Ibuprofen and famotidine (Oral route)

Pronunciation:

eye-bue-PROE-fen, fam-OH-ti-deen

Brand Names:

Duexis

Dosage Forms:

Tablet

Warnings:

Oral route(Tablet)

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Famotidine/ibuprofen is contraindicated in the setting of coronary artery bypass graft surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events .

Classifications:

Therapeutic—

Musculoskeletal Agent

Pharmacologic—

NSAID

Chemical—

Propionic Acid (class)

Uses of This Medicine:

Ibuprofen and famotidine combination is used to relieve the symptoms of rheumatoid arthritis and osteoarthritis. 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.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain, inflammation, swelling, stiffness, and joint pain. Famotidine is a histamine H2-receptor antagonist or H2-blocker. It works by decreasing the amount of acid produced by the stomach.

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 ibuprofen and famotidine 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 ibuprofen and famotidine combination in the elderly. However, elderly patients are more likely to have age-related heart, stomach, or kidney 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.

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.

Bepridil
Cisapride
Dronedarone
Ketorolac
Levoketoconazole
Mesoridazine
Pimozide
Piperaquine
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

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
Adagrasib
Amiloride
Amineptine
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amoxapine
Amprenavir
Amtolmetin Guacil
Anagrelide
Apixaban
Apomorphine
Ardeparin
Argatroban
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asciminib
Aspirin
Atazanavir
Balsalazide
Bemetizide
Bemiparin
Bendroflumethiazide
Benzthiazide
Betrixaban
Bismuth Subsalicylate
Bivalirudin
Bromfenac
Budesonide
Bufexamac
Bumetanide
Buprenorphine
Bupropion
Buserelin
Cangrelor
Carbamazepine
Cefuroxime Axetil
Celecoxib
Ceritinib
Certoparin
Chloroquine
Chlorothiazide
Chlorthalidone
Choline Magnesium Trisalicylate
Choline Salicylate
Cilostazol
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clonixin
Clopamide
Clopidogrel
Clothiapine
Clozapine
Crizotinib
Cyclopenthiazide
Cyclosporine
Cyclothiazide
Dabigatran Etexilate
Dabrafenib
Dalteparin
Danaparoid
Dasatinib
Deflazacort
Degarelix
Delamanid
Delavirdine
Desipramine
Desirudin
Deslorelin
Desmopressin
Desvenlafaxine
Deutetrabenazine
Dexamethasone
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Diazoxide
Dibenzepin
Diclofenac
Diflunisal
Digoxin
Dipyridamole
Dipyrone
Domperidone
Donepezil
Dothiepin
Doxepin
Droxicam
Duloxetine
Edoxaban
Efavirenz
Emtricitabine
Encorafenib
Enoxaparin
Entrectinib
Eplerenone
Epoprostenol
Eptifibatide
Erlotinib
Escitalopram
Ethacrynic Acid
Etodolac
Etofenamate
Etoricoxib
Etozolin
Etrasimod
Felbinac
Fenoprofen
Fepradinol
Feprazone
Feverfew
Fexinidazole
Fingolimod
Floctafenine
Fluconazole
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Formoterol
Fosamprenavir
Foscarnet
Fostemsavir
Furosemide
Gefitinib
Gepirone
Ginkgo
Glasdegib
Gonadorelin
Goserelin
Gossypol
Heparin
Histrelin
Hydrochlorothiazide
Hydrocortisone
Hydroflumethiazide
Hydroxychloroquine
Hydroxyzine
Iloprost
Imipramine
Indapamide
Indomethacin
Infigratinib
Inotersen
Inotuzumab Ozogamicin
Ivabradine
Ivosidenib
Ketoconazole
Ketoprofen
Ledipasvir
Lefamulin
Lenvatinib
Lepirudin
Leuprolide
Levofloxacin
Levomilnacipran
Lithium
Lofepramine
Lofexidine
Lornoxicam
Loxoprofen
Lumacaftor
Lumiracoxib
Macimorelin
Mavacamten
Meadowsweet
Meclofenamate
Mefenamic Acid
Melitracen
Meloxicam
Melphalan
Mesalamine
Methadone
Methotrexate
Methyclothiazide
Methylphenidate
Methylprednisolone
Metolazone
Metronidazole
Milnacipran
Mirtazapine
Mobocertinib
Morniflumate
Moxifloxacin
Nabumetone
Nadroparin
Nafarelin
Naproxen
Nefazodone
Nepafenac
Neratinib
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Nirogacestat
Nortriptyline
Octreotide
Olanzapine
Olsalazine Sodium
Ondansetron
Opipramol
Osilodrostat
Osimertinib
Oxaliplatin
Oxaprozin
Oxyphenbutazone
Ozanimod
Pacritinib
Panobinostat
Parecoxib
Parnaparin
Paroxetine
Pasireotide
Pazopanib
Pemetrexed
Pentosan Polysulfate Sodium
Pentoxifylline
Phenindione
Phenobarbital
Phenprocoumon
Phenylbutazone
Piketoprofen
Pimavanserin
Piretanide
Piroxicam
Pitolisant
Polythiazide
Ponesimod
Posaconazole
Potassium Citrate
Pranoprofen
Prasugrel
Prednisolone
Prednisone
Primidone
Proglumetacin
Propyphenazone
Proquazone
Protein C
Protriptyline
Quetiapine
Quinethazone
Quizartinib
Relugolix
Reviparin
Ribociclib
Rilpivirine
Rivaroxaban
Rofecoxib
Salicylic Acid
Salsalate
Secretin Human
Selexipag
Selpercatinib
Sertraline
Sevoflurane
Sibutramine
Siponimod
Sodium Salicylate
Solifenacin
Sotalol
Sotorasib
Sparsentan
Spironolactone
Sulfasalazine
Sulfinpyrazone
Sulindac
Sulodexide
Sulpiride
Sunitinib
Tacrolimus
Tenofovir Alafenamide
Tenofovir Disoproxil Fumarate
Tenoxicam
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tinzaparin
Tirofiban
Tizanidine
Tolazoline
Tolfenamic Acid
Tolmetin
Torsemide
Trazodone
Treprostinil
Triamterene
Trichlormethiazide
Triclabendazole
Trimipramine
Triptorelin
Valdecoxib
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilanterol
Vilazodone
Vinflunine
Vismodegib
Voclosporin
Vorapaxar
Vortioxetine
Warfarin
Xipamide
Zuclopenthixol

