Information About Vioxx

IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ROFECOXIB - ORAL (row-feh-COX-ib)

COMMON BRAND NAME(S): Vioxx

USES: This medication is a nonsteroidal anti-inflammatory drug (NSAID) which relieves pain and swelling (inflammation). It is used to treat arthritis, menstrual pain or other acute pain. This drug works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

HOW TO USE: Take this drug by mouth, generally once daily as directed. To decrease the chance of stomach upset, this drug is best taken with food. Dosage is based on your medical condition and response to therapy. Take this medication with 6 to 8 ounces (180-240ml) of water. Do not lie down for at least 30 minutes after taking this drug.

SIDE EFFECTS: Stomach upset or tiredness may occur. If these effects persist or worsen, notify your doctor promptly. Unlikely but report promptly: severe headache, change in the amount of urine, mental/mood changes, very stiff neck. Very unlikely but report promptly: dark urine, yellowing eyes or skin. If you notice any of the following unlikely but very serious side effects, stop taking this drug and consult your doctor or pharmacist immediately: black stools, persistent stomach/ abdominal pain, vomit that looks like coffee grounds. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, including: allergies (especially to aspirin/other NSAIDs), liver problems, kidney problems, heart disease, stomach/intestinal ulcers or bleeding, history of smoking, alcoholism, asthma, high blood pressure, growths in the nose (e.g., nasal polyps), serious infections, swelling (edema), blood disorders (anemia), poorly controlled diabetes, dehydration. This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information. Caution is advised when this drug is used in the elderly, as this group may be more sensitive to drug side effects. This medication should be used only when clearly needed during the first six months of pregnancy. It should not be used during the last three months of pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially of: high blood pressure drugs, (e.g., ACE inhibitors such as lisinopril), water pills (diuretics such as furosemide or thiazides), aspirin or other NSAID (e.g., ibuprofen), lithium, methotrexate, corticosteroids (e.g., prednisone), rifamycins (e.g., rifampin), blood thinners (e.g., warfarin). Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) which are similar to this drug. Aspirin, as prescribed by your doctor for reasons such as heart attack or stroke prevention (usually these dosages are 81-325 mg per day), should be continued. Consult your doctor or pharmacist for more details. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe stomach pain, coffee ground-like vomit, dark stool, ringing in the ears, change in amount of urine, unusually fast or slow heartbeat, muscle weakness, slow or shallow breathing, confusion, severe headache or loss of consciousness.

NOTES: Do not share this medication with others. Laboratory or medical tests may be performed to monitor your progress.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture.