Naproxen/esomeprazole (By mouth)

Introduction

Esomeprazole Magnesium, Naproxen (na-PROX-en)

Treats pain caused by arthritis or ankylosing spondylitis in people who might have stomach problems caused by pain medicines. This medicine is a combination of a nonsteroidal anti-inflammatory drug (NSAID) and a proton pump inhibitor that helps protect against ulcers in your stomach or intestines.

Brand Name(s)

There may be other brand names for this medicine.

Vimovo

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to naproxen or esomeprazole, or to any similar medicines. You should not use this medicine if aspirin or other NSAIDs have ever caused you to have an asthma attack, hives, or other allergic reactions. Do not use this medicine right before or right after having a coronary artery bypass graft (CABG), a type of heart surgery.

How to Use This Medicine

Delayed Release Tablet

  • 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.
  • It is best to take this medicine on an empty stomach. It is best to take this medicine 30 minutes before a meal.
  • Swallow the delayed-release tablet whole with water. Do not break, crush, chew, or dissolve it.
  • Your doctor may tell you to take vitamin D and calcium supplements while you are using this medicine.
  • This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

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 leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
  • Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

  • Make sure your doctor knows if you are also using aspirin, a blood thinner (such as warfarin, Coumadin®), a steroid medicine (such as cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, Decadron®, Medrol®, or Orapred®), or a diuretic or "water pill" (such as furosemide, hydrochlorothiazide [HCTZ], torsemide, Demadex®, or Lasix®).
  • Do not use any other NSAID medicine unless your doctor says it is okay. Some examples of other NSAIDs are aspirin, diclofenac, ibuprofen, Advil®, Aleve®, Celebrex®, Ecotrin®, Motrin®, Naprosyn®, or Voltaren®.
  • Make sure your doctor knows if you are also using cholestyramine (Questran®), cilostazol (Pletal®), diazepam (Valium®), digoxin (Lanoxin®), iron salts, ketoconazole (Nizoral®), lithium (Eskalith®), methotrexate (Rheumatrex®), probenecid (Benemid®), voriconazole (Vfend®), certain blood pressure medicines (such as atenolol, enalapril, lisinopril, metoprolol, propranolol, Accupril®, Inderal®, Lotensin®, Lotrel®, Monopril®, Prinivil®, Toprol®, or Zestril®), medicine to treat depression (such as fluoxetine, paroxetine, Celexa®, Lexapro?, Paxil®, or Zoloft®), diabetes medicine that you take by mouth (such as glyburide, Glucotrol®, or Glucovance®), medicine for seizures (such as phenytoin, Dilantin®), or medicine to treat HIV infection (such as atazanavir, nelfinavir, saquinavir, Fortovase®, Invirase®, Reyataz®, or Viracept®).

Warnings While Using This Medicine

  • Make sure your doctor knows if you are pregnant or breastfeeding. You should not use this medicine during the later part of pregnancy, unless your doctor tells you to.
  • Make sure your doctor knows if you have a history of ulcers or other stomach problems. Tell your doctor if you have kidney disease, liver disease, anemia, aspirin-sensitive asthma, bleeding problems, osteoporosis (weak bones), fluid retention or swelling, high blood pressure, congestive heart failure (CHF), or any other heart or circulation problems.
  • Naproxen may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.
  • Naproxen may cause bleeding in your stomach or intestines. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain medicines (such as steroids or a blood thinner).
  • This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
  • Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.
  • Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or eyes.
  • 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.
  • Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

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, black or tarry stools.
  • Change in how much or how often you urinate.
  • Chest pain, shortness of breath, or coughing up blood.
  • Dark-colored urine or pale stools.
  • Flu-like symptoms.
  • Joint or muscle pain.
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach.
  • Numbness or weakness in your arm or leg, or on one side of your body.
  • Rapid weight gain.
  • Severe stomach pain.
  • Skin rash or blisters with fever.
  • Sudden or severe headache, problems with vision, speech, or walking.
  • Swelling in your hands, ankles, or feet.
  • Unusual bleeding, bruising, or weakness.
  • Vomiting of blood or something that looks like coffee grounds.

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

  • Diarrhea, constipation, heartburn, indigestion, passing gas, or stomach pain.
  • Headache.
  • Mild skin rash or itching.
  • Stuffy or runny nose.

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

Review Date: 2011-02-04 Reviewed By: Keywords: ,
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