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HOW
DOES VIOXX WORK?
In the body, 2 enzymes are called COX-1 and COX-2. COX-1
helps regulate normal cell function in the stomach and
blood. COX-2 plays a role in causing arthritis pain
and inflammation by causing the release of specific
compounds into the blood called cytokines. Cytokines
are compounds that lead to pain and inflammation of
joint tissue. VIOXX is a scientific breakthrough; the
first product to target only the COX-2 enzyme. By inhibiting
COX-2 those compounds that lead to inflammation and
pain are inhibited from being released into the blood.
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HOW
EFFECTIVE IS VIOXX?
OSTEOARTHRITIS:
VIOXX was evaluated for the treatment of the signs and
symptoms of Osteoarthritis of the knee and hip. The
effectiveness of placebo (sugar pill) was compared with
VIOXX treated patients in controlled clinical trials
of 6 to 86 weeks duration that enrolled approximately
3900 patients. In patients with Osteoarthritis, treatment
with VIOXX 12.5 mg and 25 mg once daily resulted in
an improvement in patient and physician assessments
in Osteoarthritis severity taking into account joint
pain, stiffness, and range of motion measures. In six
studies of pain accompanying Osteoarthritis flare, VIOXX
provided a significant reduction in joint pain at the
first determination (after one week in one study, after
two weeks in the remaining five studies); this continued
for the duration of the studies. In all Osteoarthritis
clinical studies, once daily treatment in the morning
with VIOXX 12.5 and 25 mg was associated with a significant
reduction in joint stiffness upon first awakening in
the morning.
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ANALGESIA
AND DYSMENORRHEA:
In acute pain relief models of post-operative dental
pain, post-orthopedic surgical pain, and primary dysmenorrhea,
VIOXX relieved pain that was rated by patients as moderate
to severe. In single-dose post-operative dental pain
studies, the onset of analgesia with a single 50-mg
dose of VIOXX occurred within 45 minutes.
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HOW
TO USE THIS MEDICATION:
You should continue to take VIOXX as prescribed even
when you are feeling better. VIOXX can be taken with
or without food. VIOXX capsules come in 3 strengths:
12.5, 25, and 50 mg.
In Osteoarthritis, the recommended dose for VIOXX is
25 to 50 mg a day. VIOXX delivers 24-hour relief from
a once-daily dose.
In analgesia and dysmenorrhea, the recommended dose
for VIOXX is also 25 to 50 mg once a day. VIOXX provides
relief through the day and through the night.
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CAN
I TAKE VIOXX IF I AM TAKING OTHER MEDICATIONS?
If you are one of the many people who take low-dose
aspirin for the prevention of heart attack or stroke,
you can still take VIOXX. However, taking VIOXX and
aspirin together can increase your risk for developing
stomach ulcers compared to taking VIOXX alone. VIOXX
is not a substitute for aspirin for heart attack or
stroke prevention.
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CAN
I TAKE VIOXX IF I AM PREGNANT?
In late pregnancy VIOXX should be avoided because it
may cause problems in the final development of the heart
in the fetus.
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IS
VIOXX A SUBSTITUTE FOR CORTICOSTEROIDS?
NO. VIOXX cannot be expected to substitute for corticosteroids
or to treat corticosteroid insufficiency. Abrupt discontinuation
of this medicine may lead to exacerbation of corticosteroid-responsive
illness. Patients on prolonged corticosteroid therapy
should have their therapy tapered slowly if a decision
is made to discontinue this medication.
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INCLUDE
IN YOUR MEDICAL HISTORY/PERSONAL PROFILE:
- If you are pregnant or plan to become pregnant. VIOXX
should not be used in late pregnancy because it may
harm the fetus.
- If you are breast-feeding or plan to breast-feed.
It is not known whether VIOXX is passed through to human
breast milk and what its effects could be on a nursing
child.
- If you have kidney disease.
- If you have liver disease.
- If you have heart failure.
- If you have high blood pressure.
- If you have had an allergic reaction to aspirin or
other NSAIDs.
- If you have had a serious stomach problem (ulcers)
in the past.
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DRUG
INTERACTIONS:
Include on your medical history/personal profile all
of the other medicines you are taking or plan to take
while you are on VIOXX, even other medicines that you
can get without a prescription. VIOXX has significant
drug interactions with:
- Methotrexate (a medicine used to suppress the immune
system).
- Warfarin (a blood thinner).
- Rifampin (an antibiotic).
- ACE inhibitors (medicines used for high blood pressure
and heart failure).
- Lithium (a medicine used to treat a certain type of
depression).
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ADVERSE
REACTIONS:
Serious but rare side effects that have been reported
in patients taking VIOXX are delineated below:
- Serious stomach problems, such as stomach and intestinal
bleeding, can occur with or without warning symptoms.
These problems, if severe, could lead to hospitalization
or death. Although this happens rarely, you should watch
for signs that you may have this serious side effect.
- Serious allergic reactions including swelling of the
face, lips, tongue, and/or throat which may cause difficulty
breathing or swallowing and wheezing occur rarely but
may require treatment right away. Severe skin reactions
have also been reported.
- Serious kidney problems occur rarely, including acute
kidney failure and worsening of chronic kidney failure.
- Severe liver problems, including hepatitis, jaundice
and liver failure, occur rarely in patients taking NSAIDs,
including VIOXX. Symptoms of liver problems include
nausea, tiredness, itching, tenderness in the right
upper abdomen, and flu-like symptoms.
In addition, the following side effects have been reported:
anxiety, confusion, depression, hair loss, hallucinations,
increased levels of potassium in the blood, low blood
cell counts, palpitations, pancreatitis, tingling sensation,
unusual headache with stiff neck (aseptic meningitis),
vertigo.
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WARNINGS
- DO NOT TAKE VIOXX IF YOU:
- have had an allergic reaction such as asthma attacks,
hives, or swelling of the throat and face to aspirin
or other NSAIDs (for example, ibuprofen and naproxen).
- have had an allergic reaction to celecoxib, which
is the active ingredient of VIOXX any of its inactive
ingredients.
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NOW!
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