Caldolor

C

Generic Name: ibuprofen (Intravenous route)

eye-bue-PROE-fen

Intravenous route(Solution)

NSAIDs increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

Caldolor Neoprofen

Available Dosage Forms:

Solution

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Caldolor

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

This medicine is available only with your doctor's prescription.

Before Using Caldolor

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 and teenagers below 17 years 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.

Pregnancy Pregnancy Category Explanation 1st Trimester 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. 2nd Trimester 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 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. Breast Feeding

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

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 Ardeparin Argatroban Beta Glucan Bivalirudin Certoparin Cilostazol Citalopram Clopidogrel Clovoxamine Dabigatran Etexilate Dalteparin Danaparoid Desirudin Dipyridamole Enoxaparin Escitalopram Femoxetine Flesinoxan Fluoxetine Fluvoxamine Fondaparinux Ginkgo Heparin Lepirudin Methotrexate Nadroparin Nefazodone Parnaparin Paroxetine Pemetrexed Protein C Reviparin Rivaroxaban Sertraline Sibutramine Tacrolimus Ticlopidine Tinzaparin Tirofiban Vilazodone Zimeldine

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 Acetohexamide Alacepril Alprenolol Amikacin Amiloride Arotinolol Aspirin Atenolol Azilsartan Medoxomil Azosemide Befunolol Bemetizide Benazepril Bendroflumethiazide Benzthiazide Betaxolol Bevantolol Bisoprolol Bopindolol Bucindolol Bumetanide Bupranolol Buthiazide Candesartan Cilexetil Canrenoate Captopril Carteolol Carvedilol Celiprolol Chlorothiazide Chlorpropamide Chlorthalidone Cilazapril Clopamide Cyclopenthiazide Cyclosporine Delapril Desipramine Desvenlafaxine Dilevalol Duloxetine Enalaprilat Enalapril Maleate Eprosartan Esmolol Ethacrynic Acid Fosinopril Furosemide Gliclazide Glimepiride Glipizide Gliquidone Glyburide Hydrochlorothiazide Hydroflumethiazide Imidapril Indapamide Irbesartan Labetalol Landiolol Levobetaxolol Levobunolol Lisinopril Lithium Losartan Mepindolol Methyclothiazide Metipranolol Metolazone Metoprolol Milnacipran Moexipril Nadolol Nebivolol Nipradilol Olmesartan Medoxomil Oxprenolol Penbutolol Pentopril Perindopril Phenytoin Pindolol Piretanide Polythiazide Propranolol Quinapril Ramipril Sotalol Spirapril Spironolactone Tacrine Talinolol Tasosartan Telmisartan Temocapril Tertatolol Timolol Tolazamide Tolbutamide Torsemide Trandolapril Triamterene Trichlormethiazide Valsartan Venlafaxine Voriconazole Xipamide Zofenopril 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 medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or 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 Edema (fluid retention) or Heart attack, history of or Hypertension (high blood pressure) 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 use in patients with these conditions. Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not use for pain right before or after surgery in patients with this condition. Systemic lupus erythematosus (SLE)—May cause side effects to become worse. Proper Use of ibuprofen

This section provides information on the proper use of a number of products that contain ibuprofen. It may not be specific to Caldolor. Please read with care.

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.

Precautions While Using Caldolor

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 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. People who use this medicine for a long time might also have a higher risk.

This medicine may cause 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 may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal 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.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call 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 can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the 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.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after you receive this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, stiff neck or back, or vomiting. These could be symptoms of a serious condition called meningitis.

Tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Caldolor 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 convulsions cough coughing up blood decreased urine diarrhea difficulty in breathing or swallowing dizziness dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly dry mouth fast heartbeat fat in the stool fever or chills headache increased menstrual flow or vaginal bleeding increased thirst irregular heartbeat irritability loss of appetite lower back or side pain mood changes 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 shortness of breath 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 wheezing Less common Bloating or swelling of the face, arms, hands, lower legs, or feet decrease in 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.

See also: Caldolor side effects (in more detail)

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Caldolor

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