Naproxen and Esomeprazole (Oral)

Naproxen and esomeprazole is designed to relieve inflammation, pain, and stiffness associated with ankylosing spondylitis and arthritis.

Overview

Naproxen and esomeprazole is used to relieve the symptoms of ankylosing spondylitis and various types of arthritis in patients who are at an increased risk of stomach ulcers. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) and it works to relieve muscle and joint pain, swelling, inflammation, and stiffness. Esomeprazole is a protein pump inhibitor (PPI) and it helps to treat conditions where excess stomach acid is produced, which helps to reduce the risk of stomach ulcers.

NSAIDs like naproxen can cause an increased risk of dangerous stomach ulcers or intestinal bleeding, so by prescribing it in combination with esomeprazole the risk of these complications occurring is minimized. This is particularly important for those who are already at a high risk of stomach ulcers or intestinal bleeding due to a history of these conditions.

Naproxen and esomeprazole is designed to be taken orally and is provided in delayed release dosage form. It is only available with a doctor's prescription and is known in the US by brand name Vimovo.

Conditions Treated?

  • Ankylosing spondylitis
  • Osteoarthritis
  • Rheumatoid arthritis
  • Juvenile arthritis

Type Of Medicine?

  • Nonsteroidal anti-inflammatory drug (NSAID), (naproxen)
  • Proton pump inhibitor (PPI)

Side Effects

As well as its wanted effects, naproxen and esomeprazole can also cause a variety of unwanted side effects, some of which are very serious and require urgent medical attention. Although it is very unlikely that all side effects will occur, patients should familiarize themselves with all potential effects of the drug in order that they can recognize the appropriate moments to seek medical care.

The follow side effects should be reported to a doctor immediately:

  • Red, blistering, or peeling skin
  • Sores, ulcers, or white spots on lips, tongue, or inside of mouth
  • Bloating or swelling of face, arms, hands, lower legs, or feet (edema)
  • Pain in lower back or side
  • Chest pain
  • Difficulty breathing
  • Burning sensation in stomach or chest
  • Heartburn
  • Indigestion
  • Stomach bloating, cramp, or pain
  • Full or bloated feeling
  • Tenderness in stomach
  • Pressure in stomach
  • Upper abdominal or stomach pain
  • Upset stomach
  • Nausea
  • Vomiting
  • Vomiting of blood or material that looks like coffee grounds
  • Black, tarry stools
  • Bloody stools
  • Bloody or cloudy urine
  • Bladder pain
  • Frequent urge to urinate
  • Difficult, burning, or painful urination
  • Muscle pain or stiffness
  • Muscle twitching or spasms (tetany)
  • Seizures
  • Trembling
  • Tingling in hands or feet
  • Joint pain
  • Difficulty moving
  • Pain or burning in throat
  • Difficulty swallowing
  • Loss of appetite
  • Weight loss
  • Rapid weight gain
  • Unusual weakness or tiredness
  • Drowsiness
  • Mood or mental changes

The following side effects are less serious, and only require medical attention if they become very persistent, severe, or bothersome. In some cases, they may dissipate as the body adjusts to the medicine. If you have any questions about them or are struggling to put up with them, consult your doctor.

  • Acidic or sour stomach
  • Belching
  • Passing gas
  • Excess air or gas in stomach or intestines
  • Change in taste
  • Loss of taste
  • Sore throat
  • Cough
  • Cough producing mucus
  • Loss of voice
  • Chills
  • Fever
  • Headache
  • Pain or tenderness around eyes or cheekbones
  • Body aches or pains
  • Ear congestion
  • Stuffy or runny nose
  • Sneezing
  • Diarrhea
  • Difficulty passing stools

Some patients may also notice other side effects not listed here. In these cases, patients should report their symptoms to their doctor as soon as possible. You could also report new side effects to the FDA, or your doctor may do this on your behalf.

Dosage

The amount of naproxen and esomeprazole you take may vary depending on factors personal to you, such as the medical condition being controlled, your medical history, and other health factors. The number of doses you take each day and the length of time between each one may also vary. The average dose is one tablet, twice each day. However, you should always follow your doctor's dosage instructions rather than any other averages or recommended doses you see.

