FDA Approves IV Ibuprofen For Hospital Use Exclusively

An intravenous formulation of ibuprofen was approved by the Food and Drug Administration in June for treating mild to moderate pain, as an adjunct to opioid analgesics, and for the reduction of fever in adults.

This is the first injectable formulation of ibuprofen available and is for use only in the hospital, according to the FDA statement announcing the approval. The product, which will be marketed as Caldolor, is expected to become available later this year, according to the manufacturer, Cumberland Pharmaceuticals Inc.

In phase III studies, patients who received Caldolor reported a significant reduction in pain intensity after surgery and used significantly less morphine in the 24 hours following surgery, according to Cumberland.

An FDA statement announcing the approval cited a study of 319 women who had undergone an elective abdominal hysterectomy. Those who received Caldolor were less likely to request morphine than those who did not. “An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products,” Dr. Bob Rappaport, director of the FDA's division of anesthesia, analgesia, and rheumatology drug products, said in the statement. Until now, he noted, most NSAIDs have been available only in oral form.

For acute pain, the recommended dosage is 400-800 mg administered intravenously over 30 minutes, every 6 hours. For fever, the recommended dosage is 400 mg administered over 30 minutes, followed by 400 mg every 4-6 hours, or 100-200 mg every 4 hours, as needed, according to the FDA.

Nausea, flatulence, vomiting, and headache were the most common adverse reactions reported in clinical trials of Caldolor, which should be used with caution in patients with heart failure, renal impairment, or liver impairment; in those taking diuretics or ACE inhibitors; and in patients with a history of ulcers or gastrointestinal bleeding.

Caldolor is contraindicated in patients with asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs; during the perioperative period in patients undergoing coronary artery bypass surgery; and in patients with known hypersensitivity to ibuprofen or other NSAIDs, according to the manufacturer. Blood pressure should be monitored during treatment.