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<font face="Verdana"><font size="+1">Celebrex Online Shopping, an online informational and shopping site for celebrex and arthritis needs ...</font></font>
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Welcome to the CELEBREX® Web site, your online source of information about CELEBREX and relief from the pain and inflammation associated with osteoarthritis and adult rheumatoid arthritis. While exploring the site, you'll find answers to your questions about living with arthritis, articles written by arthritis expert, links CELEBREX and more. Click on any topic to see more information.
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There are a lot of sites in Internet about Celebrex®, most of them with obsolete information and outdated links. We have made a thorough research to built the "one-stop" informational website about Celebrex®. In these pages you will find information about arthritis, how to diagnose it and most important, how it can be treated. Our goal is to allow everybody to find the newest information about Celebrex®, without having to browse hundreds of sites. <FONT color=#ff0000>This one-stop site will be enough to find out all you need to know.
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As you may know, there are tons of sites from where you can buy Celebrex®. We have reviewed most of them and have gathered/chosen the ones that have the most efficient order fulfillment process. They are reliable companies that have several options to get Celebrex® online, depending on the amount of capsules you want or need to buy.<B>A brief d escription of arthritis pain.</B> <BR><BR><IMG align=right border=0 src="/assets/celebrex/images/pills.gif" vAlign="Top"> Arthritis is the inflammation of a joint, or joints. This inflammation may only happen in a localized area of the body, or it may be worse, more widespread, as is the case with inflammatory diseases like rheumatoid arthritis. Arthritis pain can be the result of any one of more than 100 different causes, from viral and bacterial infection to bad nutrition, to side-effects caused by certain medications. The two major kinds of arthritis, osteoarthritis and rheumatoid arthritis, have two primary symptoms in common: skeletal pain and joint inflammation.
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Osteoarthritis is the most common type of the two and a problem many older people have in common. It affects 40 million Americans, which is 80% of people over 50 years old. Rheumatoid arthritis is a multi-faceted illness, with chronic inflammation of the joints, muscles, ligaments and tendons. Arthritis is a complicated disease, harmful not only to bones and joints, but also to blood vessels, skin, eyes, kidneys, and brain. Symptoms of this painful and life-restricting affliction manifest in a variety of ways, none of them the least bit convenient. The good thing is that this debilitation is treatable with modern medicine. Celebrex has shown to provide successful results in patients suffering from arthritis pain. Arthritis can become a serious problem over time. It can restrict your ability to move around, to take care of yourself -- it can restrict your independence and enjoyment in life. This site is dedicated to offering fast and convenient service for people in need of this modern treatment for a problem which affects millions of Americans every day.
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<FONT color=#000000><FONT color=#999999 face=verdana size=+3>Features Of Rheumatoid Arthritis </FONT><FONT color=#000000 face="verdana, Arial, Helvetica, sans-serif" size=-1><BR><BR>Rheumatoid arthritis is an inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints. It has several special features that make it different from other kinds of arthritis. For example, rheumatoid arthritis generally occurs in a symmetrical pattern. This means that if one knee or hand is involved, the other one is also. The disease often affects the wrist joints and the finger joints closest to the hand. It can also affect other parts of the body besides the joints. In addition, people with the disease may have fatigue, occasional fever, and a general sense of not feeling well (malaise). <BR><BR>Another feature of rheumatoid arthritis is that it varies a lot from person to person. For some people, it lasts only a few months or a year or two and goes away without causing any noticeable damage. Other people have mild or moderate disease, with periods of worsening symptoms, called flares, and periods in which they feel better, called remissions. Still others have severe disease that is active most of the time, lasts for many years, and leads to serious joint damage and disability. <BR><BR>Although rheumatoid arthritis can have serious effects on a person's life and well-being, current treatment strategies-including pain relief and other medications, a balance between rest and exercise, and patient education and support programs-allow most people with the disease to lead active and productive lives. In recent years, research has led to a new understanding of rheumatoid arthritis and has increased the likelihood that, in time, researchers can find ways to greatly reduce the impact of this disease.