Do not change your dose of naproxen and esomeprazole unless advised to do so by your doctor. Taking too little of the drug may result in it being ineffective, while taking too much could increase the risk of serious side effects, particularly for elderly patients.

The longer a patient takes naproxen and esomeprazole for, the higher the risk of many harmful side effects or complications. Discuss the benefits and risks of long term use with your doctor. Your doctor may be able to estimate the length of treatment time. You may require more frequent tests the longer you take the medicine for.

How to take naproxen and esomeprazole

Naproxen and esomeprazole should be provided with a medication guide. Read this thoroughly before you take your first dose of the drug so that you know what to expect.

To ensure the medicine provides the best results, take naproxen and esomeprazole around 30 minutes before a meal and on an empty stomach. You should swallow the tablet whole with water. Do not break, crush, chew, or dissolve the tablet.

Sometimes your doctor will prescribe vitamin D and/or calcium supplements at the same time as naproxen and esomeprazole. Make sure you know the appropriate times to take these additional medicines.

If you miss a dose of naproxen and esomeprazole, take it as soon as possible unless it is nearly time for your next dose. In this case, skip the missed dose and continue with your usual dosing schedule. Never double doses of naproxen and esomeprazole to make up for a missed dose, as doing so could increase the risk of harmful side effects. If you have missed several doses of the drug, consult your doctor.

Interactions

There are very many drugs which may interact with naproxen and esomeprazole and cause harmful effects. Interactions may result in some medicines being ineffective, a heightened risk of serious side effects, or other health risks or complications. Doctors will try to avoid interactions where possible.

It is vital that you tell your doctor about all the other medicines you take. This includes those prescribed to you, those purchased over the counter, and any vitamins or herbal supplements that you take. Once you have been prescribed naproxen and esomeprazole, it is important to tell any other doctors you see about the new medicine. It may be helpful to keep a list of your medicines which you can present to any doctor, nurse, or pharmacist that you see.

It is particularly important to mention the following medicines:

  • NSAIDs
  • Salicylates, such as aspirin
  • Pemetrexed
  • Atazanavir
  • Nelfinavir
  • Rilpivirine
  • Rifampin
  • Clopidogrel
  • St. John's wort

Use of the following medicines at the same time as naproxen and esomeprazole is not recommended. Your doctor will either avoid prescribing naproxen and esomeprazole, or they may change some of the other medicines you take.

  • Rilpivirine (Edurant)
  • Ketorolac (Sprix)

Sometimes other interactions occur which are not recommended, but may be tolerable if both drugs are deemed absolutely necessary. In these instances, your doctor may adjust your dosages, change the frequency at which you take your medicines, or tell you to take some medicines a certain number of hours before or after naproxen and esomeprazole. It is very important that you follow your doctor's instructions closely to minimize the risk of harmful complications or side effects. If you have very many medicines to take, you could ask your doctor to help you create a dosing schedule to ensure you take the correct medicines at the correct times.

Cranberry and cranberry juice may increase the risk of certain side effects when consumed at the same time as naproxen and esomeprazole. Discuss potential risks with your doctor.

Warnings

Risk to heart and blood vessel health

Naproxen and esomeprazole increases the risk of harmful effects to the heart and blood vessels, such as heart attack or stroke, both or which can be deadly. These risks are heightened in patients with heart disease and those who are already at high risk of heart disease, for example those with a family history of the condition or those who smoke tobacco.

The risk of heart attack, stroke, or other heart and blood vessel problems is highest during the first few weeks of using naproxen and esomeprazole. During this time, your doctor may monitor you closely. Risks are also higher in patients who take higher doses of the medicine or take it for very long periods of time.

If you notice chest pain, unusual heartbeat or pulse, pain in the arm or jaw, breathing problems, slurred speech, weakness on one side of the body, or unusual sweating, seek emergency medical attention.

It is very important that you do not take naproxen and esomeprazole just before or after heart bypass surgery. Be sure to discuss all of your medicines with your surgeon or doctor if surgery is a possibility.

