Vimovo

Generic Name: esomeprazole and naproxen (ee soe MEP ra zole and na PROX en)
Brand Names: Vimovo

What is Vimovo?

Vimovo contains a combination of 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.

Vimovo is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The esomeprazole in Vimovo 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 about Vimovo

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.

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Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking Vimovo, especially in older adults.

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

Before taking Vimovo

You should not use Vimovo if you are allergic to esomeprazole (Nexium) or naproxen (Aleve, Anaprox, Naprosyn, and others), or if you have ever had a severe allergic reaction to aspirin or other NSAIDs. Do not use Vimovo just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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.

Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking Vimovo, especially in older adults.

To make sure you can safely take Vimovo, tell your doctor if you have any of these other conditions:

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

See also: Vimovo pregnancy and breastfeeding warnings (in more detail)

How should I take Vimovo?

Take Vimovo exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Vimovo is usually taken 2 times each day, at least 30 minutes before a meal. Follow your doctor's instructions.

Do not crush, chew, or break an enteric coated Vimovo tablet. Swallow it whole. The enteric coated tablet has a special coating to protect your stomach. Breaking the pill will damage this coating.

To be sure Vimovo is not causing harmful effects, your blood may need to be tested often. 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. Visit your doctor regularly.

Vimovo can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Vimovo.

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

See also: Vimovo dosage (in more detail)

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 while taking Vimovo?

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 esomeprazole and naproxen and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Ask your doctor before using an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). Taking any of these drugs with an NSAID may increase your risk of stomach bleeding.

Avoid drinking alcohol while taking Vimovo. 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. Stop using Vimovo and call your doctor at once if you have a serious side effect such as:

• pale skin, easy bruising, unusual bleeding, or any bleeding that will not stop;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• pain, swelling, warmth, or redness in one or both legs;

• low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure);

• urinating less than usual or not at all;

• swelling, rapid weight gain, feeling short of breath (even with mild exertion);

• diarrhea that is watery or bloody;

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

• nausea, upper stomach pain, itching, 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.

Less serious Vimovo side effects may include:

• constipation, mild diarrhea; 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: Vimovo side effects (in more detail)

What other drugs will affect Vimovo?

Vimovo should not be taken together with atazanavir (Reyataz) or nelfinavir (Viracept). Tell your doctor if you are taking either of these medications to treat HIV or AIDS.

Tell your doctor about all other medicines you use, especially:

• clopidogrel (Plavix) or cilostazol (Pletal);

• cholestyramine (Prevalite, Questran);

• digoxin (digitalis, Lanoxin);

• lithium (Eskalith, Lithobid, others);

• methotrexate (Rheumatrex, Trexall);

• probenecid (Benemid);

• rifampin (Rifadin, Rifater, Rifamate);

• St. John's wort;

• tacrolimus (Prograf);

• an iron supplement;

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

• steroids (prednisone and others);

• a diuretic (water pill) such as furosemide (Lasix);

• antifungal medication such as ketoconazole (Nizoral) or voriconazole (Vfend);

• aspirin or other NSAIDs such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others; or

• heart or blood pressure medication such as atenolol (Tenormin, Tenoretic), benazepril (Lotensin), carvedilol (Coreg), fosinopril (Monopril), lisinopril (Prinivil, Zestril), metoprolol (Dutoprol, Lopressor, Toprol), propranolol (Inderal, InnoPran), ramipril (Altace), 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.

Where can I get more information?

• Your pharmacist can provide more information about Vimovo.