Usual Adult Dose for Helicobacter pylori Infection

Amoxicillin: 1000 mg orally 3 times 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 either active component: amoxicillin (or other beta-lactam antibacterials [e.g., penicillins, cephalosporins]) or vonoprazan
• Coadministration with rilpivirine-containing products

Dialysis

Data not available

Comments:

• Amoxicillin can be removed from circulation by hemodialysis.
• Vonoprazan is not removed from circulation by hemodialysis.

Other Comments

Administration advice:

• Administer amoxicillin in the morning, mid-day, and evening; administer vonoprazan in the morning and evening.
• Administer with or without food.

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

• This co-packaged product contains amoxicillin capsules and vonoprazan tablets.
• 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.

• 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.