valdecoxib

Pronunciation:	val deh COCK sib
Brand:	Bextra

What is the most important information I should know about valdecoxib?

The manufacturer of valdecoxib (Bextra) has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (valdecoxib is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking valdecoxib.

Do not take valdecoxib without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to valdecoxib.

Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

Serious skin reactions have occurred in patients taking valdecoxib. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking valdecoxib and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction.

What is valdecoxib?

Valdecoxib is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Valdecoxib works by reducing substances in the body that cause inflammation, pain, and fever.

Valdecoxib is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Valdecoxib is also used to treat painful menstruation.

Valdecoxib may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking valdecoxib?

Valdecoxib should not be used for the treatment of pain after coronary artery bypass surgery (CABG). The use of valdecoxib in such patients has led to an increased incidence of cardiovascular events, deep surgical infections and wound complications. Talk to your doctor before taking valdecoxib if you are being treated for pain associated with CABG.

Before taking valdecoxib, tell your doctor if you

smoke;
drink alcohol;
have an ulcer or bleeding in the stomach;
have liver disease;
have kidney disease;
have asthma;
have congestive heart failure;
have fluid retention;
have heart disease;
have high blood pressure;
have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin); or
are taking a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others.

You may not be able to take valdecoxib, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.

Valdecoxib is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Valdecoxib should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take valdecoxib without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether valdecoxib passes into breast milk. Do not take valdecoxib without first talking to your doctor if you are breast-feeding a baby.

If you are over the age of 65 years, you may be more likely to experience side effects from valdecoxib. You may require a lower dosage or special monitoring during your therapy.

How should I take valdecoxib?

Take valdecoxib exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Valdecoxib can be taken with or without food or milk. Follow your doctor's instructions.

Store valdecoxib at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a valdecoxib overdose include drowsiness, nausea, vomiting, and stomach pain.

What should I avoid while taking valdecoxib?

There are no restrictions on food, beverages, or activity while taking valdecoxib unless otherwise directed by your doctor.

What are the possible side effects of valdecoxib?

Other, less serious side effects may be more likely to occur. Continue to take valdecoxib and talk to your doctor if you experience

diarrhea;
nausea or upset stomach; or
headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect valdecoxib?

Before taking valdecoxib, tell your doctor if you are taking any of the following drugs:

aspirin or another salicylate (form of aspirin) such as salsalate (Disalcid), choline salicylate-magnesium salicylate (Trilisate, Tricosal, others), and magnesium salicylate (Doan's, Bayer Select Backache Formula, others);
an over-the-counter cough, cold, allergy, or pain medicine that contains dextromethorphan, aspirin, ibuprofen, naproxen, or ketoprofen;
a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (HydroDiuril, others), chlorothiazide (Diuril, others), chlorthalidone (Hygroton, Thalitone), and others;
an angiotensin-converting-enzyme inhibitor (ACE inhibitor) such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and others;
a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others;
an anticoagulant (blood thinner) such as warfarin (Coumadin);
diazepam (Valium);
phenytoin (Dilantin);
glyburide (DiaBeta, others);
an oral contraceptive (Micronor, Triphasil, Levlen, others);
omeprazole (Prilosec, Zegerid);
lithium (Eskalith, Lithobid, others); or
fluconazole (Diflucan) or ketoconazole (Nizoral).

You may not be able to take valdecoxib, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with valdecoxib. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.

Where can I get more information?

Your pharmacist has additional information about valdecoxib written for health professionals that you may read.

What does my medication look like?

Valdecoxib is available with a prescription under the brand name Bextra. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Bextra 10 mg-white, film-coated, capsule-shaped tablets
Bextra 20 mg-white, film-coated, capsule-shaped tablets

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Copyright 1996-2003 Cerner Multum, Inc. Version: 4.01. Revision date: 5/8/06.

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