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What is of bextra?
of bextra is prescribed for the relief of osteoarthritis, rheumatoid
arthritis, and painful menstruation.
Are there any side effects associated with of bextra?
of 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 of 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 of bextra taken?
Follow the directions for taking of bextra provided by your doctor.
of 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 of bextra with other medications?
Some medicines may interact with of 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 of 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 of bextra?
Store of bextra at room temperature in a tightly closed container, away
from heat and light.
Important News About of bextra (valdecoxib tablets)
On April 7, the Food and Drug Administration requested that Pfizer suspend
sales of of bextra in the United States. As a result, of 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 of 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 of bextra,
the FDA has requested that sales of 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 of bextra tablets?
You may bring your unused of 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 of bextra?
• Do not take of 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 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 of 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 of bextra?
• of bextra is in a class of drugs called nonsteroidal anti-inflammatory
drugs (NSAIDs). of bextra works by reducing substances in the body that
cause inflammation, pain, and fever.
• of bextra is used to reduce pain, inflammation, and stiffness caused by
osteoarthritis and adult rheumatoid arthritis. of bextra is also used to
treat painful menstruation.
• of 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 of bextra?
• Do not take of 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 of bextra.
• Before taking of 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 of 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.
• of bextra is in the FDA pregnancy category C. This means that it is not
known whether it will be harmful to an unborn baby. of 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 of bextra without first talking
to your doctor if you are pregnant or could become pregnant during treatment.
• It is not known whether of bextra passes into breast milk. Do not take
of bextra without first talking to your doctor if you are breast-feeding a
baby.
How should I take of bextra?
• Take of 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.
• of bextra can be taken with or without food or milk. Your doctor may
recommend taking higher doses of of bextra with food. Follow your doctor's
instructions.
• Store of 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 of bextra overdose include drowsiness, nausea, vomiting,
and stomach pain.
What should I avoid while taking of bextra?
• There are no restrictions on food, beverages, or activity while taking
of bextra unless otherwise directed by your doctor.
What are the possible side effects of 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 of 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
of 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 of 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 of bextra?
• Before taking of 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 of 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 of bextra. Talk
to your doctor and pharmacist before taking any prescription or
over-the-counter medicines, including herbal products.