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
Amikacin
Atenolol
Azilsartan
Azilsartan Medoxomil
Benazepril
Betaxolol
Bisoprolol
Candesartan
Captopril
Carteolol
Carvedilol
Cefditoren Pivoxil
Cefpodoxime Proxetil
Celiprolol
Cyclosporine
Enalapril
Enalaprilat
Eprosartan
Esmolol
Fosinopril
Irbesartan
Labetalol
Levobunolol
Lisinopril
Losartan
Metipranolol
Metoprolol
Moexipril
Nadolol
Nebivolol
Olmesartan
Oxprenolol
Penbutolol
Perindopril
Pindolol
Propranolol
Quinapril
Ramipril
Sotalol
Spirapril
Telmisartan
Timolol
Trandolapril
Valsartan

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.

Ethanol
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
Dehydration or
Edema (fluid retention or swelling) or
Heart attack, recent or history of or
Heart or blood vessel disease or
Hyperkalemia (high potassium in the blood) or
Hypertension (high blood pressure) or
Hypovolemia (low amount of blood) or
Liver disease or
Stomach ulcers or bleeding, history of or
Stroke, history of or
Systemic lupus erythematosus (autoimmune disease) or
Ulcerative colitis, history of—Use with caution. May make these conditions worse.

Aspirin-sensitive asthma or
Aspirin sensitivity, history of or
Kidney disease, severe—Should not be used in patients with these conditions.

Dehydration or
Hypovolemia—Must be corrected first before using this medicine.

Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Kidney disease—Use with caution. The effects may be increased because of slower removal of famotidine from the body.

Proper Use of This Medicine:

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

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

Swallow the tablet whole. Do not break, crush, divide, or chew it.

This medicine contains ibuprofen. Do not take this medicine with other products containing ibuprofen.

Do not substitute this medicine with single-ingredient products of ibuprofen and famotidine. Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 (tablets):
- For rheumatoid arthritis and osteoarthritis:
  - Adults—1 tablet (800 milligrams (mg) ibuprofen and 26.6 mg famotidine) 3 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.

Precautions While Using This Medicine:

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

Ibuprofen 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. Check with your doctor right away if you are having chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, slurred speech, or weakness.

Ibuprofen 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 (eg, steroids or a blood thinner).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

If you are rapidly gaining weight, trouble breathing, 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.

Check with your doctor right away if you have blood in the urine, decrease in the frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These may be symptoms of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

This medicine may cause a serious allergic reaction called anaphylaxis, which 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, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, fever, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness and weakness.

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

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.

Some people who have used this medicine had symptoms of meningitis. If you have fever, headache, nausea, vomiting, and stiff neck or back while using this medicine, check with your doctor right away.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye 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:

Less common: Bladder pain; bloating or swelling of the face, arms, hands, lower legs, or feet; bloody or black, tarry stools; blurred vision; chills; clay-colored stools; cloudy urine; constipation; cough; dark-colored urine; diarrhea; difficult, burning, or painful urination; dizziness; fever; frequent urge to urinate; general feeling of discomfort or illness; headache; heartburn; indigestion; itching or rash; joint pain; light-colored stools; loss of appetite; lower back or side pain; muscle aches and pains; nausea; nervousness; pale skin; pounding in the ears; rapid weight gain; runny nose; severe stomach pain; shivering; slow or fast heartbeat; sore throat; stomach pain, cramping, or burning; sweating; tingling of the hands or feet; trouble sleeping; trouble breathing; unpleasant breath odor; unusual bleeding or bruising; unusual tiredness or weakness; unusual weight gain or loss; vomiting; vomiting of blood or material that looks like coffee grounds; yellow eyes or skin

Incidence not known: Blistering, peeling, or loosening of the skin; change in consciousness; confusion as to time, place, or person; cracks in the skin; darkening of the skin; depression; dry mouth; fainting; hallucinations; holding false beliefs that cannot be changed by fact; loss of consciousness; loss of heat from the body; pain in the lower back or side; pain in the chest, groin, or legs, especially calves of the legs; red skin lesions, often with a purple center; red, irritated eyes; red, swollen skin; scaly skin; seizures; severe headaches of sudden onset; sores, ulcers, or white spots in the mouth or on the lips; stiff neck or back; sudden loss of coordination; sudden onset of slurred speech; sudden vision changes; swollen glands; thirst; unusual excitement, nervousness, or restlessness

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:

Less common: Back pain; belching; body aches or pain; cough producing mucus; difficulty having a bowel movement; difficulty with moving; ear congestion; loss of voice; muscle stiffness; pain or tenderness around the eyes and cheekbones; sneezing; stuffy nose

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: 4/24/2024

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