Combogesic (Intravenous)

Acetaminophen and ibuprofen combination is used to relieve mild to moderate pain. It is also used with other medicines (for example, narcotic pain relievers) to relieve moderate to severe pain.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) included in this combination to help reduce inflammation, swelling, and pain.

This medicine is to be given only by or under the supervision of your doctor.

It is very important that your doctor checks your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

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

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.

This medicine may increase your risk of having a heart attack, heart failure, 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. Some signs of serious heart problems are chest pain or tightness, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Check with your doctor right away if you notice any of these warning signs.

This medicine may cause bleeding in your stomach or bowels. These problems 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, are over 60 years of age, are in poor health, or are using certain other medicines (eg, NSAIDs, steroid, blood thinner). Call your doctor right away if you have severe stomach pain, black, tarry stools, or are vomiting blood or material that looks like coffee grounds.

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.

Check with your doctor right away if you have bloody urine, a decrease in 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 could 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, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (AGEP) can occur during treatment with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips.

Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, 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. These may be symptoms of a serious skin reaction called drug rash with eosinophilia and systemic symptoms (DRESS).

Check with your doctor immediately if blurred vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause aseptic meningitis. Check with your doctor right away if you have fever, headache, nausea, stiff neck or back, or vomiting.

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

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.

In deciding to use a drug, the chances of using the drug must be weighed against the beneficial it will do. This is a decision you and your physician will make. For this medication, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medication or any other medications. Also inform 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 acetaminophen and ibuprofen combination injection in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of acetaminophen and ibuprofen combination injection in the elderly. However, elderly patients are more likely to develop age-related stomach, bowel, heart, or kidney problems, which may require caution and an adjustment in the dose for patients receiving this medication.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to 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 clinician may want to change the dose, or other precautions may be necessary. When you are receiving 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 medication with any of the following medications is not advised. Your physician may decide not to treat you with this medicine or change some of the other medicines you take.

• Ketorolac

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

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Iloprost
• Imatinib
• Imipramine
• Indapamide
• Indomethacin
• Inotersen
• Isoniazid
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Mavacamten
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine Sodium
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piretanide
• Piroxicam
• Pixantrone
• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
• Polythiazide
• Potassium Citrate
• Pranoprofen
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tocilizumab
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this medicine with any of the following medications may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your clinician may change the dose or how frequently you use one or both of the medications.

• Acebutolol
• Acenocoumarol
• Amikacin
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carbamazepine
• Carteolol
• Carvedilol
• Celiprolol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Fosphenytoin
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Lixisenatide
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Phenytoin
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan
• Warfarin
• Zidovudine

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 medications 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 drug with any of the following is usually not advised, 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

Using this medication 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 physician may change the dose or how often you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

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

• Anemia or
• Edema (fluid retention) or
• Heart attack, recent or
• Heart disease or
• Heart failure or
• Hypertension (high blood pressure) or
• Stomach or bowel issues (eg, peptic ulcer disease, bleeding), history of or
• Stroke, history of—Use with caution. May make these conditions worse.

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

• Coagulopathy (bleeding disorder) or
• Liver disease, advanced—May raise risk of stomach or bowel bleeding.

• Dehydration or
• Hypovolemia (low blood volume)—Must be corrected first prior to receiving this medicine.

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

• Kidney disease—Use is not advised in patients with this condition.

• Systemic lupus erythematosus (SLE)—May cause adverse effects to become worse.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Pain, redness, or pale skin at the injection site

Incidence not known

• Agitation
• Blistering, peeling, or loosening of the skin
• Blood in the urine
• Bloody or black, tarry stools
• Blurred vision
• Changes in vision, especially night blindness
• Chest pain, discomfort, or tightness
• Chills
• Coma
• Confusion
• Constipation
• Cough
• Cracks in the skin
• Dark urine
• Decreased urine output
• Depression
• Difficulty in speaking
• Difficulty swallowing
• Dilated neck veins
• Dizziness
• Double vision
• Fast heartbeat
• Fever
• Glare or snowy image caused by bright light
• Headache
• Heartburn
• Hives, itching, skin rash
• Inability to move the arms, legs, or facial muscles
• Inability to speak
• Indigestion
• Irritability
• Joint or muscle pain
• Lethargy
• Loss of appetite
• Loss of heat from the body
• Muscle twitching
• Nausea or vomiting
• Numbness or tingling in hands, feet, or lips
• Nervousness
• Pain or discomfort in the arms, jaw, back, or neck
• Painful or difficult urination
• Pale skin
• Pounding in the ears
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Red, swollen skin
• Red irritated eyes
• Red skin lesions, often with a purple center
• Scaly skin
• Seizures
• Slow or fast heartbeat
• Slow speech
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Stiff neck or back
• Stomach pain, cramping, or burning
• Stupor
• Sweating
• Swelling of the face, fingers, feet, or lower legs
• Swollen glands
• Trouble breathing
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting of blood or material that looks like coffee grounds
• Weakness or heaviness of legs
• Weight gain

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

Less common

• Sleepiness or unusual drowsiness

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.

In the U.S.

• Combogesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Do not drink alcoholic drinks while you are receiving this medicine. Drinking alcoholic beverages while receiving this medicine may increase your risk of liver damage and stomach bleeding.