Esomeprazole (By mouth)

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Bloody or black, tarry stools
• Fast, slow, pounding, or uneven heartbeat
• Nausea, vomiting, seizures, unusual tiredness or weakness, muscle spasms, cramps, confusion, or mental changes
• Severe diarrhea that does not go away, stomach pain, and fever

If you notice these less serious side effects, talk with your doctor:

• Dry mouth
• Fast or shallow breathing (more common in children)
• Mild headache
• Mild nausea, vomiting, constipation, diarrhea, gas, or stomach pain
• Tiredness or drowsiness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Esomeprazole (es-oh-MEP-ra-zole)

Treats heartburn, gastroesophageal reflux disease (GERD), and conditions that cause your stomach to make too much acid, such as Zollinger-Ellison syndrome. Also helps heal a damaged esophagus. Prevents stomach ulcers and stomach irritation in patients who take pain or arthritis medicine. This medicine may be used in combination with antibiotics to treat ulcers. This medicine is a proton pump inhibitor (PPI).

Brand Name(s)

Nexium

When This Medicine Should Not Be Used

How to Use This Medicine

Delayed Release Capsule, Packet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Take this medicine at least 1 hour before a meal. Take all your medicine as directed until you have finished your prescription, even if you feel better.
• Delayed-release capsule: Swallow the capsule whole. Do not break, crush, or chew it. If you cannot swallow capsules, you may open the capsule and pour the medicine into 1 tablespoon of applesauce. Do not heat the applesauce. Stir the mixture well and swallow it right away. Do not chew. Throw away any remaining mixture.
• Packets::
  • 2.5- or 5-milligram packets: Mix with 1 teaspoon (5 milliliters) of water and stir well.
  • 10-, 20-, or 40-milligram packets: Mix with 1 tablespoon (15 milliliters) of water and stir well.
  • Let your mixture thicken for 2 to 3 minutes. Stir once more, and drink within 30 minutes. Add more water to any leftover medicine and drink right away.
  • Use twice as much water if your dose is 2 packets.
• Medicine given through a feeding tube:
  • Capsule contents:
    • Open the capsule and pour the contents into a 60-mL, catheter-tipped syringe. Pour 50 mL of water into the syringe. Do not use any other liquids or syringes.
    • Place the syringe plunger back into the syringe and shake well for 15 seconds. Make sure no medicine is stuck in the tip of the syringe. Inject the medicine into the nasogastric tube right away.
    • Use water to rinse any leftover medicine through the tube.
  • Packet contents:
    • 2.5- or 5-milligram packets:Add 5 mL (1 teaspoon) of water into a catheter-tipped syringe. Pour 2.5- or 5-milligram packets into the syringe, shake well right away, and let the medicine set for 2 to 3 minutes to thicken.
    • 10-, 20-, or 40-milligram packets:Add 15 mL (1 tablespoon) of water into a catheter-tipped syringe. Pour the 10-, 20-, or 40-milligram packets into the syringe, shake well right away, and let the medicine set for 2 to 3 minutes to thicken.
    • Shake the thickened mixture once more, and inject the medicine into the tube within 30 minutes.
    • Refill the syringe with the same amount of water that was used in the mixture (5 or 15 mL). Shake it gently, and inject it into the tube to rinse any leftover medicine through the tube.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, osteoporosis, or a history of low magnesium levels in your blood.
• This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you take this medicine longer than 1 year, or if you take it with digoxin or certain diuretics (water pills). Stop using this medicine and tell your doctor right away if you have seizures, dizziness, a fast or pounding heartbeat, or muscle spasms.
• Tell your doctor right away if you have diarrhea that does not go away, stomach pain, and fever while taking this medicine.
• You may be at risk for Clostridium difficile colitis (also called C diff) if you take this medicine. C diff is an inflammation of your large intestine that causes diarrhea. You have a higher risk of this condition if you are also using antibiotics, are elderly, or have other health conditions.If you have severe diarrhea, ask your doctor before taking any medicine to stop the diarrhea.
• This medicine may increase your risk of broken bones in the hip, wrist, and spine. This is more likely if you are older than 50, if you receive high doses of this medicine, or you use it for longer than 1 year.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• If your symptoms do not improve or if they get worse, call your doctor.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.You may need blood or other lab tests to check for unwanted effects.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Esomeprazole affects digestion and may keep other drugs from working correctly. Make sure your doctor knows if you are also using medicines to treat HIV infection (such as atazanavir, nelfinavir, saquinavir, Fortovase®, Invirase®, Reyataz®, or Viracept®), cilostazol (Pletal®), diazepam (Valium®), digoxin (Lanoxin®), ketoconazole (Nizoral®), iron supplements, rifampin (Rifadin®, Rimactane®), St John's wort, tacrolimus (Prograf®), voriconazole (Vfend®), or a blood thinner (such as warfarin or Coumadin®).
• Make sure your doctor knows if you are also using a diuretic (water pill, such as bumetanide, chlorothiazide, ethacrynic acid, furosemide, hydrochlorothiazide (HCTZ), indapamide, metolazone, torsemide, Bumex®, Demadex®, Diuril®, Edecrin®, Lasix®, Lozol®, or Zaroxolyn®).