Indometacin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Ankylosing spondylitis; Osteoarthritis; Rheumatoid arthritis; Acute musculoskeletal disorders As conventional cap: 25 mg 2 or 3 times/day, may be increased, if well tolerated, by 25 or 50 mg weekly up to 150-200 mg daily or until satisfactory response is achieved. Max: 200 mg/day. As extended-release cap: 75 mg once or twice daily. Use the lowest effective dose for the shortest possible duration based on individual treatment goals. Bursitis; Tendinitis As conventional cap: 75-150 mg/day in 3-4 divided doses. As extended-release cap: 75 mg once or twice daily. Usual treatment duration: 7-14 days. Acute gout As conventional cap: 150-200 mg/day in divided doses until all clinical signs and symptoms have resolved. Dysmenorrhoea As conventional/extended-release cap: 75 mg/day, initiating at onset of cramps or bleeding then continuing until symptoms were relieved. Rectal Ankylosing spondylitis; Osteoarthritis; Rheumatoid arthritis; Acute musculoskeletal disorders; Acute gout; Dysmenorrhoea As supp: 100 mg to be inserted once daily at bedtime or bid (in the morning and at bedtime).
Dosage Details
Intravenous
Closure of patent ductus arteriosus
Child: Doses vary depending on the age of the infant at the time of initial treatment. Each course of treatment consists of up to 3 doses given at 12- to 24-hour intervals to be infused over 20-30 minutes. Neonates <48 hours Initially, 0.2 mg/kg then 0.1 mg/kg for 2 doses thereafter; 2-7 days Initially, 0.2 mg/kg then subsequent 0.2 mg/kg for 2 doses thereafter; >7 days Initially, 0.2 mg/kg then 0.25 mg/kg for 2 doses thereafter. Another course of treatment may be given if the ductus arteriosus reopens or evidence of recurrence is significant. If unresponsive after 2 courses, surgery may be required.

Oral
Acute gout
Adult: As conventional cap: 150-200 mg daily in divided doses until all clinical signs and symptoms have resolved.

Oral
Dysmenorrhoea
Adult: As conventional/extended-release cap: 75 mg daily, initiating at onset of cramps or bleeding then continuing until symptoms were relieved.

Oral
Acute musculoskeletal disorders, Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis
Adult: As conventional cap: 25 mg 2 or 3 times daily, may be increased, if well tolerated, by 25 or 50 mg weekly up to 150-200 mg daily or until satisfactory response is achieved. In patient with persistent night pain and/or morning stiffness, up to 100 mg of the total daily dose may be given at bedtime. Max: 200 mg daily. As extended-release cap: 75 mg once or twice daily, depending on patient response. Use the lowest effective dose for the shortest possible duration based on individual treatment goals.

Oral
Bursitis, Tendinitis
Adult: As conventional cap: 75-150 mg daily in 3-4 divided doses. As extended-release cap: 75 mg once or twice daily. Usual treatment duration: 7-14 days.

Rectal
Acute gout, Acute musculoskeletal disorders, Ankylosing spondylitis, Dysmenorrhoea, Osteoarthritis, Rheumatoid arthritis
Adult: As supp: 100 mg to be inserted once daily at bedtime or bid (in the morning and at bedtime). In patient with persistent night pain and/or morning stiffness, up to 100 mg of the total daily dose may be given at bedtime.
Renal Impairment
Oral:
Severe: Contraindicated.

