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What is the most important information I should know about
valdecoxib?
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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. |
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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. |
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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. |
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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. |
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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. |
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Valdecoxib is used to reduce pain, inflammation, and
stiffness caused by osteoarthritis and adult rheumatoid arthritis.
Valdecoxib is also used to treat painful menstruation. |
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Valdecoxib may also be used for purposes other than those
listed in this medication guide. |
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What should I discuss with my healthcare provider before taking
valdecoxib?
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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. |
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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. |
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Before taking valdecoxib, tell your doctor if you |
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have an ulcer or bleeding in the stomach; |
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have congestive heart failure; |
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have high blood pressure; |
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have a coagulation (bleeding) disorder or are taking an
anticoagulant (blood thinner) such as warfarin (Coumadin); or |
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are taking a steroid medicine such as prednisone (Deltasone
and others), methylprednisolone (Medrol and others), prednisolone (Prelone,
Pediapred, and others), and others. |
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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. |
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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. |
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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. |
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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. |
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How should I take valdecoxib?
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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. |
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Take each dose with a full glass of water. |
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Valdecoxib can be taken with or without food or milk. Follow
your doctor's instructions. |
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Store valdecoxib at room temperature away from moisture and
heat. |
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What happens if I miss a dose?
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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. |
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What happens if I overdose?
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Seek emergency medical attention. |
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Symptoms of a valdecoxib overdose include drowsiness, nausea,
vomiting, and stomach pain. |
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What should I avoid while taking valdecoxib?
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There are no restrictions on food, beverages, or activity
while taking valdecoxib unless otherwise directed by your doctor. |
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What are the possible side effects of valdecoxib?
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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. |
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• |
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. |
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Other, less serious side effects may be more likely to occur.
Continue to take valdecoxib and talk to your doctor if you experience |
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nausea or upset stomach; or |
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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. |
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What other drugs will affect valdecoxib?
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Before taking valdecoxib, tell your doctor if you are taking
any of the following drugs: |
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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); |
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an over-the-counter cough, cold, allergy, or pain medicine
that contains dextromethorphan, aspirin, ibuprofen, naproxen, or
ketoprofen; |
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a diuretic (water pill) such as furosemide (Lasix),
hydrochlorothiazide (HydroDiuril, others), chlorothiazide (Diuril,
others), chlorthalidone (Hygroton, Thalitone), and others; |
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an angiotensin-converting-enzyme inhibitor (ACE inhibitor)
such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec),
lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril),
and others; |
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a steroid medicine such as prednisone (Deltasone and others),
methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred,
and others), and others; |
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an anticoagulant (blood thinner) such as warfarin (Coumadin); |
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glyburide (DiaBeta, others); |
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an oral contraceptive (Micronor, Triphasil, Levlen, others); |
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omeprazole (Prilosec, Zegerid); |
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lithium (Eskalith, Lithobid, others); or |
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fluconazole (Diflucan) or ketoconazole (Nizoral). |
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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. |
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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. |
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Where can I get more information?
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Your pharmacist has additional information about valdecoxib
written for health professionals that you may read. |
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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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Every effort has been made to ensure that the information
provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and
complete, but no guarantee is made to that effect. Drug information
contained herein may be time sensitive. Multum information has been
compiled for use by healthcare practitioners and consumers in the United
States and therefore Multum does not warrant that uses outside of the
United States are appropriate, unless specifically indicated otherwise.
Multum's drug information does not endorse drugs, diagnose patients or
recommend therapy. Multum's drug information is an informational
resource designed to assist licensed healthcare practitioners in caring
for their patients and/ or to serve consumers viewing this service as a
supplement to, and not a substitute for, the expertise, skill, knowledge
and judgment of healthcare practitioners. The absence of a warning for a
given drug or drug combination in no way should be construed to indicate
that the drug or drug combination is safe, effective or appropriate for
any given patient. Multum does not assume any responsibility for any
aspect of healthcare administered with the aid of information Multum
provides. The information contained herein is not intended to cover all
possible uses, directions, precautions, warnings, drug interactions,
allergic reactions, or adverse effects. If you have questions about the
drugs you are taking, check with your doctor, nurse or pharmacist. |
Copyright 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision
date: 5/ 8/ 06. |