Brand name:

Vioxx

Pronounced: VYE-ox
Generic name: Rofecoxib

Why is this drug prescribed?

Vioxx is a new kind of painkiller used in the treatment of osteoarthritis, rheumatoid arthritis, painful menstruation (dysmenorrhea), and other types of acute pain. It is a member of the family of nonsteroidal anti-inflammatory drugs (NSAIDs) called "COX-2 inhibitors." Other drugs in this family include Celebrex and Bextra.

Like older NSAIDs such as aspirin, Motrin, and Naprosyn, these newer drugs are believed to fight pain and inflammation by inhibiting the effect of a natural enzyme called COX-2. Unlike the older medications, however, the newer drugs do not interfere with a similar substance, called COX-1, which exerts a protective effect on the lining of the stomach. The COX-2 inhibitors are therefore less likely to cause the bleeding and ulcers that sometimes accompany sustained use of the older NSAIDs.

Although COX-2 inhibitors offer many of the same benefits as aspirin, they do not share its blood-thinning effects. If you're taking low-dose aspirin to reduce the risk of a heart attack, you'll need to continue taking it in addition to Vioxx.

Most important fact about this drug

Although Vioxx is unlikely to cause stomach and intestinal bleeding, a slight danger remains. Be sure to tell your doctor if you've ever had this problem, and be on the alert for tip-offs such as stomach discomfort or black, tarry stools. These symptoms can strike without warning.

How should you take this medication?

Vioxx may be taken with or without food. If it has been prescribed for arthritis, be sure to take it faithfully once every day. Vioxx suspension should be thoroughly shaken before each use.

--If you miss a dose...

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.

--Storage instructions...

Both the tablets and the suspension may be stored at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Vioxx.

• More common side effects may include:
  Abdominal pain, diarrhea, dizziness, headache, heartburn, high blood pressure, indigestion, nausea, respiratory tract infections, stomach discomfort, swelling of the legs and ankles

• Less common side effects may include:
  Back pain, bronchitis, fatigue, flu-like symptoms, sinus inflammation, urinary tract infections, weakness

• Rare side effects may include:
  Abdominal bloating or tenderness, allergies, anxiety, appetite change, arm pain, asthma, back strain, baldness, black-tarry stool, blisters, bloody nose, blurred vision, boils, bursitis, cartilage problems, cavities, chest congestion, chest pain, chills, confusion, conjunctivitis (pinkeye), constipation, cough, cysts, decreased levels of sodium in the blood, decreased mental alertness, dental pain, depression, dermatitis, difficulty breathing, drowsiness, dry mouth, dry throat, ear infection, ear pain, ear ringing, ear wax, fainting, fever, fluid in the lungs, flushing, fungal infection, gas, gastrointestinal infection, gastrointestinal inflammation, hallucinations, heartbeat irregularities, hemorrhoids, hepatitis, hernia of the diaphragm, herpes infection, hives, impaired sensitivity to touch, inability to urinate, increased nighttime urination, increased potassium in the blood, infection, insect bite reaction, insomnia, itching, joint pain and swelling, kidney failure, laryngitis, liver failure, low blood cell counts, menopausal symptoms, menstrual disorder, migraine headache, mouth infection, mouth and throat sores, muscle aches and pains, muscle stiffness, muscle spasms, muscle weakness, nail problems, nasal congestion, numbness, pain, painful urination, pelvic pain, pneumonia, rapid or slow heartbeat, rash, runny nose, sciatic pain, severe increase in blood pressure, severe skin peeling, skin dryness, skin inflammation, skin tingling or burning, sore throat, sweating, swelling, taste disturbances, tendon inflammation, tingling sensation, tonsillitis, vaginal inflammation, vein problems, vomiting, weight gain, wheezing, yellow skin and eyes

Why should this drug not be prescribed?

Do not take Vioxx if aspirin and other NSAIDs have ever given you asthma, hives, or other allergic symptoms.

