Naproxen and esomeprazole

Generic name: Naproxen And Esomeprazole
Drug class: Nonsteroidal anti-inflammatory drugs

Usage of Naproxen and esomeprazole

Naproxen and esomeprazole combination is used to relieve the symptoms of ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis in adults and juvenile idiopathic arthritis (JIA) in children. 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 (eg, duodenal and gastric ulcers).

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

Naproxen and esomeprazole side effects

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

Blistering, peeling, or reddening of the skin

burning feeling in the chest or stomach

indigestion

loss of appetite

nausea

stomach bloating, cramping, pain, tenderness, or upset

upper abdominal or stomach pain

vomiting

weight loss

Less common

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

stomach discomfort or swelling

tingling of the hands or feet

trouble breathing

unusual weight gain or loss

vomiting of blood or material that looks like coffee grounds

Incidence not known

Chills

confusion

cough

drowsiness

dry mouth

fever

mood or mental changes

muscle cramps, spasms (tetany), or twitching

numbness and tingling around the mouth, fingertips, or feet

seizures

sore throat

stomach cramps

swollen glands

trembling

unusual bleeding or bruising

unusual tiredness or weakness

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

Belching

diarrhea

Less common

Body aches or pain

change in taste

cough producing mucus

difficulty having a bowel movement

ear congestion

excess air or gas in the stomach or bowels

fever

increased sensitivity of the skin to sunlight

loss of taste

loss of voice

loss or thinning of the hair

pain or tenderness around the eyes and cheekbones

passing gas

severe sunburn

sneezing

stuffy or runny nose

Incidence not known

Decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

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.

Before taking Naproxen and esomeprazole

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of naproxen and esomeprazole combination to treat juvenile idiopathic arthritis in children younger than 12 years of age and weighing less than 38 kilograms. Safety and efficacy have not been established.

Geriatric

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 heart, kidney, or stomach problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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.

