rofecoxib, Vioxx (cont.)

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

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 of osteoarthritis, 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 stomach and intestinal ulcers. Since NSAIDs may increase the concentration of lithium in the body, 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 increased risk of developing stomach ulcers when taking NSAIDs. This also may be true with rofecoxib.

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 recommended human dose were not harmful to fetuses; however, in studies in rabbits, doses twice the recommended 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.



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