or use machines