Rofecoxib is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It is actually a new generation NSAID that belong to cyclooxygenase 2 inhibitors. It works by reducing substances that cause inflammation, pain, and fever in the body. It is used to reduce pain, inflammation, and stiffness caused by osteoarthritis, juvenile and non-juvenile rheumatoid arthritis. It is likewise indicated for acute pain in adults; migraine headaches; and menstrual pain.
The manufacturer of rofecoxib (Vioxx) has announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking rofecoxib.
Early signs of dangerous side effects are : abdominal pain, tenderness, or discomfort; nausea; blood in your vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of your skin or eyes; "flu-like" symptoms; or unusual bruising or bleeding. In these instances, inform your doctor immediately.
Do not take rofecoxib if you have experienced asthma, hives, or an allergic reaction after taking aspirin or another NSAID such as ibuprofen, naproxen, ketoprofen, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, indomethacin, ketorolac, nabumetone, oxaprozin, piroxicam, sulindac, tolmetin, celecoxib, valdecoxib, or meloxicam. You may have the same reaction upon intake of rofecoxib.
Special precautions include if you: smoke; drink alcohol; have ever had an ulcer or bleeding in your stomach; have liver disease; have kidney disease;
have asthma; have congestive heart failure; have fluid retention; have heart disease; have high blood pressure; have a bleeding disorder or are taking a blood thinner such as warfarin (Coumadin); or are taking a steroid medicine such as prednisone, methylprednisolone and prednisolone.
Rofecoxib is not known whether it will harm an unborn baby. Therefore, it should not be taken late in pregnancy because it may affect the formation of the baby's heart. It is not known whether rofecoxib passes into breast milk. Do not take this drug without telling your doctor if you are breast-feeding. For those over 65 years old, you may be given a lower dose of this drug because of being more likely to experience the side effects of this drug. Although symptoms of rofecoxib overdose are not known, do not take a double dose. There are no restrictions on food, beverages, or activity during treatment with this medicine.
Other, less serious side effects may be more likely to occur such as dizziness; mild fatigue or weakness; or diarrhea. Talk to your doctor about any other unusual side effect.
Prior to intake of rofecoxib, tell your doctor if you are taking any of the following drugs: aspirin or an aspirin-like medication such as salsalate (Disalcid), choline salicylate-magnesium salicylate (Trilisate, Tricosal, others), and magnesium salicylate (Doan's, Bayer Select Backache Formula, others); an over-the-counter cough, cold, allergy, or pain medicine that contains aspirin, ibuprofen, naproxen, or ketoprofen; a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (Hydrodiuril, others), chlorothiazide (Diuril, others), chlorthalidone (Hygroton, Thalitone); an angiotensin-converting-enzyme inhibitor (ACE inhibitor) such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and others; a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others); an anticoagulant (blood thinner) such as warfarin (Coumadin); methotrexate (Rheumatrex, Folex); theophylline (Theo-Dur, Theobid, and others);
lithium (Eskalith, Lithobid, others); or rifampin (Rimactane, Rifadin, Rifater). Other drugs not listed here may also interact with rofecoxib. Talk to your doctor before taking any prescription or over-the-counter medicines, including herbal products.
Rofecoxib is a white to off-white to light yellow powder. It is sparingly soluble in acetone, slightly soluble in methanol and isopropyl acetate, very slightly soluble in ethanol, practically insoluble in octanol, and insoluble in water. The empirical formula for rofecoxib is C17H14O4S, and the molecular weight is 314.36. Each tablet of VIOXX for oral administration contains either 12.5 mg, 25 mg, or 50 mg of rofecoxib and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, and yellow ferric oxide. The 50 mg tablets also contain red ferric oxide. Each 5 mL of the oral suspension contains either 12.5 or 25 mg of rofecoxib and the following inactive ingredients: citric acid (monohydrate), sodium citrate (dihydrate), sorbitol solution, strawberry flavor, xanthan gum, and purified water. Added as preservatives are sodium methylparaben 0.13% and sodium propylparaben 0.02%.
Rofecoxib has the following structural formula: