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Bextra®

Brand Name: Bextra®
Active Ingredient:   valdecoxib
Strength(s): 10 mg and 20 mg
Dosage Form(s):   Tablets 
Company Name:    G.D. Searle & Co.
Availability:         Prescription only
*Date Approved by FDA:   November 16, 2001
*Approval by the FDA does not mean that the drug is available for consumers at this time.




What is Bextra used for?  

Bextra is used to relieve: 

Who should not take Bextra? 

You should not take Bextra if you: 

  • had asthma, hives or allergic reactions after taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs) or COX-2 inhibitors. Some examples of NSAIDs are ibuprofen (Motrin, Advil), naproxen (Naprosyn, Aleve), diclofenac (Voltaren, Cataflam), nabumetone (Relafen), ketoprofen (Orudis), celecoxib (Celebrex), and rofecoxib (Vioxx). You can ask your doctor or pharmacist for a complete list of these medications 
  • are allergic to valdecoxib (Bextra) or to any of the ingredients in Bextra

Special Warnings with Bextra:

Bextra and all NSAID medications can cause stomach ulcers that bleed. The chance of this serious problem increases the longer you take Bextra, but it can also happen suddenly. Stop taking Bextra and call your doctor right away if you get: 

  • a burning stomach pain 
  • black bowel movements that look like tar 
  • vomit that looks like blood or coffee grounds 

General Precautions with Bextra:

Bextra and other NSAID medications can cause serious problems such as liver damage. Some of the warning signs of liver damage are nausea, vomiting, tiredness, loss of appetite, itching, yellow coloring of skin or eyes, “flu-like” symptoms and dark urine. If this happens, stop taking Bextra and call your doctor right away. 

  • Bextra can cause fluid retention (holding of water in your body). Fluid retention can be a serious problem if you have high blood pressure or heart failure. 

Do not use Bextra if you have asthma and are allergic to aspirin. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. The same reactions to aspirin and other NSAID medicines happened in aspirin-sensitive patients. 

What should I tell my health care provider?

Tell your health care provider if you: 

  • have heart problems or high blood pressure 
  • have liver or kidney problems 
  • have or had stomach ulcers or stomach bleeding 
  • have asthma 
  • are allergic to aspirin or other NSAID medicines 
  • are pregnant or planning to become pregnant 
  • are breast-feeding 

Tell your health care provider about all the medicines that you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements. Your health care provider may have to adjust your dose or watch you more closely if you take the following medications: 

  • certain blood pressure medicines called ACE inhibitors 
  • furosemide (Lasix) 
  • fluconazole or ketoconazole 
  • lithium 
  • warfarin (coumadin) 
  • aspirin 

What are some possible side effects of Bextra? (This is NOT a complete list of side effects reported with Bextra. Your health care provider can discuss with you a more complete list of side effects.

Side effects can include: 

  • Indigestion 
  • Nausea 
  •  Stomach pain 
  • Upper respiratory tract infection 
  • Diarrhea 
  • Headache 

Rarely serious ulcers and stomach bleeding have occurred in patients taking Bextra. 

For more detailed information about Bextra, ask your health care provider or pharmacist.

http://www.fda.gov/cder/foi/nda/2001/21-341_Bextra.htm   Link to Bextra's Approved Label  

Posted: 11/22/02

 

Back to Drug Side Effects


source: FDA


last update: December 2004





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