Intravenous:
Contraindicated.
Hepatic Impairment
Oral:
Severe: Contraindicated.
Administration
Should be taken with food.
Reconstitution
IV inj: Reconstitute vial labelled as 1 mg with 1-2 mL of sterile water for injection or 0.9% NaCl to a final concentration of 0.5-1 mg/mL.
Incompatibility
IV inj: Incompatible with tolazoline hydrochloride, glucose inj (7.5%, 10%), Ca gluconate, dobutamine, dopamine, cimetidine, gentamicin sulfate, levofloxacin and tobramycin sulfate.
Contraindications
Hypersensitivity. History of aspirin- or NSAID-induced acute asthma, urticaria, or rhinitis; recent or active peptic ulcer, history of gastrointestinal bleeding or perforation related to previous NSAID use; severe heart failure. History of proctitis or rectal bleeding (rectal). Use in the setting of coronary artery bypass graft (CABG) surgery. Pregnancy (3rd trimester). Severe renal and hepatic impairment. Concomitant use with diflunisal. IV: Proven or suspected untreated infection, active bleeding (e.g. intracranial haemorrhage, gastrointestinal bleeding), thrombocytopenia, coagulation defects, proven or suspected necrotising enterocolitis, significant renal impairment, congenital heart disease when patency of ductus arteriosus is necessary (e.g. pulmonary atresia, severe tetralogy of Fallot, severe coarction of the aorta).
Special Precautions
Patient with CV disease, including hypertension; oedema, coagulation disorders, diabetes mellitus, SLE, mixed connective tissue disorders, asthma, psychiatric disorders (e.g. depression), epilepsy, Parkinson’s disease, history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease), infection (controlled), sepsis, volume depletion, alcoholism. Dehydrated and debilitated patients. Smokers. Mild to moderate renal and hepatic impairment. Neonates and elderly. Pregnancy (1st-2nd trimester) and lactation. Consider discontinuation of use in women who have difficulties conceiving or undergoing investigation for infertility.
Adverse Reactions
Significant: Na and fluid retention, anaphylactic reactions, decreased platelet adhesion and aggregation, prolonged bleeding time, anaemia, increased transaminases, hyperkalaemia, new onset or worsening of hypertension; infertility, corneal deposits and retinal or macular disturbances, acute interstitial nephritis with haematuria, proteinuria, and nephrotic syndrome (occasionally), renal papillary necrosis (long-term use); aseptic meningitis, anastomotic ulcerations, persistent headache. Rarely, severe blood dyscrasias (e.g. agranulocytosis, thrombocytopenia, aplastic anaemia), ulcerative colitis, regional ileitis.
Cardiac disorders: Tachycardia, chest pain, arrhythmia, palpitation, CHF.
Ear and labyrinth disorders: Tinnitus, vertigo.
Gastrointestinal disorders: Vomiting, nausea, epigastric pain, dyspepsia, constipation, abdominal pain, diarrhoea, heartburn, ulcerative stomatitis, melaena; tenesmus, rectal mucosal irritation (supp); perforation of preexisting sigmoid lesions (e.g. diverticula, carcinoma).
General disorders and administration site conditions: Fatigue, malaise, fever.
Hepatobiliary disorders: Cholestasis.
Investigations: Increased BUN, creatinine; reduced urine output (IV).
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Muscle weakness, involuntary muscle movements.
Nervous system disorders: Dizziness, drowsiness, convulsions, lightheadedness, peripheral neuropathy, paraesthesia.
Psychiatric disorders: Depression, anxiety, insomnia, psychiatric disturbances (e.g. hallucinations, depersonalisation), confusion.
Reproductive system and breast disorders: Vaginal bleeding, breast changes (e.g. enlargement, tenderness).
Skin and subcutaneous tissue disorders: Pruritus, hyperhidrosis, rash, urticaria, erythema nodosum, erythema multiforme, hair loss.
Vascular disorders: Syncope, hypotension.
Potentially Fatal: CV thrombotic events (e.g. MI, stroke); gastrointestinal inflammation, ulceration, bleeding, or perforation. Rarely, severe hepatic reactions (e.g. fulminant hepatitis, hepatic necrosis, hepatic failure, jaundice); fulminant necrotising fasciitis, exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
IV/PO/Rectal: C (prior to 30 weeks gestation), D (starting at 30 weeks gestation)
Patient Counseling Information
This drug may cause blurred vision, drowsiness, dizziness, or headache, if affected, do not drive or operate machinery.
MonitoringParameters
Prior to treatment initiation, evaluate cardiac risk, potential for gastrointestinal bleeding, and history of allergies. Monitor LFTs, renal function (e.g. urine output, serum creatinine, BUN), CBC, blood pressure; serum electrolyte levels (IV). Assess for inflammation, bleeding, bruising, gastrointestinal effects (e.g. abdominal pain, bleeding, dyspepsia), weight gain, oedema, mental confusion, disorientation. Perform ophthalmological examinations periodically during prolonged use.
Overdosage
Symptoms: Nausea, vomiting, epigastric pain, severe headache, dizziness, drowsiness, disorientation, mental confusion, lethargy, paraesthesia, numbness, convulsions, excitation, tinnitus, fainting, gastrointestinal bleeding; rarely, hypertension, acute renal failure, respiratory depression, and coma. Management: Symptomatic and supportive treatment. Empty stomach contents immediately if ingestion is recent. Induce emesis with syrup of ipecac if vomiting has not occurred spontaneously; if unable to vomit, perform gastric lavage. May give activated charcoal after stomach emptying and/or osmotic cathartic in symptomatic patients with known ingestion within 4 hours or in case of large overdosage. Consider correction of severe electrolyte abnormalities. Administer antacids as necessary. Monitor renal and liver function. In case of frequent or prolonged convulsions, administer IV diazepam.
Drug Interactions
May diminish the antihypertensive effects of ACE inhibitors (e.g. captopril), β-blockers (e.g. propranolol, atenolol), diuretics (loop, K-sparing, thiazides), and angiotensin II receptor antagonists (e.g. losartan). Reduced clearance and increased the risk of toxicity of methotrexate and lithium. May increase plasma concentrations with probenecid. Increased serum concentrations of digoxin and aminoglycosides (e.g. amikacin, gentamicin). Increased risk of adverse effects with corticosteroids, antiplatelet agents (e.g. aspirin, clopidogrel), anticoagulants (e.g. warfarin), SSRIs, and other NSAIDs. May enhance the effect of desmopressin. Enhanced drowsiness with haloperidol. May reduce the effect of mifepristone. Indometacin may enhance the nephrotoxic effects of ciclosporin, tacrolimus and triamterene. Increased bioavailability of tiludronic acid. May enhance the seizure-potentiating adverse effect of quinolones.
Potentially Fatal: Decreased renal clearance and increased plasma concentration with diflunisal.
Food Interaction
May decrease rate but not the extent of absorption with food.
Lab Interference
False-negative result with dexamethasone suppression test. May cause false-positive result for aldosterone/renin ratio (ARR).
Action
Description: Indometacin is an indole acetic derivative with analgesic, antipyretic, and anti-inflammatory effects. It reversibly inhibits cyclooxygenase-1 and -2 (COX-1 and -2) isoenzymes, thereby reducing the synthesis of prostaglandins in body tissues.
Synonym: indomethacin.
Onset: Approx 30 minutes.
Duration: 4-6 hours; 13-16 hours (rectal).
Pharmacokinetics:
Absorption: Readily and almost completely absorbed from the gastrointestinal tract. Food may decrease absorption. Bioavailability: 100% (oral); 80-90% (rectal). Time to peak plasma concentration: 0.5-2 hours (oral).
Distribution: Distributed into synovial fluid and CNS. Crosses the placenta; enters breast milk (small amounts). Volume of distribution: 0.34-1.57 L/kg. Plasma protein binding: Approx 99%.
Metabolism: Metabolised in the liver into glucuronide conjugate form and metabolites (desmethyl, desbenzoyl, and desmethyl-desbenzoyl), and their glucuronides. Undergoes extensive enterohepatic circulation.
Excretion: Mainly via urine (60%; 26% as unchanged drug and glucuronide conjugates); faeces (33%, mainly as metabolites; 1.5% as unchanged drug). Terminal elimination half-life: 2.6-11.2 hours.
Chemical Structure

