Usual Adult Dose for Osteoarthritis

Valdecoxib was voluntarily withdrawn from the market in April, 2005 by the manufacturer following an FDA Public Health Advisory announcing that the overall risk versus benefit profile for valdecoxib is unfavorable, based on the following: reports of serious and potentially life-threatening skin reactions, including deaths, in patients taking Bextra. The risk of these reactions have occurred in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trial that FDA believes may be relevant to chronic use, and lack of any demonstrated advantages for Bextra compared with other NSAIDs. The following dosage information applies to when the drug was available in the USA.

Initial dose: 10 mg once daily

Usual Adult Dose for Rheumatoid Arthritis

Valdecoxib was voluntarily withdrawn from the market in April, 2005 by the manufacturer following an FDA Public Health Advisory announcing that the overall risk versus benefit profile for valdecoxib is unfavorable, based on the following: reports of serious and potentially life-threatening skin reactions, including deaths, in patients taking Bextra. The risk of these reactions have occurred in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trial that FDA believes may be relevant to chronic use, and lack of any demonstrated advantages for Bextra compared with other NSAIDs. The following dosage information applies to when the drug was available in the USA.

Initial dose: 10 mg once daily

Usual Adult Dose for Dysmenorrhea

Valdecoxib was voluntarily withdrawn from the market in April, 2005 by the manufacturer following an FDA Public Health Advisory announcing that the overall risk versus benefit profile for valdecoxib is unfavorable, based on the following: reports of serious and potentially life-threatening skin reactions, including deaths, in patients taking Bextra. The risk of these reactions have occurred in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trial that FDA believes may be relevant to chronic use, and lack of any demonstrated advantages for Bextra compared with other NSAIDs. The following dosage information applies to when the drug was available in the USA.

Initial dose: 20 mg twice daily

Usual Adult Dose for Pain

Valdecoxib was voluntarily withdrawn from the market in April, 2005 by the manufacturer following an FDA Public Health Advisory announcing that the overall risk versus benefit profile for valdecoxib is unfavorable, based on the following: reports of serious and potentially life-threatening skin reactions, including deaths, in patients taking Bextra. The risk of these reactions have occurred in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trial that FDA believes may be relevant to chronic use, and lack of any demonstrated advantages for Bextra compared with other NSAIDs. The following dosage information applies to when the drug was available in the USA.

Study (n=507) - Oral or Bunionectomy Surgery: 20 or 40 mg single oral dose given 60 to 75 minutes before surgery.

Renal Dose Adjustments

Valdecoxib use in advanced renal disease is not recommended.

Liver Dose Adjustments

Valdecoxib use in patients with severe hepatic impairment (Child-Pugh Class C) is not recommended.

Initiate valdecoxib treatment with caution in patients with mild or moderate (Child-Pugh Class B) hepatic impairment and fluid retention.

Dose Adjustments

No dosage adjustment is necessary due to age or gender differences.

Precautions

Valdecoxib is contraindicated for the treatment of postoperative pain immediately following coronary artery bypass graft (CABG) surgery and should not be used in this setting.

Valdecoxib should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatories. Severe, rarely fatal, anaphylactic-like reactions to nonsteroidal anti-inflammatories have been reported in such patients.

An FDA Public Health Advisory on the use of Nonsteroidal anti-inflammatory Drug Products (NSAIDs) issued as a result of recent reports of controlled clinical trials showing that COX-2 selective agents may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery) states that physicians prescribing valdecoxib should consider this emerging information when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal bleeding, have a history of intolerance to nonselective NSAIDs, or are not doing well on nonselective NSAIDs may be appropriate candidates for COX-2 selective agents.; Individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs should be taken into account for each prescribing situation.; Consumers are advised that all over-the-counter (OTC) pain medications, including NSAIDs, should be used in strict accordance with the label directions. If use of an OTC NSAID is needed for longer than ten days, a physician should be consulted.

Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms in patient taking nonsteroidal anti-inflammatory drugs (NSAIDs). Valdecoxib should be used with extreme caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. Studies have shown that patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk of developing a GI bleed than patients with neither of these risk factors.

Valdecoxib should be used with caution in patients with comorbid conditions, or co-therapies that may increase the risk of gastrointestinal bleeding, such as treatment with corticosteroids, anticoagulants, prolonged use of NSAIDs, smoking, alcoholism, older age, and poor general health status.

Valdecoxib should be used with caution in patients with considerable dehydration. The manufacturer recommends that patients be rehydrated first before the drug is used.

Dialysis

Valdecoxib use in advanced renal disease is not recommended.

Other Comments

Valdecoxib may be taken with or without food. Administration with a high-fat meal may delay the time to peak plasma concentration by 1 to 2 hours.

Valdecoxib may be taken with an antacid (aluminum/magnesium hydroxide).

Valdecoxib should be monitored closely in patients on long therapy with valdecoxib because of reports of anemia, renal injury, and elevations of one or more liver tests.