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The U.S. Food and Drug Administration recently approved etodolac extended-release tablets (Lodine XL) as nonsteroidal anti-inflammatory drugs (NSAIDs) for the signs and symptoms of osteoarthritis and rheumatoid arthritis. They are only taken once daily, unlike other NSAIDs, which usually must be taken several times a day to relieve pain.
Etodolac extended-release tablets were tested in managing the signs and symptoms of osteoarthritis of the knee in a double-blind, randomized, controlled trial of 451 patients. In doses of 400 mg to 1,200 mg given once daily, the efficacy of etodolac extended-release tablets was comparable to 300 mg of etodolac (not extended release) given 300 mg twice daily to 400 mg three times daily.
Contraindications for etodolac extended-release tablets include patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
Serious gastrointestinal bleeding, ulceration, and perforation can occur at any time with etodolac extended-release tablets with or without warning symptoms. Thus, physicians should remain alert for signs of ulceration and bleeding in patients receiving the drug. In clinical trials of patients on NSAIDs for two years, gross bleeding or perforation occurred in about 1% of patients treated for three to six months and in about 2% to 4% of patients treated for one year.
Patients with advanced renal disease should receive etodolac extended-release tablets only with close monitoring of their kidney function. In addition, borderline elevations of liver tests may occur while on the drug; if clinical signs and symptoms of liver disease develop, the drug should be discontinued. These are other side effects that may occur in patients on etodolac extended-release tablets:
• fluid retention and edema;
• chills and fever;
• abdominal pain;
• pruritus or rash;
• blurred vision;
• urinary frequency.
Patients on long-term treatment with etodolac extended-release tablets should have their hemoglobin or hematocrit levels checked periodically.
The drug also should be avoided in late pregnancy. In nursing mothers, a decision should be made to either discontinue nursing or discontinue the drug.
Drugs that may interact with etodolac extended-release tablets include aspirin, warfarin, cyclosporine, and phenylbutazone.
Etodolac treatment is associated with a small decrease in serum uric acid levels during the first weeks of therapy, but they usually remain stable for up to one year.
Safety and effectiveness of etodolac extended-release tablets have not been established in children. Use caution when prescribing any NSAID to the elderly because they don’t tolerate side effects as well as younger patients.
The recommended dose of etodolac extended-release tablets is 400 mg to 1,000 mg given once daily. Seek the lowest effective dose for each patient, although the dose may be adjusted up or down as needed.
Etodolac extended-release tablets are available in bottles of 100 or in unit-dose packages of 100 in either 400 mg or 600 mg doses.