Safety that supports pre-, intra-, & post-operative analgesia1,2
Demonstrated safety in key clinical trials1
In key clinical pain trials the incidence of bleeding, gastric, and renal events was no greater in patients receiving Caldolor compared to placebo1*
*All patients received concomitant morphine during these studies.
Read the results of the key clinical pain trials for Caldolor:
Demonstrated safety in an orthopedic pain study2
- The most common adverse events reported were nausea, vomiting, and constipation
- No differences between groups in the incidence of adverse events or serious adverse events
- No differences in abnormal laboratory values (including creatinine) or vital sign measurements
- Adverse events and clinical abnormalities, such as blood pressure elevations, bleeding, bruising or transfusions, did not differ between groups
– Approximately 19% received anticoagulation prophylaxis within 12 hours prior to surgery
– 60% received anticoagulation prophylaxis after surgery
Read more on this orthopedic pain study for Caldolor
Not all NSAIDs are alike3
Dosing and administration information for Caldolor
Dosage/Administration for Pain
- Caldolor can be administered pre-, intra-, and post-operatively1,2
- Caldolor must be diluted prior to I.V. infusion
- 400 mg to 800 mg every 6 hours as necessary
- 3200 mg maximum daily dose
- In pivotal clinical trials, Caldolor was infused over 30 minutes
- Caldolor was safely infused in healthy volunteers over 5-7 minutes and reached peak plasma concentrations within minutes4
- Elimination half-life is the same as for oral ibuprofen4
- No limit on duration of use
Latex free
The stopper in the Caldolor vial does not contain natural rubber latex, dry natural rubber, or blends of natural rubber.
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:
Prescribing Information for Caldolor. Cumberland Pharmaceuticals Inc. Nashville, TN.
Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trialof intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Medicine. 2010;11:1284-1293.
Wright JM. The double-edged sword of COX-2 selective NSAIDs. CMAJ. 2002;167:1131-1137.
Pavliv L, Voss B, Rock A. Pharmacokinetics, safety, and tolerability of a rapid infusion of I.V. ibuprofen in healthy adults. Am J Health-Syst Pharm. 2011;68:47-51.