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<FONT color=#000000><FONT color=#999999 face=verdana size=+3>Outfoxing Pathways of Pain.</FONT><BR><BR><FONT color=#000000 face="verdana, Arial, Helvetica, sans-serif" size=-1><B>Approval of Celebrex, G. D. Searle & Co.'s new arthritis drug) ( U.S. News & World Report (Dec 14, 1998):62 (1pages).COPYRIGHT 1998 U.S. News and World Report Inc. </B><BR><BR>It was a vote with resonance from Wall Street to the homes of America's 23 million arthritis sufferers. Last week, in a stuffy hotel ballroom in Silver Spring, Md., the Food and Drug Administration's arthritis advisory committee's nine members unanimously recommended approval of Celebrex, G. D. Searle & Co.'s new arthritis drug. Those in the standing-room-only crowd of more than 300 industry scientists and market analysts stood up to watch the show of hands, and many reached for their cell phones the minute the vote was tallied to capitalize on the news. This is a nearly $2 billion-a-year market they're talking about. <BR><BR>But one arthritis-care expert remains skeptical. As a rheumatologist and spokesman for the Arthritis Foundation, Doyt Conn is as eager as anyone to see arthritis sufferers spring from their rocking chairs. But he says "time will tell" whether celecoxib, a new class of drug, to which Celebrex belongs, that targets arthritis inflammation and pain with fewer side effects, is worth the hoopla. <BR><BR>Conn's concern is that the drug, while it has been tested in more than 14,000 people (about 10 times more than typically submitted to the Food and Drug Administration, though no single patient has taken it for longer than about a year), may present unexpected side effects when used by millions for many years. "There's no reason to expect them to be any better than what we've already got. But there's good reason to hope they're safer," Conn said. <BR><BR>Bad enzyme Doctors have long known that nonsteroidal anti-inflammatory drugs, or NSAIDs, can relieve arthritis pain by blocking production of cyclooxygenase, or COX for short, an enzyme that helps make prostaglandins, the substance largely responsible for the pain and inflammation of arthritis. Philip Needleman, then chair of the pharmacology department at Washington University in St. Louis, was instrumental in figuring out in the 1980s that two enzymes help make prostaglandins, dubbed COX-1 and COX-2, and that COX-2 was the driver of the disease's symptoms. Needleman moved to Monsanto Corp., parent company of Searle, and, with an army of chemists, began working on a theory of "good enzyme, bad enzyme," to develop a drug that targets only COX-2. It doesn't affect COX-1, which protects the digestive system from its own erosive acids. Therein lies the benefit of COX-2 inhibitors: They ease pain just like common NSAIDs, including aspirin and ibuprofen, but without interfering with COX-1, thus reducing the risks of serious side effects like bleeding ulcers. About 107,000 people are hospitalized each year for upper gastrointestinal complications resulting from NSAID use; 16,500 of them die. <BR><BR>The theory that COX-2 inhibitors don't interfere with COX-1's stomach-protecting ability has proved largely true. But competitors of Searle, including Robert Palmer, group director of rheumatology clinical research and development for SmithKline Beecham, are eager to articulate the complications. Palmer points to a growing body of research that suggests that COX-1 and COX-2 may have overlapping functions and that neither is purely "good" or "bad." The FDA advisory committee urged that the drug's label warn of potential harm to the stomach and intestines, even though the risk is likely to be smaller than that of available arthritis drugs. <BR><BR>Celebrex awaits final FDA approval, likely by year-end. (Merck & Co. is close behind with Vioxx, a similar drug.) Celebrex will treat both osteoarthritis, which affects some 21 million people and results from wear and tear on the joints, and rheumatoid arthritis, an autoimmune disorder that affects about 2 million people. <BR><BR>Needleman, now co-president of Searle and chief scientist at Monsanto, is a rare scientist who has seen an idea through, from tissue in a petri dish to the imminent prospect of a new drug on the pharmacy shelf. "In science, a hypothesis is something you usually throw away," he said. "This one didn't melt." <BR><BR>Stomach-friendly pain reliever Typical nonsteroidal anti-inflammatory drugs (NSAIDs) reduce pain but they also may upset the stomach. A new NSAID called a COX-2 inhibitor works on the pain without bothering the stomach. <BR><BR>NSAIDs upset the stomach because they suppress enzymes that produce chemicals called prostaglandins, which protect the stomach from its own acids. <BR><BR>COX-2 inhibitors move directly to the source of pain to suppress the enzymes that produce other prostaglandins that cause pain and swelling.</FONT></FONT>
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<FONT color=#000000><FONT color=#999999 face=Verdana size=+3>Misconceptions
About Arthritis</FONT> <FONT color=#000000
face="verdana, Arial, Helvetica, sans-serif" size=-1><BR><BR><B>
<LI>Arthritis is an old person's disease. <BR>
<LI>Arthritis is induced by a cold, wet climate. <BR>
<LI>Arthritis is caused by a poor diet. <BR>
<LI>Arthritis can be cured. <BR>
<LI>Arthritis consists of only minor aches and pains. <BR>
<LI>"You felt fine yesterday....why so tired today?" <BR>
<LI>"You have arthritis, you can't......" </B><BR><BR><BR><BR><B>Arthritis is an
old person's disease</B> <BR><BR>The most common misconception about arthritis
is that it is a disease only of old people. In actuality, arthritis affects
children, young adults, middle-aged people, as well as the elderly. The disease
is not age or gender specific. There are over a hundred different types of
arthritis though, and some are more commonly found in particular groups.
