Vimovo

Vimovo is the brand name of a combination medicine that contains the drugs esomeprazole and naproxen.

It's used to treat osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis (a type of arthritis that affects the spine and large joints).

Naproxen is a non-steroidal anti-inflammatory drug (NSAID) that works by reducing inflammation in the body.

Esomeprazole is a proton pump inhibitor (PPI) that works by reducing the amount of acid produced in the stomach.

The esomeprazole in Vimovo may help reduce the risk of stomach ulcers in people who take NSAIDs.

The Food and Drug Administration (FDA) approved prescription Vimovo in 2010. It's marketed by Horizon Pharma USA, Inc.

Vimovo Warnings

Vimovo contains a black-box warning because the naproxen in it may cause a life-threatening stroke or heart attack.

This risk is greater if you take the medicine long-term and have heart disease.

Seek medical care if you experience any of the following symptoms while taking Vimovo:

• Chest pain
• Weakness
• Shortness of breath
• Slurred speech
• Problems with vision or balance

Don't take Vimovo right before or after heart bypass surgery.

Vimovo also contains a black-box warning because the naproxen in it may increase your risk of serious or fatal stomach bleeding.

This condition can occur at any time during treatment without warning. Elderly people have a higher risk of stomach bleeding.

Call your doctor immediately if you experience any of the following symptoms while taking Vimovo:

• Black, tarry, or bloody stools
• Coughing up blood, or vomit that looks like coffee grounds

Vimovo may also increase your risk of a bone fracture in the wrist, hip, or spine. This is more likely to happen in older people who've taken the drug for a long time or at very high doses.

Your doctor may tell you to take vitamin D and calcium supplements while taking Vimovo. Follow your healthcare provider's instructions carefully.

Before taking Vimovo, tell your doctor if you have, or have ever had:

• Liver disease
• Kidney disease
• Heart disease, heart attack, or heart failure
• High blood pressure
• Fluid retention
• Stroke
• Low levels of magnesium in the blood
• Osteoporosis or osteopenia (low bone mineral density)
• A bleeding or blood clotting disorder such as hemophilia
• An intestinal disorder such as Crohn's disease or ulcerative colitis
• Stomach bleeding or stomach ulcers
• Asthma
• A recent bout of vomiting or diarrhea
• Allergies to medicines (especially aspirin or other NSAIDs)

Be sure to let your doctor know if you smoke or use tobacco products before taking Vimovo.

Drink plenty of fluids to prevent dehydration while taking Vimovo.

Tell your doctor you take Vimovo before having any type of surgery, including a dental procedure.

Your healthcare provider will probably want to perform frequent tests to monitor your body's response to Vimovo. Keep all appointments with your doctor and laboratory.

Vimovo can cause unusual results on certain medical tests. Be sure to tell all healthcare professionals who treat you that you're taking this medicine.

Pregnancy and Vimovo

Don't take Vimovo if you're pregnant unless your doctor tells you otherwise.

Taking the medicine during the last three months of pregnancy may result in birth defects.

Vimovo can pass into breast milk and may hurt a breastfeeding baby. Don't breastfeed while taking this medicine.

There is no clinical data on overdosage with VIMOVO.

Overdosage of Naproxen

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred but were rare [see WARNINGS AND PRECAUTIONS].

A few patients have experienced seizures, but it is not clear whether or not these were drug-related. It is not known what dose of the drug would be life threatening. The oral LD50 of the drug is 500 mg/kg in rats, 1200 mg/kg in mice, 4000 mg/kg in hamsters and greater than 1000 mg/kg in dogs. In animals 0.5 g/kg of activated charcoal was effective in reducing plasma levels of naproxen.

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

Overdosage of Esomeprazole

A single oral dose of esomeprazole at 510 mg/kg (about 124 times the human dose on a body surface area basis) was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. The symptoms described in connection with deliberate esomeprazole overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of esomeprazole were uneventful. Reports of overdosage with omeprazole in humans may also be relevant. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience (see omeprazole package insert -Adverse Reactions). No specific antidote for esomeprazole is known. Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive.