Special warnings about this medication

If you develop swelling of the face, tongue, and throat, or begin to have difficulty breathing after taking a dose of Vioxx, seek medical help immediately. You may be having a serious allergic reaction to the drug.

Vioxx occasionally causes liver problems. Warning signs include nausea, fatigue, rash, itching, right upper stomach pain, flu-like symptoms, and yellowing of the skin and eyes. If you develop these symptoms, stop taking Vioxx and call your doctor immediately. Don't take the drug at all if you have a history of liver disease.

Also avoid Vioxx if you have severe kidney disease. Long-term use of NSAIDs such as Vioxx can interfere with the kidneys, especially in people with heart failure, poor kidney function, or liver problems. Also at higher risk of a problem are older adults and people taking water pills or ACE inhibitors for high blood pressure. If any of these factors apply to you, make sure the doctor is aware of it.

Vioxx is more likely to cause serious gastrointestinal side effects if you've had a problem with ulcers or stomach bleeding in the past. Older adults and those in poor health are also more vulnerable, as are people being treated with steroids such as prednisone and blood thinners such as aspirin and warfarin. Other factors that increase your risk include smoking, alcoholism, and long-term use of NSAIDs. Use Vioxx with extreme caution if you meet any of these criteria.

Caution is also warranted if you have asthma. Vioxx could trigger an attack, especially if you are also sensitive to aspirin. You should also use Vioxx cautiously when suffering from dehydration.

Vioxx sometimes causes water retention, which can aggravate swelling, high blood pressure, and heart failure. Use this drug with caution if you have any of these conditions. Report any unexplained swelling or weight gain to your doctor immediately.

Vioxx may also cause a slight increase in the risk of dangerous blood clots, and should be used with caution if you have a history of clogged arteries, angina, or heart attack. Alert your doctor without delay if you develop chest pain.

If you've been taking a steroid medication for arthritis, do not discontinue it abruptly when you begin therapy with Vioxx. Vioxx is not a substitute for such drugs.

Because Vioxx relieves inflammation, fever, and pain, it may hide signs of an infection.

Let any doctor you're seeing know that you're taking this drug.

The safety and effectiveness of Vioxx in children below the age of 18 have not been evaluated.

Possible food and drug interactions
when taking this medication

If Vioxx is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Vioxx with the following:

Aluminum and magnesium antacids such as Maalox and Mylanta
Amitriptyline (Elavil)
Aspirin
Blood pressure medications known as ACE-inhibitors, including Capoten, Lotensin, and Vasotec
Calcium carbonate antacids such as Alka-Mints and Tums
Lithium (Eskalith, Lithobid)
Methotrexate (Rheumatrex)
Rifampin (Rifadin, Rimactane)
Tacrine (Cognex)
Theophylline (Theo-Dur)
Warfarin (Coumadin)
Water pills (diuretics) such as Lasix and HydroDIURIL
Zileuton (Zyflo)

Special information
if you are pregnant or breastfeeding

Vioxx should never be used during the third trimester of pregnancy because it may cause problems in the developing baby. If you are pregnant or plan to become pregnant, consult with your doctor.

It is not known whether Vioxx appears in breast milk. However, most drugs do, and if Vioxx is one of them, it could cause serious side effects in the nursing infant. If you decide to take Vioxx, you should give up breastfeeding.

Recommended dosage

ADULTS

Osteoarthritis

The usual starting dose is 12.5 milligrams once daily. The doctor may increase your dose to a maximum of 25 milligrams once daily if needed.

Rheumatoid Arthritis

The recommended dose is 25 milligrams once daily. Taking any more than this on a regular basis is not recommended.

Acute Pain and Dysmenorrhea

The recommended dose is 50 milligrams once daily as needed, for no more than 5 days. Taking this much on a regular basis is not recommended.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose with Vioxx, seek medical attention immediately.

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