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Etodolac (etodolac)

BOXED WARNING

NSAIDs may increase risk of serious cardiovascular (CV) thrombotic events, MI, and stroke, which can be fatal; increased risk with duration of use and with cardiovascular disease (CVD) or risk factors for CVD. Increased risk of serious GI adverse events (eg, bleeding, ulceration, stomach/intestinal perforation) that can be fatal and occur anytime during use without warning symptoms; elderly patients are at a greater risk. Contraindicated for the treatment of perioperative pain in the setting of CABG surgery.

OTHER BRAND NAMES

Lodine (Discontinued)

THERAPEUTIC CLASS

NSAID

DEA CLASS

RX

INDICATIONS

Acute and long-term use in the management of signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA). Management of acute pain.

ADULT DOSAGE

Acute Pain

200-400mg q6-8h
Max: 1000mg/day

Use lowest effective dose for the shortest duration; after observing response to initial therapy, adjust dose and frequency

Osteoarthritis

Acute and Long-Term Management of Signs/Symptoms:

Initial: 300mg bid-tid, or 400mg bid, or 500mg bid
May give a lower dose of 600mg/day for long-term use
Max:
1000mg/day

Use lowest effective dose for the shortest duration; after observing response to initial therapy, adjust dose and frequency

Rheumatoid Arthritis

Acute and Long-Term Management of Signs/Symptoms:

Initial: 300mg bid-tid, or 400mg bid, or 500mg bid
May give a lower dose of 600mg/day for long-term use
Max: 1000mg/day

Use lowest effective dose for the shortest duration; after observing response to initial therapy, adjust dose and frequency

DOSING CONSIDERATIONS

Hepatic Impairment
Severe: Consider reducing dose

Elderly
Caution w/ dose selection

ADMINISTRATION

Oral route

HOW SUPPLIED

Cap: 200mg, 300mg; Tab: 400mg, 500mg

CONTRAINDICATIONS

History of asthma, urticaria, or other allergic-type reactions with aspirin (ASA) or other NSAIDs. Treatment of perioperative pain in the setting of CABG surgery.

WARNINGS/PRECAUTIONS

May cause HTN or worsen preexisting HTN. Fluid retention and edema reported; caution with fluid retention or heart failure (HF). Extreme caution with prior history of ulcer disease, GI bleeding, or risk factors for GI bleeding (eg, prolonged NSAID therapy, older age, poor general health status); d/c if serious GI event occurs. Renal papillary necrosis and other renal injury reported after long-term use; increased risk with renal/hepatic impairment, HF, and elderly. Caution with preexisting kidney disease. Not recommended for use with advanced renal disease. Caution with mild to moderate renal impairment. Anaphylactoid reactions may occur. Avoid with ASA triad. Caution with asthma and avoid with ASA-sensitive asthma. May cause serious skin adverse events (eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis); d/c at 1st appearance of skin rash or any other signs of hypersensitivity. Avoid in late pregnancy; may cause premature closure of ductus arteriosus. Not a substitute for corticosteroids or for the treatment of corticosteroid insufficiency; may mask signs of inflammation and fever. May cause elevations of LFTs or severe hepatic reactions (eg, jaundice, fulminant hepatitis, liver necrosis, hepatic failure); d/c if liver disease or systemic manifestations occur, or if abnormal LFTs persist/worsen. Anemia reported; monitor Hgb/Hct if signs or symptoms of anemia develop. May inhibit platelet aggregation and prolong bleeding time; monitor patients with coagulation disorders. Caution in debilitated and elderly. Lab test interactions may occur.

ADVERSE REACTIONS

Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, heartburn, N/V, GI ulcers, abnormal renal function, anemia, dizziness, headaches, increased bleeding time, pruritus, rashes.

DRUG INTERACTIONS

May impair response with thiazides or loop diuretics. Increased risk of GI bleeding with oral corticosteroids, anticoagulants, alcohol use, and smoking. Risk of renal toxicity with diuretics and ACE inhibitors. May diminish antihypertensive effect of ACE inhibitors. May decrease peak concentration with antacids. Not recommended with ASA; may increase adverse effects. May elevate cyclosporine, digoxin, and methotrexate (MTX) levels. May enhance nephrotoxicity associated with cyclosporine. Avoid use prior to or concomitantly with high doses of MTX. May enhance MTX toxicity; caution with concomitant use. May reduce natriuretic effect of furosemide and thiazides in some patients, with possible loss of BP control; monitor for signs of renal insufficiency/failure and diuretic efficacy. May increase lithium levels and reduce lithium clearance; monitor for signs of lithium toxicity, and assess lithium levels when NSAID dosage adjustments are required. Phenylbutazone may increase free fraction of etodolac; not recommended concomitantly. Caution with warfarin; prolonged PT, with or without bleeding, may occur with warfarin; monitor patients carefully.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

NSAID; has not been established. Suspected to inhibit prostaglandin synthetase.

PHARMACOKINETICS

Absorption: Well-absorbed. Systemic bioavailability (100%); Cmax=14-37mg/mL, Tmax=80 min. Administration in various populations resulted in different pharmacokinetic parameters. Distribution: Plasma protein binding (>99%); Vd=390mL/kg. Metabolism: Liver (extensive); hydroxylation, glucuronidation; 6-, 7-, and 8-hydroxylated-etodolac, etodolac glucuronide (metabolites). Elimination: Urine (1% unchanged, 72% parent drug and metabolites), feces (16%); T1/2=6.4 hrs.

ASSESSMENT

Assess for previous hypersensitivity to the drug or any of its components; history of asthma, urticaria, or allergic-type reactions with ASA or other NSAIDs; ASA triad; CVD; risk factors for CVD; HTN; fluid retention; HF; history of ulcer disease; history of/risk factors for GI bleeding; general health status; renal/hepatic impairment; coagulation disorders; pregnancy/nursing status; and possible drug interactions. Obtain baseline CBC and BP.

MONITORING

Monitor for bleeding time, GI bleeding/ulceration/perforation, CV thrombotic events, MI, HTN, stroke, fluid retention, edema, asthma, hypersensitivity, and other adverse reactions. Monitor for BP, LFTs, and renal function. Monitor for CBC and chemistry profile periodically with long-term use.

PATIENT COUNSELING

Inform to seek medical advice if symptoms of CV events, GI ulceration/bleeding, skin/hypersensitivity reactions, unexplained weight gain or edema, hepatotoxicity, or anaphylactoid reactions occur. Instruct to avoid use in late pregnancy.

STORAGE

20-25°C (68-77°F). (Cap) Protect from moisture. (Tab) Store in original container until ready to use.

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