Amoxicillin and vonoprazan (Voquezna Dual Pak) is a combination medicine used to prevent stomach ulcer in adults caused by infection with Helicobacter pylori (H. pylori).

Amoxicillin and vonoprazan may also be used for purposes not listed in this medication guide.

Tell your doctor about all your other medicines. Some drugs should not be used with amoxicillin and vonoprazan.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take one vonoprazan tablet twice daily (in the morning and evening), plus two amoxicillin capsules three times daily (in the morning, mid-day, and evening), with or without food for 14 days, unless your doctor tells you otherwise.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Amoxicillin and vonoprazan will not treat a viral infection (flu or a common cold).

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using amoxicillin and vonoprazan.

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

Store at room temperature away from moisture and heat.

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

You should not use amoxicillin and vonoprazan if you are allergic to amoxicillin or vonoprazan, or similar medicines such as:

• a penicillin antibiotic, including ampicillin, Augmentin, Principen, Timentin, Trimox, and others; or

• a cephalosporin antibiotic such as cefdinir, cefprozil, cefuroxime, cephalexin, Duricef, Omnicef, Cefzil, Keflex, Spectracef, and others.

Some drugs should not be used with amoxicillin and vonoprazan. Your treatment plan may change if you also use:

• rilpivirine-containing products.

Tell your doctor if you have ever had:

• liver or kidney disease.

It is not known if amoxicillin and vonoprazan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while using this medicine. If you use a breast pump during this time, throw out the milk and do not feed it to your baby for at least 2 days after your last dose.

Use the medicine as soon as you can, but skip the missed dose if you are more than 4 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Amoxicillin and vonoprazan may cause serious side effects. Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);

• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• kidney problems--swelling, urinating less, feeling tired or short of breath.

Common side effects of amoxicillin and vonoprazan may include:

• diarrhea, stomach pain;

• vaginal itching or discharge; or

• runny or stuffy nose, sneezing, cough, or sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• anticoagulants such as dabigatran, rivaroxaban, apixaban;

• insulin or oral diabetes medicine (especially nateglinide, pioglitazone, repaglinide, or rosiglitazone); o

• probenecid.

This list is not complete. Other drugs may affect amoxicillin and vonoprazan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.