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Your doctor may also suggest that you try other treatments. You may not be getting all the relief you need. Ask your doctor if prescription CELEBREX is right for your pain. CELEBREX was approved by the FDA in 1998 and has been prescribed for over 30 million people in the U.S.* Just one prescription CELEBREX provides 24-hour, all day and all night relief from the pain, swelling, and stiffness of arthritis. What is CELEBREX? CELEBREX is a prescription medicine for: Relief of the joint pain, swelling, and stiffness of osteoarthritis (OA). OA is a type of arthritis caused by wear and tear on bones and joints Relief of the joint pain, swelling, and stiffness of adult rheumatoid arthritis (RA). RA is an autoimmune disease that attacks healthy joint tissue, starting a process of inflammation and joint damage Management of acute pain in adults (such as pain from strains and sprains) or pain after surgery Treatment of primary dysmenorrhea (painful menstrual cramps) Relief of signs and symptoms of ankylosing spondylitis, a painful form of arthritis that primarily affects the spine. Ankylosing spondylitis usually strikes young adults. It can cause inflammation, pain and stiffness in the shoulders, knees, hips, ribs, and feet What makes CELEBREX different? CELEBREX works to relieve arthritis pain by targeting a certain enzyme in the body. An enzyme is a protein that causes chemical changes in other substances in the body. The enzyme that CELEBREX targets is called COX-2. The COX-2 enzyme plays a key role in causing both pain and inflammation. The body also makes an enzyme called COX-1. This enzyme helps protect the lining of the stomach. Most pain relievers work by blocking the actions of both COX-1 and COX-2. CELEBREX is different because, when taken at suggested doses, it targets the COX-2 enzyme, but not the COX-1. For this reason, doctors refer to CELEBREX as a COX-2–specific inhibitor. CELEBREX works to relieve arthritis pain by targeting a certain enzyme in the body. An enzyme is a protein that causes chemical changes in other substances in the body. The enzyme that CELEBREX targets is called COX-2. The COX-2 enzyme plays a key role in causing both pain and inflammation. The body also makes an enzyme called COX-1. This enzyme helps protect the lining of the stomach. Most pain relievers work by blocking the actions of both COX-1 and COX-2. CELEBREX is different because, when taken at suggested doses, it targets the COX-2 enzyme, but not the COX-1. For this reason, doctors refer to CELEBREX as a COX-2– What are the most common side effects of CELEBREX? All medicines have possible side effects. Although CELEBREX is usually well-tolerated, in clinical trials some common side effects were indigestion, diarrhea, and abdominal pain. In studies, the percentage of patients who stopped taking CELEBREX due to side effects was similar to the percentage of patients who were taking a placebo (a sugar pill) and stopped because of side effects. Are there other side effects? CELEBREX may increase the chance of serious heart problems, such as heart attacks or strokes, which can lead to death. Serious skin reactions or stomach and intestine problems, such as bleeding and ulcers, can occur without warning and may cause death. As always, patients should discuss their individual health history with their doctors to understand these risks. There is no cure for arthritis. But, you can treat your symptoms with CELEBREX. Just one prescription CELEBREX provides 24-hour, all day and all night relief from the pain, swelling, and stiffness of osteoarthritis and adult rheumatoid arthritis. It's important to know that no medicine can get rid of all symptoms for all people. Each person responds differently to medications. Will CELEBREX cure my arthritis? There is no cure for arthritis. However, CELEBREX can help reduce the pain, inflammation, and stiffness of osteoarthritis and adult rheumatoid arthritis and ankylosing spondylitis. As is true of any medicine, not all people will experience the same results from taking CELEBREX. To get the best results, be sure to follow your doctor's instructions, and let your doctor know if you feel CELEBREX is working for you. Improving treatment success One of the most important things you can do to improve your treatment results is to give your prescribed medicine time to work. Ask your doctor how long it will take your medication to deliver optimal pain relief, and take as directed until your follow-up appointment. Recording your pain and stiffness levels in a journal can be an excellent way to help your doctor assess how well your treatment is working. You can also improve your treatment results by changing your diet and exercise routine. Talk with your doctor before starting any exercise plan or making changes to your treatment regimen. To get the best results from your treatment, be sure to follow your doctor's instructions and let him or her know how CELEBREX is working for your pain. For more information, please see full Prescribing