Rheumatoid arthritis, fibromyalgia, and lupus are more commonly found in women
than men. Gout and ankylosing spondylitis appear more often in men than women.
Older people are more inclined to have osteoarthritis, the degenerative form of
arthritis linked to wear-and-tear on the joints. Anyone can have arthritis.
<BR><BR><B>Arthritis is induced by a cold, wet climate</B> <BR><BR>It has long
been theorized that arthritis is caused by a cold, wet climate. Moving to a
warm, dry climate has been regarded by some as the cure. Logically, one can
infer that if a warm climate cured arthritis, then no one in Southern California
or other warm regions would have arthritis. Warmth is soothing to everyone.
People without arthritis often feel better in warm climates too. Warmth can
relieve symptoms of arthritis, as does soaking in a hottub or taking a hot
shower. Bone rubbing on bone after cartilage has worn away causes pain in any
climate however. Climate itself is neither the cause, nor the cure.
<BR><BR>Since moving to Southern California from Ohio, I can say that the warm
climate has reduced the minor aches and pains that accompany my arthritic
condition. I believe part of the reason is attributable to the fact that I am
able to be more active in this climate. The fear of falling on the ice and in
the snow is no longer a problem. I am able to walk much more and I believe the
exercise has helped me tremendously. It has not reversed the serious damage the
disease has done to my cartilage and joints however. <BR><BR><B>Arthritis is
caused by a poor diet</B> <BR><BR>There has been an abundance of speculation
about the importance of diet in regard to arthritis. It is certain that a
nutritious, well-balanced diet and ideal weight maintenance improves overall
health and wellness for everyone. There are a few examples where there is a
definite diet connection such as between high uric acid levels and gout. There
is no scientific evidence though that specific foods prevent or cause arthritis.
Unless a person is found to have a particular food allergy which causes their
arthritis to flare, there is no proven direct link between a particular food
source and arthritis. Good diet does not prevent arthritis. <BR><BR><B>Arthritis
can be cured</B> <BR><BR>The notion that arthritis can be cured is a fallacy.
Since there are so many types of arthritis, the prognosis varies, but there is
no known cure for the disease. Arthritis is a chronic disease characterized by
periods of flares and remissions. Much has been discovered in terms of treatment
and slowing down the disease progression, but nothing yet has been found to
successfully halt the disease. Pain management and learning how to better live
with arthritis is an important focus since the disease is a lifelong process.
There has been no scientific evidence that a cure for arthritis exists.
<BR><BR><B>Arthritis consists of only minor aches and pains</B> <BR><BR>It is
another common misconception that arthritis exhibits only minor aches and pains.
Television commercials, which claim that a couple of aspirin or tylenol take
away the minor aches and pains of arthritis, mislead the public. Such
advertising, along with a lack of knowledge about the disease, expand some
people's unawareness of the more complex forms of arthritis which require more
aggressive forms of treatment. Joint destruction, loss of range of motion,
deformities, chronic pain, and fatigue are among the changes that occur when a
person is affected by arthritis. Arthritis consists of much more than just minor
aches and pains. <BR><BR><B>"You felt fine yesterday....why so tired today?"
</B><BR><BR>It is often difficult for the family and friends of an arthritic to
comprehend why they feel so much better or so much worse on any particular day.
The inconsistency of arthritis can even lead some people to believe the disease
is "all in your head". Arthritis is characterized by a mix of good days and bad
days. Some days the pain and fatigue is more exacerbated. A balance between rest
and activity is necessary to best manage living with arthritis. There is
variation in the duration and severity of the symptoms of arthritis.
