Detailed Drug Information:

DRUG CLASS AND MECHANISM: Rofecoxib is a nonsteroidalanti-inflammatory drug (NSAID) that is used to treat pain, particularly the pain of osteoarthritis and menstrual cramps. Prostaglandins are chemicals that are important in promoting inflammation and its signs--pain, fever, swelling and tenderness.Rofecoxib blocks the enzyme that makes prostaglandins (cyclooxygenase-2) and thereby reduces the amounts of prostaglandins. As a consequence, inflammation and its accompanying pain, fever, swelling and tenderness also are reduced. Rofecoxib is similar to celecoxib (Celebrex). Both drugs differ from other NSAIDsin that they cause less irritation and ulceration of the stomach and intestine(at least during short-term treatment), and they do not interfere with the clottingof blood.

PREPARATIONS: Tablets: 12.5 mg, 25 mg, and 50mg. Oral Suspension: 12.5 mg/5 mland 25mg/5ml

STORAGE: Store at room temperature, 15-30°C (59-86°F)

PRESCRIBED FOR: Rofecoxib is used for treating the pain, swelling, and tenderness caused by osteoarthritis and rheumatoid arthritis in adults. Rofecoxib is also used for treating acute pain such as headache and menstrual cramps.

DOSING: The lowest effective dose should be used. For the management ofosteoarthritis, the usual dose is 12.5 mg (tablet or suspension) once daily.The maximum dose is 25 mg once daily. For the treatment of acute pain and menstrual cramps the usual dose is 50 mg once daily. It may be taken with or without food.

DRUG INTERACTIONS: Concomitant use of rofecoxib with aspirin or other NSAIDs (e.g., ibuprofen, naproxen, etc.) may increase the occurrence of stomachand intestinal ulcers. Since NSAIDs may increase the concentration of lithium in thebody, lithium levels should be monitored during and after therapy with rofecoxib.

Rofecoxib may accentuate the effect of the anticoagulant (blood thinner) warfarin (Coumadin), and promote bleeding. Persons taking warfarin should have the clotting of their blood tested, particularly during the first few days after starting or stopping rofecoxib.

Rifampin decreases the concentration of rofecoxib in the body by 50% and thus may reduce the effectiveness of rofecoxib.

Rofecoxib may increase the concentration of methotrexate by 23% and may lead to increased side effects of methotrexate. Persons taking both drugs should be closely monitored for these side effects.

Persons who drink more than three alcoholic beverages per day may be at increasedrisk of developing stomach ulcers when taking NSAIDs. This also may be true withrofecoxib.

PREGNANCY: The use of rofecoxib in pregnant women has not been studied. In studies in rats, doses that were 10 or 28 fold higher than the recommendedhuman dose were not harmful to fetuses; however, in studies in rabbits, doses twice therecommended dose for humans were harmful to the fetuses. Therefore, rofecoxib should be used in pregnant women only when the potential benefits outweigh the potential risk to the fetus.

NURSING MOTHERS: The use of rofecoxib in nursing mothers has not been evaluated.

SIDE EFFECTS: Although stomach and intestinal ulcers occurwith the use of rofecoxib, they occur less frequently than with other NSAIDs inshort-term studies. Rofecoxib does not interfere with the function of the platelets in the blood, and, as a result, it does not interfere with blood clotting and promote bleeding like other NSAIDs.

The most common side effects of rofecoxib are headache, abdominal pain, dyspepsia, diarrhea, nausea, heartburn and water retention. Other side effects include insomnia,urinary retention (inability to urinate), heart failure, aggravation of hypertension, chest pain, ringing in the ears, stomach and intestinal ulcers, bleeding, blurred vision, anxiety, weight gain, flu-like symptoms, drowsiness and weakness.

Allergic type reactions can occur with rofecoxib. Persons who have developed allergic reactions (rash, itching, difficulty breathing) from aspirin or otherNSAIDs may experience an allergic reaction to rofecoxib and should not use rofecoxib.

Vioxx should be used cautiously in patients with heart disease.