esomeprazole and naproxen

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Pronunciation: ee soe MEP ra zole and na PROX en

Brand: Vimovo

What is the most important information I should know about esomeprazole and naproxen?

Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

What is esomeprazole and naproxen?

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause inflammation, pain, and fever.

Esomeprazole is a proton pump inhibitor. It decreases the amount of acid produced in the stomach.

Esomeprazole and naproxen is a combination medicine used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The esomeprazole in this medicine helps reduce the risk of stomach ulcers in people who may be at risk for them while receiving treatment with an NSAID.

Esomeprazole and naproxen may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking esomeprazole and naproxen?

Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use this medicine if you are allergic to esomeprazole (Nexium) or naproxen (Aleve, Naprosyn), or if:

  • you are allergic to lansoprazole, omeprazole, pantoprazole, rabeprazole, AcipHex, Nexium, Prevacid, Prilosec, Protonix, and others; or
  • you have had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure esomeprazole and naproxen is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, fluid retention, high cholesterol, diabetes, or if you smoke;
  • a history of heart attack, stroke, or blood clot;
  • a history of stomach ulcer, stomach bleeding, or intestinal disorder (Crohn's disease, ulcerative colitis);
  • asthma;
  • liver or kidney disease; or
  • low levels of magnesium in your blood.

Taking a proton pump inhibitor such as esomeprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medication long term or at high doses, and in those who are age 50 and older. It is not clear whether esomeprazole is the actual cause of an increased risk of fracture.

Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Naproxen can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking esomeprazole and naproxen.

How should I take esomeprazole and naproxen?

Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Esomeprazole and naproxen is usually taken 2 times each day, at least 30 minutes before a meal.

Do not crush, chew, or break a delayed-release tablet. Swallow it whole.

If you use this medicine long-term, you may need frequent medical tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using esomeprazole and naproxen.

If you use esomeprazole and naproxen for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Store at room temperature away from moisture, heat, and light.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include vomiting, stomach pain, severe weakness, confusion, sweating, fast heart rate, dizziness, bloody or tarry stools, and weak or shallow breathing.

What should I avoid while taking esomeprazole and naproxen?

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking esomeprazole and naproxen and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking esomeprazole and naproxen.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to naproxen. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

What are the possible side effects of esomeprazole and naproxen?

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using esomeprazole and naproxen and call your doctor at once if you have:

  • diarrhea that is watery or bloody;
  • shortness of breath (even with mild exertion);
  • swelling or rapid weight gain;
  • the first sign of any skin rash, no matter how mild;
  • signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems --nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems --little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
  • low red blood cells (anemia) --pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • stomach pain, nausea, vomiting, heartburn;
  • constipation, diarrhea, gas; or
  • dizziness.

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 FDA at 1-800-FDA-1088.

What other drugs will affect esomeprazole and naproxen?

Ask your doctor before using naproxen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use naproxen if you are also using any of the following drugs:

  • atazanavir:
  • clopidogrel;
  • cholestyramine;
  • erlotinib;
  • ketoconazole;
  • lithium;
  • methotrexate;
  • mycophenolate mofetil;
  • probenecid;
  • rifampin;
  • St. John's wort;
  • a blood thinner (warfarin, Coumadin, Jantoven);
  • heart or blood pressure medication, including a diuretic or "water pill";
  • medicine or supplements that contain iron;
  • medicine to prevent organ transplant rejection (cyclosporine, tacrolimus); or
  • steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with naproxen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about esomeprazole and naproxen.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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