Vioxx

VIOXX tablets, 25 mg, are yellow, round tablets engraved MRK 110 on one side and VIOXX on the other.

HOW DOES VIOXX WORK?

In the body, 2 enzymes are called COX-1 and COX-2. COX-1 helps regulate normal cell function in the stomach and blood. COX-2 plays a role in causing arthritis pain and inflammation by causing the release of specific compounds into the blood called cytokines. Cytokines are compounds that lead to pain and inflammation of joint tissue. VIOXX is a scientific breakthrough; the first product to target only the COX-2 enzyme. By inhibiting COX-2 those compounds that lead to inflammation and pain are inhibited from being released into the blood.

HOW EFFECTIVE IS VIOXX?

OSTEOARTHRITIS:

VIOXX was evaluated for the treatment of the signs and symptoms of Osteoarthritis of the knee and hip. The effectiveness of placebo (sugar pill) was compared with VIOXX treated patients in controlled clinical trials of 6 to 86 weeks duration that enrolled approximately 3900 patients. In patients with Osteoarthritis, treatment with VIOXX 12.5 mg and 25 mg once daily resulted in an improvement in patient and physician assessments in Osteoarthritis severity taking into account joint pain, stiffness, and range of motion measures. In six studies of pain accompanying Osteoarthritis flare, VIOXX provided a significant reduction in joint pain at the first determination (after one week in one study, after two weeks in the remaining five studies); this continued for the duration of the studies. In all Osteoarthritis clinical studies, once daily treatment in the morning with VIOXX 12.5 and 25 mg was associated with a significant reduction in joint stiffness upon first awakening in the morning.

ANALGESIA AND DYSMENORRHEA:

In acute pain relief models of post-operative dental pain, post-orthopedic surgical pain, and primary dysmenorrhea, VIOXX relieved pain that was rated by patients as moderate to severe. In single-dose post-operative dental pain studies, the onset of analgesia with a single 50-mg dose of VIOXX occurred within 45 minutes.

HOW TO USE THIS MEDICATION:

You should continue to take VIOXX as prescribed even when you are feeling better. VIOXX can be taken with or without food. VIOXX capsules come in 3 strengths: 12.5, 25, and 50 mg.

In Osteoarthritis, the recommended dose for VIOXX is 25 to 50 mg a day. VIOXX delivers 24-hour relief from a once-daily dose.

In analgesia and dysmenorrhea, the recommended dose for VIOXX is also 25 to 50 mg once a day. VIOXX provides relief through the day and through the night.

CAN I TAKE VIOXX IF I AM TAKING OTHER MEDICATIONS?

If you are one of the many people who take low-dose aspirin for the prevention of heart attack or stroke, you can still take VIOXX. However, taking VIOXX and aspirin together can increase your risk for developing stomach ulcers compared to taking VIOXX alone. VIOXX is not a substitute for aspirin for heart attack or stroke prevention.

CAN I TAKE VIOXX IF I AM PREGNANT?

In late pregnancy VIOXX should be avoided because it may cause problems in the final development of the heart in the fetus.

IS VIOXX A SUBSTITUTE FOR CORTICOSTEROIDS?

NO. VIOXX cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of this medicine may lead to exacerbation of corticosteroid-responsive illness. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue this medication.

INCLUDE IN YOUR MEDICAL HISTORY/PERSONAL PROFILE:

- If you are pregnant or plan to become pregnant. VIOXX should not be used in late pregnancy because it may harm the fetus.

- If you are breast-feeding or plan to breast-feed. It is not known whether VIOXX is passed through to human breast milk and what its effects could be on a nursing child.

- If you have kidney disease

- If you have liver disease

- If you have heart failure

- If you have high blood pressure

- If you have had an allergic reaction to aspirin or other NSAIDs

- If you have had a serious stomach problem (ulcers) in the past.

DRUG INTERACTIONS:

Include on your medical history/personal profile all of the other medicines you are taking or plan to take while you are on VIOXX, even other medicines that you can get without a prescription. VIOXX has significant drug interactions with:

- Methotrexate (a medicine used to suppress the immune system).

- Warfarin (a blood thinner).

- Rifampin (an antibiotic).

- ACE inhibitors (medicines used for high blood pressure and heart failure).

- Lithium (a medicine used to treat a certain type of depression).

ADVERSE REACTIONS:

Serious but rare side effects that have been reported in patients taking VIOXX are delineated below:

- Serious stomach problems, such as stomach and intestinal bleeding, can occur with or without warning symptoms. These problems, if severe, could lead to hospitalization or death. Although this happens rarely, you should watch for signs that you may have this serious side effect.

- Serious allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing and wheezing occur rarely but may require treatment right away. Severe skin reactions have also been reported.

- Serious kidney problems occur rarely, including acute kidney failure and worsening of chronic kidney failure.

- Severe liver problems, including hepatitis, jaundice and liver failure, occur rarely in patients taking NSAIDs, including VIOXX. Symptoms of liver problems include nausea, tiredness, itching, tenderness in the right upper abdomen, and flu-like symptoms.

In addition, the following side effects have been reported: anxiety, confusion, depression, hair loss, hallucinations, increased levels of potassium in the blood, low blood cell counts, palpitations, pancreatitis, tingling sensation, unusual headache with stiff neck (aseptic meningitis), vertigo.

WARNINGS:

Do not take VIOXX if you:

- have had an allergic reaction such as asthma attacks, hives, or swelling of the throat and face to aspirin or other NSAIDs (for example, ibuprofen and naproxen).

- have had an allergic reaction to refecoxib, which is the active ingredient of VIOXX, or to any of its inactive ingredients.