VALDECOXIB (Systemic)*
Some commonly used brand names are:
In the U.S.?
- Not commercially available
Note: | Valdecoxib was voluntarily withdrawn from the market in April 2005. |
* Not commercially available in the U.S.
Category
- Antirheumatic (nonsteroidalanti-inflammatory), antidysmenorrheal
Description
Valdecoxib (val-de-KOX-ib) is a non-steroidal anti-inflammatory drug. Nonsteroidalanti-inflammatory drugs (also called NSAIDs) are used to relieve some symptomscaused by arthritis (rheumatism), such as inflammation, swelling, stiffness,and joint pain. However, this medicine does not cure arthritis and will helpyou only as long as you continue to take it. It may also be used to treatpain associated with menstrual periods.
This medicine is available only with your doctor's prescription, in thefollowing dosage form:
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For valdecoxib, thefollowing should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to valdecoxib, other nonsteroidal anti-inflammatory drugs,aspirin or other salicylates or sulfonamides. Also tell your health care professionalif 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 defectsand other problems. Valdecoxib may cause problems in the baby's heart andlungs 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 intohuman breast milk. Although most medicines pass into breast milk in smallamounts, many of them may be used safely while breast-feeding. Mothers whoare taking this medicine and who wish to breast-feed should discuss this withtheir doctor.
Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of valdecoxibin children with use in other age groups.
Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingvaldecoxib, it is especially important that your doctor and pharmacist knowif you are taking any of the following:
- Aspirin?Use of valdecoxib with this medicine may cause stomachupset or problems
- Fluconazole (e.g., Diflucan) or
- Ketoconazole (e.g., Nizoral) or
- Lithium (e.g., Lithane)?Taking these medicines may cause theamount of valdecoxib in your blood to be too high
- Oral contraceptives (birth control pills), norethindrone/ethinylestradiol (e.g., Ortho-Novum 1/35)?May increase your chance of gettingoral contraceptive side effects.
Other medical problems?The presence of other medicalproblems may affect the use of valdecoxib. Make sure you tell your doctorif 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 effectsmay be increased
- Allergy to aspirin or other nonsteroidal anti-inflammatory medicinesor
- Asthma with inflammation in the nose (with or without polyps) orwith spasm in the breathing tubes caused by aspirin or other non-steroidalanti-inflammatory medicines or
- Skin rash after taking aspirin or NSAIDs?Using valdecoxib withthese 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 greaterrisk 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?Higherrisk of serious heart complications and infection in these patients. Valdecoxibshould not be used.
Proper Use of This Medicine
Dosing?The following section is for information only, since the drugis no longer available.
- Oral dosage form (tablets):
- For dysmenorrhea (pain with your menstrual period)
- For osteoarthritis
- For rheumatoid arthritis
Storage?To store this medicine:
- Keep out of the reach of children.
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Ifyou will be taking this medicine for a long time, itis very important that your doctor check you at regular visits .
Stomach problems may be more likely to occur if you drink alcoholic beverageswhile being treated with this medicine. Therefore, donot regularly drink alcoholic beverages while taking this medicine,unless otherwise directed by your doctor.
Serious side effects can occur during treatment with this medicine. Sometimesserious side effects can occur without any warning. However, possible warningsigns often occur, including swelling of the face, fingers, feet, and/or lowerlegs; severe stomach pain, black, sticky stools, and/or vomiting of bloodor material that looks like coffee grounds; unusual weight gain; and/or skinrash. Stop taking this medicine and check with your doctorimmediately if you notice any of these warning signs.
Serious skin reactions can occur during treatment with valdecoxib. Check with your doctor right away if you have any of the followingsymptoms while taking this medicine: blistering, peeling, loosening of skin,chills, cough, diarrhea, fever, itching, joint or muscle pain, red irritatedeyes, red skin lesions, often with a purple center, sore throat, sores ulcers,white spots in mouth or on lips, or unusual tiredness or weakness.
Check with your doctor immediately if fever, drowsiness,itching of the skin, tiredness, nausea, or stomach pain occurs; these effectsmay 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 toaspirin, 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 changesin 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 eyelidsor around the eyes. If these effects occur, get emergency help at once. Donot try to drive yourself. Call an ambulance, lie down, cover yourself tokeep warm, and prop your feet higher than your head. Stay in that positionuntil help arrives.
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Check with your doctorimmediately 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 stickystools; 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 thehands or feet; trouble breathing with exertion; unusual bleeding or bruising; unusualtiredness or weakness; vomiting of blood or materialthat looks like coffee grounds; yellow eyes or skin
Incidence not known
Blistering, peeling, loosening of skin; constipation; cracks in the skin; darkened urine; difficulty swallowing; fast heartbeat; hives; indigestion; itching, puffiness, orswelling of the eyelids or around the eyes, face, lips or tongue; itching; joint or muscle pain; large, hive-like swelling on face, eyelids, lips, tongue, throat,hands, legs, feet, sex organs; loss of appetite; loss of heat from the body; nausea; pains in stomach, side, or abdomen, possibly radiating to theback; red, irritated eyes; red skin lesions, often with a purple center; red,swollen skin; scaly skin; shortness of breath; skin rash; sores, ulcers, or white spots in mouth or on lips; tightness in chest; vomiting; wheezing; yellow eyes or skin
Symptoms of overdose
Get emergency help immediately if any of the followingsymptoms of overdose occur
Bloody or black tarry stools; continuingthirst; dizziness; drowsiness; headache, severe or continuing; nausea and/or vomiting; shortness of breath; stomach pain; sudden decrease in theamount of urine; swelling of face, fingers, and/orlower legs; tightness in chest and/or wheezing; troubled breathing; unusual tirednessor weakness; vomiting of blood or material that lookslike coffee grounds; weight gain
Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.
Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.
Developed: 12/17/2001
Revised: 04/08/2005
