Vonoprazan Tablets; Amoxicillin Capsules; Clarithromycin Tablets

What is this medication?

VONOPRAZAN; AMOXICILLIN; CLARITHROMYCIN (von OH pra zan; a mox i SIL in; kla RITH roe mye sin) treats ulcers caused by H. pylori bacteria. Vonoprazan works by reducing the amount of acid in the stomach. Amoxicillin and clarithromycin work by killing or preventing the growth of bacteria. It is a combination of a potassium-competitive acid blocker (PCAB), a penicillin antibiotic, and a macrolide antibiotic.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): VOQUEZNA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Mononucleosis
• Myasthenia gravis
• Neuroendocrine tumors
• An unusual or allergic reaction to vonoprazan, amoxicillin, clarithromycin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 4 hours late. If it is more than 4 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

Do not take this medication with any of the following:

• Alfuzosin
• Certain benzodiazepines, such as alprazolam or triazolam
• Certain medications for fungal infections, such as fluconazole, ketoconazole, posaconazole
• Certain medications for cholesterol, such as lomitapide, lovastatin, simvastatin
• Cisapride
• Conivaptan
• Dolasetron
• Dronedarone
• Elagolix
• Eletriptan
• Eplerenone
• Ergot alkaloids, such as ergotamine or dihydroergotamine
• Finerenone
• Flibanserin
• Levoketoconazole
• Lonafarnib
• Lurasidone
• Mavacamten
• Naloxegol
• Pacritinib
• Pimozide
• Ranolazine
• Red yeast rice
• Rilpivirine
• Saquinavir
• Silodosin
• Thioridazine
• Tolvaptan
• Ubrogepant
• Voclosporin

This medication may also interact with the following:

• Allopurinol
• Certain antivirals for hepatitis or HIV
• Certain medications for cancer, such as dasatinib, erlotinib, nilotinib
• Certain medications that treat or prevent blood clots, such as clopidogrel, warfarin
• Colchicine
• Estrogen and progestin hormones
• Cyclosporine
• Iron supplements
• Mycophenolate
• Probenecid
• Tacrolimus

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not treat diarrhea with over the counter products. Contact your care team if you have diarrhea that lasts more than 2 days or if it is severe and watery.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

If you have diabetes, you may get a false-positive result for sugar in your urine. Check with your care team.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy. Estrogen and progestin hormones may not work as well while you are taking this medication. Your care team can help you find the contraceptive option that works for you.

Do not breastfeed while taking this medication and for 2 days after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Severe diarrhea, fever
• Severe or prolonged vomiting or diarrhea
• Unusual vaginal discharge, itching, or odor

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Change in taste
• Diarrhea
• Headache
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Keep this medication in the original packaging until you are ready to take it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.