Esomeprazole and naproxen

Generic name: Esomeprazole And Naproxen
Brand names: Vimovo
Dosage form: oral delayed release tablet (20 mg-375 mg; 20 mg-500 mg)
Drug class: Nonsteroidal anti-inflammatory drugs

Usage of Esomeprazole and naproxen

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Esomeprazole is a proton pump inhibitor.

Esomeprazole and naproxen is a combination medicine used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The esomeprazole in esomeprazole and naproxen 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.

Esomeprazole and naproxen side effects

Get emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny or stuffy nose, wheezing, difficult 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).

Stop taking this medicine and 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.

Esomeprazole and naproxen may cause serious side effects. Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • heart problems-- swelling, rapid weight gain, feeling short of breath;
  • kidney problems-- fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
  • liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes);
  • low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.
  • Taking esomeprazole and naproxen long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

    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.

    Common side effects of esomeprazole and naproxen may include:

  • stomach discomfort; or
  • diarrhea.
  • 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.

    Before taking Esomeprazole and naproxen

    Naproxen can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. 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 naproxen, 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 also allergic to medicines like esomeprazole, such as lansoprazole, omeprazole, pantoprazole, rabeprazole, Dexilant, Nexium, Prevacid, Protonix, and others;
  • you had breathing problems, kidney problems, or a severe allergic reaction after taking this medicine in the past;
  • you have had an asthma attack or severe allergic reaction after taking aspirin or an NSAID; or
  • you also take an HIV medicine that contains rilpivirine (Complera, Edurant, Odefsey).
  • Tell your doctor if you have ever had:

  • heart disease, high blood pressure;
  • asthma;
  • Crohn's disease, ulcerative colitis, inflammatory bowel disease;
  • stomach or intestinal bleeding after taking an NSAID;
  • liver or kidney disease;
  • low levels of magnesium in your blood; or
  • if you smoke or drink alcohol.
  • You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

    If you are pregnant, you should not take naproxen unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

    It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

    Esomeprazole and naproxen is not approved for use by anyone younger than 12 years old or weighing less than 38 kilograms (84 pounds).

    Relate drugs

    How to use Esomeprazole and naproxen

    Usual Adult Dose for Ankylosing Spondylitis:

    One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a dayComments:-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.Uses: For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug (NSAID) associated gastric ulcers

    Usual Adult Dose for Osteoarthritis:

    One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a dayComments:-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.Uses: For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug (NSAID) associated gastric ulcers

    Usual Adult Dose for Rheumatoid Arthritis:

    One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a dayComments:-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.Uses: For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug (NSAID) associated gastric ulcers

    Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

    12 years or older:-At least 38 kg to less than 50 kg: One tablet (esomeprazole 20 mg-naproxen 375 mg) orally twice a day-Greater than 50 kg: One tablet (esomeprazole 20 mg-naproxen 375 mg or esomeprazole 20 mg-naproxen 500 mg) orally twice a dayComments:-Not interchangeable with the individual components of naproxen and esomeprazole magnesium.Use: For the relief of signs and symptoms of juvenile idiopathic arthritis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers

    Warnings

    Naproxen can increase your risk of fatal heart attack or stroke. Do not use esomeprazole and naproxen 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.

    Esomeprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

    Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

    Esomeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

    You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

    What other drugs will affect Esomeprazole and naproxen

    Ask your doctor before using esomeprazole and naproxen if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

    Tell your doctor about all your current medicines. Many drugs can affect esomeprazole and naproxen, especially:

  • clopidogrel;
  • digoxin;
  • methotrexate;
  • rifampin;
  • St. John's wort;
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • a diuretic or "water pill";
  • heart or blood pressure medication; or
  • steroid medicine such as prednisone or methylprednisolone.
  • This list is not complete and many other drugs may affect esomeprazole and naproxen. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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