Generic Name: ibuprofen (EYE-bue-PROE-fen)
Brand Name: Caldolor
Caldolor injection is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, a heart attack, a stroke). The risk may be greater if you already have heart problems or if you take Caldolor injection for a long time. Do not use Caldolor injection right before or after bypass heart surgery.
Caldolor injection may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
Caldolor injection is used for:
Treating mild to moderate pain or reducing fever. It is also used for treating moderate to severe pain if used with opioid pain medicines (eg, oxycodone). It may also be used for other conditions as determined by your doctor.
Caldolor injection is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.
Do NOT use Caldolor injection if:
- you are allergic to any ingredient in Caldolor injection
- you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or another NSAID (eg, ibuprofen, celecoxib)
- you have recently had or will be having bypass heart surgery (CABG)
- you are in the last 3 months of pregnancy
Contact your doctor or health care provider right away if any of these apply to you.
Before using Caldolor injection:
Some medical conditions may interact with Caldolor injection. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
- if you have a history of swelling or fluid buildup, lupus, asthma, growths in the nose (nasal polyps), or mouth sores or inflammation
- if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure, a heart attack), or blood vessel disease, or if you are at risk of any of these diseases
- if you have poor health, dehydration or low fluid volume, or low blood sodium levels; or if you smoke, drink alcohol, or have a history of alcohol abuse
Some MEDICINES MAY INTERACT with Caldolor injection. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, enoxaparin, heparin, warfarin), corticosteroids (eg, prednisone), direct factor Xa inhibitors (eg, rivaroxaban), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), thienopyridines (eg, clopidogrel), or zidovudine because the risk of stomach bleeding may be increased
- Probenecid because it may increase the risk of Caldolor injection's side effects
- Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Caldolor injection
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), diuretics (eg, furosemide, hydrochlorothiazide), or salicylates (eg, aspirin) because their effectiveness may be decreased by Caldolor injection
This may not be a complete list of all interactions that may occur. Ask your health care provider if Caldolor injection may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Caldolor injection:
Use Caldolor injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Caldolor injection is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Caldolor injection at home, a health care provider will teach you how to use it. Be sure you understand how to use Caldolor injection. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Caldolor injection if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Caldolor injection and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about the proper use of Caldolor injection.
Important safety information:
- Caldolor injection may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Caldolor injection with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Serious stomach ulcers or bleeding can occur with the use of Caldolor injection. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Caldolor injection with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Caldolor injection has ibuprofen in it. Before you start any new medicine, check the label to see if it has ibuprofen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do not take aspirin while you are using Caldolor injection unless your doctor tells you to.
- Lab tests, including kidney and liver function, complete blood cell counts, and blood pressure, may be performed while you use Caldolor injection. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Caldolor injection with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding and kidney problems.
- Caldolor injection should be used with extreme caution in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Caldolor injection may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Caldolor injection while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Caldolor injection.
Possible side effects of Caldolor injection:
All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; dizziness; gas; headache; heartburn; nausea; stomach pain or upset; vomiting.
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; change in the amount of urine produced; chest, jaw, or left arm pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, cough, or persistent sore throat; numbness of an arm or leg; one-sided weakness; pale stools; red, swollen, blistered, or peeling skin; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; slurred speech; stiff neck; sudden or unexplained weight gain; swelling of the hands, legs, or feet; unusual bruising or bleeding; unusual muscle pain, weakness, or cramps; unusual tiredness or weakness; vision changes (eg, blurred or decreased vision, color vision changes); vomit that looks like coffee grounds; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe or persistent dizziness, drowsiness, nausea, or vomiting; severe or persistent stomach pain.Proper storage of Caldolor injection:
Store Caldolor injection at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Caldolor injection out of the reach of children and away from pets.
- If you have any questions about Caldolor injection, please talk with your doctor, pharmacist, or other health care provider.
- Caldolor injection is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Caldolor injection or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Caldolor injection. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Caldolor injection. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Caldolor injection.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.