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What is the most important information I should know about rofecoxib?
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The manufacturer of rofecoxib (Vioxx) has announced a voluntary
withdrawal of the drug from the U.S. and worldwide market. This
withdrawal is due to safety concerns of an increased risk of
cardiovascular events (including heart attack and stroke) in patients
taking rofecoxib. |
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Notify your doctor immediately if you develop abdominal pain,
tenderness, or discomfort; nausea; blood in your vomit; bloody, black,
or tarry stools; unexplained weight gain; swelling or water retention;
fatigue or lethargy; a skin rash; itching; yellowing of your 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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Rofecoxib is in a class of drugs called nonsteroidal
anti-inflammatory drugs (NSAIDs). Rofecoxib works by reducing substances
that cause inflammation, pain, and fever in the body. |
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Rofecoxib is used to reduce pain, inflammation, and stiffness caused
by osteoarthritis, rheumatoid arthritis and certain forms of juvenile
rheumatoid arthritis; to manage acute pain in adults; to treat migraines;
and to treat menstrual pain. |
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Rofecoxib 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
rofecoxib?
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The manufacturer of rofecoxib (Vioxx) has announced a voluntary
withdrawal of the drug from the U.S. and worldwide market. This
withdrawal is due to safety concerns of an increased risk of
cardiovascular events (including heart attack and stroke) in patients
taking rofecoxib. |
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Do not take rofecoxib without first talking to your doctor if you
have experienced asthma, hives, or an allergic reaction after taking
aspirin or another NSAID such as ibuprofen (Motrin, Advil, Nuprin),
naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis,
Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid),
etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid),
indomethacin (Indocin), ketorolac (Toradol), nabumetone (Relafen),
oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), tolmetin (Tolectin),
celecoxib (Celebrex), valdecoxib (Bextra), or meloxicam (Mobic). You may
experience a similar reaction to rofecoxib. |
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Before taking rofecoxib, tell your doctor if you |
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have ever had an ulcer or bleeding in your 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 rofecoxib, 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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Rofecoxib is in the FDA pregnancy category C. This means that it is
not known whether it will harm an unborn baby. Rofecoxib should not be
taken late in pregnancy (the third trimester) because it may affect the
formation of the baby's heart. Do not take rofecoxib 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 rofecoxib passes into breast milk. Do not
take rofecoxib without first talking to your doctor if you are
breast-feeding. |
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If you are over the age of 65 years, you may be more likely to
experience side effects from rofecoxib. You may require a lower dosage
or special monitoring during treatment. |
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How should I take rofecoxib?
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Take rofecoxib 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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Shake the rofecoxib suspension well before measuring a dose. Use a
dose-measuring cup or spoon, not a regular table spoon, to measure the
liquid form of rofecoxib to ensure that you measure the correct amount
of medicine. If you do not have a dose-measuring device, ask your
pharmacist where you can get one. |
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Rofecoxib can be taken with or without food or milk. |
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Store rofecoxib 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 your doctor directs otherwise. |
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What happens if I overdose?
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Seek emergency medical attention. |
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Symptoms of a rofecoxib overdose are not known. |
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What should I avoid while taking rofecoxib?
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There are no restrictions on food, beverages, or activity during
treatment with rofecoxib, unless otherwise directed by your doctor. |
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What are the possible side effects of rofecoxib?
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Notify your doctor immediately if you develop abdominal pain,
tenderness, or discomfort; nausea; blood in your vomit; bloody, black,
or tarry stools; unexplained weight gain; swelling or water retention;
fatigue or lethargy; a skin rash; itching; yellowing of your 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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If you experience any of the following serious side effects, stop
taking rofecoxib and seek medical treatment or contact your doctor
immediately: |
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an allergic reaction (difficulty breathing; closing of your throat;
swelling of your lips, tongue, or face; or hives); |
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abdominal pain, tenderness, or discomfort; |
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bloody, black, or tarry stools; |
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unexplained weight gain; |
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swelling or water retention; |
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unusual fatigue or lethargy; |
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a skin rash or itching; |
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yellowing of your skin or eyes; |
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"flu-like" symptoms; or |
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unusual bruising or bleeding. |
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Other, less serious side effects may be more likely to occur.
Continue to take rofecoxib and talk to your doctor if you experience |
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mild fatigue or weakness; 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 rofecoxib?
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Before taking rofecoxib, tell your doctor if you are taking any of
the following drugs: |
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aspirin or an aspirin-like medication 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 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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methotrexate (Rheumatrex, Folex); |
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theophylline (Theo-Dur, Theobid, and others); |
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lithium (Eskalith, Lithobid, others); or |
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rifampin (Rimactane, Rifadin, Rifater). |
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You may not be able to take an rofecoxib, 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 rofecoxib.
Talk to your doctor and pharmacist before taking any prescription or
over-the-counter medicines, including herbal products. |
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Where can I get more information?
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Your pharmacist has additional information about rofecoxib 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 1996-2005 Cerner Multum, Inc. Version: 7.01. Revision date: 1/
19/ 05. |