Chemical Structure Image
Indometacin_01

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3715, Indomethacin. https://pubchem.ncbi.nlm.nih.gov/compound/Indomethacin. Accessed Oct. 26, 2020.

Storage
Cap: Store between 20-25°C. IV inj: Store at 25°C. Protect from light. Supp: Store below 25°C. Do not freeze. Storage instructions may vary among products (refer to detailed product guideline).
ATC Classification
C01EB03 - indometacin ; Belongs to the class of other cardiac preparations.
M01AB01 - indometacin ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
References
Anon. Indomethacin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 19/08/2020.

Anon. Indomethacin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/08/2020.

Buckingham R (ed). Indometacin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/08/2020.

Indocid Capsules 25 mg (Aspen Pharma Trading Limited). MHRA. https://products.mhra.gov.uk/. Accessed 19/08/2020.

Indocid Suppositories 100 mg (Aspen Pharma Trading Limited). MHRA. https://products.mhra.gov.uk/. Accessed 19/08/2020.

Indomen Capsule (Y.S.P. Industries [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 14/10/2020.

Indomethacin Capsule, Extended Release (Amneal Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/08/2020.

Indomethacin Capsules (Jubilant Cadista Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/08/2020.

Indomethacin Injection, Powder, Lyophilized, for Solution (Fresenius Kabi USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/08/2020.

Indomethacin Suppository (Cosette Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/08/2020.

Joint Formulary Committee. Indometacin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/08/2020.

Pardelprin MR Capsules 75 mg (Accord-UK Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 19/08/2020.

Disclaimer: This information is independently developed by MIMS based on Indometacin 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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