Oruvail (Ketoprofen)

Ketoprofen (kee toe proe' fen) Actron®¶ Nexcede®¶ Orudis®¶ Orudis® KT¶ Oruvail®¶ People who take nonsteroidal anti-inflammatory drugs (NSAIDs) other than aspirin, such as ketoprofen, may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as ketoprofen if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech. If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take ketoprofen right before or right after the surgery. NSAIDs such as ketoprofen may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink more than three alcoholic drinks per day while taking ketoprofen. Tell your doctor if you drink large amounts of alcohol or if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn); or oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers or bleeding in your stomach or intestines or other bleeding disorders. If you experience any of the following symptoms, stop taking ketoprofen and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools. Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to ketoprofen. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects. Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with prescription ketoprofen and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Prescription ketoprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Prescription ketoprofen capsules are also used to relieve pain, including menstrual pain (pain that occurs before or during a menstrual period). Nonprescription ketoprofen is used to relieve minor aches and pain from headaches, menstrual periods, toothaches, the common cold, muscle aches, and backaches, and to reduce fever. Ketoprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Prescription ketoprofen comes as a capsule and extended-release (long-acting) capsule to take by mouth. The capsules are usually taken three or four times a day for arthritis or every 6 to 8 hours as needed for pain. The extended-release capsules are usually taken once daily. If you take ketoprofen regularly, take it at around the same times every day. Nonprescription ketoprofen comes as a tablet to take by mouth. It is usually taken with a full glass of water or other liquid every 4 to 6 hours as needed. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ketoprofen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or written on the label. Ketoprofen may be taken with food or milk to prevent upset stomach. Your doctor may also recommend that you take ketoprofen with an antacid to reduce stomach upset. Your doctor may start you on an average dose of prescription ketoprofen and may increase or decrease on your dose depending on how well you respond to the medication and the side effects you experience. Follow these directions carefully. Stop taking nonprescription ketoprofen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days or your fever lasts for more than 3 days.

Before taking ketoprofen, tell your doctor and pharmacist if you are allergic to ketoprofen, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in ketoprofen capsules or extended-release capsules. Ask your pharmacist for a list of the inactive ingredients. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); diuretics ('water pills'); lithium (Lithobid); medications for diabetes; methotrexate (Otrexup, Rasuvo, Trexall); phenytoin (Dilantin, Phenytek); and probenecid (Probalan). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects. tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; or liver or kidney disease. tell your doctor if you are pregnant especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breastfeeding. If you become pregnant while taking ketoprofen, call your doctor. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ketoprofen.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Ketoprofen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: constipation diarrhea sores in the mouth headache dizziness nervousness drowsiness difficulty falling asleep or staying asleep ringing in the ears Some side effects may be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more ketoprofen until you speak to your doctor. changes in vision unexplained weight gain shortness of breath or difficulty breathing swelling of the abdomen, feet, ankles, or lower legs fever blisters rash itching hives swelling of the eyes, face, lips, tongue, throat, arms, or hands hoarseness difficulty swallowing excessive tiredness unusual bleeding or bruising lack of energy loss of appetite nausea pain in the upper right part of the stomach flu-like symptoms yellowing of the skin or eyes pale skin fast heartbeat cloudy, discolored, or bloody urine back pain difficult or painful urination Ketoprofen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking ketoprofen. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. ¶ This branded product is no longer on the market. Generic alternatives may be available.