Etodolac

Oral
Osteoarthritis, Rheumatoid arthritis

Oral
Acute pain

Oral
Juvenile rheumatoid arthritis

Etodolac Should be taken with food.

Hypersensitivity. History of asthma, urticaria or other allergic-type reactions after receiving aspirin or other NSAIDs. Active gastrointestinal bleeding or ulceration, history of recurrent peptic ulceration (with 2 or more distinct episodes), history of gastrointestinal bleeding or perforation related to previous NSAID therapy, severe heart failure. Use in the setting of CABG surgery. Pregnancy (3rd trimester).

Patient with recent MI, hypertension, mild to moderate CHF, established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, oedema, risk factors for CV disease (e.g. hyperlipidaemia, diabetes mellitus), coagulation disorders, history of gastrointestinal disease (e.g. ulcerative colitis, Crohn's disease), other forms of asthma, SLE and mixed connective tissue disorders. Patient taking oral corticosteroids, anticoagulants (e.g. warfarin), antiplatelet agents (e.g. aspirin) or SSRIs. Smoking or alcohol use. Dehydrated or debilitated patients. Renal and hepatic impairment. Children and elderly. Pregnancy (1st-2nd trimester) and lactation.

Significant: New onset or worsening of hypertension; fluid retention and oedema; anaphylactoid reactions; decreased platelet aggregation, prolonged bleeding time, anaemia; elevated transaminases; renal papillary necrosis and other renal injury (chronic use); aseptic meningitis (particularly in patients with SLE and mixed connective tissue disorders).
Ear and labyrinth disorders: Tinnitus.
Eye disorders: Abnormal vision.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, heartburn, melaena, epigastric pain.
General disorders and administration site conditions: Fatigue, malaise, fever.
Nervous system disorders: Headache, dizziness, drowsiness.
Psychiatric disorders: Depression.
Renal and urinary disorders: Dysuria, urinary frequency.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Potentially Fatal: Increased risk of serious CV thrombotic events (e.g. MI, stroke), serious gastrointestinal bleeding, ulceration, inflammation or perforation; exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms; severe bronchospasm (particularly in patients with aspirin-sensitive asthma). Rarely, severe hepatic reactions (e.g. fulminant hepatitis, liver necrosis, hepatic failure).

PO: 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.)

This drug may cause dizziness, drowsiness or abnormal vision, if affected, do not drive or operate machinery.

Monitor blood pressure; CBC and chemistry profile (periodically during chronic therapy); LFTs (at baseline and periodically during chronic therapy); renal function (urine output, serum BUN and creatinine), occult blood loss. Assess for signs or symptoms of serious skin reactions, hepatotoxicity, and bleeding (particularly gastrointestinal bleeding).

Symptoms: Nausea, vomiting, epigastric pain, lethargy, drowsiness, convulsion, anaphylactoid reactions and gastrointestinal bleeding. Rarely, diarrhoea, disorientation, excitation, tinnitus, fainting, dizziness, hypertension, acute renal failure, respiratory depression and coma. Management: Symptomatic and supportive treatment. Induce emesis and/or administer activated charcoal and/or osmotic cathartic within 4 hours of ingestion. Alternatively, consider performing gastric lavage within 1 hour of ingestion. Closely monitor renal and hepatic functions. Administer IV diazepam to treat frequent or prolonged convulsions.

Concomitant use with other NSAIDs may increase the risk of adverse or toxic effects. May decrease the antihypertensive effects of ACE inhibitors. May reduce the natriuretic effect of furosemide and thiazide diuretics. Increased risk of gastrointestinal ulceration or bleeding with oral corticosteroids, anticoagulants (e.g. warfarin), antiplatelet agents (e.g. aspirin) or SSRIs. May increase the serum levels or enhance the toxicity of digoxin, lithium and methotrexate. Increased risk of nephrotoxicity with ciclosporin and tacrolimus.

Food may reduce the peak serum concentration.

May cause false-positive results for urinary bilirubin, ketone bodies in urine (using diagnostic dipstick method), and aldosterone/renin ratio (ARR).

Description:
Mechanism of Action: Etodolac, a pyrano-indoleacetic acid derivative, is an NSAID that has antipyretic, analgesic and anti-inflammatory properties. It has been shown to selectively inhibit the cyclooxygenase-2 (COX-2) enzyme, resulting in reduced formation of prostaglandin precursors.
Onset: Analgesia: Approx 30 minutes (conventional form). Arthritis (chronic therapy): Usually within 2 weeks.
Duration: 4-6 hours (mean range).
Pharmacokinetics:
Absorption: Well absorbed. Food may reduce the peak plasma concentration. Bioavailability: ≥80%. Time to peak plasma concentration: 80 ± 30 minutes (conventional form); approx 5-7 hours (extended-release tab).
Distribution: Distributed to synovial fluid. Volume of distribution: 0.49 L/kg (conventional form); approx 0.54 L/kg (extended-release tab). Plasma protein binding: >99%, mainly to albumin.
Metabolism: Extensively metabolised in the liver into several hydroxylated metabolites and etodolac glucuronide; the hydroxylated metabolites undergo further glucuronidation.
Excretion: Mainly via urine (72%; approx 1% as unchanged drug); faeces (16%). Elimination half-life: 6.4 hours (conventional form); 8.4 hours (extended-release tab).

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3308, Etodolac. https://pubchem.ncbi.nlm.nih.gov/compound/Etodolac. Accessed Sept. 24, 2024.

Store between 20-25°C. Protect from excessive heat and moisture.

Thuốc kháng viêm không steroid

M01AB08 - etodolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

Anon. Etodolac. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 09/09/2024.

Brayfield A, Cadart C (eds). Etodolac. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2024.

Etodolac Capsule (ANI Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/09/2024.

Etodolac Tablet, Film Coated (Apotex Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/09/2024.

Etodolac Tablet, Film Coated, Extended Release (Teva Pharmaceuticals USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/09/2024.

Etodolac. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 09/09/2024.

Etopan XL 600 mg Tablets (Sun Pharmaceutical Industries Europe B.V.). MHRA. https://products.mhra.gov.uk. Accessed 09/09/2024.

Joint Formulary Committee. Etodolac. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2024.

Lodine 600 mg SR Tablets (Almirall, S.A.). MHRA. https://products.mhra.gov.uk. Accessed 09/09/2024.