• Basic Info
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Uses

Consider potential benefits and risks of etodolac therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Management of juvenile rheumatoid arthritis in children 6–16 years of age.

Pain

Relief of pain in adults.

Dosage and Administration

General

• Consider potential benefits and risks of etodolac therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Oral Administration

Administer orally once daily as extended-release tablets or 2 or 3 times daily as conventional capsules or tablets.

Dosage

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.

Pediatric Patients

Inflammatory Diseases

Juvenile Rheumatoid Arthritis

Oral

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Initially, 300 mg 2 or 3 times daily, 400 mg twice daily, or 500 mg twice daily as conventional capsules or tablets. Base subsequent dosage on clinical response and tolerance.

Alternatively, initial dosage of 400–1000 mg once daily as extended-release tablets. Base subsequent dosage on clinical response and tolerance.

Pain

Oral

1 g daily as conventional capsules or tablets given in divided doses of 200–400 mg every 6–8 hours.

Prescribing Limits

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Maximum 1.2 g daily.

Pain

Oral

Maximum 1 g daily.

Cautions

Contraindications

• Known hypersensitivity to etodolac or any ingredient in the formulation.
• History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.
• Treatment of perioperative pain in the setting of CABG surgery.

Warnings/Precautions

Warnings

Cardiovascular Effects

Selective COX-2 inhibitors have been associated with increased risk of serious cardiovascular events (e.g., MI, stroke) in certain situations. Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events. Current data insufficient to assess risk associated with etodolac.

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary.

Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs. (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events. Use with caution in patients with hypertension; monitor BP. Impaired response to certain diuretics may occur. (See Specific Drugs under Interactions.)

Fluid retention and edema reported. Caution in patients with fluid retention or heart failure.

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol; alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole) or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.

Potential for overt renal decompensation. Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist. (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.

Immediate medical intervention and discontinuance for anaphylaxis.

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning. Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.

Elevations of serum ALT or AST reported.

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results. Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.

Hematologic Effects

Anemia reported rarely. Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.

May inhibit platelet aggregation and prolong bleeding time.

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.

May mask certain signs of infection.

Obtain CBC and chemistry profile periodically during long-term use.

Specific Populations

Pregnancy

Category C. Avoid use in third trimester because of possible premature closure of the ductus arteriosus.

Lactation

Not known whether distributed into milk. Discontinue nursing or the drug.

Pediatric Use

Safety and efficacy of etodolac conventional tablets or capsules not established in children.

Safety and efficacy of etodolac extended-release tablets not established in children <6 years of age.

Safety and efficacy of etodolac extended-release tablets in children 6–16 years of age supported by studies (of Lodine^® XL extended-release tablets [no longer commercially available in the US]) in adults with rheumatoid arthritis and by safety, efficacy, and pharmacokinetic data from trials in children with juvenile rheumatoid arthritis.

Geriatric Use

Caution advised. Safety similar to that in younger adults. However, geriatric patients appear to tolerate NSAIA-induced adverse effects less well than younger individuals.

Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.

Renal Impairment

Metabolites eliminated principally via the kidney.

Use with caution in patients with renal disease. Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.

Common Adverse Effects

Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, GI bleeding, GI perforation, nausea, peptic ulcer, vomiting, renal function abnormalities, anemia, dizziness, edema, liver function test abnormalities, headache, prolonged bleeding time, pruritus, rash, tinnitus.