Vonoprazan

Vonoprazan is used in adults to lower stomach acid and help heal erosive esophagitis (damage to your esophagus caused by stomach acid).

Vonoprazan is also used with antibiotics to treat infections caused by Helicobacter pylori (H. pylori).

Vonoprazan may also be used for other reasons not mentioned in this medication guide.

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

You may take vonoprazan with or without food, but take it at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

Do not change your dose or stop using this medicine without your doctor's advice.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use vonoprazan if you are allergic to it, or if you use:

• rilpivirine-containing products.

Tell your doctor if you have or have ever had:

• low levels of calcium in your blood (hypocalcemia);
• low blood levels of potassium or magnesium;
• if you take a diuretic ("water pill"); or
• liver or kidney disease.

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

Ask a doctor if it is safe to breastfeed while using vonoprazan.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty 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).

Vonoprazan may cause serious side effects. Call your doctor right away if you have:

• blood in your urine, burning when you urinate, little or no urination;
• seizures, mood changes;
• severe stomach problems, including severe stomach pain, diarrhea that is watery or bloody, or a fever that will not go away;
• sudden pain or trouble moving your hip, wrist, or back;
• shortness of breath, sudden dizziness (like you might pass out), numbness or tingling in the arms and legs, muscle weakness, pale skin, feeling tired; or
• irregular heartbeat, jitteriness, muscle aches or weakness, or spasms.

Common side effects of vonoprazan may include:

• altered sense of taste;
• vaginal itching or discharge;
• bloating, indigestion, diarrhea, stomach pain;
• symptoms similar to a common cold;
• headache, high blood pressure; or
• pain and burning when you urinate, painful urination.

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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Erosive Esophagitis:

For healing: 20 mg orally once a day-Duration of therapy: 8 weeksFor maintenance of healing: 10 mg orally once a day-Duration of therapy: Up to 6 monthsUse: For healing, and to maintain healing, of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis

Usual Adult Dose for Helicobacter pylori Infection:

Dual therapy: 20 mg orally twice a day, taken concomitantly with amoxicillin -Duration of therapy: 14 daysTriple therapy: 20 mg orally twice a day, taken concomitantly with amoxicillin and clarithromycin-Duration of therapy: 14 daysComments:-The manufacturer product information should be consulted for amoxicillin and/or clarithromycin dosing.-Administer each dose of this drug in the morning and evening, 12 hours apart. Uses: -In combination with amoxicillin and clarithromycin, for the treatment of Helicobacter pylori (H pylori) infection-In combination with amoxicillin, for the treatment of H pylori infection

For the treatment of erosive esophagitis: take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late. Do not take two doses at the same time.

For the treatment of infections caused by H. pylori: take the medicine as soon as you can, but skip the missed dose if you are more than 4 hours late. Do not take two doses at the same 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.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medicines work.

Vonoprazan can make it harder for your body to absorb other medicines you take by mouth.

Other drugs may affect vonoprazan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.