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.
Should be taken with food. Take w/ or immediately after meals.
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.
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.
PO: C (Avoid use during 3rd trimester or near delivery.), Z (NSAIDs use in >20 weeks gestation may cause oligohydramnios and foetal renal impairment. Foetal ductus arteriosus premature closure and persistent pulmonary hypertension may occur >30 weeks gestation. Avoid NSAIDs 30 weeks and later. If an NSAID is needed during 20-30 weeks, use lowest effective dose for shortest duration.)
Patient Counseling Information
This drug may cause dizziness, drowsiness, fatigue or abnormal vision, if affected, do not drive or operate machinery.
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).
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.
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.
May decrease GI upset and serum peak levels when taken w/ food. Alcohol enhances gastric mucosal irritation.
False-positive reaction for urinary bilirubin and ketones.
Description: 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%).
M01AB08 - etodolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
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