Vimovo

The active ingredients in Vimovo are naproxen and esomeprazole magnesium. Naproxen is a non-steroidal anti-inflammatory drug (NSAID) that reduces joint pain, swelling, redness, and inflammation associated with osteoarthritis, osteoporosis, and ankylosing spondylitis. With long-term use, naproxen can cause damage to the stomach and result in stomach ulcers. Esomeprazole is a proton pump inhibitor (PPI), typically used as a heartburn medication, that reduces the acidity of your stomach to reduce the damaging effects of naproxen.

The naproxen component of the tablet uses a delayed-release formulation to provide pain relief over 12 hours, whereas the esomeprazole component is immediate-release to provide quick stomach protection.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Vimovo. However, the following is a synopsis of the general guidelines for the use of Vimovo:

-Swallow Vimovo tablets with water at least 30 minutes before a meal.

-Do not chew, split, or crush Vimovo tablets.

-Vimovo is typically dosed twice daily.

-If you miss a dose, take the missed dose as soon as you remember and the next dose at the scheduled time. Do not take two doses of Vimovo at once.

The use of naproxen should be limited to the lowest effective dose for the shortest amount of time needed.

The most common side effects of Vimovo include:

-Upset stomach, nausea, or vomiting

-Diarrhea, flatulence

-Headache, dizziness

Some individuals may experience serious side effects while using Vimovo. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

-Serious abdominal pain or stomach pain, or blood in vomit or stool: these can be signs of a more serious condition, such as erosive gastritis and peptic ulcer disease.

-A skin rash with fever and blistering of the skin: this can be a sign of a severe skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can be fatal.

-Because Vimovo contains an NSAID, it can increase your risk of having a heart attack or stroke. Call 911 immediately if you have signs of a heart attack (chest pain, shortness of breath) or stroke (weakness on one side of your body, facial drooping, headache, or sudden changes in your vision or speech).

-New or worsening high blood pressure, swelling, and heart failure.

-Kidney damage: symptoms include a change in how often you urinate, bloody urine, fever, weakness, loss of appetite, and nausea.

-Liver damage: symptoms include jaundice (yellowing of your skin or eyes), nausea, diarrhea, fatigue, pain in the upper right abdomen, and flu-like symptoms.

These are not all of the possible side effects of Vimovo. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Vimovo, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

-Hypertension (high blood pressure), heart failure, a history of stroke or heart attack, or any other cardiovascular condition. If you are taking Vimovo long-term, you should have your blood pressure monitored regularly.

-A history of stomach or bowel ulcer or bleeding.

-Liver or kidney problems: Naproxen can worsen hepatic or renal dysfunction.

-Electrolyte imbalances, such as low magnesium, potassium, or calcium. Long-term use of PPIs can decrease magnesium levels and occasionally other electrolytes. Low magnesium can present as fatigue, muscle spasms and cramps, or muscle weakness.

-Low vitamin B12 levels: The long-term use of PPIs can lead to B12 deficiency.

-Osteoporosis: The long-term use of PPIs has been linked to an increased risk of bone fractures.

-Vision problems: blurred vision has been reported with the use of NSAIDs.

Patients with risk factors for adverse effects should consider therapy that does not involve NSAIDs.

Caution is advised when high doses are required.

Boxed Warning

-Vimovo and other NSAIDs have been associated with cardiovascular adverse events such as heart attacks, strokes, or blood clots, events which can be fatal. Caution should be exercised for people taking Vimovo who have cardiovascular disease.

-The use of Vimovo can increase the retention of sodium in the body, which can result in increased blood pressure or worsening of heart failure, leading to swelling of the feet or legs and quick water weight gain.

-Vimovo is associated with gastrointestinal adverse events such as ulceration, bleeding, perforation, and obstruction of the stomach and bowel.

-Caution is advised when Vimovo is used during the third trimester of pregnancy or after 20 weeks of pregnancy.

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

Vimovo is contraindicated in people who:

-Have had an allergic reaction or hypersensitivity to naproxen, esomeprazole, substituted benzimidazoles, or the inactive ingredients of the formulation.

-Have a history of asthma, hives, or an allergic-type reaction after taking acetylsalicylic acid (ASA) or other NSAIDS.

-Have had a heart attack, stroke, or mini-stroke.

-Have angina or congestive heart failure.

-Have an active stomach or bowel ulcer, or an active intestinal bleed.

-Have a bleeding disorder.

-Have severe liver problems or kidney problems.

-Are in your third trimester or 20 weeks of pregnancy, or are breastfeeding.

-Have an inflammatory bowel disease like Crohn's disease or ulcerative colitis.

-Are less than 18 years of age.

-Are taking rilpivirine.

-Need pain treated before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Vimovo will start to provide pain relief within hours, however, it can take up to 5 doses before the lasting pain-relief effect is achieved.

When Vimovo is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

-Aspirin: Naproxen is not recommended for use with other NSAIDs, with the exception of aspirin (ASA) for heart protection.

-Other NSAIDs like ibuprofen, celecoxib, ketorolac, etc.

-Other PPIs such as omeprazole, pantoprazole, lansoprazole, etc.

-Clopidogrel: Naproxen can reduce the concentration and efficacy of clopidogrel and reduce its antiplatelet effects.

-Methotrexate: The use of PPIs like esomeprazole with methotrexate can increase methotrexate concentrations and side effects

-ACE inhibitors like ramipril and perindopril, or angiotensin receptor blockers like valsartan or candesartan, NSAIDs can reduce the blood pressure-lowering effects of ACE inhibitors.

-Antiviral medications like rilpivirine, atazanavir, nelfinavir, saquinavir: The use of PPIs can affect the absorption of antivirals and reduce their efficacy.

-Anti-coagulants (e.g., warfarin), oral corticosteroids (e.g., prednisone), and SSRIs (e.g., sertraline, citalopram) can increase the risk of gastrointestinal bleeding when taken with naproxen.

-Corticosteroids: The combination of steroids and NSAIDs can increase the risk of gastrointestinal side effects.

-Digoxin: NSAIDs can increase the risk of toxicity from digoxin.

-Diuretics (water pills): NSAIDs can reduce the effectiveness of diuretics.

-Medications that induce the enzymes CYP2C19 and CYP3A4, like rifampin and St. John’s Wort, can decrease the efficacy of esomeprazole.

Vimovo is available as 375mg/20mg and 500mg/20mg of naproxen/esomeprazole tablets.

Vimovo should be stored at room temperature and away from moisture.

Vimovo is manufactured by Xedition Pharmaceuticals Inc. under Grunenthal GmbH

Yes, there are generic versions of Vimovo.

Osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis are chronic conditions. Speak with your doctor before you stop taking Vimovo to ensure you have other methods of pain control.

If you use Vimovo long-term, you may need to wean off esomeprazole. Stopping PPIs abruptly can lead to increased stomach acid secretion and heartburn.

Naproxen can cause defects in the unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Naproxen has the potential to cause adverse effects in nursing infants. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.