Etodolac

Name: Etodolac

Etodolac Usage

  • Etodolac comes in tablet and capsule forms.
  • It is taken 2 or 3 times daily for arthritis and up to 4 times daily for other causes of pain.
  • Once-daily extended-release tablets are also available.
  • Take etodolac with water at around the same time(s) each day.

Etodolac Dosage

The recommended total daily dose of etodolac for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in well-controlled trials.

Osteoarthritis and Rheumatoid Arthritis

The recommended starting dose of etodolac for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg two or three times daily, or 400 mg twice daily, or 500 mg twice daily. A lower dose of 600 mg/day may suffice for long-term administration. Doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

Where can i get more information?

Your pharmacist can provide more information about etodolac.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Cautions for Etodolac

Contraindications

  • Known hypersensitivity to etodolac or any ingredient in the formulation.1 2 3

  • History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.1 2 3

  • In the setting of CABG surgery.508

Warnings/Precautions

Warnings

Cardiovascular Thrombotic Effects

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.500 502 508

Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information500 501 502 indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.500

Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.500 502 506 508

Increased risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use.500 502 505 506 508

In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.508

In patients receiving NSAIAs following MI, increased risk of reinfarction and death observed beginning in the first week of treatment.505

Increased 1-year mortality rate observed in patients receiving NSAIAs following MI;500 508 511 absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.508 511

Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs.6 7 8 500 501 502 503 506 FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.500

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events throughout therapy, even in those without prior cardiovascular symptoms) and at the lowest effective dosage for the shortest duration necessary.1 500 508

Some clinicians suggest that it may be prudent to avoid NSAIA use, whenever possible, in patients with cardiovascular disease.505 511 512 516 Avoid use in patients with recent MI unless benefits of therapy are expected to outweigh risk of recurrent cardiovascular thrombotic events; if used, monitor for cardiac ischemia.508 Contraindicated in the setting of CABG surgery.508

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.1 502 508 (See Specific Drugs under Interactions.)

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.1 2 3

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).

Hypertension

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.1 Use with caution in patients with hypertension; monitor BP.1

Impaired response to ACE inhibitors, angiotensin II receptor antagonists, β-blockers, and certain diuretics may occur.1 508 509 (See Specific Drugs under Interactions.)

Heart Failure and Edema

Fluid retention and edema reported.1 508

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) may increase morbidity and mortality in patients with heart failure.500 501 504 507 508

NSAIAs may diminish cardiovascular effects of diuretics, ACE inhibitors, or angiotensin II receptor antagonists used to treat heart failure or edema.508 (See Specific Drugs under Interactions.)

Manufacturer recommends avoiding use in patients with severe heart failure unless benefits of therapy are expected to outweigh risk of worsening heart failure; if used, monitor for worsening heart failure.508

Some experts recommend avoiding use, whenever possible, in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.507

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.1 2 3

Potential for overt renal decompensation.1 2 3 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.1 2 3 5 (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.1 2 3

Immediate medical intervention and discontinuance for anaphylaxis.1 2 3

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.1 2 3

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.1 Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).1

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.1 2 3

Elevations of serum ALT or AST reported.1 2 3

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.1 2 3 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.1 2 3

Hematologic Effects

Anemia reported rarely.1 2 3 Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.1 2 3

May inhibit platelet aggregation and prolong bleeding time.1 2 3

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.1 2 3

May mask certain signs of infection.1 2 3

Obtain CBC and chemistry profile periodically during long-term use.1

Specific Populations

Pregnancy

Category C.1 2 3 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.1 2 3

Lactation

Not known whether distributed into milk.1 2 3 Discontinue nursing or the drug.1 2 3

Pediatric Use

Safety and efficacy of etodolac conventional tablets or capsules not established in children.1

Safety and efficacy of etodolac extended-release tablets not established in children <6 years of age.2

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.2

Geriatric Use

Caution advised.1 3 Safety similar to that in younger adults.1 2 3 However, geriatric patients appear to tolerate NSAIA-induced adverse effects less well than younger individuals.1 2

Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.1 2

Renal Impairment

Metabolites eliminated principally via the kidney.1 3

Use with caution in patients with renal disease.1 2 Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.1 2 3

