Vimovo (generic: esomeprazole/naproxen) is a prescription medication used to treat the pain and inflammation associated with osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Vimovo is also used to prevent ulcers. It is 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.
This medication comes in tablet form and is taken twice daily, at least 30 minutes before a meal. Swallow Vimovo tablets whole.
Common side effects of Vimovo include indigestion, stomach pain, stomach ulcers, and diarrhea.
Vimovo 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.
Vimovo may cause serious side effects. See "Drug Precautions".
- 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:
- 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:
- Bone Fracture: Talk to your healthcare provider about your risk for fractures if you take Vimovo 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:
- abnormal or fast heart beat
- jerking movements or shaking (tremors)
- muscle weakness
- spasms of the hands and feet
- cramps or muscle aches
- spasm of the voice box
- passing black sticky bowel movements (stools)
- having bloody diarrhea
- vomiting or coughing up blood or dark particles that look like coffee grounds
- reddening of your skin with blisters or peeling
- blisters and bleeding of your lips, eye lids, mouth, nose, and genitals.
- yellowing of the skin or the whites of your eyes
- dark urine
- feel tired
- right upper stomach area (abdomen) pain
- flu-like symptoms
Your doctor may check the level of magnesium in your body before you start taking Vimovo, during treatment, or if you will be taking Vimovo for a long period of time.
The most common side effects of Vimovo include:
- inflammation of the lining of the stomach, with or without loss of the protective layer of the stomach (erosive gastritis)
- stomach ulcers
- upper stomach-area (abdominal) pain
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 Vimovo. 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. Since Vimovo contains naproxen, talk to your healthcare provider before taking any other NSAID-containing products.
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
- 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)
Ask your healthcare provider if you are not sure if your medicine is one that is listed above.
Using Vimovo with other medicines can cause serious side effects. Vimovo may affect the way other medicines work, and other medicines may affect how Vimovo works.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
Vimovo, 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 Vimovo, should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG).
NSAID-containing medicines, such as Vimovo, 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
- 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 Vimovo:
- 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 Vimovo.
- 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).
Vimovo can cause drowsiness, dizziness, or depression. You should not drive or do other activities that require you to be alert until you know how Vimovo 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 Vimovo there are no specific foods that you must exclude from your diet when receiving Vimovo.
Before you take Vimovo, 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 plan to become pregnant
- are breastfeeding or plan to breastfeed
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your healthcare provider if you are pregnant or plan to become pregnant. In late pregnancy, naproxen, a component of Vimovo, should be avoided because it may cause harm to the unborn baby.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Vimovo can pass into your milk and may harm your baby. You should not breastfeed while taking Vimovo. Talk to your healthcare provider about the best way to feed your baby if you take Vimovo.
Vimovo 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 Vimovo.
Your healthcare provider will tell you how many Vimovo to take and when to take them.Do not change your dose or stop Vimovo without first talking to your healthcare provider.
Take Vimovo at least 30 minutes before a meal.Swallow Vimovo tablets whole with liquid. Do not split, chew, crush or dissolve the Vimovo tablet. Tell your healthcare provider if you cannot swallow the tablet whole. You may need a different medicine.
You may use antacids while taking Vimovo.
If you forget to take a dose of Vimovo, 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 Vimovo.
If you take too much Vimovo, tell your healthcare provider or go to the closest hospital emergency room right away. Symptoms that you have taken too much Vimovo may include:
- feeling weak and tired
- feeling sleepy
- upper stomach-area pain or discomfort
- heartburn, indigestion, or nausea
- a change in breathing or you stop breathing
- movements of a body part that you cannot control
- coordination problems and decreased movement
If you take more Vimovo than your healthcare provider recommends, call your Poison Control Center at 1-800-222-1222.
Vimovo is available in tablets containing either:
- 375 mg enteric coated naproxen and 20 mg esomeprazole (as magnesium trihydrate) tablets printed with 375/20 in black, or
- 500 mg enteric coated naproxen and 20 mg esomeprazole (as magnesium trihydrate) tablets printed with 500/20 in black.
Active ingredients: naproxen and esomeprazole magnesium
Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, glyceryl monostearate, hypromellose, iron oxide black, magnesium stearate, methacrylic acid copolymer dispersion, methylparaben, polysorbate 80, polydextrose, polyethylene glycol, povidone, propylene glycol, propylparaben, titanium dioxide, and triethyl citrate.
Store Vimovo at 59°F to 86°F (15°C to 30°C).
Keep Vimovo in the original container and keep the bottle tightly closed. Keep Vimovo dry.
Keep Vimovo and all medicines out of the reach of children.
Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of VIMOVO, 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.
VIMOVO is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs, including naproxen, a component of VIMOVO, 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.
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