Caldolor

Caldolor injection is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

Caldolor injection is used to reduce fever and treat pain.

Caldolor may also be used for purposes not listed in this medication guide.

Caldolor is FDA approved for adult and pediatric patients ages 3 months and older for:

• Management of mild to moderate pain, including postoperative pain
• Management of moderate to severe pain, including postoperative pain, as an adjunct to opioid analgesics
• Reduction of fever

Caldolor can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. You should not receive this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Caldolor, especially in older adults.

Caldolor can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. You should not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not be treated with Caldolor if you are allergic to ibuprofen, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure Caldolor is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• liver or kidney disease;
• fluid retention; or
• a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, or lupus.

If you are pregnant, you should not receive Caldolor unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

You should not breast-feed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction to Caldolor: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction: (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Caldolor and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Tell your caregivers at once if you have:

• changes in your vision;
• swelling, rapid weight gain, feeling short of breath;
• severe headache, pounding in your neck or ears;
• little or no urination;
• high potassium level - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• liver problems - loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

If your baby has been treated with Neoprofen, tell the doctor at once if the baby has:

• signs of infection such as fever, chills, fussiness;
• unusual bleeding; or
• bruising, swelling, warmth, redness, or irritation where the IV needle is placed.

Common Caldolor side effects may include:

• nausea, vomiting, gas;
• headache; or
• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Caldolor is given as an infusion into a vein. A healthcare provider will give you this injection.

Drink plenty of liquids while you are receiving Caldolor injection.

Because you will receive your injection in a clinical setting, you are not likely to miss a dose.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid taking aspirin while you are receiving Caldolor.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ibuprofen (such as aspirin, ketoprofen, or naproxen).

Tell your doctor about all your other medicines, especially:

• lithium;
• methotrexate;
• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medication, including a diuretic or "water pill"; or
• steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with ibuprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.