Trade Names:Etodolac- Capsules 200 mg- Capsules 300 mg- Tablets 400 mg- Tablets 500 mg- Tablets, extended-release 400 mg- Tablets, extended-release 500 mg- Tablets, extended-release 600 mgApo-Etodolac (Canada)
Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.
Well-absorbed. Bioavailability is 80% or more. C max is approximately 14 to 37 mcg/mL. T max is approximately 1.4 h. Food decreases C max approximately 50% and increases T max by 1.4 to 3.8 h.
Vd is approximately 390 mL/kg. More than 99% protein bound.
Extensively metabolized in the liver.
Terminal t ½ is 6.4 h. Cl is 49 mL/h/kg. Approximately 72% is recovered in the urine, with 1% as unchanged drug; 16% is excreted in feces.
Cl may be reduced.Hemodialysis
50% greater apparent Cl of total etodolac.
Relief of mild to moderate pain; relief of signs and symptoms of rheumatoid arthritis and osteoarthritis.
Treatment of perioperative pain in the setting of coronary artery bypass graft surgery; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; hypersensitivity to any component of the product.
PO 200 to 400 mg q 6 to 8 h as needed. Dosages more than 1,000 mg/day have not been adequately evaluated.Osteoarthritis/Rheumatoid ArthritisAdults
PO 300 mg twice daily or 3 times daily, or 400 or 500 mg twice daily. Dosages more than 1,000 mg/day have not been adequately evaluated.
Store at 68° to 77°F. Dispense in tight, light-resistant container. Protect from moisture.
Antihypertensive effect of ACE inhibitors may be diminished.Anticoagulants
May increase PT. Watch for signs and symptoms of bleeding.Aspirin
Protein binding of etodolac may be reduced; in addition, the risk of gastric erosion and bleeding may be increased.Diuretics
May decrease diuretic effect.Lithium
May increase lithium levels and effects.Methotrexate
May increase methotrexate levels.
Drug may cause small decrease.Urinary bilirubin test
Drug may cause false-positive results.Urinary dipstick tests
Drug may cause results that are false positive for ketones.
Dizziness, headache (1% to 10%); asthenia, depression, malaise, nervousness (at least 1%).
Pruritus, rash (1% to 10%); cutaneous vasculitis with purpura, erythema multiforme, hyperpigmentation, Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).
Tinnitus (1% to 10%); blurred vision (at least 1%).
Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, GI ulcers, gross bleeding/perforation, heartburn, nausea, vomiting (1% to 10%); gastritis, melena (at least 1%).
Abnormal renal function (1% to 10%); dysuria, urinary frequency (at least 1%); elevated BUN, renal failure, renal insufficiency, renal papillary necrosis (postmarketing).
Anemia (1% to 10%).
Increased bleeding time (1% to 10%); agranulocytosis, hemolytic anemia, leukopenia, neutropenia, pancytopenia (postmarketing).
Elevated liver enzymes (1% to 10%); cholestatic hepatitis, cholestatic jaundice, duodenitis, hepatic failure, intestinal ulceration, jaundice, liver necrosis, pancreatitis (postmarketing).
Hyperglycemia in previously controlled diabetic patients (postmarketing).
Pulmonary infiltration with eosinophilia (postmarketing).
Edema (1% to 10%); chills and fever (at least 1%); allergic reactions, anaphylactic/anaphylactoid reactions (postmarketing).
NSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke, which can be fatal. This risk may increase with length of therapy. Patients with CV disease or risk factors for CV disease may be at greater risk. Contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery. NSAIDs cause an increased risk of serious GI adverse reactions, including bleeding, inflammation, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur any time during use and without warning symptoms. Elderly patients are at greater risk of serious GI events.
Check CBC and obtain a chemistry profile in patients on long-term therapy. Assess location, duration, and intensity of pain before and 60 min after administration. Assess renal function before and during therapy. Evaluate patients who develop signs or symptoms suggestive of liver dysfunction or who develop abnormal liver function for development of more severe hepatic reactions while on therapy. Monitor blood pressure closely. Carefully monitor patients who may be adversely affected by alterations in platelet function (eg, patients with coagulation disorders or receiving anticoagulant therapy).
Category C . Avoid in late pregnancy.
Safety and efficacy not established.
Use with caution.
May occur; use with caution in aspirin-sensitive individuals because of possible cross-sensitivity.
Not recommended in patients with advanced renal disease. Acute renal insufficiency, interstitial nephritis, hyperkalemia, hyponatremia, and renal papillary necrosis may occur.
Cl may be reduced in patients with severe hepatic failure.
Use with caution in patients with fluid retention or heart failure.
Do not administer to patients with aspirin triad, which occurs typically in asthmatic patients who experience rhinitis with or without nasal polyps, or in patients who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.
Patients with asthma may have aspirin-sensitive asthma, which may be associated with severe and sometimes fatal bronchospasm. Do not administer etodolac to patients with this type of aspirin sensitivity and use with caution in patients with preexisting asthma.
New hypertension or worsening of preexisting hypertension, either of which may contribute to increased risk of CV events, may occur.
NSAIDs inhibit platelet aggregation and have been reported to prolong bleeding time.
Serious and sometimes fatal skin adverse reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, may occur.
Acute renal failure, anaphylactoid reactions, drowsiness, epigastric pain, GI bleeding, hypertension, lethargy, nausea, respiratory depression, vomiting.
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