"The US Food and Drug Administration's (FDA's) Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted yesterday to recommend premarket approval of the Cartiva Synthetic Cartilage Implant for use in pati"...
(ketoprofen) Extended-Release Capsules
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (See WARNINGS ).
- Orudis (ketoprofen) and Oruvail are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (See WARNINGS).
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events (See WARNINGS).
Ketoprofen is a nonsteroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula:
Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4).
Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95° C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20° C.
Orudis®(ketoprofen) capsules contain 25 mg, 50 mg, or 75 mg of ketoprofen for oral administration. The inactive ingredients present are D&C Yellow 10, FD&C Blue 1, FD&C Yellow 6, gelatin, lactose, magnesium stearate, and titanium dioxide. The 25 mg dosage strength also contains D&C Red 28 and FD&C Red 40.
Each Oruvail®(ketoprofen) 100 mg, 150 mg, or 200 mg capsule contains ketoprofen in the form of hundreds of coated pellets. The dissolution of the pellets is pH dependent, with optimum dissolution occurring at pH 6.5 - 7.5. There is no dissolution at pH 1.
In addition to the active ingredient, each 100 mg, 150 mg, or 200 mg capsule of Oruvail contains the following inactive ingredients: D&C Red 22, D&C Red 28, FD&C Blue 1, ethyl cellulose, gelatin, shellac, silicon dioxide, sodium lauryl sulfate, starch, sucrose, talc, titanium dioxide, and other proprietary ingredients. The 100 and 150 mg capsules also contain D&C Yellow 10 and FD&C Green 3.
What are the possible side effects of ketoprofen (Actron, Orudis KT)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking ketoprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- confusion, tremors or shaking;
- urinating less than usual or not at...
What are the precautions when taking ketoprofen (Orudis)?
Before taking ketoprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding or clotting problems, blood disorders (such as anemia), heart disease (such as previous heart attack), high blood pressure, liver disease, growths in the nose (nasal polyps), throat/stomach/intestinal problems (such as...
Last reviewed on RxList: 2/21/2006
This monograph has been modified to include the generic and brand name in many instances.
Additional Orudis Information
Orudis - User Reviews
Orudis User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options