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VALDECOXIB 20MG-ORAL, Bextra (cont.)

USES: Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and swelling (inflammation), in particular menstrual pain (dysmenorrhea). This drug should not be used for relieving pain after surgery, especially heart bypass surgery (CABG). There is an increased risk of blood clots forming, resulting in heart attacks and strokes, in heart bypass patients (see also Precautions section). This drug works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

OTHER USES: This medication may also be used to treat arthritis (rheumatoid-type) and to reduce fever.

HOW TO USE: Take this medication by mouth usually once or twice daily either with or without food or take as directed by your doctor. Take this medication with a full glass (8 oz or 240 ml) of water unless your doctor directs you otherwise. Do not lie down for 30 minutes after taking this medication. The dosage is based on your medical condition and response to therapy. The lowest effective dosage should always be used (see also Precautions section).

SIDE EFFECTS: Stomach upset, nausea, diarrhea, or headache may occur. If any of these effects persist or worsen, notify your doctor. Tell your doctor immediately if any of these serious side effects occur: swelling, unusual tiredness and weakness, weight gain. Tell your doctor immediately if any of these unlikely but serious side effects occur: change in amount of urine, dizziness, blurred vision, yellowing eyes or skin, dark urine. If you notice any of these highly unlikely but very serious side effects, stop taking valdecoxib and consult your doctor or pharmacist immediately: coffee-ground vomit, black stools, persistent stomach pain, chest pain, one-sided weakness, slurred speech, sudden vision changes. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before taking valdecoxib, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs, aspirin or NSAIDs such as ibuprofen or celecoxib; or if you have any other allergies. This medication is not recommended for use if you have the following medical conditions: kidney disease, severe liver disease. Tell your doctor your medical history, especially of: liver problems, asthma, nasal polyps, swelling problems (fluid retention), stomach problems (e.g., bleeding, ulcers), blood disorders (e.g., anemia), heart disease, high blood pressure, tobacco or alcohol use, dehydration, poorly controlled diabetes, persistent runny nose. Related drugs (rofecoxib and celecoxib) rarely have caused blood clots to form, resulting in heart attacks and strokes. This medication has rarely caused similar problems in heart bypass patients right after surgery, but not in other people studied to date. Talk to your doctor or pharmacist about the benefits and risks of treatment, as well as other possible medication choices. This medication may cause stomach bleeding. Daily use of alcohol and this medication may increase your risk for stomach bleeding. This medication should be used only when clearly needed during pregnancy but should not be used during the third trimester. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended.



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