Information. CELEBREX makes it easy for your doctor to customize your treatment to fit your individual treatment needs. For most people, just one prescription CELEBREX works hard to provide 24-hour, all day and all night relief from your arthritis pain and can be taken as needed for relief from acute pain. It targets the pain, inflammation, and stiffness that's part of arthritis. CELEBREX is available in 100-mg and 200-mg capsules. CELEBREX is also available in a 400-mg capsule. Your doctor will find the dosage that's right for your pain. CELEBREX should always be taken exactly as your doctor has prescribed. Taking CELEBREX on a regular basis will help it work better against your arthritis pain. When to take CELEBREX CELEBREX can be taken with or without food at any time of the day. You may find that if you take it at the same time every day, you'll be less likely to skip a dose by mistake. If you do forget to take a dose, don't double up. Taking too much of any medication at one time can present a health risk. Wait and take it at your next regularly scheduled time. If you have questions, be sure to call your doctor. It's important to take the time to talk with your doctor or pharmacist about how you should take CELEBREX CELEBREX makes it easy for your doctor to customize your treatment to fit your individual treatment needs. For most people, just one prescription CELEBREX works hard to provide 24-hour, all day and all night relief from your arthritis pain and can be taken as needed for relief from acute pain. It targets the pain, inflammation, and stiffness that's part of arthritis. CELEBREX is available in 100-mg and 200-mg capsules. CELEBREX is also available in a 400-mg capsule. Your doctor will find the dosage that's right for your pain. CELEBREX should always be taken exactly as your doctor has prescribed. Taking CELEBREX on a regular basis will help it work better against your arthritis pain. When to take CELEBREX CELEBREX can be taken with or without food at any time of the day. You may find that if you take it at the same time every day, you'll be less likely to skip a dose by mistake. If you do forget to take a dose, don't double up. Taking too much of any medication at one time can present a health risk. Wait and take it at your next regularly scheduled time. If you have questions, be sure to call your doctor. It's important to take the time to talk with your doctor or pharmacist about how you should take CELEBREX CELEBREX can be taken by adults suffering from arthritis pain, inflammation, and stiffness. It can also be taken for relief from acute pain. Some examples of acute pain include pain from strains and sprains or pain after surgery. Sometimes CELEBREX is prescribed to relieve painful menstrual cramps. What if I'm pregnant or nursing? No studies of CELEBREX in pregnant women have been performed. CELEBREX should be used during pregnancy only if you and your doctor decide that the potential benefit justifies the potential risk to the fetus. Women in the third trimester of pregnancy should not take CELEBREX. The effects of CELEBREX on labor and delivery in pregnant women are unknown. You should not take CELEBREX if you are breast-feeding because CELEBREX is passed through human milk. Limited data from one subject indicates that CELEBREX is also passed through human milk. Because many drugs are passed through human milk, a decision should be made whether to stop nursing or to stop taking CELEBREX. Who should not take CELEBREX? You should not take CELEBREX if you: Have had allergic reactions to certain drugs called sulfonamides Have experienced asthma, hives, or allergic reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) Are in late pregnancy Are breast-feeding Are having or have recently had a certain kind of heart surgery called coronary artery bypass graft (CABG) The word arthritis means "joint inflammation." When joints are inflamed, it causes pain. For many people, arthritis pain has a large impact on their life. There are a lot of things that can impact the intensity of arthritis pain. Pain is often affected by physical and emotional factors like depression, activity levels, and stress. Because pain is stressful, it may create a vicious cycle with an ever-widening impact. Why is pain important? Pain is important. It lets us know when something is wrong. Pain is our body's warning that lets us know that we have an injury. We have nerves that take signals from an injury to the brain. The signals are read and our brain tells us to get away from danger. Pain can come from an injury with a clear cause such as a cut or a burn. It can also come from a source that's hard to pinpoint. Doctors are just now starting to realize the full impact that pain can have on overall health. When pain is ignored, it can lead to serious health problems. Managing your pain While there is not yet a cure for arthritis, much can be done today to reduce pain and boost joint function. Learning how to manage pain over the long term is essential to maintaining a good quality of life. The