Risk of stomach or bowel problems

NSAIDs like naproxen can cause very severe stomach or bowel problems, such as ulcers or bleeding, sometimes very suddenly and without warning. This risk is heightened in elderly patients, and in those who have had stomach or bowel ulcers or bleeding in the past. Esomeprazole can help to reduce the risks of these problems. However, you should still discuss potential risks with your doctor, and you should learn about the warning signs of bowel or stomach ulcers or bleeding so that you can recognize the need for urgent medical attention.

Risk of fractures in patients with osteoporosis

Naproxen and esomeprazole may increase the risk of fractures, particularly of the wrists, hip, and spine, in patients with osteoporosis (weak bones). The risks are particularly high in patients aged 50 years or more, and in those who take the drug in high doses or for periods of longer than a year. Discuss potential risks with your doctor. Your doctor may prescribe vitamin D or calcium supplements to help improve bone strength.

Vitamin or mineral deficiencies

Long term use of naproxen and esomeprazole can in rare instances result in magnesium deficiency. This risk is heightened if patients also use digoxin or certain diuretics at the same time. You can expect your doctor to request regular blood tests if you have been taking naproxen and esomeprazole for more than a year.

Naproxen and esomeprazole may also make it harder for the body to absorb vitamin B12, which may result in a deficiency. However, B12 deficiency is only likely if the drug has been used for 3 years or more.

Interactions with other side effects

Some medical conditions may interact with naproxen and esomeprazole and cause harmful effects. It is very important to tell your doctor about all the medical conditions you currently suffer from, as well as those you have suffered from in the past.

The following conditions may be worsened by naproxen and esomeprazole:

  • Congestive heart failure
  • Heart attack, recent or history of
  • Stroke, or history of
  • Heart or blood vessel disease
  • Hypertension (high blood pressure)
  • Bleeding problems, such as hemophilia
  • Anemia
  • Hypomagnesemia (low blood magnesium levels), or history of
  • Edema (fluid retention)
  • Kidney disease
  • Liver disease
  • Systemic lupus erythematosus (SLE)
  • Stomach ulcers or bleeding, or history of
  • Ulcerative colitis, or history of
  • Osteoporosis (weak bones)

Patients with the following conditions should not take naproxen and esomeprazole:

  • Aspirin sensitivity, or history of
  • Aspirin-sensitive asthma

Naproxen and esomeprazole should not be used to relieve pain either just before or just after heart surgery, such as coronary artery bypass graft (CABG).

Smoking

Since naproxen and esomeprazole can increase the risk of heart attack and stroke, patients are advised to avoid smoking while taking the medicine in order to reduce these risks. If you think you may struggle to quit smoking, ask your doctor for advice.

Allergies

Naproxen and esomeprazole can cause anaphylaxis, which is a very severe and dangerous allergic reaction. Tell your doctor if you have had an allergic reaction to naproxen or esomeprazole in the past, or to other NSAIDs or aspirin. You should also mention all other allergies you suffer from, including drug, chemical, dye, food, and animal allergies, so that your doctor can check if you are allergic to any of the ingredients in naproxen and esomeprazole tablets.

Seek immediate medical attention if you have any of the following signs of allergy:

  • Rash, hives, or itching
  • Cough
  • Wheezing
  • Shortness of breath
  • Swelling of face, lips, tongue, or throat

Keep all appointments

Since naproxen and esomeprazole poses risks of very serious health problems, your doctor will want to monitor your health very closely throughout treatment with the drug. They may regularly request blood, urine, and other laboratory tests to check for unwanted effects. They will also want to see you periodically to assess how well the drug is working. If the drug does not appear to be helping symptoms adequately enough and the risks of the medicine outweigh its benefits, your doctor may discontinue use.

Fertility, pregnancy, and breastfeeding

NSAIDs such as naproxen and esomeprazole may affect ovulation in women, which might make it harder to get pregnant. These effects dissipate once the drug is stopped. If you want to become pregnant while taking naproxen and esomeprazole, speak to your doctor.

The use of NSAIDs during the third trimester of pregnancy can be very harmful to the fetus. Use of the drug is not recommended after 30 weeks of gestation. Tell your doctor if there is a chance you are pregnant before taking the drug, and if you become pregnant while taking it, consult your doctor immediately.

