Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Celecoxib is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain.

Celecoxib is used to treat juvenile rheumatoid arthritis in children who are at least 2 years old. It is also used in the treatment of hereditary polyps in the colon.

Elyxyb is used to treat migraine headaches with or without aura in adults. Elyxyb will only treat migraine headaches, but it will not prevent a headache that has already begun.

Celecoxib can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Celecoxib may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults. You should not take this medicine if you already have bleeding in your stomach or intestines.

Take celecoxib exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.

You may take celecoxib with or without food.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture with water. You may save this applesauce mixture for later use in a refrigerator for up to 6 hours.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Pain:

Acute pain: 400 mg initially, followed by 200 mg if needed on the first day. Then, 200 mg twice daily as needed.

Usual Adult Dose for Dysmenorrhea:

400 mg initially, followed by 200 mg if needed on the first day. Then, 200 mg twice daily as needed.

Usual Adult Dose for Osteoarthritis:

200 mg orally once daily or 100 mg orally twice daily.

Usual Adult Dose for Rheumatoid Arthritis:

100 to 200 mg orally twice daily.

Usual Adult Dose for Familial Adenomatous Polyposis:

400 mg orally twice daily with food.

Usual Adult Dose for Ankylosing Spondylitis:

200 mg orally once daily or 100 mg orally twice daily. If after 6 weeks of therapy no results are observed, a trial dose of 400 mg orally daily may be worthwhile. If no response is seen after 6 weeks, consideration should be given to alternate treatment options.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

2 years or older:

10 to less than or equal to 25 kg: 50 mg orally twice daily

Greater than 25 kg: 100 mg orally twice daily

You should not use celecoxib if you are allergic to it, or if you have:

• an allergy to sulfa drugs; or

• a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure celecoxib is safe for you, tell your doctor if you have ever had:

• a stomach ulcer, bleeding in your stomach or intestines;

• heart disease, high blood pressure;

• asthma;

• bleeding problems;

• liver or kidney disease; or

• if you smoke or drink alcohol.

If you are pregnant, you should not take celecoxib unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

This medicine may affect fertility (ability to have children) in women. Ask your doctor about this risk.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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.

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

Avoid taking aspirin or other NSAIDs while you are taking celecoxib, unless your doctor tells you to.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to celecoxib (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction to celecoxib (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using celecoxib and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Stop using this medicine and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;

• heart problems - swelling, rapid weight gain, feeling short of breath;

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems - nausea, stomach pain (upper right side), itching, tiredness, dark urine, jaundice (yellowing of the skin or eyes);

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common celecoxib side effects may include:

• stomach pain, heartburn, gas, diarrhea, constipation, nausea, vomiting;

• swelling in your hands or feet;

• dizziness; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using celecoxib if you take an antidepressant, steroid medicine, or medicine to treat or prevent blood clots. Taking certain medicines with an NSAID may increase your risk of a stomach ulcer or bleeding.

Many drugs can interact with celecoxib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Your blood pressure should be checked regularly during your treatment.

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.

• Consensi® (containing Amlodipine, Celecoxib)