Vioxx Information Article
Vioxx Brand Name:
Vioxx Active Ingredient: rofecoxib Strength(s): 12.5mg & 25mg tablets or 12.5mg/5ml & 25mg/5ml suspension Dosage Form(s): Tablets and oral suspension Company Name: Merck & Co., Inc. Availability: Prescription only
*Date Approved by the FDA: May 21, 1999
*Approval by FDA does not mean that the drug is available to consumers at this time.
Do not stop taking any medications that you have been prescribed without first talking to your doctor. Serious problems such as liver damage have occurred in people treated with NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If you experience any of these symptoms, call your health care provider right away.
Vioxx can cause your body to retain fluid and swell. Your health care provider will decide if Vioxx is right for you, if you: retain fluids, have high blood pressure, have heart failure. If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since this type of reaction to aspirin and other NSAIDs have occurred in aspirin-sensitive patients, Vioxx should not be given to aspirin-sensitive patients.
Side effects can include:
Upper respiratory tract infection, Diarrhea, Nausea, Heartburn, Swelling of the lower legs or feet, High blood pressure. Rarely, serious ulcers have occurred in patients taking Vioxx.
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 Each tablet of VIOXX for oral administration contains either 12.5 or 25 mg of rofecoxib and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, 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%. VIOXX has demonstrated significant reduction in joint pain compared to placebo.
VIOXX was evaluated for the treatment of the signs and symptoms of OA of the knee and hip in placebo- and active-controlled clinical trials of 6 to 86 weeks duration that enrolled approximately 3900 patients. In patients with OA, treatment with VIOXX 12.5 mg and 25 mg once daily resulted in improvement in patient and physician global assessments and in the WOMAC (Western Ontario and McMaster Universities) osteoarthritis questionnaire, including pain, stiffness, and functional measures of OA. In six studies of pain accompanying OA flare, VIOXX provided a significant reduction in 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 OA 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. At doses of 12.5 and 25 mg, the effectiveness of VIOXX was shown to be comparable to ibuprofen 800 mg TID and diclofenac 50 mg TID for treatment of the signs and symptoms of OA. The ibuprofen studies were 6 week studies; the diclofenac studies were 12 month studies in which patients could receive additional arthritis medication during the last 6 months.
VIOXX cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids 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 corticosteroids.
The pharmacological activity of VIOXX in reducing inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infectious complications of presumed noninfectious, painful conditions. Drug Interactions ACE-inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of Angiotensin Converting Enzyme (ACE) inhibitors. In patients with mild to moderate hypertension, administration of 25 mg daily of VIOXX with the ACE inhibitor benazepril, 10 to 40 mg for 4 weeks, was associated with an average increase in mean arterial pressure of about 3 mm Hg compared to ACE inhibitor alone. This interaction should be given consideration in patients taking VIOXX concomitantly with ACE-inhibitors.
Preventing Drug Reactions: People who have had an adverse drug reaction in the past are more likely to have adverse reactions to other drugs.
Celebrex Information Article: Osteoarthritis (OA): CELEBREX has demonstrated significant reduction in joint pain compared to placebo.
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Vioxx Information Article
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