<BR><BR><B>"You have arthritis, you can't...." </B><BR><BR>The limitations which
arthritis imposes on an individual can cause people closest to them to become
overprotective. Sometimes people do too much to try and help the person with
arthritis. The disease does interfere with some physical ability, but certainly
the arthritic person should not be viewed as totally dependent and invalid. A
certain amount of help and dependence is likely to be required. It must be
remembered though that it is best to maintain as much independence as possible
for both physical and emotional reasons. There is much a person with arthritis
CAN do. </FONT></LI></FONT>
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<FONT color=#000000 face="verdana, Arial, Helvetica, sans-serif" size=-1><A
name=q0 style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">What is
Celebrex? </A><BR>Celebrex™ is a nonsteroidal anti-inflammatory drug that
exhibits anti-inflammatory, analgesic, and antipyretic activities in animal
models. <A href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back
to top</A><BR><BR><BR><A name=q1
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">How does
Celebrex work? </A><BR>NSAIDs target an enzyme called cyclooxegenase that is
responsible for much inflammation behind pain. But it turned out there are two
types of this enzyme. Cox-2 was behind the inflammation, while cox-1 actually
protects the stomach lining. Unfortunately, NSAIDs target both which often can
result in ulcers. <BR><BR>The mechanism of action of Celebrex™ is believed to be
due to inhibition of prostaglandin synthesis, primarily via inhibition of
cyclooxygenase-2 (COX-2), and at therapeutic concentrations in humans, Celebrex™
does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme. <BR><BR>The theory was
that if scientists could develop a more specific drug that targeted just cox-2,
it would alleviate pain and inflammation while not effecting the delicate lining
of the stomach. <BR><BR>In studies of about 13,000 patients, it appeared to work
almost as well as prescription-strength naproxen in-patients with
osteoarthritis. In rheumatoid arthritis sufferers, it appeared to work almost as
well as another popular NSAID, diclofenac. <BR><BR>Clinical testing involving
some 4,500 endoscopies -- probing a tube into patients' stomachs to see if
ulcers were forming even before they experienced symptoms. Some 25 percent to 40
percent of patients taking ibuprofen or naproxen showed these mini-ulcers, vs. 5
percent to 10 percent of Celebrex patients. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q2
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">What other
clinical studies have been done? </A><BR>Celebrex™ has demonstrated significant
reduction in joint pain secondary to osteoarthritis (OA) compared to a placebo.
Celebrex™ was evaluated for treatment of the signs and the symptoms of OA of the
knee and hip in approximately 4,200 patients in placebo- and active-controlled
clinical trials of up to 12 weeks duration. In patients with OA, treatment with
Celebrex™ 100 mg twice per day or 200 mg once per day resulted in improvement in
WOMAC (Western Ontario and McMaster Universities) osteoarthritis index, a
composite of pain, stiffness, and functional measures in OA. In three 12-week
studies of pain accompanying OA flare, Celebrex™ doses of 100 mg twice per day
and 200 mg twice per day provided significant reduction of pain within 24-48
hours of initiation of dosing. At doses of 100 mg twice per day or 200 mg twice
per day the effectiveness of Celebrex™ was shown to be similar to that of
naproxen 500 mg BID. Doses of 200 mg twice per day provided no additional
benefit above that seen with 100 mg twice per day. A total daily dose of 200 mg
has been shown to be equally effective whether administered as 100 mg twice per
day or 200 mg once per day. <BR><BR><BR>Celebrex™ has demonstrated significant
reduction in joint tenderness/pain and joint swelling in Rheumatoid Arthritis
compared to placebo. Celebrex™ was evaluated for treatment of the signs and
symptoms of RA in approximately 2,100 patients in placebo- and active-controlled
clinical trials of up to 24 weeks in duration. Celebrex™ was shown to be
superior to placebo in these studies, using the ACR20 Responder Index, a
composite of clinical, laboratory, and functional measures in RA. Celebrex™
doses of 100 mg twice per day and 200 mg twice per day were similar in
effectiveness and both were comparable to naproxen 500 mg twice per
day.<BR><BR><BR>Although Celebrex™ 100 mg twice per day and 200 mg twice per day
provided similar overall effectiveness, some patients derived additional benefit
from the 200 mg twice per day dose. Doses of 400-mg day provided no additional
benefit above that seen with 100-200 mg twice per day.<A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q3
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">What is the
appropriate dose of Celebrex? </A><BR>As with any medication, the lowest dose of
Celebrex™ should be sought for each patient. For relief of the signs and
symptoms of osteoarthritis the recommended oral dose is 200 mg per day
administered as a single dose or as 100 mg twice per day. <BR><BR><BR>For relief
of the signs and symptoms of rheumatoid arthritis the recommended oral dose is
100 to 200 mg twice per day. (these doses are only generalizations; doses may
vary depending on the patient's medical history). <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q4
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">How is Celebrex
supplied? </A><BR>Celebrex™ 100-mg capsules are white, reverse printed white on
blue band of body and cap with markings of 7767 on the cap and 100 on the body.
<BR><BR><BR>Celebrex™ 200-mg capsules are white, with reverse printed white on
gold band with markings of 7767 on the cap and 200 on the body. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q5
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">In what
populations is Celebrex contraindicated? <BR><BR></A>
<UL>
<LI>Celebrex™ is contraindicated in patients with known hypersensitivity to
celecoxib.
<LI>Celebrex™ should not be given to patients who have demonstrated
allergic-type reactions to sulfonamides.
