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Naproxen and esomeprazole (Oral route)

Pronunciation:

na-PROX-en, es-oh-MEP-ra-zole mag-NEE-zee-um

Brand Names:

  • Vimovo

Dosage Forms:

  • Tablet, Delayed Release

Warnings:

Oral route(Tablet, Delayed Release)

Esomeprazole magnesium/naproxen may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. Esomeprazole magnesium/naproxen contains an NSAID. NSAID-containing products can also cause an increased risk of serious and potentially fatal gastrointestinal adverse events (eg, bleeding, ulceration, and perforation of the stomach or intestines), especially in the elderly .

Classifications:

Therapeutic—

Antirheumatic

Pharmacologic—

NSAID

Chemical—

Propionic Acid (class)

Uses of This Medicine:

Naproxen and esomeprazole combination is used to relieve the symptoms of ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis. It is used for patients who have an increased risk for stomach ulcers and who need to take a nonsteroidal anti-inflammatory drug (NSAID) for arthritis or ankylosing spondylitis.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain, inflammation, swelling, stiffness, and joint pain. Esomeprazole is a proton pump inhibitor (PPI) that is used to treat certain conditions where too much acid is produced in the stomach (e.g., duodenal and gastric ulcers).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of naproxen and esomeprazole combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naproxen and esomeprazole combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy—

Pregnancy CategoryExplanation
1st TrimesterCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd TrimesterCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd TrimesterDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Ketorolac
  • Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Atazanavir
  • Beta Glucan
  • Bivalirudin
  • Bosutinib
  • Certoparin
  • Cilostazol
  • Citalopram
  • Clopidogrel
  • Clovoxamine
  • Cyclosporine
  • Dabigatran Etexilate
  • Dabrafenib
  • Dalteparin
  • Danaparoid
  • Dasatinib
  • Desirudin
  • Dipyridamole
  • Duloxetine
  • Enoxaparin
  • Eptifibatide
  • Erlotinib
  • Escitalopram
  • Eslicarbazepine Acetate
  • Femoxetine
  • Feverfew
  • Flesinoxan
  • Fluoxetine
  • Fondaparinux
  • Ginkgo
  • Gossypol
  • Heparin
  • Ketoconazole
  • Lepirudin
  • Levomilnacipran
  • Meadowsweet
  • Methotrexate
  • Milnacipran
  • Mycophenolate Mofetil
  • Nadroparin
  • Nefazodone
  • Nelfinavir
  • Nilotinib
  • Parnaparin
  • Paroxetine
  • Pazopanib
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Pixantrone
  • Ponatinib
  • Posaconazole
  • Pralatrexate
  • Prasugrel
  • Protein C
  • Reviparin
  • Rivaroxaban
  • Saquinavir
  • Sibutramine
  • Tacrolimus
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Venlafaxine
  • Vilazodone
  • Vismodegib
  • Vortioxetine
  • Warfarin
  • Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Acetohexamide
  • Alacepril
  • Alprenolol
  • Amiloride
  • Amlodipine
  • Arotinolol
  • Atenolol
  • Azilsartan Medoxomil
  • Azosemide
  • Befunolol
  • Bemetizide
  • Benazepril
  • Bendroflumethiazide
  • Benzthiazide
  • Bepridil
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Bucindolol
  • Bumetanide
  • Bupranolol
  • Buthiazide
  • Candesartan Cilexetil
  • Canrenoate
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Chlorothiazide
  • Chlorpropamide
  • Chlorthalidone
  • Cilazapril
  • Clopamide
  • Cranberry
  • Cyclopenthiazide
  • Delapril
  • Desvenlafaxine
  • Dilevalol
  • Diltiazem
  • Enalaprilat
  • Enalapril Maleate
  • Eprosartan
  • Esmolol
  • Ethacrynic Acid
  • Felodipine
  • Flunarizine
  • Fosinopril
  • Furosemide
  • Gallopamil
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Imidapril
  • Indapamide
  • Irbesartan
  • Isradipine
  • Labetalol
  • Lacidipine
  • Landiolol
  • Levobetaxolol
  • Levobunolol
  • Lidoflazine
  • Lisinopril
  • Lithium
  • Losartan
  • Manidipine
  • Mepindolol
  • Methyclothiazide
  • Metipranolol
  • Metolazone
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Nicardipine
  • Nifedipine
  • Nilvadipine
  • Nimodipine
  • Nipradilol
  • Nisoldipine
  • Nitrendipine
  • Olmesartan Medoxomil
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Pindolol
  • Piretanide
  • Polythiazide
  • Pranidipine
  • Propranolol
  • Quinapril
  • Ramipril
  • Risedronate
  • Sotalol
  • Spirapril
  • Spironolactone
  • Talinolol
  • Tasosartan
  • Telmisartan
  • Temocapril
  • Tertatolol
  • Timolol
  • Tolazamide
  • Tolbutamide
  • Torsemide
  • Trandolapril
  • Triamterene
  • Trichlormethiazide
  • Valsartan
  • Verapamil
  • Warfarin
  • Xipamide
  • Zofenopril