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (delayed-release tablets):
  • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
    • Adults—One tablet two times a day.
    • Children—Use and dose must be determined by your doctor.

Vimovo 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.

Vimovo 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.

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.

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 Vimovo, 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 Vimovo 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 Vimovo in the original container and keep the bottle tightly closed. Keep tablets dry.
• Keep this and all medicines out of the reach of children.

Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use this medicine if you are allergic to esomeprazole (Nexium) or naproxen (Aleve, Naprosyn), or if:

• you are allergic to lansoprazole, omeprazole, pantoprazole, rabeprazole, AcipHex, Nexium, Prevacid, Prilosec, Protonix, and others;

• you have had an asthma attack or severe allergic reaction after taking aspirin or an NSAID; or

• you also take an HIV medicine that contains rilpivirine (Complera, Edurant, Odefsey).

To make sure esomeprazole and naproxen is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure, or if you smoke;

• a heart attack, stroke, or blood clot;

• a stomach ulcer, stomach bleeding, or intestinal disorder (Crohn's disease, ulcerative colitis, inflammatory bowel disease);

• asthma;

• lupus;

• liver or kidney disease; or

• low levels of magnesium in your blood.

Taking a proton pump inhibitor such as 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.

Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Naproxen can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.

Esomeprazole and naproxen is not approved for use by anyone younger than 12 years old or weighing less than 38 kilograms (84 pounds).

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects.

Do not use this medicine together with medicines containing rilpivirine (Complera®, Edurant®, Odefsey®).

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. Get emergency help right away if you have any symptoms of a heart attack or stroke. Some possible symptoms are chest pain or discomfort, uneven heartbeat, pain that spreads to your arm or jaw, unusual sweating, feeling faint, trouble breathing, slurred speech, or weakness on one side of your body.

Naproxen may cause bleeding in your stomach or intestines. This problem can happen without warning signs. 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 of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner).

This medicine may cause a serious type of allergic reaction, called anaphylaxis. This 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 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.

Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

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.

If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

This medicine may cause kidney damage. Tell your doctor right away if you have the following symptoms: blood in the urine, decreased urine output, confusion, dizziness, headache, muscle twitching, rapid weight gain, swelling of your face, ankles, or hands, or unusual tiredness or weakness.

Hyperkalemia may occur while you are receiving this medicine. Call your doctor right away if you have confusion, weakness, uneven heartbeat, trouble breathing, numbness or tingling in your hands, feet, or lips.

Check with your doctor right away if you have a fever, joint pain, skin rash, swelling of the body, feet, or ankles, or unusual weight gain after taking this medicine. These could be symptoms of acute interstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

This medicine may cause hypomagnesemia (low magnesium in the blood). Your doctor may want to check your blood levels if you are taking this medicine for more than 1 year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have the following symptoms: convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Check with your doctor right away if you have watery stool that does not go away, stomach pain, and fever while taking this medicine.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop the medicine for a while, or to change to a different medicine before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take Vimovo at least 30 minutes before meals.
• Swallow whole with some water or other drink.
• Do not chew, break, or crush.
• To gain the most benefit, do not miss doses.
• Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Tell all of your health care providers that you take Vimovo. This includes your doctors, nurses, pharmacists, and dentists.
• Take calcium and vitamin D as you were told by your doctor.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine for longer than you were told by your doctor.
• Have your blood work checked if you are on Vimovo for a long time. Talk with your doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.
• Talk with your doctor before you drink alcohol.
• If you smoke, talk with your doctor.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Vimovo with your other drugs.
• If you have asthma, talk with your doctor. You may be more sensitive to this medicine.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

Vimovo is contraindicated in the following patients:

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to any components of the drug product, including omeprazole. Hypersensitivity reactions to esomeprazole may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Warnings and Precautions (5.7, 5.8, 5.9, 5.17) and Postmarketing Experience (6.2)].
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)].
• In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)].
• Proton pump inhibitors (PPIs), including esomeprazole magnesium, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].