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Precautions and Warnings With Naproxen/Esomeprazole Magnesium

Specific Naproxen/Esomeprazole Magnesium Precautions and Warnings

Some warnings and precautions to be aware of before taking this drug include the following:
 
  • There is a "Medication Guide" (an FDA-approved handout) that should be dispensed along with naproxen/esomeprazole magnesium. This medication guide discusses the risks associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs). Make sure to read this guide before using this medication and periodically thereafter.

 

  • The use of proton pump inhibitors (including this medication) may increase the risk of a potentially serious condition known as Clostridium difficile-associated diarrhea (CDAD). If you develop diarrhea that does not seem to improve (especially if it is watery and accompanied by a fever and abdominal pain), seek immediate medical attention. 
 
 
    • Chest pain
    • Shortness of breath
    • Weakness
    • Slurred speech.
 
  • All NSAIDs, including naproxen/esomeprazole magnesium, have been reported to cause problems in the stomach and intestines, including bleeding (known as gastrointestinal bleeding), stomach ulcers, or holes in the stomach or intestines (called perforations). Extreme caution should be used if this drug is prescribed for people with a history of ulcers or gastrointestinal bleeding. To decrease the risk of these problems, you should take the smallest effective dose for the shortest period of time.

Contact your healthcare provider immediately if you experience any signs or symptoms of stomach ulcers or bleeding, including:

    • Indigestion
    • Black, tarry stools
    • Vomiting blood
    • Abdominal (stomach) pain.
 
  • Liver damage can occur in people taking naproxen/esomeprazole magnesium. It may be a good idea for your healthcare provider to monitor your liver by checking your liver enzymes (using a simple, standard blood test). Contact your healthcare provider immediately if you notice things such as:
 
    • Nausea
    • Tiredness
    • Lethargy
    • Itchy or yellowing skin
    • Abdominal (stomach) pain
    • Flu-like symptoms.
 
  • All NSAIDs, including naproxen/esomeprazole magnesium, may cause high blood pressure or make it worse in people who already have it. Therefore, this medication should be used with caution in people with known high blood pressure.
 
  • All NSAIDs, including naproxen/esomeprazole magnesium, may cause congestive heart failure or fluid retention. Contact your healthcare provider if you notice unexplained weight gain or swelling while taking this drug. Also, this medication should be used with caution in people with heart failure.
 
 
  • Kidney damage can occur in people taking NSAIDs, including naproxen/esomeprazole magnesium. This occurrence is more common in the elderly, as well as in people with kidney disease, heart failure, liver problems, and those taking a diuretic or ACE inhibitor.
 
  • NSAIDs, including naproxen/esomeprazole magnesium, have been reported to cause allergic reactions. Seek immediate medical attention if you notice things such as difficulty breathing or swelling of the face and throat.
 
  • In rare cases, people taking naproxen/esomeprazole magnesium can develop a serious rash. If you notice an unexplained rash or develop blisters, fever, or itchy skin, stop taking this medication and call your healthcare provider right away.
 
  • There have been reports of anemia in people taking NSAIDs. Therefore, if you are taking naproxen/esomeprazole magnesium for an extended period of time and show signs of anemia, such as pale skin or extreme fatigue, talk to your healthcare provider.
 
  • Naproxen/esomeprazole magnesium contains a proton pump inhibitor (esomeprazole). Studies indicate that people who take proton pump inhibitor medications may be at an increased risk for broken bones. The risk appears to be highest for people who take such medications at high doses or for long periods of time (over a year). You and your healthcare provider should take this into account when deciding if the benefits of this medication outweigh the risks for your particular situation.

 

  • Proton pump inhibitors (PPIs), including the one in naproxen/esomeprazole, may cause low blood magnesium levels (hypomagnesemia). Seek immediate medical attention if you develop any symptoms of hypomagnesemia, such as muscle spasms, an irregular heart rhythm (arrhythmia), or seizures. Your healthcare provider may want to check your magnesium levels (using a simple blood test) periodically. 
 
  • It is possible that naproxen/esomeprazole magnesium could make asthma worse, especially in people with aspirin-sensitive asthma.
 
  • Naproxen/esomeprazole magnesium is a pregnancy Category C or D medicine (depending on the trimester), meaning that it might not be safe for use during pregnancy, although the full risks are currently unknown (see Vimovo and Pregnancy for more information).
 
  • Naproxen/esomeprazole magnesium passes through breast milk. Therefore, if you are breastfeeding a child, check with your healthcare provider (or your child's healthcare provider) before taking this medication (see Vimovo and Breastfeeding).
 
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Naproxen/Esomeprazole Magnesium Drug Information

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