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.1

Interactions for Etodolac

Role, if any, of CYP enzymes in etodolac metabolism not known.1 2 3

Specific Drugs

Drug

Interaction

Comments

ACE inhibitors

Reduced BP response to ACE inhibitor1 2 3

Possible deterioration of renal function in individuals with renal impairment5

Monitor BP1 2

Angiotensin II receptor antagonists

Reduced BP response to angiotensin II receptor antagonist5

Possible deterioration of renal function in individuals with renal impairment5

Monitor BP5

Antacids

Decreased peak plasma etodolac concentration; no effect on extent of etodolac absorption1 2 3

Aspirin

Increased risk of GI ulceration and other complications1

No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs1 502 508

Manufacturer states that concomitant use not recommended1 2 3

Cyclosporine

Possible increase in serum cyclosporine concentrations; possible increase in nephrotoxic effects of cyclosporine1 2 3

Monitor for cyclosporine toxicity1 2 3

Digoxin

Possible increase in plasma digoxin concentrations1 2 3

Monitor plasma digoxin concentrations1 2 3

Diuretics (furosemide, thiazides)

Reduced natriuretic effects1 2 3

Monitor for diuretic efficacy and renal failure1

Glyburide

Pharmacokinetic interaction unlikely1 2 3

Lithium

Increased plasma lithium concentrations1 2 3

Monitor for lithium toxicity1 2 3

Methotrexate

Pharmacokinetics of methotrexate not altered2 3

Caution advised2 3

Phenytoin

Pharmacokinetic interaction unlikely1 2 3

Warfarin

Reports of bleeding complications and increases in PT1 2 3

Caution advised1 2 3

Etodolac Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration; bioavailability is about 80%.1 2 3 Peak plasma concentration usually attained within about 1.4 hours (conventional capsules and tablets) or 6.7 hours (extended-release tablets).1 2 3

Onset

Conventional capsules or tablets provide pain relief within 30 minutes.1

Duration

Duration of pain relief averages 4–5 or 5–6 hours following administration of a 200- or 400-mg dose of etodolac (conventional capsules or tablets), respectively.1

Food

Food delays time to reach peak plasma concentration by about 2.4 hours but does not affect extent of absorption following administration as conventional capsules or tablets.1

Food increases peak plasma concentration but does not affect extent of absorption following administration as extended-release tablets.2 3

Distribution

Plasma Protein Binding

>99% (principally albumin).1 2 3

Elimination

Metabolism

Extensively metabolized; metabolites do not contribute substantially to effects of drug.1 2 3

Elimination Route

Excreted in urine (72%) mainly as metabolites and in feces (16%).1 2 3

Half-life

Conventional capsules and tablets: 6.4 hours1

Extended-release tablets: 8.4 hours in adults;2 3 12.1 hours in pediatric patients.2

Special Populations

In geriatric patients, no age-related effect on half-life.1 2 3

In patients with compensated hepatic cirrhosis, disposition of total and unbound etodolac not altered.1 2 Not studied in patients with severe hepatic failure.2

In patients with mild to moderate renal impairment (Clcr 37–88 mL/minute), disposition of total and unbound etodolac not altered.1

Clinical pharmacology

Pharmacodynamics

Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of Etodolac, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition.

Etodolac is a racemic mixture of [-]R- and [+]S-Etodolac. As with other NSAIDs, it has been demonstrated in animals that the [+]S-form is biologically active. Both enantiomers are stable and there is no [-]R to [+]S conversion in vivo.

Pharmacokinetics

Absorption

The systemic bioavailability of Etodolac is 100% as compared to solution and at least 80% as determined from mass balance studies. Etodolac is well absorbed and had a relative bioavailability of 100% when 200 mg capsules were compared with a solution of Etodolac. Based on mass balance studies, the systemic availability of Etodolac from either the tablet or capsule formulation is at least 80%. Etodolac does not undergo significant first-pass metabolism following oral administration. Mean (± 1 SD) peak plasma concentrations (Cmax) range from approximately 14 ± 4 to 37 ± 9 mcg/mL after 200 to 600 mg single doses and are reached in 80 ± 30 minutes (see Table 1 for summary of pharmacokinetic parameters). The dose-proportionality based on the area under the plasma concentration-time curve (AUC) is linear following doses up to 600 mg every 12 hours. Peak concentrations are dose proportional for both total and free Etodolac following doses up to 400 mg every 12 hours, but following a 600 mg dose, the peak is about 20% higher than predicted on the basis of lower doses. The extent of absorption of Etodolac is not affected when Etodolac is administered after a meal. Food intake, however, reduces the peak concentration reached by approximately one-half and increases the time to peak concentration by 1.4 to 3.8 hours.

