Saturday, June 13, 2009

FDA's approval of Injectable ibuprofen

We did know about the oral form of ibuprofen, now FDA has approved the injectable form of ibuprofen. Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options said Dr. Bob Rappaport, Director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. But until now (as for as my knowldge goes, diclofenac sodium is being used), there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral product.

In a clinical trial of 319 women who had undergone an elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when administered Caldolor.

Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots and those who have a prior 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. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions. Though the side effects like nausea, flatulence, vomiting, and headache are being noticed during clinical trials. Its a good move becoz., the dose by IP route will be less and definitely reduce the risk of the ulcerogenecity (a common problem due to NSAIDs).

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