"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. [see WARNINGS AND PRECAUTIONS].
- CALDOLOR is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
Gastrointestinal Bleeding, Ulceration and Perforation
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see WARNINGS AND PRECAUTIONS].
CALDOLOR (ibuprofen) Injection is a nonsteroidal anti-inflammatory drug, available as an 800 mg/8 mL single-dose vial (100 mg/mL) for intravenous administration. The chemical name is ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74°C to 77°C. It has a molecular weight of 206.28. It is very slightly soluble in water ( < 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula of ibuprofen is represented below:
Each 1 mL of solution contains 100 mg of ibuprofen in Water for Injection, USP. The inactive ingredients in CALDOLOR include: 78 mg/mL arginine at a molar ratio of 0.92:1 arginine:ibuprofen. The solution pH is about 7.4.
CALDOLOR is sterile and is intended for intravenous administration only.
What are the possible side effects of ibuprofen (Caldolor)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have:
- chest pain, shortness of breath, sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- swelling or rapid weight gain;
- little or no urinating;
- nausea, upper stomach pain, itching, loss of appetite, dark urine,...
Last reviewed on RxList: 6/7/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Caldolor Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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