Table 1. Mean (CV%)† Pharmacokinetic Parameters of Etodolac in Normal Healthy Adults and Various Special Populations

†% Coefficient of variation

*Age Range (years)

N/A = not available


PK
Parameters
Normal
Healthy
Adults
(18-65)*
(n=179)
Healthy
Males
(18-65)

(n=176)
Healthy
Females
(27-65)

(n=3)
Elderly
(>65)
(70-84)
Hemodialysis
(24-65)
(n=9)
Renal
Impairment
(46-73)

(n=10)
Hepatic
Impairment
(34-60)

(n=9)
Dialysis
On
Dialysis
Off
Tmax, h 1.4
(61%)†
1.4
(60%)
1.7
(60%)
1.2
(43%)
1.7
(88%)
0.9
(67%)
2.1
(46%)
1.1
(15%)
Oral Clearance,
mL/h/kg
(CL/F)
49.1
(33%)
49.4
(33%)
35.7
(28%)
45.7
(27%)
N/A N/A 58.3
(19%)
42.0
(43%)
Apparent Volume of Distribution, mL/kg (Vd/F) 393
(29%)
394
(29%)
300
(8%)
414
(38%)
N/A N/A N/A N/A
Terminal Half-Life, h 6.4
(22%)
6.4
(22%)
7.9
(35%)
6.5
(24%)
5.1
(22%)
7.5
(34%)
N/A 5.7
(24%)
Distribution

The mean apparent volume of distribution (Vd/F) of Etodolac is approximately 390 mL/kg. Etodolac is more than 99% bound to plasma proteins, primarily to albumin. The free fraction is less than 1% and is independent of Etodolac total concentration over the dose range studied. It is not known whether Etodolac is excreted in human milk; however, based on its physical-chemical properties, excretion into breast milk is expected. Data from in vitro studies, using peak serum concentrations at reported therapeutic doses in humans, show that the Etodolac free fraction is not significantly altered by acetaminophen, ibuprofen, indomethacin, naproxen, piroxicam, chlorpropamide, glipizide, glyburide, phenytoin, and probenecid.

Metabolism

Etodolac is extensively metabolized in the liver. The role, if any, of a specific cytochrome P450 system in the metabolism of Etodolac is unknown. Several Etodolac metabolites have been identified in human plasma and urine. Other metabolites remain to be identified. The metabolites include 6-, 7-, and 8-hydroxylated-Etodolac and Etodolac glucuronide. After a single dose of 14C-Etodolac, hydroxylated metabolites accounted for less than 10% of total drug in serum. On chronic dosing, hydroxylated-Etodolac metabolite does not accumulate in the plasma of patients with normal renal function. The extent of accumulation of hydroxylated-Etodolac metabolites in patients with renal dysfunction has not been studied. The hydroxylated-Etodolac metabolites undergo further glucuronidation followed by renal excretion and partial elimination in the feces.

Excretion

The mean oral clearance of Etodolac following oral dosing is 49 (±16) mL/h/kg. Approximately 1% of an Etodolac dose is excreted unchanged in the urine with 72% of the dose excreted into urine as parent drug plus metabolite:

-  Etodolac, unchanged 1%
-  Etodolac glucuronide 13%
-  hydroxylated metabolites (6-, 7-, and 8-OH) 5%
-  hydroxylated metabolite glucuronides 20%
-  unidentified metabolites 33%

Although renal elimination is a significant pathway of excretion for Etodolac metabolites, no dosing adjustment in patients with mild to moderate renal dysfunction is generally necessary. The terminal half-life (t½) of Etodolac is 6.4 hours (22% CV). In patients with severe renal dysfunction or undergoing hemodialysis, dosing adjustment is not generally necessary.

Fecal excretion accounted for 16% of the dose.

Special Populations

Geriatric
In Etodolac clinical studies, no overall differences in safety or effectiveness were observed between these patients and younger patients. In pharmacokinetic studies, age was shown not to have any effect on Etodolac half-life or protein binding, and there was no change in expected drug accumulation. Therefore, no dosage adjustment is generally necessary in the elderly on the basis of pharmacokinetics (see PRECAUTIONS, Geriatric Use).

