In the treatment of post-operative orthopedic pain1*

Patients treated with Caldolor experienced...

Post-op patients woke up in significantly less pain and remained in less pain1

Patients wake up in significantly less pain and remain in less pain
All patients had access to morphine for breakthrough pain.

Patients used 31% less morphine for rescue1

Morphine Usage Following Orthopedic Surgery

Caldolor dosing was initiated pre-operatively and continued in the post-operative period.

Singla et al. Pain Medicine, 2010.
*Compared to placebo plus morphine. Results of a multi-center, randomized, double-blind placebo-controlled trial of patients undergoing total knee or hip replacement, reconstruction, or arthroplasty (N=185). Patients received 800 mg Caldolor or placebo preemptively and every 6 hours after surgery. All patients received intra-operative fentanyl; no other analgesia was given during surgery. Pain was assessed in the immediate post-operative period.

The most common adverse events reported in this clinical trial were nausea, vomiting, and constipation.

Efficacy: Abdominal Hysterectomy Pain · Efficacy: Dose Ranging Pain

Important Safety Information

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.

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

Warning: Risk of Serious Cardiovascular and Gastrointestinal Events

Cardiovascular Risk

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use.
  • 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. Events can occur at any time without warning symptoms. Elderly patients are at greater risk.

Indications for CALDOLOR

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.

Please see full Prescribing Information, including Boxed Warning.

References:

  1. Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen
    (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Medicine. 2010;11:1284-1293.