Esomeprazole & Naproxen

Esomeprazole/naproxen is a prescription medication used to treat the pain and inflammation associated with osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It is also used to prevent ulcers.

It comes as a single tablet containing 2 medications, esomeprazole and naproxen. Esomeprazole belongs to a group of drugs called proton pump inhibitors which work by reducing acid production in the stomach. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that works by blocking the production of substances that cause inflammation.

Esomeprazole/naproxen is taken twice daily, at least 30 minutes before a meal. Swallow tablets whole.

Common side effects include indigestion, stomach pain, stomach ulcers, and diarrhea. 

Esomeprazole/naproxen is a prescription medicine used to:

• relieve signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
• decrease the risk of developing stomach (gastric) ulcers in people who are at risk of developing gastric ulcers with NSAIDs

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Esomeprazole & Naproxen may be found in some form under the following brand names:

• Vimovo

Esomeprazole/naproxen may cause serious side effects including:

• High blood pressure.
• Heart problems such as congestive heart failure. Tell your healthcare provider about any swelling of your body, hands or feet, sudden weight gain or trouble breathing.
• Active bleeding. Tell your healthcare provider if you have signs of active bleeding including passing black stools, bloody diarrhea, and vomiting blood.
• Serious allergic reactions. Tell your healthcare provider or get medical help right away if you develop sudden wheezing, swelling of your lips, tongue, throat or body, rash, fainting or problems breathing or swallowing (severe allergic reaction).
• Serious skin reactions. Tell your healthcare provider or get medical help right away if you develop a symptoms similar to the ones listed above for allergic reactions.
• Liver problems. Tell your healthcare provider if you develop yellowing skin or whites of the eyes, dark urine, and pain in the upper right stomach area.
• Bone Fracture. Talk to your healthcare provider about your risk for fractures if you take esomeprazole/naproxen for a long period of time.
• People who are taking high (defined as more than once daily) doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist or spine.
• Low magnesium levels. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you have any of these symptoms of low magnesium levels:

• seizures
• dizziness
• abnormal or fast heart beat
• jitteriness
• jerking movements or shaking (tremors)
• muscle weakness
• spasms of the hands and feet
• cramps or muscle aches
• spasm of the voice box

The most common side effects of esomeprazole/naproxen include:

• inflammation of the lining of the stomach, with or without loss of the protective layer of the stomach (erosive gastritis)
• indigestion
• diarrhea
• stomach ulcers
• upper stomach-area (abdominal) pain
• nausea

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of esomeprazole/naproxen. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• steroid hormones (corticosteroids)
• St. John's Wort
• rifampin (Rifater, Rifamate, Rimactane, Rifadin)
• a medicine for high blood pressure or heart problems
• "blood thinning" medications including warfarin (Coumadin), clopidogrel (Plavix), and others
• aspirin
• cholestyramine (Questran, Questran Light, Locholest, Locholest Light, Prevalite)
• cyclosporine (Gengraf, Neoral, Sandimmune) or tacrolimus (Prograf)
• a water pill (diuretic)
• lithium carbonate
• methotrexate sodium (Trexall)
• blood thinner medicines, including warfarin sodium (Coumadin, Jantoven), dicumarol, or a blood thinner that contains heparin
• an antidepressant medicine
• erlotinib (or another anticancer drug from the same class)

This is not a complete list of drug interactions. Ask your healthcare provider or pharmacist for more information.

Esomeprazole/naproxen, which contains naproxen [a nonsteroidal anti-inflammatory drug (NSAID)] and esomeprazole magnesium, may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

• with longer use of NSAID medicines
• in people who have heart disease

NSAID-containing medicines, such as esomeprazole/naproxen, should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG).

NSAID-containing medicines, such as esomeprazole/naproxen, can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

• can happen without warning symptoms
• may cause death

The chance of a person getting an ulcer or bleeding increases with:

• taking medicines called steroid hormones (corticosteroids) and blood thinners (anticoagulants)
• longer use
• smoking
• drinking alcohol
• older age
• having poor health

NSAID medicines should only be used:

• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

• different types of arthritis
• menstrual cramps and other types of short-term pain

Do not take an NSAID medicine:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery

Do not take esomeprazole/naproxen:

• If you had an asthma attack, hives, or other allergic reaction after taking aspirin or other NSAID medicine.
• If you are allergic to any of the ingredients in esomeprazole/naproxen. 
• If you are allergic to any other Proton Pump Inhibitor (PPI) medicine.
• For pain right before or after heart bypass surgery.
• If you are in the late stages of pregnancy (third trimester).

Esomeprazole/naproxen can cause drowsiness, dizziness, or depression. You should not drive or do other activities that require you to be alert until you know how this medication affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of esomeprazole/naproxen there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take esomeprazole/naproxen, tell your healthcare provider about all your medical conditions, including if you:

• have been told that you have low magnesium levels in your blood
• have liver or kidney problems
• have ulcerative colitis or Crohn’s disease (inflammatory bowel disease or IBD)
• have any other medical conditions
• are pregnant or breastfeeding

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Esomeprazole/naproxen falls into category C prior to 30 weeks gestation and category D starting at 30 weeks gestation. In late pregnancy, naproxen, (one component of this medication) should be avoided because it may cause harm to the unborn baby.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Esomeprazole/naproxen can pass into your milk and may harm your baby. You should not breastfeed while taking esomeprazole/naproxen. Talk to your healthcare provider about the best way to feed your baby if you take this medication.

• Take esomeprazole/naproxen exactly as your healthcare provider tells you to take it.
• Your healthcare provider may tell you to take Vitamin D and Calcium supplements during treatment with esomeprazole/naproxen.
• Your healthcare provider will tell you how many esomeprazole/naproxen tablets to take and when to take them. Do not change your dose or stop esomeprazole/naproxen without first talking to your healthcare provider.
• Take esomeprazole/naproxen at least 30 minutes before a meal. Swallow esomeprazole/naproxen tablets whole with liquid. Do not split, chew, crush or dissolve the esomeprazole/naproxen tablet. Tell your healthcare provider if you cannot swallow the tablet whole. You may need a different medicine.
• You may use antacids while taking esomeprazole/naproxen.
• If you forget to take a dose of esomeprazole/naproxen, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at one time to make up for a missed dose.
• Your healthcare provider may do certain tests from time to time to check you for side effect of esomeprazole/naproxen.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• how you respond to this medication
• age
• your liver function

The recommended dose is 375 mg naproxen and 20 mg of esomeprazole or 500 mg naproxen and 20 mg of esomeprazole twice daily.

If you take too much esomeprazole/naproxen, tell your healthcare provider or go to the closest hospital emergency room right away. Symptoms that you have taken too much may include:

• feeling weak and tired
• dizziness
• feeling sleepy
• upper stomach-area pain or discomfort
• heartburn, indigestion, or nausea
• a change in breathing or you stop breathing
• vomiting
• bleeding
• movements of a body part that you cannot control
• coordination problems and decreased movement

If you take more esomeprazole/naproxen than your healthcare provider recommends, call your Poison Control Center at 1-800-222-1222.

• Store at 59°F to 86°F (15°C to 30°C).
• Keep esomeprazole/naproxen in the original container and keep the bottle tightly closed. Keep tablets dry.
• Keep this and all medicines out of the reach of children.

Cardiovascular Risk

Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of esomeprazole/naproxen, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

Esomeprazole/naproxen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

NSAIDs, including naproxen, a component of esomeprazole/naproxen, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.