Mylan-Naproxen/Esomeprazole MR

How does this medication work? What will it do for me?

This is a combination medication that contains esomeprazole and naproxen. Esomeprazole belongs to the class of medications called proton pump inhibitors and naproxen belongs to the class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

This combination medication is used to treat signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (long-term inflammation disease of the joints), and to decrease the risk of developing stomach ulcers for people at risk due to NSAIDs.

Esomeprazole works by reducing the amount of acid that the stomach produces.

Naproxen relieves pain and reduces swelling and inflammation by reducing a substance in the body that leads to inflammation and pain. If immediate relief of pain is desired, esomeprazole - naproxen should not be used as it releases medication over a longer period of time.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended daily dose of esomeprazole - naproxen is one 375/20 mg tablet twice daily or one 500/20 mg tablet twice daily. The lowest dose possible for the shortest time period to control the pain should be used.

Esomeprazole - naproxen should be taken at least 30 minutes before meals. You should swallow the esomeprazole - naproxen tablet whole with water. It should not be split, chewed, or crushed.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

What form(s) does this medication come in?

375 mg/20 mg
Each yellow, oval, film-coated biconvex tablet imprinted with "NE3" in black ink on one side of the tablet and plain on the other side, contains 375 mg of naproxen and 20 mg of esomeprazole. Nonmedicinal ingredients: ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, di- acetylated monoglycerides, glyceryl stearate, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polysorbate 80, povidone, polyethylene glycol, propylene glycol, shellac glaze, sodium carbonate anhydrous, titanium dioxide, and triethyl citrate.

500 mg / 20 mg
Each yellow film-coated, oval, biconvex tablet imprinted with "NE4" in black ink on one side of the tablet and plain on the other side, contains 500 mg of naproxen and 20 mg of esomeprazole. Nonmedicinal ingredients: ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, di- acetylated monoglycerides, glyceryl stearate, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polysorbate 80, povidone, polyethylene glycol, propylene glycol, shellac glaze, sodium carbonate anhydrous, titanium dioxide, and triethyl citrate.

How should I use this medication?

The recommended daily dose of esomeprazole - naproxen is one 375/20 mg tablet twice daily or one 500/20 mg tablet twice daily. The lowest dose possible for the shortest time period to control the pain should be used.

Esomeprazole - naproxen should be taken at least 30 minutes before meals. You should swallow the esomeprazole - naproxen tablet whole with water. It should not be split, chewed, or crushed.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to naproxen, esomeprazole, or any ingredients of this medication
• are 18 years of age or younger
• are breast-feeding
• are in the third trimester (last 3 months) of pregnancy
• are taking the medication rilpivirine
• have a bleeding disorder including bleeding in the brain
• have an active ulcer or bleeding in the stomach or intestines
• have a history of asthma or allergic-type reactions after taking ASA or other NSAIDs (i.e., complete or partial syndrome of ASA-intolerance-rhinosinusitis, hives, swelling of the skin, or sac-like growths of the inflamed nose tissue)
• have high blood potassium
• have inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
• have scheduled heart bypass surgery or have recently had this surgery
• have severe kidney disease
• have severe untreated heart failure
• have severely impaired liver function or active liver disease

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• burning or discomfort of the stomach
• diarrhea
• difficulty sleeping
• drowsiness
• dry mouth
• headache
• impaired sense of taste
• increased sensitivity to sunlight
• nausea
• upset stomach

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• confusion
• decreased consciousness
• dizziness or lightheadedness
• hallucinations (seeing or hearing things that aren't there)
• hearing problems
• increased frequency of infections
• inflammation of airways (bronchitis)
• inflammation in the mouth, or irritation of the tube that leads from the back of the mouth to the stomach
• loss of appetite
• malaise or fatigue
• muscular weakness or pain
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, pain or difficulty urinating)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of meningitis not caused by infection (e.g., severe, throbbing headache or with stiff neck or back)
• skin rash, itching, or hives
• spinning sensation
• swelling of the feet and lower legs, or weight gain
• symptoms of low levels of magnesium in the blood (e.g., abdominal eye movements, muscle spasms or cramps, muscle weakness, numbness, or fatigue)
• vomiting or persistent indigestion, nausea, stomach pain, or diarrhea

Stop taking the medication and seek immediate medical attention if any of the following occur:

