Vioxx

What is it?

An NSAID and eoxib available as tablets in 2 strengths containing rofecoxib; off-white, contain 12.5mg, marked MSD 74 and yellow, contain 25mg marked MSD 110.All are marked VIOXX. Also, VIOXX SUSPENSION, a liquid in 2 strengths containing 12.5mg and 25mg of rofecoxib per 5ml. Also, VIOXX ACUTE, available as tablets in 2 strengths containing rofecoxib. Yellow, contain 25mg, marked MSD 741 and orange, contain 50mg, marked MSD 744.

Medical Uses

Vioxx and Vioxx suspension, relief of symptoms of osteo- and rheumatoid arthritis; Vioxx acute, acute pain, period pain.

Dosage

Adults, Vioxx and Vioxx suspension, osteoarthritis, 12.5mg once each day to start, increasing to 25mg once daily, if needed. Rheumatoid arthritis, 25mg once each day. Vioxx acute, acute pain, only while symptoms occurring, 50mg once each day to start then reduce to 25mg once daily as soon as possible. Period pain, 25mg or 50mg once each day with 50mg maximum daily dose.

Special Care

Pregnancy, previous stomach ulcer or bleeding, impaired kidney or liver function, cirrhosis of liver, heart failure, fluid retention, high blood pressure, uncompensated heart failure, dehydration, malfunction of left ventricle, patients with previous ischaemic heart disease - stop Vioxx if condition worsens. Elderly patients and those with heart, kidney or liver disorders must be closely monitored. If symptoms of liver malfunction occur, tests must be performed.

Avoid Use

Children, breastfeeding, last 3 months of pregnancy, serious kidney or liver disorders, allergic reactions or asthma occurring with aspirin or anti-inflammatories, active stomach ulcer or bleeding in gastrointestinal tract, inflammation of bowel, serious congestive heart failure.

Possible Drug and Food Interactions

Ace inhibitors, theophylline, cyelosporin, amitriptyline, methotrexate, tacrolimus, high dose NSAIDs and aspirin, warfarin, tacrine, midazolam, oral anticoagulants, zileuton, β-blockers, rifampicin, lithium, diuretics.

Known Side Effects

Headache, gastrointestinal upset, stomach and abdominal pains, fluid retention, dizziness, high blood pressure, dizziness, itching, raised liver enzymes, decreased haemocrit. Any adverse side effects must be reported to the Committee on the Safety of Medicines (CSM).