esomeprazole delayed-release tablets
Generic Name: naproxen/esomeprazole (na-PROX-en/ES-oh-MEP-ra-zole)
Brand Name: Vimovo
Naproxen/esomeprazole delayed-release tablets contains a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, a heart attack, stroke). The risk may be greater if you already have heart problems or if you take naproxen/esomeprazole delayed-release tablets for a long time. Do not use naproxen/esomeprazole delayed-release tablets right before or after bypass heart surgery.
Naproxen/esomeprazole delayed-release tablets may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
Naproxen/esomeprazole delayed-release tablets is used for:
Treating rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis in certain patients at risk of developing stomach ulcers when using NSAIDs. It may also be used for other conditions as determined by your doctor.
Naproxen/esomeprazole delayed-release tablets is an NSAID and a proton pump inhibitor (PPI) combination. Exactly how the NSAID works is not known. It may block certain substances in the body that are linked to inflammation and pain. NSAIDs treat symptoms of pain and inflammation. The PPI works by decreasing the amount of acid produced in the stomach. This decreases the risk of developing an ulcer from using an NSAID.
Do NOT use naproxen/esomeprazole delayed-release tablets if:
- you are allergic to any ingredient in naproxen/esomeprazole delayed-release tablets or to other PPIs (eg, lansoprazole, omeprazole)
- you have had an asthma attack or a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, nasal swelling, dizziness) to aspirin or another NSAID (eg, ibuprofen, celecoxib)
- you have recently had or will be having bypass heart surgery
- you have severe liver problems; severe kidney problems; certain stomach or bowel problems (eg, an active ulcer or bleeding, inflammatory bowel disease); high blood potassium levels; or severe, uncontrolled heart failure
- you have bleeding in the brain
- you are in the last 3 months of pregnancy
- you are taking another medicine that contains naproxen
- you are taking atazanavir, clopidogrel, dasatinib, nelfinavir, another NSAID (eg, ibuprofen, oxaprozin), rifampin, rilpivirine, or St. John's wort
Contact your doctor or health care provider right away if any of these apply to you.
Before using naproxen/esomeprazole delayed-release tablets:
Some medical conditions may interact with naproxen/esomeprazole delayed-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney or liver problems, diabetes, Helicobacter pylori infection, or stomach or bowel problems (eg, bleeding, perforation, ulcers, ulcerative colitis, Crohn disease)
- if you have a history of swelling or fluid buildup, an autoimmune disorder (eg, lupus), asthma, growths in the nose (nasal polyps), or mouth inflammation
- if you have a history of high blood pressure, blood disorders, high blood cholesterol or lipid levels, bleeding or clotting problems, bleeding in the brain, heart problems (eg, heart failure), blood vessel disease, or stroke, or if you are at risk of any of these diseases
- if you have poor health; dehydration or low fluid volume; blood electrolyte problems (eg, low blood sodium or magnesium levels, high blood potassium levels); are on a low-salt (sodium) diet; or use tobacco, drink alcohol, or have a history of alcohol abuse
- if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)
Some MEDICINES MAY INTERACT with naproxen/esomeprazole delayed-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for aches and pains, arthritis, blood thinning, cancer, circulation problems, clotting problems, depression or other mental or mood problems, diabetes, fluid retention or swelling, gout, high blood pressure, high cholesterol, HIV infection, immune system suppression, infections, inflammation, iron supplementation, irregular heartbeat or other heart problems, osteoporosis or weak bones, seizures) multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with naproxen/esomeprazole delayed-release tablets. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with naproxen/esomeprazole delayed-release tablets.
This may not be a complete list of all interactions that may occur. Ask your health care provider if naproxen/esomeprazole delayed-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use naproxen/esomeprazole delayed-release tablets:
Use naproxen/esomeprazole delayed-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Naproxen/esomeprazole delayed-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get naproxen/esomeprazole delayed-release tablets refilled.
- Take naproxen/esomeprazole delayed-release tablets by mouth at least 30 minutes before a meal unless your doctor tells you otherwise. Talk with your doctor or pharmacist if you have persistent stomach upset.
- Take naproxen/esomeprazole delayed-release tablets with a full glass of water (8 oz [240 mL]).
- Swallow naproxen/esomeprazole delayed-release tablets whole. Do not break, crush, chew, or dissolve before swallowing. Tell your doctor if you cannot swallow tablets whole. You may need a different medicine.
