Rofecoxib (Systemic)
   
Rofecoxib (Systemic)
US Brand Names
• Vioxx
Description
Rofecoxib (roe-fe-COKS-ib) is used to relieve some symptoms caused by arthritis, such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.
Rofecoxib is also used to relieve other kinds of pain, such as menstrual cramps, and pain following surgery.
This medicine is available only with your doctor's prescription, in the following dosage form(s):
Oral
• Oral suspension (U.S.)
• Tablets (U.S.)
Special Considerations
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rofecoxib, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to rofecoxib. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy
Rofecoxib has not been studied in pregnant women. However, there is a chance that this medicine may cause unwanted effects on the heart or blood flow of the fetus or newborn baby if it is taken regularly during the last few months of pregnancy. Studies in animals have shown that rofecoxib has caused birth defects of the spine. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.
Breast-feeding
It is not known whether rofecoxib passes into breast milk. However, rofecoxib may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.
Children
Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of rofecoxib in children with use in older age groups.
Older adults
This medicine has been tested in a limited number of elderly patients 65 years of age and older and has not been shown to cause different side effects or problems in older people than it does in younger adults.
Other medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking rofecoxib, it is especially important that your health care professional know if you are taking any of the following:
• Aspirin-The chance of serious side effects may be increased
• Lithium (e.g., Lithane)-Higher blood levels of lithium and an increased chance of side effects may occur
• Rifampin-Lower blood levels of rofecoxib may occur
Other medical problems
The presence of other medical problems may affect the use of rofecoxib. Make sure you tell your doctor if you have any other medical problems, especially:
• Alcohol abuse or
• Bleeding problems or
• Stomach ulcer or other stomach or intestinal problems
• Tobacco use (or recent history of)-The chance of side effects may be increased
• Anemia or
• Asthma or
• Dehydration or
• Fluid retention (swelling of feet or lower legs) or
• Heart disease or
• High blood pressure or
• Kidney disease or
• Liver disease-Rofecoxib may make these conditions worse
Administration
For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your health care professional. Taking too much of this medicine may increase the chance of unwanted effects.
Dosing
The dose of rofecoxib will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of rofecoxib. If your dose is different, do not change it unless your doctor tells you to do so.
The number of tablets or teaspoonfuls of suspension that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking rofecoxib .
• For oral dosage form (suspension, tablets):
o For osteoarthritis:
§ Adults-12.5 to 25 milligrams (mg) once a day.
§ Children-Use and dose must be determined by your doctor.
o Pain or menstrual cramps:
§ Adults-50 mg to start and 50 mg daily as needed for up to five days.
§ Children-Use and dose must be determined by your doctor.
Missed dose
If your health care professional has ordered you to take this medicine according to a regular schedule, and you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
To store this medicine:
• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
Precautions
If you will be taking this medicine for a long time, your doctor should check your progress at regular visits.
Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine, unless otherwise directed by your doctor .
Taking two or more of the nonsteroidal anti-inflammatory drugs together on a regular basis may increase the chance of unwanted effects. Also, taking acetaminophen, aspirin or other salicylates, or ketorolac (e.g., Toradol) regularly while you are taking a nonsteroidal anti-inflammatory drug may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your health care professional directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with this medicine for more than a few days, and do not take any ketorolac (e.g., Toradol) while taking this medicine, unless your doctor has directed you to do so and is following your progress .
Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without warning. However, possible warning signs often occur, including severe stomach pain, black tarry stools, and/or vomiting of blood or material that looks like coffee grounds; skin rash; swelling of the face, fingers, feet, and/or lower legs. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .
Rofecoxib may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention . The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once. Ask someone to drive you to the nearest hospital emergency room. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
More common
Congestion in chest; cough; fever; sneezing; sore throat.
Less common or rare
Bloody or black, tarry stools; chills; burning feeling in chest or stomach; hives; loss of appetite; muscle aches and pain; prolonged or severe vomiting; shortness of breath; skin rash; tenderness in the stomach area; unusual weight gain; vomiting of blood or material that looks like coffee grounds.
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
More common
Back pain; diarrhea; dizziness; headache; heartburn; loss of energy or weakness; nausea; stuffy or runny nose; swelling of legs and feet.
Less common or rare
Blurred vision; constipation.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
June 14, 1999 
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