There are few appropriate studies to assess potential effects of naproxen and esomeprazole on nursing infants when it is taken by women who are breastfeeding. However, it is thought that NSAIDs like naproxen may be harmful. For this reason, patients are advised to either avoid naproxen and esomeprazole, or discontinue breastfeeding. Discuss the benefits and risks of the drug with your doctor in order to come to a decision.

Pediatric use

Naproxen and esomeprazole appears to be a safe and effective treatment for juvenile arthritis in pediatric patients aged 12 years and over who also weigh over 38 kg (84 pounds). However, the safety and efficacy of the drug in younger children has not been established.

Geriatric use

Naproxen and esomeprazole appears to be just as effective in elderly patients as it is in younger patients. However, elderly patients are more likely to have age-related kidney, heart or blood vessel, and stomach or bowel problems, which may put them at a higher risk of serious side effects. Doctors may administer lower doses initially, and they may want to administer more tests before prescribing the drug to assess patient health. Closer monitoring of the patient, particularly during the first few weeks of treatment, may also be necessary.

Storage

Naproxen and esomeprazole should be stored in the container it was provided to you in with the lid tightly closed at all times. Keep the medicine at room temperature, do not allow it to freeze, and do not expose it to direct light, heat, or moisture. Do not store the medicine in the bathroom.

Always keep naproxen and esomeprazole out of sight and reach of children. The lid of the medicine container should be tightly closed at all times when not in use. The drug may be extremely harmful to those it has not been prescribed to, but particularly children. Keep the medicine away from pets.

If you have leftover or expired naproxen and esomeprazole, ask your healthcare provider how to dispose of it. Do not simply throw it in the trash or flush it down the toilet, as it may come to harm other people or the environment. There may be a local medicine take-back program you could use. These are often offered by healthcare providers, pharmacies, or local garbage or recycling departments.

Summary

Naproxen and esomeprazole is a combination medicine used to relieve the symptoms of ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, and juvenile arthritis in patients who are also at high risk of stomach or bowel ulcers or bleeding. Naproxen is a NSAID and works to reduce the body's inflammatory responses, but it can cause stomach or bowel ulcers or bleeding. Esomeprazole works to reduce excess stomach acid which is responsible for stomach ulcers.

Patients may notice mild stomach upset, gas, and bloating, changes to taste, mild fever or headache, and body aches and pains while taking naproxen and esomeprazole. These side effects are minor and only require medical attention if they become very severe or persistent. If patients notice severe burning sensations in the stomach or chest, abdominal pain, vomiting of blood or bloody stools or urine, seizures or muscle spasms, breathing problems or changes to heartbeat, they should seek urgent medical attention.

NSAIDs like naproxen can increase the risk of serious heart and blood vessel problems and may cause stroke or heart attack. These risks are heightened in those with heart disease or a history or heart problems, heart attack, or stroke. The risk of these complications arising is highest in the first few weeks of treatment. The drug should not be used just before or right after heart surgery. Patients should tell their doctor about all medicines that they take, but particularly other NSAIDs, salicylates like aspirin, and rilpivirine and ketolorac.

Naproxen and esomeprazole is suitable for children over the age of 12 years and appears to be an effective treatment for juvenile arthritis. It can be an effective treatment in elderly patients, but this age group may be at a heightened risk of stomach or bowel ulcers or bleeding due to their age. The drug is not recommended for use during pregnancy, particularly during the third trimester, due to risk of harmful effects on the fetus. It is also not recommended for use while breastfeeding.

People who have had an allergic reaction to naproxen, esomeprazole, aspirin, or other NSAIDs in the past should not take naproxen and esomeprazole tablets. The medicine can cause anaphylaxis, which is a very severe allergic reaction. If signs of allergy are noticed, such as wheezing, shortness of breath swelling or face or tongue, or skin rash, hives or itching, occur, patients should seek emergency medical attention.

The amount of naproxen and esomeprazole a patient takes will vary depending on their medical history. On average, patients take one tablet, twice each day. The medicine should be taken on an empty stomach around 30 minutes before a meal. The tablets should be swallowed whole with water. Sometimes vitamin D or calcium supplements may be prescribed at the same time.