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naproxen-esomeprazole magnesium

COMMON BRAND NAME(S): Vimovo

GENERIC NAME(S): NAPROXEN/ESOMEPRAZOLE MAGNESIUM

WARNINGS:

The naproxen in this combination medication may rarely cause blood clots to form, causing a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG). Also, this drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This can occur without warning symptoms and at any time during treatment. The risk of bleeding is greater in older adults. Esomeprazole decreases the risk of bleeding.

Stop taking this medication and get medical help right away if you notice any of the following rare but very serious side effects: chest/jaw/left arm pain, severe dizziness, weakness on one side of the body, vision changes, slurred speech, black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. (See also Precautions section.)

Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.

Who should not take naproxen-esomeprazole magnesium?
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Uses

This medication is used to treat the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis when there is a high risk for stomach bleeding/ulcer. This product contains 2 medications: esomeprazole and naproxen. This product should not be used to relieve sudden pain. The naproxen starts to work slower than other naproxen products because of a special coating (delayed-release).

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It reduces pain, swelling, and joint stiffness. Naproxen can cause stomach ulcers, especially in patients with a history of stomach ulcers. Esomeprazole is a proton pump inhibitor (PPI) that blocks acid production in the stomach. This combination provides the benefits of naproxen and may reduce the risk of ulcers or bleeding that can occur with naproxen use.

How to use naproxen-esomeprazole magnesium

Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice daily (in the morning and evening) at least 30 minutes before a meal. Take it with a full glass (8 ounces or 240 milliliters) of water unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug. Swallow the tablet whole. Do not break, chew, crush or dissolve the tablet. Doing so can destroy the slow release of the drug and may increase side effects. If needed, you can take antacids while using this medication.

The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take it more frequently, or take it for longer than prescribed.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. It may take up to 2 weeks of taking this drug until you get the full benefit.

Tell your doctor if your condition persists or worsens.

Side Effects

See also Warning section.

Upset stomach, heartburn, diarrhea, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, lightheadedness/fainting, signs of a lung infection (such as fever, cough, trouble breathing), difficult/painful swallowing, swelling of the hands/feet, sudden/unexplained weight gain, change in amount of urine, symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures).

This drug may rarely cause serious (possibly fatal) liver disease. Stop taking this medication and get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, dark urine, yellowing eyes/skin.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash/blisters, unexplained fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking naproxen/esomeprazole, tell your doctor or pharmacist if you are allergic to either of them; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or to other proton-pump inhibitors such as omeprazole, pantoprazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), liver disease, stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), heart disease (such as history of heart attack), high blood pressure, stroke, swelling (edema, fluid retention), low sodium blood levels, blood disorders (such as anemia), bleeding or clotting problems, growths in the nose (nasal polyps).

Kidney problems can sometimes occur with the use of NSAID medications, including naproxen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase the risk of stomach bleeding. Consult your doctor or pharmacist for more information.

Proton pump inhibitors (such as esomeprazole) may increase your risk for bone fractures, especially with longer use, higher doses, and in older adults. Talk with your doctor or pharmacist about ways to prevent bone loss/fracture, such as by taking calcium (such as calcium citrate) and vitamin D supplements.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially stomach bleeding and kidney problems.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

Naproxen passes into breast milk. It is unknown if esomeprazole passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aliskiren, ACE Inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), corticosteroids (such as prednisone), lithium, methotrexate (especially high-dose treatment), pemetrexed, probenecid, rifampin, St John's wort, "water pills" (diuretics such as furosemide).

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Some products need stomach acid so that the body can absorb them properly. These include atazanavir, digoxin, erlotinib, nelfinavir, rilpivirine, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others. Esomeprazole decreases stomach acid, so it may change how well these other products work. Before using esomeprazole, consult your doctor or pharmacist about the other medications you take and for advice on how to reduce or avoid these types of interactions.

Do not take other products containing naproxen or proton pump inhibitors such as omeprazole. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib or ibuprofen). These drugs are similar to the naproxen in this product and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, coffee ground-like vomit, trouble breathing, extreme drowsiness, loss of consciousness, seizures.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as blood pressure, complete blood count-CBC and magnesium, liver and kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised May 2014. Copyright(c) 2014 First Databank, Inc.

Images

VIMOVO DR 500-20 MG TABLET
VIMOVO DR 500-20 MG TABLET
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VIMOVO DR 375-20 MG TABLET
VIMOVO DR 375-20 MG TABLET
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VIMOVO DR 500-20 MG TABLET
VIMOVO DR 500-20 MG TABLET

Identification

color
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shape
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imprint
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This medicine is a yellow, oval, film-coated tablet imprinted with "500/20".
VIMOVO DR 375-20 MG TABLET
VIMOVO DR 375-20 MG TABLET

Identification

color
No data.
shape
No data.
imprint
No data.
This medicine is a yellow, oval, film-coated tablet imprinted with "375/20".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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