• asthma symptoms (e.g., shortness of breath, wheezing, chest tightness)
• blurred vision or any other vision problems
• chills, fever, muscle aches or pains, or flu-like symptoms, especially if they occur before or together with a rash
• hearing problems
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of bleeding in the stomach (e.g., bloody, black, or  tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• symptoms of subacute cutaneous lupus erythematosus (SCLE; e.g., new or worsening joint pain, rash on skin exposed to sunlight)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Allergy: Some people who are allergic to other anti-inflammatory medications also experience allergic reactions to naproxen. Before you take naproxen, inform your doctor about any previous adverse reactions you have had to medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Bleeding: Naproxen affects how the platelets in the blood stick together to stop bleeding. You may find that it is harder to stop cuts from bleeding or you bruise more easily. This can be made worse if you take other medications that affect blood clotting. Talk to your doctor or pharmacist if you take medications to prevent blood clots or if you experience unusual bruising or bleeding.

Breathing problems: People who have asthma, long-term breathing problems, or allergic conditions such as hay fever or nasal polyps are more likely to experience difficulty breathing and allergic reactions caused by NSAIDs. If you have a history of allergic reactions to other substances, or respiratory illness, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Blood tests: If you are taking esomeprazole - naproxen for a long time, you should get a blood test done to make sure that different blood components and enzymes are in the normal range (e.g., hemoglobin, hematocrit, red blood cells, white blood cells, magnesium, sodium, potassium, etc.).

Diarrhea: When gastric acid is decreased, the number of bacteria normally in the digestive system increases. Occasionally, this can cause serious infection in the digestive tract. If you experience severe watery or bloody diarrhea, fever, or abdominal pain while taking esomeprazole, contact your doctor as soon as possible.

Dizziness: While taking esomeprazole - naproxen, use caution while driving and carrying out activities that require you to be alert. If you are feeling dizzy, drowsy, or lightheaded, you should not drive or operate machinery.

Eye problems: If you experience blurred and/or diminished vision while taking esomeprazole - naproxen, you should stop taking this medication and get an eye exam. Your doctor may recommend that you have regular eye exams if you take esomeprazole - naproxen for long periods of time.

Fertility: As with other NSAIDs, this medication may make it more difficult for a couple to conceive if the woman is taking naproxen. Stopping the medication allows the body's chemistry to return to normal which often resolves this issue. Women who are trying to conceive, having difficulty conceiving, or are being tested to see if they are infertile should avoid using esomeprazole - naproxen.

Fluid retention: Use of naproxen can cause fluid retention and swelling. This can lead to high blood pressure and worsening of heart failure. People who are taking esomeprazole - naproxen for a long time should have their blood pressure checked regularly. In addition, if you have heart failure, decreased heart function, blood pressure, increased age, or another condition that puts you at risk of fluid retention, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect dosing and effectiveness of this medication, and whether any special monitoring is needed.

Gastrointestinal: As with other NSAIDs, naproxen can increase the risk of ulcers, bleeding, perforation, and obstruction in the digestive system. Esomeprazole helps to prevent these complications, but they can still occur. If you have a history of stomach or intestinal ulcer or gastrointestinal bleeding, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect dosing and effectiveness of this medication, and whether any special monitoring is needed. If you notice symptoms of stomach or intestinal ulcers or bleeding (such as black tarry stools, vomiting blood or material that looks like coffee grounds, or coughing up blood), stop taking the medication and seek medical attention immediately.

Heart attack and stroke: This medication is associated with an increased risk of heart attack or stroke. The risk is increased with higher total daily doses and taking the medication over a long period of time. If you have a history of heart disease (e.g., heart attack, stroke, heart failure, blood vessel disorders) or have risk factors for heart disease (e.g., high blood pressure, high cholesterol, diabetes, smoking, kidney disease), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication should not be taken by people who have recently had or are planning to have open heart (bypass) surgery.

High blood potassium: There is a risk of high blood potassium when taking naproxen. The people who are most at risk are seniors; people who have diabetes or kidney failure; and people taking beta-adrenergic blockers (e.g., metoprolol, atenolol), angiotensin converting enzyme (ACE) inhibitors (e.g., ramipril, enalapril), or some diuretics (e.g., triamterene, amiloride). People with high blood potassium levels should not take this medication.

