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 HOW
DOES CELEBREX 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. CELEBREX 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 CELEBREX?
OSTEOARTHRITIS:
The effectiveness of CELEBREX was evaluated for the
treatment of the signs and symptoms of Osteoarthritis
of the knee and hip. To make this determination a placebo
(sugar pill) was compared with CELEBREX treated patients
in controlled clinical trials involving approximately
4,200 patients with Osteoarthritis. The clinical trials
lasted up to 12 weeks in duration. In patients with
Osteoarthritis, treatment with CELEBREX 100 mg BID or
200 mg one time each day resulted in an improvement
in patient and physician assessments in Osteoarthritis
severity taking into account joint pain, stiffness,
and range of motion measures. In three 12-week studies
of joint pain accompanying Osteoarthritis flare, CELEBREX
doses of 100 mg given twice daily and 200 mg given twice
daily provided significant reduction of pain within
24-48 hours of initiation of dosing. A total daily dose
of 200 mg has been shown to be equally effective whether
administered as 100 mg twice a day or 200 mg once a
day.
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RHEUMATOID
ARTHRITIS:
Patients treated with CELEBREX demonstrated a significant
reduction in joint tenderness/pain and joint swelling
compared to placebo (sugar pill). CELEBREX was evaluated
for treatment of the signs and symptoms of Rheumatoid
Arthritis in approximately 2,100 patients by comparing
placebo and CELEBREX treated patients in clinical trials
of up to 24 weeks in duration. CELEBREX was shown to
be superior to placebo in these studies, using a Rheumatoid
Arthritis severity index, a composite score taking into
account join pain, stiffness, and range of motion measures
as well as laboratory measures. In this study, it was
shown that CELEBREX doses of 100 mg twice a day and
200 mg twice a day were similar in effectiveness. Although
in general, the higher dosage is recommended for more
severe disease.
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HOW
TO USE THIS MEDICATION:
You should continue to take CELEBREX as prescribed even
when you are feeling better. CELEBREX can be taken with
or without food. CELEBREX capsules come in 2 strengths:
100 mg and 200 mg.
In Osteoarthritis, the recommended dose for CELEBREX
is 200 mg a day. CELEBREX delivers 24-hour relief from
a once-daily dose of 200 mg. Or if preferred, a dose
of 100 mg twice a day is available.
In Rheumatoid Arthritis, the recommended dose for CELEBREX
is 100 mg to 200 mg, twice a day. CELEBREX provides
relief through the day and through the night.
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CAN
I TAKE CELEBREX 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 CELEBREX. However, taking CELEBREX
and aspirin together can increase your risk for developing
stomach ulcers compared to taking CELEBREX alone. CELEBREX
is not a substitute for aspirin for heart attack or
stroke prevention.
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CAN
I TAKE CELEBREX IF I AM PREGNANT?
In late pregnancy CELEBREX should be avoided because
it may cause problems in the final development of the
heart in the fetus.
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IS
CELEBREX A SUBSTITUTE FOR CORTICOSTEROIDS?
NO. CELEBREX 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 CELEBREX, even other medicines that
you can get without a prescription. CELEBREX 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 CELEBREX 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 CELEBREX. 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 CELEBREX 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 CELEBREX any of its inactive
ingredients.
ORDER
NOW!
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