<LI>Celebrex™ should not be given to patients who have experienced asthma,
urticaria, or allergic-type NSAIDs have been reported in such patients.<A
href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR></LI></UL><A name=q6
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">What are side
effects associated with Celebrex? </A><BR>Of the Celebrex treated patients in
controlled trials, approximately 4,250 were patients with OA, approximately
2,100 were patients with RA, and approximately 1,050 were patients with
post-surgical pain. More than 8,500 patients have received a total daily dose of
Celebrex of 200 mg (100 mg BID or 200 mg QD) or more, including more than 400
treated at 800 mg (400 mg BID). Approximately 3,900 patients have received
Celebrex at these doses for 6 months or more; approximately 2,300 of these have
received it for 1 year or more and 124 of these have received it for 2 years or
more. <BR><BR><B>Adverse events from controlled trials: Table 1</B> lists all
adverse events, regardless of causality, occurring in >=2% of patients
receiving Celebrex from 12 controlled studies conducted in patients with OA or
RA that included a placebo and/or a positive control group.
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<A name=q7 style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">How
does the risk for ulcers, bleeding, perforation etc. compare with other NSAIDs?
</A><BR>Serious gastrointestinal toxicity such as bleeding, ulceration, and
perforation of the stomach, small intestine or large intestine, can occur at any
time, with or without warning symptoms, in patients treated with nonsteroidal
anti-inflammatory drugs (NSAIDs). Minor upper gastrointestinal problems, such as
dyspepsia, are common and may also occur at any time during NSAID therapy.
Therefore, physicians and patients should remain alert for ulceration and
bleeding, even in the absence of previous GI tract symptoms. Patients should be
informed about the signs and/or symptoms of serious GI toxicity and the steps to
take if they occur. The utility of periodic laboratory monitoring has not been
demonstrated, nor has it been adequately assessed. Only one in five patients who
develop a serious upper GI adverse event on NSAID therapy is symptomatic. It has
been demonstrated that upper GI ulcers, gross bleeding or perforation, caused by
NSAIDs, appear to occur in approximately 1% of patients treated for 3-6 months,
and in about 2-4% of patients treated for one year. These trends continue thus,
increasing the likelihood of developing a serious GI event at some time during
the course of therapy. However, even short-term therapy is not without risk.
<BR><BR>It is unclear, at the present time, how the above rates apply to
Celebrex™ Among 5,285 patients who received Celebrex™ in controlled clinical
trials of 1 to 6 months duration (most were 3 month studies) at a daily dose of
200 mg or more, 2 (0.04%) experienced significant upper GI bleeding, at 14 and
22 days after initiation of dosing. Approximately 40% of these 5,285 patients
were in studies that required them to be free of ulcers by endoscopy at study
entry. Thus it is unclear if this study population is representative of the
general population. Prospective, long-term studies required to compare the
incidence of serious, clinically significant upper GI adverse events in patients
taking Celebrex™ vs. comparator NSAID products have not been performed. NSAIDs
should be prescribed with extreme caution in patients with a prior history of
ulcer disease or gastrointestinal bleeding. Most spontaneous reports of fatal GI
events are in elderly or debilitated patients and therefore special care should
be taken in treating this population. To minimize the potential risk for an
adverse GI event, the lowest effective dose should be used for the shortest
possible duration. For high-risk patients, alternate therapies that do not
involve NSAIDs should be considered. <BR><BR>Studies have shown that patients
with a prior history of peptic ulcer disease and/or gastrointestinal bleeding
and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI
bleed than patients with neither of these risk factors. In addition to a past
history of ulcer disease, pharmacoepidemiological studies have identified
several other co-therapies or co-morbid conditions that may increase the risk
for GI bleeding such as: treatment with oral corticosteroids, treatment with
anticoagulants, longer duration of NSAID therapy, smoking, alcoholism, older
age, and poor general health status. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q8
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Does age effect
the excretion of the medication? </A><BR>At steady state, elderly subjects (over
65 years old) had a 40% higher Cmax and a 50% higher AUC compared to the young
subjects. In elderly females, celecoxib Cmax and AUC are higher than those for
elderly males, but these increases are predominantly due to lower body weight in
elderly females. Dose adjustment in the elderly is not generally necessary.
However, for patients of less than 50 kg in body weight, initiate therapy at the
lowest recommended dose. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q9
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Can Celebrex be
used in pediatric populations? </A><BR>Celebrex™ capsules have not been
investigated in pediatric patients below 18 years of age. Therefore, the use in
this population is not recommended at this time <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q10
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Should pregnant
women take Celebrex? </A><BR>There are no studies in pregnant women or nursing
mothers. Therefore, Celebrex™ should not used during pregnancy or while nursing.
In late pregnancy Celebrex may cause premature closure of the ductus arteriosus.