Etodolac is eliminated primarily by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see WARNINGS, Renal Effects).

Pediatric
Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

Race
Pharmacokinetic differences due to race have not been identified. Clinical studies included patients of many races, all of whom responded in a similar fashion.

Hepatic Insufficiency
Etodolac is predominantly metabolized by the liver. In patients with compensated hepatic cirrhosis, the disposition of total and free Etodolac is not altered. Patients with acute and chronic hepatic diseases do not generally require reduced doses of Etodolac compared to patients with normal hepatic function. However, Etodolac clearance is dependent on liver function and could be reduced in patients with severe hepatic failure. Etodolac plasma protein binding did not change in patients with compensated hepatic cirrhosis given Etodolac.

Renal Insufficiency
Etodolac pharmacokinetics have been investigated in subjects with renal insufficiency. Etodolac renal clearance was unchanged in the presence of mild-to-moderate renal failure (creatinine clearance 37 to 88 mL/min). Furthermore, there were no significant differences in the disposition of total and free Etodolac in these patients. However, Etodolac should be used with caution in such patients because, as with other NSAIDs, it may further decrease renal function in some patients. In patients undergoing hemodialysis, there was a 50% greater apparent clearance of total Etodolac, due to a 50% greater unbound fraction. Free Etodolac clearance was not altered, indicating the importance of protein binding in Etodolac's disposition. Etodolac is not significantly removed from the blood in patients undergoing hemodialysis.

Principal display panel- 500mg

PRINCIPAL DISPLAY PANEL - 500 mg

BOTTLE LABEL APOTEX CORP.

NDC 60505-0102-1

Etodolac TABELTS USP 

500 mg

Rx only 

100 Tablets

 

Etodolac 
Etodolac tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60505-0041
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Etodolac (Etodolac) Etodolac 400 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE  
HYDROXYPROPYL CELLULOSE (TYPE H)  
HYPROMELLOSE 2208 (100 MPA.S)  
MAGNESIUM STEARATE  
METHYLCELLULOSE (100 CPS)  
POLYETHYLENE GLYCOL 1500  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code APO;041;400
Contains     
Packaging
# Item Code Package Description
1 NDC:60505-0041-1 100 TABLET, FILM COATED in 1 BOTTLE
2 NDC:60505-0041-2 500 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076004 05/01/2003
Etodolac 
Etodolac tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60505-0102
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Etodolac (Etodolac) Etodolac 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE  
HYDROXYPROPYL CELLULOSE (TYPE H)  
HYPROMELLOSE 2208 (100 MPA.S)  
MAGNESIUM STEARATE  
METHYLCELLULOSE (100 CPS)  
POLYETHYLENE GLYCOL 1500  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE (to off-white) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code APO;102;500
Contains     
Packaging
# Item Code Package Description
1 NDC:60505-0102-1 100 TABLET, FILM COATED in 1 BOTTLE
2 NDC:60505-0102-2 500 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076004 05/01/2003
Labeler - Apotex Corp. (845263701)
Registrant - Apotex Inc. (209429182)
Establishment
Name Address ID/FEI Operations
Apotex Inc. 205576023 manufacture(60505-0041, 60505-0102), analysis(60505-0041, 60505-0102)
Revised: 11/2016   Apotex Corp.

Pharmacologic Category

  • Analgesic, Nonopioid
  • Nonsteroidal Anti-inflammatory Drug (NSAID), Oral

Use Labeled Indications

Acute pain: Management of acute pain (immediate release only).

Arthritis: Relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and juvenile arthritis (ER only).

Dosing Geriatric

Refer to adult dosing, use with caution. The elderly are more sensitive to antiprostaglandin effects and may need dosage adjustments.

Monitoring Parameters

CBC, chemistry profile, weight gain, edema, liver function tests (baseline and periodically during chronic therapy), renal function (serum BUN, serum creatinine, urine output); occult blood loss; blood pressure; observe for bleeding, bruising; gastrointestinal effects (abdominal pain, bleeding, dyspepsia).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience heartburn, nausea, vomiting, constipation, flatulence, or diarrhea. Have patient report immediately to prescriber signs of abdominal ulcers (severe abdominal or back pain; black, tarry, or bloody stools; vomiting blood or vomit that looks like coffee grounds; or weight gain or abnormal swelling), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, numbness or tingling feeling), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), shortness of breath, excessive weight gain, swelling of arms or legs, angina, tachycardia, severe headache, severe dizziness, passing out, loss of strength and energy, vision changes, tinnitus, mood changes, depression, severe abdominal pain, severe back pain, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating, and advising patients.

