In the U.S.—

In Canada—

• Analgesic
• Antidysmenorrheal
• Antirheumatic, nonsteroidal anti-inflammatory

Celecoxib ( sell–a–COKS–ib) is used to relieve some symptoms caused by arthritis, such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

Celecoxib may also be used for the following problems:

• Familial adenomatous polyposis (polyps in the intestines);
• Moderate or severe pain, such as after dental or orthopedic procedures;
• Pain during menstruation

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Capsules (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For celecoxib, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to celecoxib, other nonsteroidal anti-inflammatory drugs, aspirin or other salicylates, or sulfonamide-type medicines. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Celecoxib has not been studied in pregnant women. However, there is a chance that this medicine may cause unwanted effects on the heart or blood flow of the fetus or newborn baby if it is taken regularly during the last few months of pregnancy. Studies in animals have shown that celecoxib has caused birth defects of the ribs and sternebrae. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether celecoxib passes into breast milk. However, celecoxib may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of celecoxib in children with use in older age groups.

Older adults—This medicine has been tested in a limited number of elderly patients 65 years of age and older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, elderly patients may be more sensitive to the side effects of celecoxib.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking celecoxib, it is especially important that your health care professional know if you are taking any of the following:

• Aspirin or
• Fluconazole (e.g., Diflucan)—The chance of serious side effects may be increased

• Lithium (e.g., Lithane)—Higher blood levels of celecoxib and an increased chance of side effects may occur

• Alcohol abuse or
• Bleeding problems or
• Stomach ulcer or other stomach or intestinal problems or
• Tobacco use (or recent history of)—The chance of side effects may be increased

• Anemia or
• Asthma or
• Dehydration or
• Fluid retention (swelling of feet or lower legs) or
• Heart disease or
• High blood pressure or
• Kidney disease or
• Liver disease—Celecoxib may make these conditions worse

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your health care professional. Taking too much of this medicine may increase the chance of unwanted effects.

Dosing—

The dose of celecoxib will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of celecoxib. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking celecoxib.

• For oral dosage form (capsules):
  • For familial adenomatous polyposis (polyps in the intestines):
    • Adults— 400 mg twice a day with food.
    • Children—Use and dose must be determined by your doctor.
  • For moderate or severe pain, such as after dental or orthopedic procedures:
    • Adults— On the first day take 400 mg for the first dose then 200 mg as needed as a second dose. After the first day take 200 mg twice a day.
    • Children—Use and dose must be determined by your doctor.
  • Pain during menstruation:
    • Adults— On the first day take 400 mg for the first dose then 200 mg as needed as a second dose. After the first day take 200 mg twice a day.
    • Children—Use and dose must be determined by your doctor.
  • For rheumatoid arthritis:
    • Adults— 100 to 200 mg twice a day.
    • Children—Use and dose must be determined by your doctor.
  • For osteoarthritis:
    • Adults— 200 mg a day as a single dose or 100 mg twice day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If your health care professional has ordered you to take this medicine according to a regular schedule, and you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the next dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If you will be taking this medicine for a long time, your doctor should check your progress at regular visits.

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine, unless otherwise directed by your doctor.

Taking two or more of the nonsteroidal anti-inflammatory drugs together on a regular basis may increase the chance of unwanted effects. Also, taking acetaminophen, aspirin or other salicylates, or ketorolac (e.g., Toradol) regularly while you are taking a nonsteroidal anti-inflammatory drug may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your health care professional directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with this medicine for more than a few days, and do not take any ketorolac (e.g., Toradol) while you are taking this medicine, unless your doctor has directed you to do so and is following your progress.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

Check with your doctor immediately if fever, drowsiness, itching of the skin, tiredness, nausea, or stomach pain occurs; these effects may be the first signs of liver toxicity.

Celecoxib may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin, other nonsteroidal anti-inflammatory drugs, or sulfonamide-type drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once. Ask someone to drive you to the nearest hospital emergency room. If this is not possible, do not try to drive yourself. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Cough;  fever;  skin rash;  sneezing;  sore throat;  swelling of face, fingers, feet, and/or lower legs 
  
  

• Less common or rare
  • Bloody or black tarry stools;  burning feeling in chest or stomach;  chills;  congestion in chest;  cough;  diarrhea;  fatigue;  fever;  loss of appetite;  muscle aches and pains;  nausea;  shortness of breath;  stomach pain (severe);  tenderness in stomach area;  unusual weight gain;  vomiting of blood or material that looks like coffee grounds;  weakness 
  
  

• Symptoms of overdose
  • Bloody or black, tarry stools;  continuing thirst;  dizziness;  drowsiness ;  headache, severe or continuing;  nausea and/or vomiting;  shortness of breath;  stomach pain;  sudden decrease in the amount of urine;  swelling of face, fingers, and/or lower legs;  tightness in chest and/or wheezing;  troubled breathing;  unusual tiredness or weakness;  vomiting of blood or material that looks like coffee grounds;  weight gain 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Back pain;  dizziness;  gas;  headache;  heartburn ;  inability to sleep;  nausea ;  pain or burning in throat;  stomach pain;  stuffy or runny nose 
  
  

• Less common
  • Anxiety;  blurred vision;  buzzing or ringing noise in ears;  change in sense of taste;  constipation;  decreased appetite;  depression;  difficulty swallowing;  dry mouth;  fast heartbeat;  increased sweating;  joint or muscle pain or stiffness;  loss of energy or weakness;  nervousness;  numbness or tingling in fingers and/or toes;  pain or burning in throat;  pounding heartbeat;  sleepiness;  sudden sweating and feelings of warmth;  unusual tiredness;  vomiting 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.