Vonoprazan, Clarithromycin, and Amoxicillin

Vonoprazan, clarithromycin, and amoxicillin are used to treat and prevent the return of ulcers (sores in the lining of the stomach or intestine) caused by a certain type of bacteria (H. pylori). Vonoprazan is in a class of medications called potassium-competitive acid blockers (PCAB). Clarithromycin and amoxicillin are in a class of medications called antibiotics. Vonoprazan works by decreasing the amount of acid made in the stomach. Clarithromycin and amoxicillin work by stopping the growth of the bacteria that may cause ulcers. Antibiotics will not work for colds, flu, or other viral infections.

Vonoprazan comes as a tablet, clarithromycin comes as a tablet, and amoxicillin comes as a capsule, all to be taken by mouth. These medications are usually taken with or without food twice a day, 12 hours apart, for 14 days. To help you take the right number of capsules and tablets at each dose, the medication is packaged in dosing cards. Each dosing card contains all of the medication needed for both daily doses. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take the medication exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Take vonoprazan, clarithromycin, and amoxicillin until you finish the prescription, even if you feel better. If you stop taking antibiotics too soon your infection may not be completely treated and the bacteria may become resistant to antibiotics.

If your condition does not improve or gets worse, call your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking vonoprazan, clarithromycin, and amoxicillin,

• tell your doctor and pharmacist if you are allergic to vonoprazan; clarithromycin; amoxicillin; penicillin antibiotics; cephalosporin antibiotics such as cefaclor, cefadroxil, cefdinir, cefixime, cefpodoxime, cefprozil, cefuroxime, and cephalexin; other antibiotics such as azithromycin or erythromycin; any other medications; or any of the ingredients in vonoprazan tablets, clarithromycin tablets, or amoxicillin capsules. Ask your pharmacist for a list of the ingredients.
• Some medications should not be taken with vonoprazan, clarithromycin, and amoxicillin. Other medications may cause dosing changes or extra monitoring when taken with vonoprazan, clarithromycin, and amoxicillin. Make sure you have discussed any medications you are currently taking or plan to take before starting vonoprazan, clarithromycin, and amoxicillin with your doctor and pharmacist. Before starting, stopping or changing any medications while taking vonoprazan, clarithromycin, and amoxicillin, get the advice of your healthcare provider.
• The following nonprescription or herbal products may interact with vonoprazan, clarithromycin, and amoxicillin: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking vonoprazan, clarithromycin, and amoxicillin. Do not start this medication while taking vonoprazan, clarithromycin, and amoxicillin without discussing with your healthcare provider
• tell your doctor if you have or have ever had jaundice (yellowing of the skin or eyes) or other liver problems while taking clarithromycin. Your doctor will probably tell you not to take vonoprazan, clarithromycin, and amoxicillin.
• tell your doctor if you have or have ever had QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death) or an irregular heartbeat; low levels of potassium or magnesium in your blood; mononucleosis (a virus; also called 'mono'); myasthenia gravis (a disease that causes muscle weakness); or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking vonoprazan, clarithromycin, and amoxicillin, call your doctor. Vonoprazan, clarithromycin, and amoxicillin may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while taking vonoprazan, clarithromycin, and amoxicillin and for 2 days after your final dose.
• you should know that vonoprazan, clarithromycin, and amoxicillin may make you dizzy, confused, or disoriented. Do not drive a car or operate machinery until you know how this medication affects you.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose (one vonoprazan tablet, one clarithromycin tablet, and two amoxicillin capsules) as soon as you remember it. However, if it is within 4 hours of your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Vonoprazan, clarithromycin, and amoxicillin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• stomach pain
• change in ability to taste food
• headache
• sore throat
• vaginal itching and/or discharge

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• blistering or peeling skin
• rash; hives; itching; swelling of the lips, face, or tongue; shortness of breath; difficulty breathing or swallowing
• yellow eyes or skin, loss of appetite, dark urine; itching, abdominal pain, unexplained bruising or bleeding, or loss of appetite
• severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
• severe vomiting that may occur 1 to 4 hours after you take vonoprazan, clarithromycin, and amoxicillin
• difficulty urinating or decreased urination
• cloudy or bloody urine

Vonoprazan, clarithromycin, and amoxicillin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• stomach pain
• nausea
• vomiting
• diarrhea
• difficulty urinating
• cloudy or bloody urine
• decreased urination

Keep all appointments with your doctor and laboratory.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking vonoprazan, clarithromycin, and amoxicillin.

If you are diabetic, use Clinistix or TesTape (not Clinitest) to test your urine for sugar while taking this medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Voquezna^® Triple Pak^®