Kidney function: If you have mild-to-moderate kidney impairment, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Long-term use of NSAIDs can cause decreased kidney function. If you notice any changes in kidney function, such as decreased urine production or increased fluid retention contact your doctor.

Liver function: If you have mild-to-moderate liver impairment, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Osteoporosis fractures: Long-term use of esomeprazole may be related to an increased risk of bone fractures in the hip, wrist, or spine, as a result of weakened bones. This risk is further increased if you are already at risk of developing osteoporosis. If you have osteoporosis or have risk factors for developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Other anti-inflammatory medications: Esomeprazole - naproxen should not be used with other anti-inflammatory medications including naproxen. However, low doses of ASA may be used to prevent heart disease or blood vessel problems.

Sun sensitivity: Esomeprazole - naproxen may make you more sensitive to sunlight. Any exposure to sunlight may cause sunburn, skin blisters, skin rash, redness, itching, or discoloration. You should limit your exposure to sunlight, tanning booths, and sun lamps. You should also use a sunscreen with at least SPF 30. In addition, if you are taking esomeprazole - naproxen and are in the sun, make sure to cover up (wear sunscreen, long sleeves, and a hat).

Urinary problems: Esomeprazole - naproxen may cause problems such as bladder pain, painful urination, frequent urination, blood in the urine, and irritation of the bladder. If you experience any urinary symptoms, stop taking this medication and consult with your health care provider.

Vitamin B12: Long-term use of esomeprazole may lead to Vitamin B12 deficiency. If you are a vegetarian or have low Vitamin B12 levels, discuss with your doctor whether any special monitoring is required.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Use of naproxen during pregnancy may increase the risk of kidney damage in the developing baby. Naproxen should not be used during the last 3 months of pregnancy, as there is an increased risk of the child developing heart problems and of the mother having a longer labour. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if naproxen or esomeprazole pass into breast milk. Due to the potential for harm to a baby if they are exposed to this medication, breast-feeding must be stopped before starting this medication.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors appear to have a higher risk of side effects with this medication. The lowest effective dosage should be used under close medical supervision.

What other drugs could interact with this medication?

There may be an interaction between esomeprazole - naproxen and any of the following:

• 5-ASA medications (e.g., mesalamine, olsalazine, sulfasalazine)
• acetylsalicylic acid (ASA)
• alcohol
• aliskiren
• alpha-agonists (e.g., clonidine, methyldopa)
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• apalutamide
• apixaban
• "azole" antifungal medications (e.g., itraconazole, ketoconazole, voriconazole)
• antacids
• birth control pills
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• bimatoprost
• bisphosphonates (e.g., alendronate, etidronate, risedronate)
• bosutinib
• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
• capecitabine
• carbamazepine
• celecoxib
• cholestyramine
• clobazam
• clarithromycin
• clopidogrel
• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclosporine
• dabigatran
• deferasirox
• desmopressin
• dexmethylphenidate
• diazepam
• digoxin
• dipyridamole
• diuretics (water pills e.g., hydrochlorothiazide, furosemide, triamterene)
• edoxaban
• enzalutamide
• eplerenone
• glucosamine
• haloperidol
• heparin
• herbal medications that affect blood clotting (e.g., ginkgo biloba, garlic, ginger, ginseng, glucosamine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)
• hydralazine
• ifosfamide
• imipramine
• latanoprost
• ledipasvir
• lithium
• low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• lumacaftor and ivacaftor
• metformin
• methotrexate
• multivitamins/minerals with vitamin A and vitamin E
• mycophenolate
• other nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, diclofenac, ketorolac, naproxen)
• omega-3 fatty acids
• obinutuzumab
• octreotide
• pasireotide
• pentoxifylline
• phenytoin
• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
• riociguat
• rifampin
• rilpivirine
• rivaroxaban
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• sodium phosphates
• sucralfate
• sulfonamides (e.g., sulfamethoxazole)
• sulfonylureas (e.g., glyburide)
• tacrolimus
• tenofovir
• ticagrelor
• ticlopidine
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• certain tyrosine kinase inhibitors (e.g., bosutinib, dabrafenib, dasatinib, erlotinib, pazopanib)
• vaccines
• velpatasvir
• vitamin E
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Mylan-NaproxenEsomeprazole-MR