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Indication1: Caldolor is indicated in adults for the management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, and reduction of fever.

IMPORTANT SAFETY INFORMATION1
Contraindications
Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen and in patients who have experienced asthma, urticarial, or allergic-type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS1

Cardiovascular Risk

  • Non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • Caldolor is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
  • NSAIDs increase the 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 are at greater risk for serious gastrointestinal events.

WARNINGS AND PRECAUTIONS1
Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots, and in those who have a history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. Ibuprofen has been associated with high blood pressure, serious skin reactions, and serious allergic reactions.

ADVERSE EVENTS1
The most common adverse events reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.

DISCLAIMER:
PLEASE SEE FULL PRESCRIBING INFORMATION INCLUDING BOXED WARING

1. Prescribing Information for Caldolor, Cumberland Pharmaceuticals Inc. Nashville, TN.