In the U.S.—

• Antirheumatic (nonsteroidal anti-inflammatory), antidysmenorrheal

Valdecoxib ( val-de-KOX-ib ) is a non-steroidal anti-inflammatory drug. Nonsteroidal anti-inflammatory drugs (also called NSAIDs) are used to relieve some symptoms caused by arthritis (rheumatism), 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. It may also be used to treat pain associated with menstrual periods.

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

Oral
• Tablets (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 valdecoxib, the following should be considered:

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

Pregnancy—Valdecoxib has not been studied in pregnant women. However, studies in animals have shown that valdecoxib causes birth defects and other problems. Valdecoxib may cause problems in the baby's heart and lungs and is not recommended late in pregnancy. 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 valdecoxib passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

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

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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 valdecoxib, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Aspirin—Use of valdecoxib with this medicine may cause stomach upset or problems

• Fluconazole (e.g., Diflucan) or
• Ketoconazole (e.g., Nizoral) or
• Lithium (e.g., Lithane)—Taking these medicines may cause the amount of valdecoxib in your blood to be too high

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

• Anaphylaxis due to allergy to aspirin or other nonsteroidal anti-inflammatory medicines or
• Asthma with inflammation in the nose (with or without polyps) or with spasm in the breathing tubes caused by aspirin or other non-steroidal anti-inflammatory medicines—Using valdecoxib with these medicines may cause these problems to become much worse.

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

Dosing—

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.

The dose of valdecoxcib 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 valdecoxcib. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets 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 valdecoxcib.

• For oral dosage form (tablets):
  • For dysmenorrhea (pain with your menstrual period):
    • Adults—Take 20 milligrams (mg) twice a day.
    • Children—Use and dose must be determined by your doctor.
  • For osteoarthritis:
    • Adults—Take 10 mg once a day.
    • Children—Use and dose must be determined by your doctor.
  • For rheumatoid arthritis:
    • Adults—Take 10 mg once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If your health care professional ordered you to take this medicine according to a regular schedule, and you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed 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. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

If you will be taking this medicine for a long time, it is very important that your doctor check you 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.

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, sticky 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.

Valdecoxib 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. 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 immediately if any of the following side effects occur:

• Less common
  • Bloating or swelling of face, arms, hands, lower legs, feet;  blood in urine;  bloody, black or sticky stools;  blurred vision;  chills;  decreased or painful urination;  dizziness;  fever;  muscle aches and pains;  nausea;  nervousness;  pale skin;  pounding in the ears;  rapid weight gain;  severe stomach pain;  tingling of the hands or feet;  trouble breathing with exertion;  unusual bleeding or bruising;  unusual tiredness or weakness;  vomiting of blood or material that looks like coffee grounds;  yellow eyes or skin  
  
  

• Symptoms of Overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • 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
  • Acid or sour stomach;  belching;  cough;  diarrhea;  ear congestion;  headache;  heartburn;  indigestion;  sore throat 
  
  

• Less common
  • Abdominal fullness;  accidental injury ;  back pain;  bloating in the abdomen;  excess gas;  rash;  stuffy or runny nose 
  
  

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