It is not known whether this drug is excreted in human milk. Because many drugs
are excreted in human milk and because of the potential for serious adverse
reactions in nursing infants from Celebrex™ is not recommended in this
population. <A href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>**
back to top</A><BR><BR><BR><A name=q11
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Should
individuals with hepatic impairment take Celebrex? </A><BR>Celebrex™ capsules
should be introduced at a reduced dose in patients with moderate hepatic
impairment. Patients with severe hepatic impairment have not been studied,
therefore, the use of Celebrex™ in these patients is not recommended at this
time. <A href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back
to top</A><BR><BR><BR><A name=q12
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">What about
patients with renal insufficiency? </A><BR>In a cross-study comparison,
celecoxib AUC was approximately 40% lower in patients with chronic renal
insufficiency (GFR 35-60 ml/min) than that seen in subjects with normal renal
function. No significant relationship was found between GFR and celecoxib
clearance. Patients with severe renal insufficiency have not been studied. <A
href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q13
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Should
individuals with a history of asthma take Celebrex? </A><BR>Patients with asthma
may have aspirin-sensitive asthma. The use of aspirin in patients with
aspirin-sensitive asthma has been associated with severe bronchospasm, which can
be fatal. Since cross reactivity, including bronchospasm, between aspirin and
other nonsteroidal anti-inflammatory drugs has been reported in such
aspirin-sensitive patients, Celebrex™ should not be administered to patients
with this form of aspirin sensitivity and should be used with caution in
patients with preexisting asthma. <BR><BR>Celebrex™ can cause discomfort and,
rarely, more serious side effects, such as gastrointestinal bleeding, which may
result in hospitalization and even fatal outcomes. Although serious GI tract
ulcerations and bleeding can occur without warning symptoms, patients should be
alert for the signs and symptoms of ulcerations and bleeding, and should ask for
medical advice when observing any indicative signs or symptoms. Patients should
promptly report signs or symptoms of gastrointestinal ulceration or bleeding,
skin rash, unexplained weight gain, or edema to their physicians. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q14
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Are there any
significant drug interactions associated with Celebrex? </A><BR>
<UL>
<LI>NSAIDS: Reports suggest that NSAIDs may diminish the antihypertensive effect
of Angiotensin Converting Enzyme (ACE) inhibitors. This interaction should be
given consideration in patients taking Celebrex™ concomitantly with
ACE-inhibitors. Clinical studies, as well as post marketing observations, have
shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides
in some patients. This response has been attributed to inhibition of renal
prostaglandin synthesis.
<LI>Aspirin: Celebrex™ can be used with low dose aspirin. However, concomitant
administration of aspirin with Celebrex™ may result in an increased rate of GI
ulceration or other complications, compared to use of Celebrex™ alone. Because
of its lack of platelet effects, Celebrex™ is not a substitute for aspirin for
cardiovascular prophylaxis.
<LI>Fluconazole: Concomitant administration of fluconazole at 200 mg QD resulted
in a two-fold increase in celecoxib plasma concentration. This increase is due
to the inhibition of celecoxib metabolism via P450 2C9 by fluconazole (see
Pharmacokinetics - Metabolism). Celebrex™ should be introduced at the lowest
recommended dose in patients receiving fluconazole.
<LI>Lithium: In a study conducted in healthy subjects, mean steady-state lithium
plasma levels increased approximately 17% in subjects receiving lithium 450 mg
twice per day with Celebrex™ 200 mg twice per day as compared to subjects
receiving lithium alone. Patients on lithium treatment should be closely
monitored when Celebrex™ is introduced or withdrawn.
<LI>Methotrexate: In an interaction study of rheumatoid arthritis patients
taking methotrexate, Celebrex™ did not have a significant effect on the
pharmacokinetics of methotrexate.
<LI>Warfarin: Anticoagulant activity should be monitored, particularly in the
first few days, after initiating or changing CELEBREX therapy in patients
receiving warfarin or similar agents, since these patients are at an increased
risk of bleeding complications. The effect of celecoxib on the anticoagulant
effect of warfarin was studied in a group of healthy subjects receiving daily
doses of 2 to 5 mg of warfarin. In these subjects, celecoxib did not alter the
anticoagulant effect of warfarin as determined by prothrombin time. However, in
post-marketing experience, bleeding events have been reported, predominantly in
the elderly, in association with increases in prothrombin time in patients
receiving CELEBREX concurrently with warfarin <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR></LI></UL><A name=q15
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Is it safe to
use Celebrex while taking aspirin? </A><BR>Approximately 11% of patients
(440/4,000) enrolled in 4 of the 5 endoscopic studies were taking aspirin
(<=325 mg/day). In the Celebrex™ groups, the endoscopic ulcer rate appeared
to be higher in aspirin users than in non-users. However, the increased rate of
ulcers in these aspirin users was less than the endoscopic ulcer rates observed
in the active comparator groups, with or without aspirin. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q16
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Does Celebrex
provide the same benefits as aspirin for cardiovascular prophylaxis? </A><BR>In
clinical trials, Celebrex™ at single doses up to 800 mg and multiple doses of
600 mg BID for up to 7 days duration (higher than recommended therapeutic doses)
had no effect on platelet aggregation and bleeding time. Comparators (naproxen
500 mg two times per day, ibuprofen 800 mg three time per day, diclofenac 75 mg
two times per day) significantly reduced platelet aggregation and prolonged
bleeding time. <BR><BR>Significant upper GI bleeding, at 14 and 22 days after
initiation of dosing. Approximately 40% of these 5,285 patients were in studies
that required them to be free of ulcers by endoscopy at study entry. Thus it is
unclear if this study population is representative of the general population.