- If you also take antacids or cholestyramine, ask your doctor or pharmacist how to take them with naproxen/esomeprazole delayed-release tablets.
- Continue to take naproxen/esomeprazole delayed-release tablets even if you feel well. Do not miss any doses.
- If you miss a dose of naproxen/esomeprazole delayed-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use naproxen/esomeprazole delayed-release tablets.
Important safety information:
- Naproxen/esomeprazole delayed-release tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use naproxen/esomeprazole delayed-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Serious stomach ulcers or bleeding can occur with the use of an NSAID. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking naproxen/esomeprazole delayed-release tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
- Do NOT change your dose, stop taking naproxen/esomeprazole delayed-release tablets, or take naproxen/esomeprazole delayed-release tablets for longer than prescribed without checking with your doctor.
- Naproxen/esomeprazole delayed-release tablets may increase the risk of a serious form of diarrhea. Contact your doctor right away if stomach pain or cramps, severe or persistent diarrhea, or bloody or watery stools occur. Discuss any questions or concerns with your doctor.
- Naproxen/esomeprazole delayed-release tablets may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use naproxen/esomeprazole delayed-release tablets in high doses, for long periods of time, or if you are older than 50 years old. Contact your doctor if you have any questions about this information.
- Naproxen/esomeprazole delayed-release tablets contains a PPI. Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking naproxen/esomeprazole delayed-release tablets for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).
- Check with your doctor to see whether you should take a calcium and vitamin D supplement while you take naproxen/esomeprazole delayed-release tablets.
- Tell your doctor or dentist that you take naproxen/esomeprazole delayed-release tablets before you receive any medical or dental care, emergency care, or surgery.
- Naproxen/esomeprazole delayed-release tablets has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do not take aspirin while you are using naproxen/esomeprazole delayed-release tablets unless your doctor tells you to.
- Naproxen/esomeprazole delayed-release tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take naproxen/esomeprazole delayed-release tablets.
- Lab tests, including liver and kidney function, complete blood cell counts, eye exams, and blood pressure, may be performed while you use naproxen/esomeprazole delayed-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use naproxen/esomeprazole delayed-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding; kidney problems; or hip, wrist, and spine fractures.
- Naproxen/esomeprazole delayed-release tablets should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Naproxen/esomeprazole delayed-release tablets may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking naproxen/esomeprazole delayed-release tablets while you are pregnant. Naproxen/esomeprazole delayed-release tablets is found in breast milk. Do not breast-feed while taking naproxen/esomeprazole delayed-release tablets.
Possible side effects of naproxen/esomeprazole delayed-release tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; dizziness; drowsiness; gas; heartburn; mild diarrhea or stomach pain; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; wheezing); bloody, watery, or black, tarry stools; bone pain; chest, jaw, or arm pain; confusion; decreased consciousness; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, depression); one-sided weakness; red, swollen, blistered, or peeling skin (with or without fever); ringing in the ears or hearing changes; seizures; sensitivity to the sun; severe or persistent headache or dizziness; severe or persistent heartburn, stomach pain, diarrhea, nausea, or vomiting; shortness of breath; slurred speech; stiff neck; stomach cramps; sudden or unexplained weight gain; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); tremors; trouble swallowing; unexplained weight loss; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; urination problems (eg, decreased, difficult, or painful urination); vision or hearing changes; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; confusion; decreased coordination; decreased urination; fast heartbeat; flushing; heartburn; loss of consciousness; seizures; severe heartburn, nausea, or stomach pain; severe or persistent dizziness, drowsiness, or headache; slow or difficult breathing; sluggishness; uncontrolled movements; unusual bleeding or bruising; unusual sweating; unusual tiredness or weakness; vision changes; vomiting that may or may not look like coffee grounds.Proper storage of naproxen/esomeprazole delayed-release tablets:
Store naproxen/esomeprazole delayed-release tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in the original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep naproxen/esomeprazole delayed-release tablets out of the reach of children and away from pets.
- If you have any questions about naproxen/esomeprazole delayed-release tablets, please talk with your doctor, pharmacist, or other health care provider.
- Naproxen/esomeprazole delayed-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take naproxen/esomeprazole delayed-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about naproxen/esomeprazole delayed-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to naproxen/esomeprazole delayed-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using naproxen/esomeprazole delayed-release tablets.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.