Archive for 24 de junho de 2009


June 12, 2009 — The US Food and Drug Administration (FDA) yesterday approved an injectable formulation of ibuprofen (Caldolor, Cumberland Pharmaceuticals, Inc) for the treatment of pain and fever. The product will be available for hospital use only.

“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” commented Bob Rappaport, MD, in an agency news release. “But until now 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 products.”

Dr. Rappaport is director of the Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research.

Adjunctive use of ibuprofen injection may also reduce the need for opiate pain relief. In a clinical trial of 319 women who had undergone abdominal hysterectomy, patients receiving the product were less likely to require morphine on an as-needed basis.

When treating acute pain, the recommended dosing regimen for injectable ibuprofen is 400 to 800 mg administered for 30 minutes every 6 hours. To treat fever, a 400-mg dose should be followed by 400 mg every 4 to 6 hours or 100 to 200 mg every 4 hours as needed.

Adverse events reported most commonly in clinical studies were nausea, flatulence, vomiting, and headache. Hypertension, serious dermatologic reactions, and severe allergic reactions may also occur.

As with other NSAIDs, ibuprofen injection should be used with caution in patients with congestive heart failure, those with kidney impairment, those at risk for blood clots, and patients with a prior history of ulcers or gastrointestinal bleeding. To reduce the risk for adverse events in these patients, the lowest effective dose should be administered for the shortest duration of time.

Fonte: Medscape Pharmacists.

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E agora, José?!

HCTZ a “Paltry” Antihypertensive, With No Effect on Outcomes, New Analysis Suggests

Lisa Nainggolan

June 16, 2009 (Milan, Italy) – Hydrochlorothiazide (HCTZ), the most commonly employed blood-pressure-lowering drug in the US, used at the usual doses prescribed–12.5 mg to 25 mg/per day–is a “paltry” antihypertensive, inferior to all other drug classes, and there is no published evidence that it reduces heart attack or stroke [1]. These are the controversial conclusions of a new pooled analysis of trials reported by Dr Franz Messerli (St Luke’s-Roosevelt Hospital, New York, NY) during a late-breaking clinical-trial session here at the European Meeting on Hypertension 2009 this weekend.

Messerli stressed that his conclusions relate to 24-hour ambulatory BP monitoring and that, “when it comes to office BP, HCTZ isn’t that bad. In the clinic, BP [with HCTZ] looks fairly decent, it’s almost as good as other antihypertensive drugs, which means very simply that HCTZ lowers the BP fairly well during the day, when the patient sees the doctor in the office, but at night and early-morning hours, it loses its antihypertensive efficacy, so it creates a false sense of security for the patient and the doctor alike.

“In a nutshell, HCTZ has lousy antihypertensive efficacy, there are no outcomes data for it, and it should not be used as initial therapy,” Messerli told heartwire . He added that since conducting this analysis, he has pretty much ceased to use HCTZ. “I used it extensively before this analysis, absolutely. I personally use much more chlorthalidone now, for which we have good, solid outcomes data. But unfortunately there are numerous fixed-dose combinations with HCTZ available at the current time, so you cannot escape the use of it completely.” And Messerli says he fears the new US Joint National Committee (JNC) guidelines on hypertension, due to be updated later this year (JNC 8), will continue to recommend use of thiazide diuretics as first-line therapy, “and they are fully aware that thiazides translate–at least to the American physicians–as HCTZ and nothing else.”

fonte: Medscapes Pharmacist

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