Etodolac


Generic Medicine Info
Indications and Dosage
Oral
Acute pain
Adult: As conventional tab/cap: 200-400 mg 6-8 hrly. Max: 1,000 mg daily.

Oral
Osteoarthritis, Rheumatoid arthritis
Adult: As conventional tab/cap: 600-1,000 mg daily in divided doses, adjust according to response. As extended-release tab: 400-1,000 mg once daily, according to response.
Administration
Should be taken with food. Take w/ or immediately after meals.
Contraindications
Hypersensitivity to etodolac or other NSAIDs. GI bleeding or perforation related to previous NSAID therapy, severe heart failure, active or history of peptic ulcer disease. Treatment of perioperative pain in the setting of CABG. 3rd trimester of pregnancy.
Special Precautions
Patient w/ CHF, uncontrolled HTN, ischaemic heart disease, peripheral arterial disease, cerebrovascular disease and those w/ risk factors for CV disease (e.g. HTN, hyperlipidaemia, DM, smoking); bronchial asthma, history of GI disease (e.g. ulcerative colitis, Crohn’s disease). Renal or hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Oedema, HTN, cardiac failure, nausea, epigastric pain, diarrhoea, indigestion, heartburn, flatulence, abdominal pain, constipation, vomiting, ulcerative stomatitis, dyspepsia, haematemesis, melaena, rectal bleeding, exacerbation of colitis, vasculitis, headaches, dizziness, abnormal vision, pyrexia, drowsiness, tinnitus, rash, pruritus, fatigue, depression, insomnia, confusion, paraesthesia, tremor, weakness, dyspnoea, palpitations, bilirubinuria, hepatic function abnormalities, jaundice, urinary frequency, Crohn’s disease, photosensitivity, asthma, nephritis, anaemia.
Potentially Fatal: Serious CV thrombotic events (e.g. stroke, MI), GI effects (e.g. perforation, bleeding and ulceration), fulminant hepatitis, liver necrosis, hepatic failure. Very rarely, serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis).
PO: C, Z (NSAIDs caused foetal ductus arteriosus premature closure, foetal renal impairment and persistent pulmonary hypertension. Avoid near term, else use lowest dose for shortest time.)
Patient Counseling Information
This drug may cause dizziness, drowsiness, fatigue or abnormal vision, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor for signs and symptoms of GI bleeding and hepatic dysfunction; renal function, BP at the beginning of therapy and periodically; CBC and chemistry profile (long-term therapy).
Overdosage
Symptoms: Lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding, coma, HTN, acute renal failure, resp depression. Management: Symptomatic and supportive treatment. Perform emesis and/or administer activated charcoal or osmotic cathartic w/in 4 hr of ingestion.
Drug Interactions
May increase the effect of lithium, warfarin and methotrexate. Increased risk of adverse effect w/ aspirin or other NSAIDs. May reduce the effect of diuretics, mifepristone and antihypertensives. Increased risk of nephrotoxicity w/ ciclosporin, diuretics and tacrolimus, Increased risk of GI bleeding w/ SSRIs, anti-platelets and corticosteroids. Increased risk of convulsions w/ quinolone antibiotics. Increased risk of haematological toxicity when given w/ zidovudine. May exacerbate cardiac failure, reduce GFR and increase serum level w/ of cardiac glycoside.
Food Interaction
May decrease GI upset and serum peak levels when taken w/ food. Alcohol enhances gastric mucosal irritation.
Lab Interference
False-positive reaction for urinary bilirubin and ketones.
Action
Description:
Mechanism of Action: Etodolac is an NSAID derived from pyrano-indoleacetic acid which inhibits cyclooxygenase 2 (COX-2), resulting in decreased prostaglandin precursor formation.
Onset: Analgesia: Approx 30 min (conventional preparation). Arthritis (chronic use): W/in 2 wk.
Duration: Mean range: 4-6 hr.
Pharmacokinetics:
Absorption: Rapidly absorbed. Bioavailability: ≥80%. Time to peak plasma concentration: W/in approx 2 hr.
Distribution: Distributed to synovial fluid. Volume of distribution: Approx 390 mL/kg. Plasma protein binding: >99%, primarily to albumin.
Metabolism: Extensively metabolised in the liver to hydroxylated metabolites and etodolac glucuronide; hydroxylated metabolites undergo further glucuronidation.
Excretion: Mainly via urine (73%); faeces (16%).
Chemical Structure

Chemical Structure Image
Etodolac

Source: National Center for Biotechnology Information. PubChem Database. Etodolac, CID=3308, https://pubchem.ncbi.nlm.nih.gov/compound/Etodolac (accessed on Jan. 23, 2020)

Storage
Store between 20-25˚C.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB08 - etodolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
References
Anon. Etodolac. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 24/05/2016.

Buckingham R (ed). Etodolac. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/05/2016.

Etodolac Capsule (ANI Pharmaceuticals, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 24/05/2016.

Joint Formulary Committee. Etodolac. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/05/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Etodolac. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 24/05/2016.

Disclaimer: This information is independently developed by MIMS based on Etodolac from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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