Valdecoxib (Systemic)

Brand name(s): ercially availab

Before Using This Medicine

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 or sulfonamides. 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

• Oral contraceptives (birth control pills), norethindrone/ethinyl estradiol (e.g., Ortho-Novum 1/35)-May increase your chance of getting oral contraceptive side effects.

Other medical problems-The presence of other medical problems may affect the use of valdecoxib. Make sure you tell your doctor if you have any other medical problems, especially:

• 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

• 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 or
• Skin rash after taking aspirin or NSAIDs-Using valdecoxib with these medicines may cause these problems to become much worse.

• Allergy to sulfonamides (sulfamethoxazole and trimethoprim [e.g., Bactrim, Cotrim], sulfisoxazole [e.g., Gantrisin])-May be at greater risk of serious skin reactions

• 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

• Pain after coronary artery bypass graft (CABG) surgery-Higher risk of serious heart complications and infection in these patients. Valdecoxib should not be used.

Last Revised: 04/08/2005