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What is bextra?
bextra is prescribed for the relief of osteoarthritis, rheumatoid arthritis, and painful menstruation.

Are there any side effects associated with bextra?
bextra side effects may include abdominal pain, diarrhea, headache, indigestion, nausea, swelling in the hands and feet, and upper respiratory infection. If the side effects continue or are bothersome, check with your doctor. Less common and rare bextra side effects may include abdominal fullness, abnormal or bloody stools, abnormal taste, acne, allergic reactions, anxiety, appendicitis, appetite changes, back pain, bad breath, bad dreams, belching, blood disorders, breast pain, brittle bones, burning or tingling sensation, cervical dysplasia, chest pain, chills, clotting problems, colitis, confusion, constipation, convulsions, coughing, cysts and tumors, dehydration, depression, digestive tract inflammation, dizziness, drowsiness, dry mouth, ear and vision problems, eye pain and problems, facial swelling, fatigue, fever, gallstones, general feeling of illness, generalized swelling, glandular problems, goiter, gout, hair loss, heart and circulation problems, heartburn, hemorrhoids, hepatitis, high cholesterol, high or low blood pressure, hot flushes, incontinence, impotence, infections, inflamed tendons or bones, intestinal problems and bleeding, joint problems, kidney failure, loss of sensation, mania, menstrual problems, migraine, mouth inflammation, muscle pain, muscle tension, nerve pain and problems, nervousness, nosebleeds, pain, prostate problems, psychosis, rash and other skin problems, respiratory problems, runny nose, skin inflammation, sleep problems, sore throat, stiff neck, stroke, swallowing problems, sweating, swelling around the eyes, tarry stools, thirst, tooth disorders, tremors, tumors, twitching, ulcer, urinary problems, vertigo, vomiting, weakness, and weight changes.

How is bextra taken?
Follow the directions for taking bextra provided by your doctor. bextra can be taken with or without food, and can be taken along with antacids if necessary. If you miss a dose take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take two doses at once.

Are there any effects of taking bextra with other medications?
Some medicines may interact with bextra. Inform your doctor of all prescription and over-the-counter medicine that you are taking. It is especially important to check with your doctor before combining bextra with aspirin, blood pressure medications known as ACE inhibitors, cough medications containing dextromethorphan, fluconazole, ketoconazole, lithium, warfarin, or water pills.

How should I store bextra?
Store bextra at room temperature in a tightly closed container, away from heat and light.


Important News About bextra (valdecoxib tablets)
On April 7, the Food and Drug Administration requested that Pfizer suspend sales of bextra in the United States. As a result, bextra will no longer be available to patients in the United States. The FDA is requiring all manufacturers of prescription non-steroidal anti-inflammatory arthritis medicines to provide additional information about cardiovascular and gastrointestinal risks. The FDA is also asking all the manufacturers of over-the-counter NSAIDs to revise their labels to include more information on cardiovascular, gastrointestinal and skin risks.

Why will bextra no longer be available?

In light of the FDA's position that there is an increased cardiovascular risk for all prescription non-steroidal anti-inflammatory arthritis medicines, as well as the increased rate of rare, serious skin reactions with bextra, the FDA has requested that sales of bextra be suspended.

What should you do?

You should contact your physician to discuss alternative treatments.

How do I get a refund for my unused bextra tablets?

You may bring your unused bextra tablets to your local pharmacy and request a refund. Or you may contact the National Notification Center (NNC) at 1-866-608-3935 to receive a patient product return kit by mail. NNC will process your refund on Pfizer's behalf.

The patient return kit and required documents must be completed and postmarked or received by UPS no later than September 15, 2005, in order to be eligible for a refund.


 

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~KEYWORD1~~
valdecoxib (val deh COCK sib)





What is the most important information I should know about bextra?
Do not take bextra 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), rofecoxib (Vioxx), 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 bextra.
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.
Stop taking bextra 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 bextra?
bextra is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). bextra works by reducing substances in the body that cause inflammation, pain, and fever.
bextra is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. bextra is also used to treat painful menstruation.
bextra may also be used for purposes other than those listed in this medication guide.




What should I discuss with my healthcare provider before taking bextra?
Do not take bextra 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), rofecoxib (Vioxx), 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 bextra.
Before taking bextra, tell your doctor if you have
a history of stomach ulcers or bleeding in the stomach;
liver disease;
kidney disease;
asthma;
congestive heart failure;
fluid retention;
heart disease;
high blood pressure; or
a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin).
You may not be able to take bextra, 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.
bextra is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. bextra should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take bextra without first talking to your doctor if you are pregnant or could become pregnant during treatment.
It is not known whether bextra passes into breast milk. Do not take bextra without first talking to your doctor if you are breast-feeding a baby.




How should I take bextra?
Take bextra 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.
bextra can be taken with or without food or milk. Your doctor may recommend taking higher doses of bextra with food. Follow your doctor's instructions.
Store bextra 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 bextra overdose include drowsiness, nausea, vomiting, and stomach pain.




What should I avoid while taking bextra?
There are no restrictions on food, beverages, or activity while taking bextra unless otherwise directed by your doctor.




What are the possible side effects of bextra?
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.
Stop taking bextra 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.
If you experience any of the following serious side effects, stop taking bextra and seek medical treatment or contact your doctor immediately:
abdominal pain, tenderness, or discomfort;
bloody, black, or tarry stools;
nausea or heartburn;
bloody vomit;
unexplained weight gain;
swelling or water retention;
unusual fatigue or lethargy;
yellowing of the skin or eyes;
"flu-like" symptoms; or
unusual bruising or bleeding.
Other, less serious side effects may be more likely to occur. Continue to take bextra 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 bextra?
Before taking bextra, 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 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);
lithium (Eskalith, Lithobid, others); or
fluconazole (Diflucan) or ketoconazole (Nizoral).
You may not be able to take bextra, 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 bextra. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.






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