etodolac 200 mg capsule

Uses

Conventional capsules and tablets and extended-release tablets of etodolac are used for anti-inflammatory and analgesic effects in the acute and chronic symptomatic treatment of osteoarthritis and rheumatoid arthritis. Extended-release tablets of etodolac also are used for the symptomatic treatment of juvenile rheumatoid arthritis in pediatric patients 6-16 years of age. Conventional capsules and tablets of etodolac also are used for the relief of pain. Extended-release tablets of etodolac are not recommended for the management of acute pain.

The potential benefits and risks of etodolac therapy as well as alternative therapies should be considered prior to initiating etodolac therapy. The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed.

Patients should be advised that etodolac, like other NSAIAs, is not free of potential adverse effects, including some that can cause discomfort, and that more serious effects (e.g., myocardial infarction, stroke, GI bleeding), which may require hospitalization and may even be fatal, also can occur. NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors and prototypical NSAIAs, increase the risk of serious adverse cardiovascular thrombotic events, including myocardial infarction and stroke, in patients with or without cardiovascular disease or risk factors for cardiovascular disease. Available data suggest that the increase in risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use. Use of NSAIAs also is associated with an increased risk of heart failure. The risk of potentially serious adverse GI effects also should be considered in patients receiving etodolac, particularly in patients receiving chronic therapy with the drug. NSAIAs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Patients should be advised to read the medication guide for NSAIAs that is provided to the patient each time the drug is dispensed.

Dosage and Administration

Administration

The potential benefits and risks of etodolac therapy as well as alternative therapies should be considered prior to initiating etodolac therapy.

Etodolac is administered orally. While the extent of GI absorption of etodolac administered as conventional capsules or tablets does not appear to be affected substantially by concomitant administration with food or antacids, peak concentrations may be reduced by about 50 or 15-20%, respectively; in addition, the time to peak concentration may be delayed substantially by concomitant administration with food but not antacids.

The extent of GI absorption of etodolac administered as extended-release tablets is not affected substantially by concomitant administration with food or antacids; however, peak plasma concentrations are increased by 54% when the extended-release preparation is administered with food and reduced by 15-20% when administered with antacid. Concomitant administration with antacids does not affect time to peak concentrations.

Dosage

The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed. Dosage of etodolac must be carefully adjusted according to individual requirements and response, using the lowest possible effective dosage.

The manufacturers state that safety and efficacy of etodolac conventional capsules and tablets have not been established in children. Safety and efficacy of extended-release tablets of etodolac have not been established in pediatric patients younger than 6 years of age.

Pain

For the relief of acute pain, the usual recommended adult dosage of etodolac as conventional capsules or tablets is up to 1 g daily given in divided doses of 200-400 mg every 6-8 hours. Etodolac dosages exceeding 1 g daily have not been evaluated in controlled clinical studies.

Inflammatory Diseases

For the acute or chronic symptomatic treatment of osteoarthritis or rheumatoid arthritis in adults, the usual initial dosage of etodolac as conventional capsules or tablets is 600-1000 mg daily, usually administered in 2 divided doses; dosages of 900 mg daily usually are given in 3 divided doses. For the symptomatic treatment of osteoarthritis or rheumatoid arthritis, the usual initial dosage of etodolac as extended-release tablets is 400-1000 mg once daily. Subsequent dosage should be adjusted according to the patient's response and tolerance.

Some adults receiving long-term therapy with etodolac may respond to dosages of 600 mg daily. Etodolac dosages exceeding 1 g daily as conventional capsules or tablets or 1.2 g daily as extended-release tablets, respectively, have not been evaluated in controlled clinical studies.

During chronic therapy, a therapeutic response generally is evident within 2 weeks (sometimes within 1 week); when a satisfactory response occurs, dosage of the drug should be reviewed and adjusted as needed.

For the symptomatic treatment of juvenile rheumatoid arthritis in pediatric patients 6-16 years of age, the recommended dosage of etodolac as extended-release tablets is 400 mg once daily in those weighing 20-30 kg, 600 mg once daily in those weighing 31-45 kg, 800 mg once daily in those weighing 46-60 kg, or 1 g once daily in those weighing more than 60 kg.