Brand Name

    US Brand Name

    Caldolor

    Neoprofen


    Description

    Ibuprofen injection is a nonsteroidal antiinflammatory drug (NSAID) that is used alone or together with other medicines (eg, opioid analgesics) to relieve mild to severe pain. It is also used to treat fever.

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

    This product is available in the following dosage forms:

    • Solution

    Before Using

    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 ibuprofen injection in children younger than 3 months of age. 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 ibuprofen injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, heart, or stomach problems, which may require an adjustment in the dose for patients receiving ibuprofen injection.

    Breastfeeding

    Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

    Drug Interactions

    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 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 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

    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
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Amiloride
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Amtolmetin Guacil
    • Anagrelide
    • Apixaban
    • Ardeparin
    • Argatroban
    • Asciminib
    • Aspirin
    • Balsalazide
    • Bemetizide
    • Bemiparin
    • Bendroflumethiazide
    • Benzthiazide
    • Betrixaban
    • Bismuth Subsalicylate
    • Bivalirudin
    • Bromfenac
    • Budesonide
    • Bufexamac
    • Bumetanide
    • Cangrelor
    • Carbamazepine
    • Celecoxib
    • Certoparin
    • Chlorothiazide
    • Chlorthalidone
    • Choline Magnesium Trisalicylate
    • Choline Salicylate
    • Cilostazol
    • Citalopram
    • Clomipramine
    • Clonixin

    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
    • Celiprolol
    • 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

    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
    • Dehydration or
    • Edema (fluid retention) or
    • Heart attack, recent or
    • Hyperkalemia (high potassium in the blood) or
    • Hypertension (high blood pressure) or
    • Hypovolemia (low blood volume) or
    • Kidney disease or
    • Liver disease or
    • Stomach ulcers or bleeding, history of or
    • Stroke, 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 (eg, coronary artery bypass graft [CABG])—Should not be used for pain right before or after surgery.
    • Systemic lupus erythematosus (SLE)—May cause side effects to become worse.

    Proper Use

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

    Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.


    Precautions

    It is very important that your doctor check your progress while you or your child receives this medicine. This will allow your doctor to see if the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

    This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur in people who already have heart disease or in people who use this medicine for a longer time. Tell your doctor if you or your child has chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, slurred speech, unusual sweating, or faintness.

    This medicine may increase risk of bleeding problems. including bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely to occur 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, steroids or a blood thinner).

    Liver problems may occur while you are using this medicine. Check with your doctor right away if you or your child has stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

    If you or your child are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, trouble breathing, 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 receiving this medicine. Call your doctor right away if you or your child has confusion, weakness, uneven heartbeat, trouble breathing, numbness or tingling in your hands, feet, or lips.

    This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

    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, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, 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 your 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 immediately if blurred vision, difficulty in reading, or any other change in color vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

    Check with your doctor right away if you or your child starts to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

    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.

    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

    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 or nurse immediately if any of the following side effects occur:

    More common

    • Black, tarry stools
    • bleeding gums
    • blurred vision
    • chest pain or tightness
    • confusion
    • cough
    • coughing up blood
    • decreased urine
    • diarrhea
    • difficulty with breathing or swallowing
    • dizziness
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • dry mouth
    • fast heartbeat
    • fever or chills
    • headache
    • increased menstrual flow or vaginal bleeding
    • increased thirst
    • irregular heartbeat
    • irritability
    • loss of appetite
    • lower back or side pain
    • muscle pain, cramps, or twitching
    • nausea or vomiting
    • nervousness
    • nosebleeds
    • numbness or tingling in the hands, feet, or lips
    • pain, warmth, or burning in the fingers, toes, and legs
    • painful or difficult urination
    • pale skin
    • paralysis
    • pounding in the ears
    • problems with vision or hearing
    • prolonged bleeding from cuts
    • rapid breathing
    • red or black, tarry stools
    • red or dark brown urine
    • restlessness
    • seizures
    • slow or fast heartbeat
    • sneezing
    • sore throat
    • sores, ulcers, or white spots on the lips or in the mouth
    • stomach pain
    • sweating
    • swelling of the feet or lower legs
    • swollen glands
    • trouble breathing
    • unusual bleeding or bruising
    • unusual tiredness or weakness

    Less common

    • Bloating or swelling of the face, arms, hands, lower legs, or feet
    • decrease in the frequency of urination
    • decrease in urine volume
    • difficulty in passing urine (dribbling)
    • rapid weight gain
    • unusual weight gain or loss

    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

    • Excess air or gas in the stomach or intestines
    • full feeling
    • passing gas

    Less common

    • Acid or sour stomach
    • belching
    • heartburn
    • indigestion
    • stomach discomfort, upset, or pain

    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.






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