1 What is Caldolor?

Brand: Caldolor, Neoprofen

Generic: Ibuprofen injection

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

2 What to Know 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:

1. 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.

2. Pediatric Population:
Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen injection in children younger than 6 months of age. Safety and efficacy have not been established.

3. Geriatric Population:
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.

4. Pregnancy:
1st and 2nd Trimester: Category C: Animal 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 Trimester: Category D: Studies 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.

5. Breastfeeding:
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.

6. 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 Amineptine Amitriptyline Amitriptylinoxide Amoxapine Anagrelide Apixaban Ardeparin Argatroban
  • Beta Glucan Bivalirudin
  • Certoparin Cilostazol Citalopram Clomipramine Clopidogrel Cyclosporine
  • Dabigatran Etexilate Dalteparin Danaparoid Desipramine Desirudin Desvenlafaxine Dibenzepin Digoxin Dipyridamole Dothiepin Doxepin Duloxetine
  • Edoxaban Enoxaparin Eptifibatide Erlotinib Escitalopram
  • Feverfew Fluoxetine Fluvoxamine Fondaparinux
  • Ginkgo Gossypol
  • Heparin
  • Imipramine
  • Lepirudin Levomilnacipran Lofepramine
  • Meadowsweet Melitracen Methotrexate Milnacipran
  • Nadroparin Nefazodone Nortriptyline
  • Opipramol
  • Parnaparin Paroxetine Pemetrexed Pentosan Polysulfate Sodium Pentoxifylline Pralatrexate Prasugrel Protein C Protriptyline
  • Reboxetine Reviparin Rivaroxaban
  • Sertraline Sibutramine
  • Tacrolimus Tianeptine Ticlopidine Tinzaparin Tirofiban Trimipramine
  • Venlafaxine Vilazodone Vortioxetine

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 Alacepril Alprenolol Amikacin Amiloride Arotinolol Aspirin Atenolol Azosemide
  • Befunolol Bemetizide Benazepril Bendroflumethiazide Benzthiazide Betaxolol Bevantolol Bisoprolol Bopindolol Bucindolol Bumetanide Bupranolol Buthiazide
  • Canrenoate Captopril Carteolol Carvedilol Celiprolol Chlorothiazide Chlorthalidone Cilazapril Clopamide Cyclopenthiazide
  • Delapril Dilevalol
  • Enalapril Enalaprilat Esmolol Ethacrynic Acid
  • Fosinopril Furosemide
  • Hydrochlorothiazide Hydroflumethiazide
  • Imidapril Indapamide
  • Labetalol Landiolol Levobunolol Lisinopril Lithium
  • Mepindolol Methyclothiazide Metipranolol Metolazone Metoprolol Moexipril
  • Nadolol Nebivolol Nipradilol
  • Oxprenolol
  • Penbutolol Pentopril Perindopril Pindolol Piretanide Polythiazide Propranolol
  • Quinapril
  • Ramipril
  • Sotalol Spirapril Spironolactone
  • Talinolol Temocapril Tertatolol Timolol Torsemide Trandolapril Triamterene Trichlormethiazide
  • Xipamide
  • Zofenopril

7. 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

8. 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
  • Bleeding problems
  • Congestive heart failure
  • Dehydration
  • Edema (fluid retention)
  • Heart attack, recent
  • Hyperkalemia (high potassium in the blood)
  • Hypertension (high blood pressure)
  • Hypovolemia (low blood volume)
  • Kidney disease
  • Liver disease
  • Stomach ulcers or bleeding, history of
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Aspirin-sensitive asthma
  • 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.

3 Proper Usage

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.

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.

4 Precautions to Take

It is very important that your doctor check your progress while you receive 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.

Heart Attack, Stroke:
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. People who use this medicine for a long time might also have a higher risk. Tell your doctor if you have 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 (such as steroids or a blood thinner).

Liver Problems:
Liver problems may occur while you are using this medicine. Check with your doctor right away if you are having more than one of these symptoms: abdominal or 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 are rapidly gaining weight, having shortness of breath, 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.

Kidney Problems:
This medicine may cause kidney damage. Tell your doctor right away if you have the following symptoms: 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 may occur while you are receiving this medicine. Call your doctor right away if you have confusion, weakness, uneven heartbeat, trouble breathing, numbness or tingling in your hands, feet, or lips.

Allergic Reactions:
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis 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.

Skin reactions:
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, a severe skin rash or acne, sores or ulcers on the skin, or fever or chills while you are using this medicine.

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

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.

5 Potential 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

  • Abdominal or Stomach pain
  • Black, Tarry stools
  • Bleeding gums
  • Blurred vision
  • Chest pain
  • 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 or cramps
  • Muscle 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
  • Sweating
  • Swelling of the feet or lower legs
  • Swollen glands
  • Tightness in the chest
  • Troubled breathing with exertion
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness
  • 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

  • Abdominal or Stomach discomfort
  • 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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