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Rofecoxib

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(roe fa cox' ib)

Brand name(s): Vioxx®

Contents of this page:

IMPORTANT WARNING:

Merck & Co., Inc. announced a voluntary withdrawal of rofecoxib (Vioxx) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on rofecoxib. Rofecoxib is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. For more information visit the FDA website at: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#vioxx, http://www.fda.gov/cder/drug/infopage/vioxx/PHA_vioxx.htm, http://www.fda.gov/bbs/topics/news/2004/NEW01122.html and http://www.fda.gov/cder/drug/infopage/vioxx/vioxxQA.htm.

Why is this medication prescribed?

Rofecoxib is used to relieve the pain, tenderness, inflammation (swelling), and stiffness caused by arthritis and to treat painful menstrual periods and pain from other causes. Rofecoxib is in a class of nonsteroidal anti-inflammatory medications (NSAIDs) called COX-2 inhibitors. It works by stopping the body's production of a substance that causes pain and inflammation. COX-2 inhibitors may cause less stomach bleeding and ulcers than similar medications.

How should this medicine be used?

Rofecoxib comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken once a day with or without food. To help you remember to take rofecoxib, take it around the same time every day. Follow the directions on the prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rofecoxib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly.

Before taking rofecoxib, carefully read the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking rofecoxib,

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Rofecoxib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

Rofecoxib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests to check your body's response to rofecoxib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Last Revised - 09/01/2004


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