Prospective, long-term studies required to compare the incidence of serious,
clinically significant upper GI adverse events in patients taking Celebrex™ vs.
comparator NSAID products have not been performed. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q17
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">How does the
intake of food effect Celebrex? </A><BR>When Celebrex™ capsules were taken with
a high fat meal, peak plasma levels were delayed for about 1 to 2 hours with an
increase in total absorption (AUC) of 10% to 20%. Coadministration of Celebrex™
with an aluminum- and magnesium-containing antacid resulted in a reduction in
plasma celecoxib concentrations with a decrease of 37% in Cmax and 10% in AUC.
Celebrex™ capsules can be administered without regard to the timing of meals. <A
href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q18
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Should Celebrex
be prescribed in individuals with a history of ulcers? </A><BR>NSAIDs should be
prescribed with extreme caution in patients with a prior history of ulcer
disease or gastrointestinal bleeding. Most spontaneous reports of fatal GI
events are in elderly or debilitated patients and therefore special care should
be taken in treating this population. To minimize the potential risk for an and
who use NSAIDs, have a greater than 10-fold higher risk for developing a GI
bleed than patients with neither of these risk factors. In addition to a past
history of ulcer disease, pharmacoepidemiological studies have identified
several other co-therapies or co-morbid conditions that may increase the risk
for GI bleeding such as: treatment with oral corticosteroids, treatment with
anticoagulants, longer duration of NSAID therapy, smoking, alcoholism, older
age, and poor general health status. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q19
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Are
anaphylactic reactions associated with Celebrex? </A><BR>Anaphylactoid reactions
were not reported in patients receiving Celebrex™ in clinical trials. However,
as with NSAIDs in general, anaphylactoid reactions may occur in patients without
known prior exposure to Celebrex™. Celebrex™ should not be given to patients
with the aspirin triad. This symptom complex typically occurs in asthmatic
patients who experience rhinitis with or without nasal polyps, or who exhibit
severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.
Emergency help should be sought in cases where an anaphylactoid reaction occurs.
<A href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q20
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Should
individuals with a history of asthma take Celebrex? </A><BR>Patients with asthma
may have aspirin-sensitive asthma. The use of aspirin in patients with
aspirin-sensitive asthma has been associated with severe bronchospasm, which can
be fatal. Since cross reactivity, including bronchospasm, between aspirin and
other nonsteroidal anti-inflammatory drugs has been reported in such
aspirin-sensitive patients, Celebrex™ should not be administered to patients
with this form of aspirin sensitivity and should be used with caution in
patients with preexisting asthma. <BR><BR>Celebrex™ can cause discomfort and,
rarely, more serious side effects, such as gastrointestinal bleeding, which may
result in hospitalization and even fatal outcomes. Although serious GI tract
ulcerations and bleeding can occur without warning symptoms, patients should be
alert for the signs and symptoms of ulcerations and bleeding, and should ask for
medical advice when observing any indicative signs or symptoms. Patients should
promptly report signs or symptoms of gastrointestinal ulceration or bleeding,
skin rash, unexplained weight gain, or edema to their physicians. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q21
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Should
individuals with advanced renal disease take Celebrex? </A><BR>No information is
available regarding the use of Celebrex™ in patients with advanced kidney
disease. Therefore, treatment with Celebrex™ is not recommended in these
patients. If Celebrex™ therapy must be initiated, close monitoring of the
patient's kidney function is advisable. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q22
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Can Celebrex
replace the use of corticosteroids? </A><BR>Celebrex™ cannot be expected to
substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt
discontinuation of corticosteroids 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
corticosteroids. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q23
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Does Celebrex
effect any liver tests? </A><BR>Borderline elevations of one or more liver tests
may occur in up to 15% of patients taking NSAIDs, and notable elevations of ALT
or AST (approximately three or more times the upper limit of normal) have been
reported in approximately 1% of patients in clinical trials with NSAIDs. These
laboratory abnormalities may progress, may remain unchanged, or may be transient
with continuing therapy. Rare cases of severe hepatic reactions, including
jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure (some
with fatal outcome) have been reported with NSAIDs. In controlled clinical
trials of Celebrex™, the incidence of borderline elevations of liver tests was
6% for Celebrex™ and 5% for placebo, and approximately 0.2% of patients taking
Celebrex™ and 0.3% of patients taking placebo had notable elevations of ALT and
AST. <BR><BR>A patient with symptoms and/or signs suggesting liver dysfunction,
or in whom an abnormal liver test has occurred, should be monitored carefully
for evidence of the development of a more severe hepatic reaction while on
