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, CELEBREX 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

CELEBREX 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 CELEBREX 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 CELEBREX, 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 CELEBREX 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—CELEBREX 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 CELEBREX, 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 CELEBREX 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 CELEBREX 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 CELEBREX:

• 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.