Esomeprazole Injection

WHY is this medicine prescribed?

Esomeprazole injection is used to treat gastroesophageal reflux disease (GERD; a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus [the tube between the throat and stomach]) in adults and children 1 month of age or older who have had damage to their esophagus and are unable to take esomeprazole by mouth. Esomeprazole injection is also used in adults to reduce the risk of further ulcer bleeding after an endoscopy (examination of the inside of the esophagus, stomach, and intestines). Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Esomeprazole injection comes as a powder to be mixed with liquid and given intravenously (into a vein) by a doctor or nurse in a medical facility. For the treatment of GERD, esomeprazole is usually given intravenously once a day. For the prevention of re-bleeding after an endoscopy, esomeprazole injection is usually given as a continuous intravenous infusion for 72 hours.

What SPECIAL PRECAUTIONS should I follow?

Before receiving esomeprazole injection,

• tell your doctor and pharmacist if you are allergic to esomeprazole, dexlansoprazole (Dexilant), lansoprazole (Prevacid), omeprazole (Prilosec, in Talicia, in Zegerid), pantoprazole (Protonix), rabeprazole (AcipHex), any other medications, or any of the ingredients in esomeprazole injection. Ask your pharmacist for a list of the ingredients.

• Some medications should not be taken with esomeprazole injection. Other medications may cause dosing changes or extra monitoring when taken with esomeprazole injection. Make sure you have discussed any medications you are currently taking or plan to take before starting esomeprazole injection with your doctor and pharmacist. Before starting, stopping, or changing any medications while receiving esomeprazole injection, please get the advice of your doctor or pharmacist.

• The following nonprescription or herbal products may interact with esomeprazole injection: iron supplements, St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start receiving esomeprazole injection. Do not start any of these medications while receiving esomeprazole injection without discussing with your healthcare provider.

• tell your doctor if you have or have ever had a low level of magnesium or calcium in your blood; osteoporosis (a condition in which the bones become thin and weak and break easily), an autoimmune disease (condition that develops when the immune system attacks healthy cells in the body by mistake) such as systemic lupus erythematosus, or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving esomeprazole injection, call your doctor.

• talk to your doctor about the risks and benefits of using esomeprazole injection if you are 70 years of age or older.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

Esomeprazole injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• diarrhea
• gas
• constipation
• dry mouth
• dizziness
• pain, swelling, itching, or redness near the spot the medication was injected
• in men, difficulty achieving or maintaining an erection

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

• blisters, peeling, or bleeding skin; sores on the lips, nose, mouth, or genitals; swollen glands; shortness of breath; fever; or flu-like symptoms
• hives; rash; itching; swelling of the eyes, face, lips, mouth, throat, or tongue; difficulty breathing or swallowing; or hoarseness
• dizziness; irregular, fast, or pounding heartbeat; muscle spasms; uncontrollable shaking of a part of the body; excessive tiredness; lightheadedness; or seizures
• severe diarrhea with watery stools, stomach pain, or fever
• new or worsening joint pain; rash on cheeks or arms that is sensitive to sunlight, new or worsening joint pain
• increased or decreased urination, blood in urine, fatigue, nausea, loss of appetite, fever, rash, or joint pain

People who receive proton pump inhibitors such as esomeprazole may be more likely to fracture their wrists, hips, or spine than people who do not take or receive one of these medications. People who receive proton pump inhibitors may also develop fundic gland polyps (a type of growth on the stomach lining). These risks are highest in people who take high doses of one of these medications or take them for one year or longer. Talk to your doctor about the risks of receiving esomeprazole injection.

Esomeprazole injection may cause other side effects. Call your doctor if you have any unusual problems while receiving 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving esomeprazole injection.

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.