Interactions with 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

Acalabrutinib

Aceclofenac

Acemetacin

Acenocoumarol

Amiloride

Amineptine

Amitriptyline

Amitriptylinoxide

Amoxapine

Amphetamine

Amtolmetin Guacil

Anagrelide

Apixaban

Ardeparin

Argatroban

Aspirin

Atazanavir

Atezolizumab

Balsalazide

Belumosudil

Belzutifan

Bemetizide

Bemiparin

Bendroflumethiazide

Benzphetamine

Benzthiazide

Betamethasone

Betrixaban

Bismuth Subsalicylate

Bivalirudin

Bosutinib

Bromfenac

Budesonide

Bufexamac

Bumetanide

Cangrelor

Capecitabine

Cefuroxime Axetil

Celecoxib

Ceritinib

Certoparin

Chlorothiazide

Chlorthalidone

Choline Magnesium Trisalicylate

Choline Salicylate

Cilostazol

Citalopram

Clomipramine

Clonixin

Clopamide

Clopidogrel

Cortisone

Cyclopenthiazide

Cyclosporine

Cyclothiazide

Dabigatran Etexilate

Dacomitinib

Dalteparin

Danaparoid

Dasatinib

Deflazacort

Desipramine

Desirudin

Desmopressin

Desvenlafaxine

Dexamethasone

Dexibuprofen

Dexketoprofen

Dextroamphetamine

Diazoxide

Dibenzepin

Diclofenac

Diflunisal

Digoxin

Dipyridamole

Dipyrone

Dothiepin

Doxepin

Droxicam

Duloxetine

Edoxaban

Emtricitabine

Enoxaparin

Eplerenone

Epoprostenol

Eptifibatide

Erlotinib

Escitalopram

Eslicarbazepine Acetate

Ethacrynic Acid

Etodolac

Etofenamate

Etoricoxib

Etozolin

Felbinac

Fenoprofen

Fepradinol

Feprazone

Feverfew

Floctafenine

Fluconazole

Flufenamic Acid

Fluocortolone

Fluoxetine

Flurbiprofen

Fluvoxamine

Fondaparinux

Furosemide

Gefitinib

Ginkgo

Gossypol

Heparin

Hydrochlorothiazide

Hydrocortisone

Hydroflumethiazide

Ibuprofen

Iloprost

Imipramine

Indapamide

Indomethacin

Infigratinib

Inotersen

Ketoconazole

Ketoprofen

Ledipasvir

Lepirudin

Levoketoconazole

Levomilnacipran

Lisdexamfetamine

Lithium

Lofepramine

Lornoxicam

Loxoprofen

Lumiracoxib

Magnesium Salicylate

Meadowsweet

Meclofenamate

Mefenamic Acid

Melitracen

Meloxicam

Melphalan

Mesalamine

Methamphetamine

Methotrexate

Methyclothiazide

Methylphenidate

Methylprednisolone

Metolazone

Milnacipran

Morniflumate

Mycophenolate Mofetil

Nabumetone

Nadroparin

Nefazodone

Nelfinavir

Nepafenac

Neratinib

Niflumic Acid

Nilotinib

Nimesulide

Nimesulide Beta Cyclodextrin

Nortriptyline

Octreotide

Olsalazine

Opipramol

Oxaprozin

OxyphenbUTAzone

Palbociclib

Paramethasone

Parecoxib

Parnaparin

Paroxetine

Pazopanib

Pemetrexed

Pentosan Polysulfate Sodium

Pentoxifylline

Pexidartinib

Phenindione

Phenobarbital

Phenprocoumon

Phenylbutazone

Phenyl Salicylate

Piketoprofen

Piretanide

Piroxicam

Pixantrone

Polythiazide

Posaconazole

Potassium Citrate

Prasugrel

Prednisolone

Prednisone

Primidone

Probenecid

Proglumetacin

Propyphenazone

Proquazone

Protein C

Protriptyline

Quinethazone

Reviparin

Rivaroxaban

Rofecoxib

Salicylamide

Salicylic Acid

Salsalate

Saquinavir

Secretin Human

Selexipag

Selpercatinib

Sertraline

Sibutramine

Sodium Salicylate

Sotorasib

Sparsentan

Spironolactone

Sulfasalazine

Sulfinpyrazone

Sulindac

Sulodexide

Sunitinib

Tacrolimus

Tenofovir Alafenamide

Tenofovir Disoproxil Fumarate

Tenoxicam

Thiopental

Tianeptine

Tiaprofenic Acid

Ticagrelor

Ticlopidine

Tinzaparin

Tirofiban

Tolfenamic Acid

Tolmetin

Torsemide

Trazodone

Treprostinil

Triamterene

Trichlormethiazide

Trimipramine

Trolamine Salicylate

Valdecoxib

Velpatasvir

Venlafaxine

Vilazodone

Vismodegib

Vorapaxar

Vortioxetine

Warfarin

Xipamide

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

Atenolol

Azilsartan

Azilsartan Medoxomil

Benazepril

BeTaxolol

Bisoprolol

Candesartan

Captopril

Carteolol

Carvedilol

Celiprolol

Enalapril

Enalaprilat

Eprosartan

Esmolol

Fosinopril

Irbesartan

Labetalol

Levobunolol

Levothyroxine

Lisinopril

Losartan

Metipranolol

Metoprolol

Moexipril

Nadolol

Nebivolol

Olmesartan

Oxprenolol

Penbutolol

Perindopril

Pindolol

Propranolol

Quinapril

Ramipril

Risedronate

Sotalol

Spirapril

Telmisartan

Timolol

Trandolapril

Valsartan

Voriconazole

Warfarin

Interactions with Food/Tobacco/Alcohol

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

Using this medicine with any of the following may cause an increased risk of certain side effects 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.

Cranberry

Relate drugs

How to use Naproxen and esomeprazole

Take 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 your doctor ordered. 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 or pharmacist 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 juvenile idiopathic arthritis:

Children 12 years of age and older and weighs more than 50 kilograms (kg)—1 tablet (375 milligrams (mg) naproxen and 20 mg esomeprazole or 500 mg naproxen and 20 mg esomeprazole) 2 times a day.

Children 12 years of age and older and weighs 38 kg to less than 50 kg—1 tablet (375 milligrams (mg) naproxen and 20 mg esomeprazole) 2 times a day.

Children younger than 12 years of age and weighs less than 38 kg—Use and dose must be determined by your doctor.

For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:

Adults—1 tablet (375 milligrams (mg) naproxen and 20 mg esomeprazole or 500 mg naproxen and 20 mg esomeprazole) 2 times a 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.

Warnings

It is very important that your doctor check your or your child's progress at regular visits 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.

Do not use this medicine together with medicines containing rilpivirine (Complera®, Edurant®, Odefsey®). Using these medicines together may cause unwanted side 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. Get emergency help right away if you have any symptoms of a heart attack or stroke. Some possible symptoms are chest pain or discomfort, uneven heartbeat, pain that spreads to your arm or jaw, unusual sweating, feeling faint, trouble breathing, slurred speech, or weakness on one side of your body.

Naproxen may cause bleeding in your stomach or bowels. 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 (eg, steroids or a blood thinner).

This medicine may cause a serious type of allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child 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, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Using this medicine during the later part of a 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 or your child 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.

If you or your child are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

This medicine may cause kidney problems. Tell your doctor right away if you or your child has blood in the urine, decreased urine output, confusion, dizziness, headache, muscle twitching, rapid weight gain, swelling of your face, ankles, or hands, or unusual tiredness or weakness.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Call your doctor right away if you have confusion, nausea or vomiting, weakness or heaviness of the legs, uneven heartbeat, trouble breathing, numbness or tingling in your hands, feet, or lips.

Check with your doctor right away if you or your child has a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after using this medicine. These could be symptoms of acute tubulointerstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

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 1 year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have seizures, fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Serious stomach conditions may occur while taking this medicine alone. Check with your doctor immediately if you or your child has stomach cramps, bloated feeling, watery and severe diarrhea which may be bloody sometimes, fever, nausea, vomiting, or unusual tiredness or weakness.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you or your child has joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are receiving this medicine for more than 1 year. Talk to your doctor if you have concerns.

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

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

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 (eg, atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

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