Etodolac Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Osteoarthritis

Capsules or tablets: 300 mg orally 2 to 3 times a day or 400 mg orally twice a day or 500 mg orally twice a day. Total daily dose should not exceed 1200 mg.

Extended-release tablets: 400 to 1200 mg orally, given once daily.

Usual Adult Dose for Rheumatoid Arthritis

Capsules or tablets: 300 mg orally 2 to 3 times a day or 400 mg orally twice a day or 500 mg orally twice a day. Total daily dose should not exceed 1200 mg.

Extended-release tablets: 400 to 1200 mg orally, given once daily.

Usual Adult Dose for Pain

Capsules or tablets: 200 to 400 mg orally every 6 to 8 hours. Total daily dose should not exceed 1200 mg.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Extended-release tablets:
6 to 16 years: dose based on weight, given orally once daily

For 20 to 30 kg, dose is 400 mg
For 31 to 45 kg, dose is 600 mg
For 46 to 60 kg, dose is 800 mg
For greater than 60 kg, dose is 1000 mg

Renal Dose Adjustments

Dosage adjustment of etodolac is generally not required in patients with mild to moderate renal impairment. Monitoring of kidney function is advisable. Etodolac is not recommended in patients with advanced renal disease.

Liver Dose Adjustments

Etodolac should be used with caution in patients with mild to moderate hepatic disease.

Dose Adjustments

Patients weighing less than 60 kg should not exceed 20 mg/kg/day.

The dosage regimen should be adjusted based on patient response and tolerance to etodolac. The lowest effective dose should be used for maintenance therapy.

Precautions

NSAIDs may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of administration. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with NSAIDs, the lowest effective dose should be used for the shortest duration possible. Prescribers and patients should remain vigilant for the development of such events, even in the absence of previous CV symptoms. Patients should be advised about the signs and/or symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. It has been shown that the incidence of upper GI ulcers, gross bleeding, or perforation, caused by NSAIDs, increases with duration of use. However, even short-term therapy is not without risk. Patients should be informed about the signs and symptoms of serious GI toxicities and the steps to take if they occur. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or GI bleeding. Patients with a prior history of peptic ulcer disease, and/or GI bleeding, and who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Since elderly patients are at greater risk for serious GI events, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered. NSAIDs should be administered with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.

Etodolac is contraindicated for the treatment of perioperative pain in patients undergoing coronary artery bypass graft (CABG) surgery. Patients with a hypersensitivity (angioedema, bronchospasm, urticaria, or rhinitis) to aspirin or other NSAIDs may be cross sensitive to etodolac. Patients with the "triad" of asthma, nasal polyps, and aspirin or other NSAID hypersensitivity are at particular risk. Fatal reactions have been reported in such patients. The use of etodolac is considered contraindicated in these patients.

NSAIDs, including etodolac, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to an increased incidence of CV events. NSAIDs, including etodolac, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of NSAID therapy and throughout the course of therapy.

Fluid retention and edema have been observed in some patients taking NSAIDs, including etodolac. Caution should be used when using etodolac in patients with fluid retention, hypertension, or heart failure.

Long-term NSAIDs use has resulted in renal papillary necrosis and other renal injury. No information is available from controlled clinical trials regarding the use of etodolac in patients with advanced renal disease. Therefore, treatment with etodolac is not recommended in patients with advanced renal disease. Renal function may be further compromised by the use of etodolac in patients with renal dysfunction, heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Renal blood flow in patients with renal dysfunction, edematous disorders, or hypovolemic states is dependent upon renal prostaglandin synthesis. If etodolac must be used, periodic monitoring of renal function is recommended. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. Caution is advised in patients with pre-existing kidney disease.

Patients who present with considerable dehydration should be rehydrated before starting therapy with etodolac.

NSAIDs, including etodolac, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Etodolac should not be used as a substitute for corticosteroids or to treat corticosteroid insufficiency.

Borderline elevations of one or more liver tests have been reported in patients treated with etodolac. Elevations in ALT or AST (approximately three or more times the upper limit of normal) have been reported in clinical trials. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes, have been reported. Etodolac should be discontinued if clinical signs and symptoms consistent with liver disease develop or if systemic manifestations occur (e.g., eosinophilia, rash, etc.).

Anemia has been reported in patients receiving NSAIDs, including etodolac. This may due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including etodolac, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Patients receiving etodolac who are also receiving anticoagulants or those who have coagulation disorders should be carefully monitored.

Patients receiving NSAIDs for long-term treatment should have their CBC and chemistry profile checked periodically.

Dialysis

Etodolac is not dialyzable.

Other Comments

If no improvement is seen within 2 to 4 weeks of therapy, an alternative NSAID should be considered.

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