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CELEBREX DRUG INFORMATION, ABOUT CELEBREX

IMPORTANT WARNING

The Food and Drug Administration (FDA) announced on April 7, 2005 that they are asking makers of prescription nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the package insert information to include a ''boxed'' or serious warning about the increased risk of potentially life-threatening gastrointestinal (GI) bleeding and cardiovascular events (including stroke and heart attack) which are associated with the use of NSAID. The information should say that patients who have just had heart surgery should not take NSAIDs. The FDA has also asked makers of nonprescription (over-the-counter (OTC)) NSAIDs to include information on the label about possible gastrointestinal (GI) bleeding and cardiovascular events . Also, skin reactions may occur in people taking these drugs. Talk to your doctor if you are taking one of these drugs if you have questions or concerns about these potential dangers. For more information see the FDA website: http://www.fda.gov/cder/drug/infopage/COX2/default.htm.

WHAT IS CELEBREX?

Celebrex is a nonsteroidal anti-inflammatory drug (NSAID) which relieves pain and inflammation, causing swelling. It treats pain, swelling and stiffness caused by arthritis. Celebrex works by blocking the enzyme in your body which makes prostaglandins. Decreasing the level of prostaglandins helps to reduce pain and swelling.

HOW TO USE CELEBREX

Take Celebrex by mouth, usually once or twice daily, as directed by your medical care professional.
To decrease the chance of stomach upset, it is best to take Celebrex with food.
Your dose will be based on your medical condition and your response to therapy.
Take Celebrex with 6 to 8 ounces of water.
Do not lie down for 30 minutes, at least, after taking Celebrex.

CELEBREX SIDE EFFECTS

If these Celebrex side effects may occur. If they do not go away or if they get worse, call your doctor:

nausea
stomach upset
diarrhea
gas

These Celebrex side affects are unlikely, but report them to your doctor if they occur:

severe headache
fatigue
change in amount of urine
yellowing of your eyes or skin
unexplained weight gain

These Celebrex side effects are unlikely, but they are very serious. If they occur, stop taking Celebrex and report them to your doctor immediately:

black stools
vomit which looks like coffee grounds
persistent stomach or abdominal pain

Allergic reactions to Celebrex are not common, but can occur. Seek immediate medical attention if you have any of these symptoms:

itching
rash
trouble breathing
dizziness
swelling

If you notice other Celebrex side effect not listed here, contact your doctor or pharmacist.

IMPORTANT NOTE:

This information is intended to be supplemental only and not a substitute for the expertise and judgment of your doctor, pharmacist or other healthcare professional. It should not be interpreted to indicate that use of the medication is appropriate, effective or safe for you. Consult your physician before you use this medicine

CELEBREX PRECAUTIONS

Your doctor needs to know your medical history. Specifically tell him or her about:

alcohol consumption
allergies (especially allergies to medicines such as sulfas or NSAID (for example, ibuprofen)
asthma
blood disorders (anemia)
dehydration
diabetes which is not well controlled
kidney problems
liver problems
heart disease
high blood pressure
nasal polyps (growths in your nose)
swelling (edema)
serious infections
stomach ulcers
stomach bleeding

CELEBREX AND ALCOHOL CONSUMPTION

Celebrex may cause stomach bleeding. Daily alcohol consumption, especially when combined with Celebrex, may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information.

CELEBREX and PREGNANCY

Celebrex should be used only when clearly needed during the first trimester of pregnancy. Celebrex is not recommended for use during the last 6 months of pregnancy. The risks and benefits of using Celebrex during pregnancy should be discussed with your doctor.

CELEBREX and BREAST FEEDING

It is not known whether or not Celebrex is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using Celebrex `is not recommended. Consult your doctor before breast-feeding.

CELEBREX and the ELDERLY

The elderly may be more sensitive to Celebrex. Use caution.

CELEBREX DRUG INTERACTIONS

Your doctor needs to know about all medications, prescription and over-the-counter, that you use, especially the following:

ACE inhibitors (like captopril or lisinopril)
"blood thinners" (like warfarin)
corticosteroids (like prednisone)
diuretics (like hydrochlorothiazide or furosemide)
fluconazole
lithium
high blood pressure medication
NSAID (like ibuprofen or naproxen)

Read all your prescription and nonprescription medication labels carefully. Some may contain the above drugs or drugs similar to Celebrex, like pain relievers of fever reducers (NSAIDs such as aspirin, ibuprofen or naproxen).

If your doctor has prescribed asprin for heart attack or stroke prevention, continue taking it. Ask your doctor for more information.

Do not start or stop taking Celebrex or any medication without your doctor's approval.

CELEBREX OVERDOSE

Call your local poison control center (1-800-222-1222) or emergency room immediately if you have any of these possible Celebrex overdose symptoms:

breathing - slow or shallow
confusion
heartbeat - unusually fast or slow
stomach pain - severe
headache - severe
loss of consciousness
ringing in the ears
muscle weakness
stool - dark
urine decrease or increase
vomit which looks like coffee ground

NOTES

Do not give your Celebrex medication to anyone else.

Your doctor may schedule laboratory and/or medical tests to monitor your progress.

CELEBREX MISSED DOSE

Missed doses of Celebrex should be taken as soon as remembered. However, if it is close to the time of your next dose, skip the missed dose and resume your usual dosing schedule. Do not take a double dose to catch up. ssed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

STORAGE

Store Celebrex at room temperature away from light and moisture. Do not store in the bathroom.

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