ROFECOXIB-ORAL SUSPENSION, Vioxx (cont.)
PRECAUTIONS: Before taking rofecoxib, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs, aspirin, other NSAIDs (e.g., ibuprofen), other COX-2 inhibitors (e.g., celecoxib); or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, heart disease (e.g., history of heart attack, high blood pressure, congestive heart failure), history of strokes, history of blood clots, alcohol use, swelling (edema), blood disorders (anemia), serious infections, stomach problems (bleeding or ulcers), asthma, growths in the nose (nasal polyps), dehydration, poorly controlled diabetes. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of this medication, especially stomach bleeding and kidney effects. This medication should be used only when clearly needed during the first 6 months of pregnancy. It should not be used during the last 3 months of pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Due to the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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