therapy with Celebrex™. If clinical signs and symptoms consistent with liver
disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash,
etc.), Celebrex™ should be discontinued. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q24
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">What are the
warning signs and symptoms of hepatotoxicity? </A><BR>The warning signs and
symptoms of hepatotoxicity include: nausea, fatigue, lethargy, pruritus,
jaundice, right upper quadrant tenderness and "flu-like" symptoms. If these
occur, patients should be instructed to stop therapy and seek immediate medical
therapy. <A href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>**
back to top</A><BR><BR><BR><A name=q25
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Does Celebrex
effect any other laboratory values? </A><BR>During the controlled clinical
trials, there was an increased incidence of hyperchloremia in patients receiving
celecoxib compared with patients on placebo. Other laboratory abnormalities that
occurred more frequently in the patients receiving celecoxib included
hypophosphatemia, and elevated BUN. These laboratory abnormalities were also
seen in patients who received comparator NSAIDs in these studies. The clinical
significance of these abnormalities has not been established. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q26
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Does Celebrex
have any effect on the kidneys? </A><BR>Long-term administration of NSAIDs has
resulted in renal papillary necrosis and other renal injury. Renal toxicity has
also been seen in patients in whom renal prostaglandins have a compensatory role
in the maintenance of renal perfusion. In these patients, administration of a
nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in
prostaglandin formation and, secondarily, in renal blood flow, which may
precipitate overt renal decompensation. Patients at greatest risk of this
reaction are those with impaired renal function, heart failure, liver
dysfunction, those taking diuretics and ACE inhibitors, and the elderly.
Discontinuation of NSAID therapy is usually followed by recovery to the
pretreatment state. Clinical trials with Celebrex™ have shown renal effects
similar to those observed with comparator NSAIDs. <BR><BR>Caution should also be
used when initiating treatment with Celebrex™ in patients with considerable
dehydration. It is advisable to rehydrate patients first and then start therapy
with Celebrex™. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q27
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">What effect
does Celebrex have on the blood? </A><BR>Anemia is sometimes seen in patients
receiving Celebrex™. In controlled clinical trials the incidence of anemia was
0.6% with Celebrex™ and 0.4% with placebo. Patients on long-term treatment with
Celebrex™ should have their hemoglobin or hematocrit checked if they exhibit any
signs or symptoms of anemia or blood loss. Celebrex™ does not generally affect
platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT),
and does not appear to inhibit platelet aggregation at indicated dosages. <A
href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q28
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Does Celebrex
cause fluid retention or edema? </A><BR>Fluid retention and edema have been
observed in some patients taking Celebrex™. Therefore, Celebrex™ should be used
with caution in patients with fluid retention, hypertension, or heart failure.
<A href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q29
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Is Celebrex
indicated in the pediatric population? </A><BR>Safety and effectiveness in
pediatric patients below the age of 18 years have not been evaluated. Therefore
it is not in the pediatric population. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q30
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">Has the safety
and efficacy been examined in elderly population aged 65 plus? </A><BR>Of the
total number of patients who received Celebrex™ in clinical trials, more than
2,100 were 65-74 years of age, while approximately 800 additional patients were
75 years and over. While the incidence of adverse experiences tended to be
higher in elderly patients, no substantial differences in safety and
effectiveness were observed between these subjects and younger subjects. Other
reported clinical experience has not identified differences in response between
the elderly and younger patients, but greater sensitivity of some older
individuals cannot be ruled out. <BR><BR>In clinical studies comparing renal
function as measured by the GFR, BUN and creatinine, and platelet function as
measured by bleeding time and platelet aggregation, the results were not
different between elderly and young volunteers. <A href="#top"
style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q31
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">What about an
overdose with Celebrex? </A><BR>Symptoms following acute NSAID overdoses are
usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain,
which are generally reversible with supportive care. Gastrointestinal bleeding
can occur. Hypertension, acute renal failure, respiratory depression and coma
may occur, but are rare. Anaphylactoid reactions have been reported with
therapeutic ingestion of NSAIDs, and may occur following an overdose. If an
overdose should occur individuals should seek immediate medical attention. <A
href="#top" style="COLOR: #405c94; TEXT-DECORATION: none"><BR>** back to
top</A><BR><BR><BR><A name=q32
style="COLOR: #000000; FONT-WEIGHT: bold; TEXT-DECORATION: none">How should
Celebrex be stored? </A><BR>Store at 25°C (77°F); excursions permitted to
15-30°C (59-86°F). Like all medications out of the reach of children.</FONT>
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