Etodolac dosing 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

What other drugs will affect etodolac?

Ask your doctor before using etodolac if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • cyclosporine;

  • lithium;

  • methotrexate;

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • heart or blood pressure medication, including a diuretic or "water pill"; or

  • steroid medicine (prednisone and others).

This list is not complete. Other drugs may interact with etodolac, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

For the Consumer

Applies to etodolac: oral capsule, oral tablet, oral tablet extended release

Along with its needed effects, etodolac may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking etodolac:

More common
  • Abdominal or stomach bloating, burning, cramping, or pain
  • belching
  • bloody or black, tarry stools
  • blurred vision
  • body aches or pain
  • cloudy urine
  • congestion
  • constipation
  • cough or hoarseness
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • dizziness
  • dryness or soreness of throat
  • feeling of indigestion
  • fever or chills
  • headache
  • increased bleeding time
  • itching skin
  • loss of appetite
  • lower back or side pain
  • nausea and vomiting
  • nervousness
  • pain in the chest below the breastbone
  • painful or difficult urination
  • pale skin
  • pounding in the ears
  • rash
  • runny nose
  • severe stomach pain
  • slow or fast heartbeat
  • swelling
  • tender, swollen glands in neck
  • trouble in swallowing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • voice changes
  • vomiting of blood or material that looks like coffee grounds
  • weight loss
Symptoms of overdose
  • Agitation
  • change in consciousness
  • confusion
  • depression
  • difficult or troubled breathing
  • hives
  • hostility
  • irregular, fast or slow, or shallow breathing
  • irritability
  • loss of consciousness
  • muscle twitching
  • pain or discomfort in chest, upper stomach, or throat
  • pale or blue lips, fingernails, or skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • seizures
  • shortness of breath
  • sleepiness
  • stupor
  • swelling of face, ankles, or hands
  • tightness in chest
  • unusual drowsiness, dullness, or feeling of sluggishness
  • wheezing

Some side effects of etodolac may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Bloated, full feeling
  • continuing ringing or buzzing or other unexplained noise in ears
  • excess air or gas in stomach or intestines
  • hearing loss
  • lack or loss of strength
  • passing gas
  • sneezing
  • stuffy nose

Usual Adult Dose for Osteoarthritis

Immediate Release:
-Initial dose: 300 mg orally 2 to 3 times a day or 400 mg to 500 mg orally twice a day
-Maintenance dose: A lower dose of 600 mg/day may suffice for long-term use
-Maximum dose: 1000 mg/day

Extended Release: 400 mg to 1000 mg orally once a day

Comments:
-Therapeutic response can be seen within 1 week of therapy, however, is most often observed by 2 weeks; doses should be adjusted accordingly after satisfactory response is achieved.

Uses: For acute and long-term use in the management of signs and symptoms of osteoarthritis and rheumatoid arthritis

Usual Adult Dose for Pain

Immediate Release: 200 mg to 400 mg orally every 6 to 8 hours
-Maximum dose: 1000 mg/day

Use: For the management of acute pain

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended.
Advanced renal disease: Not recommended; if treatment is necessary, close monitoring of renal function is advised.

Precautions

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:
-Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
-This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
-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 events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.

Extended Release: Safety and efficacy have not been established in patients younger than 6 years.

Immediate Release: Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Upsides

  • Used to relieve mild-to-moderate acute pain associated with osteoarthritis and rheumatoid arthritis.
  • May also be used to relieve mild-to-moderate acute pain due to other causes.

Response and Effectiveness

  • Peak plasma concentrations of etodolac are reached within 50 to 110 minutes after oral administration, and the peak analgesic effect occurs between one to two hours following a dose. Food does not affect the absorption of etodolac. Effects of etodolac usually last six to eight hours.

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Etodolac Identification

Substance Name

Etodolac

CAS Registry Number

41340-25-4

Drug Class

Analgesic Agents

Nonsteroidal Antiinflammatory Agents

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