vimovo

Vimovo contains a combination of esomeprazole and naproxen.

Esomeprazole is a proton pump inhibitor. It decreases the amount of acid produced in the stomach. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause inflammation, pain, and fever.

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

Vimovo may also be used for purposes not listed in this medication guide.

Important information

The naproxen in Vimovo may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use Vimovo just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking Vimovo.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take Vimovo during pregnancy unless your doctor has told you to.

Beore taking Vimovo

You should not use Vimovo if you are allergic to esomeprazole or similar medicines (lansoprazole, omeprazole, pantoprazole, Nexium, Prevacid, Prilosec, Protonix, and others), or if you have ever had a severe allergic reaction to naproxen (Aleve, Anaprox, Naprosyn), aspirin, or other NSAIDs.

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

To make sure Vimovo is safe for you, tell your doctor if you have:

• liver or kidney disease;

• heart disease, high blood pressure, fluid retention, or a history of stroke, heart attack, or congestive heart failure;

• low levels of magnesium in your blood;

• a bleeding or blood clotting disorder, such as hemophilia;

• a history of stomach ulcer, stomach bleeding, or intestinal disorder (Crohn"s disease, ulcerative colitis);

• asthma, or a history of allergic reaction to aspirin, especially aspirin triad syndrome;

• if you are on a low econazole topical diet;

• if you are vomiting or having diarrhea; or

• if you smoke.

Taking 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. Tell your doctor if you have osteoporosis or osteopenia (low bone mineral density).

FDA pregnancy category D. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take Vimovo during pregnancy unless your doctor has told you to.

See also: Pregnancy and breastfeeding warnings (in more detail)

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

How should I take Vimovo?

Vimovo is usually taken 2 times each day, at least 30 minutes before a meal. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

While using Vimovo, you may need frequent blood tests. Your blood pressure and kidney or liver function may also need to be tested. You may also need eye exams if you have any changes in your vision.

If you use Vimovo 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.

This medication can cause unusual results with certain medical tests, and you may need to stop using the medicine for a short time before a test. Tell any doctor who treats you that you are using Vimovo.

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

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 feeling weak or tired, nausea, vomiting, stomach pain or discomfort, severe dizziness or drowsiness, bleeding, uncontrolled muscle movements, weak or shallow breathing, or loss of coordination.

What should I avoid?

Ask a doctor or pharmacist before using any other pain or arthritis medicine. Many medicines available over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen). Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains naproxen or another NSAID.

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

Ask your doctor before using Vimovo 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.

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

Vimovo side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Vimovo: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

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

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• diarrhea that is watery or bloody;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

• wheezing, chest tightness, trouble breathing;

• kidney problems - urinating more or less than usual, blood in your urine, swelling, rapid weight gain;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); 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 Vimovo side effects may include:

• constipation, mild diarrhea;

• nausea, vomiting, heartburn, gas;

• dizziness; or

• mild stomach pain.

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.

See also: Side effects (in more detail)

Vimovo dosing information

Usual Adult Dose of Vimovo for Ankylosing Spondylitis:

Esomeprazole-naproxen: 20 mg-375 mg or 20 mg-500 mg: one tablet orally twice daily.

Usual Adult Dose of Vimovo for Osteoarthritis:

Esomeprazole-naproxen: 20 mg-375 mg or 20 mg-500 mg: one tablet orally twice daily.

Usual Adult Dose of Vimovo for Rheumatoid Arthritis:

Esomeprazole-naproxen: 20 mg-375 mg or 20 mg-500 mg: one tablet orally twice daily.

What other drugs will affect Vimovo?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Vimovo, especially:

• atazanavir:

• cholestyramine;

• clopidogrel;

• cyclosporine;

• digoxin;

• erlotinib;

• iron supplements;

• ketoconazole;

• lithium;

• methotrexate;

• mycophenolate mofetil;

• rifampin;

• St. John"s wort;

• tacrolimus;

• an antidepressant;

• a blood thinner (warfarin, Coumadin, Jantoven);

• a diuretic or "water pill";

• heart or blood pressure medication;

• NSAIDs - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• steroid medicine - prednisone and others.

This list is not complete and other drugs may interact with Vimovo. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Not all possible interactions are listed in this medication guide.