most important thing you can do to overcome arthritis is to become an active participant in managing your pain. Talk to your doctor about the pain you are feeling. Together you can find the best treatment plan for you. Patient Information Sheet Celecoxib (marketed as Celebrex) This is a summary of the most important information about Celebrex. For details, talk to your healthcare provider. -------------------------------------------------------------------------------- FDA ALERT-[4/7/2005]: Celebrex has been linked to an increased risk of serious cardiovascular (CV) events (such as heart attack or stroke) which appears to be a risk shared by all medicines called non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin). FDA has requested that the package insert (labeling) for all NSAIDs, including Celebrex, be revised to include a “boxed” or serious warning to highlight the potential increased risk of CV events, and the well known risk of serious, and potentially life-threatening, stomach bleeding. FDA has also requested that the package insert for all NSAIDs be revised to state that patients who have just had heart surgery should not take these medicines. -------------------------------------------------------------------------------- What is Celebrex? Celebrex is used to: relieve symptoms of osteoarthritis (the arthritis caused by age-related “wear and tear” on bones and joints) relieve symptoms of rheumatoid arthritis in adults manage acute pain in adults (like the short term pain you can get after a dental or surgical operation) treat painful menstrual cycles reduce the number of colon and rectum growths (colorectal polyps) in patients with a disease called Familial Adenomatous Polyposis (FAP). FAP is an inherited disease in which the rectum and colon are covered with many polyps. Celebrex is used along with the usual care for FAP patients such as surgery and exams of the rectum and colon. Who Should Not Take Celebrex? Do not take Celebrex if you: have had an allergic-type reaction to sulfa medicines. have had asthma, hives or allergic-type reactions after taking aspirin or other NSAID (nonsteroidal anti-inflammatory drugs) medicines. If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since this type of reaction also has occurred after taking NSAIDs Celebrex should not be given to aspirin-sensitive patients. Some examples of NSAIDs are ibuprofen (Motrin, Advil), naproxen (Naprosyn, Aleve), diclofenac (Voltaren, Cataflam), and ketoprofen (Orudis). You can ask your doctor or pharmacist for a complete list of these medications. are pregnant, especially during your last 3 months What are The Risks? Celebrex and other NSAID medicines can cause serious problems such as: Stomach ulcers that bleed. The chance of this serious problem increases the longer you take Celebrex, but it can also happen suddenly. Stop taking Celebrex and call your healthcare professional right away if you get a burning stomach pain, black bowel movements that look like tar, or vomit that looks like blood or coffee grounds. Liver damage. Some of the warning signs of liver damage are nausea, vomiting, tiredness, loss of appetite, itching, yellow coloring of skin or eyes, “flu-like” symptoms and dark urine. If this happens, stop taking Celebrex and call your healthcare professional right away. Kidney problems that include sudden kidney failure or worsening of kidney problems that you already have. Fluid retention (holding of water in your body) and swelling. Fluid retention can be a serious problem if you have high blood pressure or heart failure. In addition to the serious side effects listed above, some common, but less serious side effects with Celebrex may include: headache indigestion upper respiratory tract infection (a "cold") diarrhea sinus inflammation stomach pain nausea What Should I Tell My Healthcare Professional? Tell your healthcare professional if you: have heart problems or high blood pressure have liver or kidney problems have or had stomach ulcers or stomach bleeding have asthma are allergic to aspirin or other NSAID medicines are trying to become pregnant, are already pregnant, or are breast-feeding Are There Any Interactions With Drugs or Foods? Tell your healthcare professional about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Celebrex works or Celebrex may affect how your other medicines work. Your healthcare professional may have to adjust your dose or watch you closely if you take any of the following medications: certain blood pressure medicines called ACE inhibitors furosemide fluconazole or ketoconazole phenytoin warfarin aspirin Celebrex This page contains drug information on Celebrex. The information provided includes the following: what is Celebrex the possible side effects of Celebrex what happens if you miss a dose of Celebrex what happens if you overdose with Celebrex the most important information about Celebrex how to use Celebrex other drugs that may affect Celebrex what to avoid while using Celebrex Generic Name: celecoxib (oral) (seh leh COCK sib) Brand Names: Celebrex