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia or
  • Bleeding problems or
  • Congestive heart failure or
  • Crohn's disease, history of or
  • Diarrhea or
  • Edema (fluid retention or swelling) or
  • Heart attack, history of or
  • Heart or blood vessel disease or
  • Hypertension (high blood pressure) or
  • Hypomagnesemia (low magnesium in the blood), history of or
  • Kidney disease or
  • Liver disease or
  • Osteoporosis (weak bones) or
  • Stomach ulcers or bleeding, history of or
  • Stroke, history of or
  • Ulcerative colitis, history of—Use with caution. May make these conditions worse.
  • Aspirin-sensitive asthma or
  • Aspirin sensitivity, history of—Should not be used in patients with these conditions.
  • Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Proper Use of This Medicine:

Use this medicine exactly as ordered by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take this medicine on an empty stomach about 30 minutes before a meal.

Swallow the delayed-release tablet whole with water. Do not break, crush, chew, or dissolve it.

Your doctor may tell you to take vitamin D and calcium supplements while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (delayed-release tablets):
    • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
      • Adults—One tablet two times per day.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects.

Naproxen may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

Naproxen may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner).

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or eyes.

This medicine may cause hypomagnesemia (low magnesium in the blood). Your doctor may want to check your blood levels if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Stop using this medicine and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness.

Check with your doctor right away if you have watery stool that does not go away, stomach pain, and fever while taking this medicine.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop the medicine for a while, or to change to a different medicine before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Burning feeling in the chest or stomach
indigestion
loss of appetite
nausea
stomach bloating, cramping, or pain
tenderness in the stomach area
upper abdominal or stomach pain
upset stomach
vomiting
weight loss
Less common
Abdominal or stomach discomfort
black, tarry stools
bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
bloody stools
chest pain
difficult, burning, or painful urination
difficulty with moving
difficulty with swallowing
frequent urge to urinate
full or bloated feeling
heartburn
lower back or side pain
muscle pain or stiffness
pain in the joints
pain or burning in the throat
pressure in the stomach
rapid weight gain
sores, ulcers, or white spots on the lips or tongue or inside the mouth
swelling of the abdominal or stomach area
tingling of the hands or feet
unusual weight gain or loss
vomiting of blood or material that looks like coffee grounds
Incidence not known
Drowsiness
mood or mental changes
muscle spasms (tetany) or twitching
seizures
trembling
unusual tiredness or weakness
vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Acid or sour stomach
belching
diarrhea
Less common
Body aches or pain
change in taste
chills
cough
cough producing mucus
difficulty having a bowel movement (stool)
difficulty with breathing
ear congestion
excess air or gas in the stomach or intestines
fever
headache
loss of taste
loss of voice
pain or tenderness around the eyes and cheekbones
passing gas
shortness of breath or troubled breathing
sneezing
sore throat
stuffy or runny nose
tightness of the chest or wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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


Last Updated: 4/4/2014

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