Generic Medicine Info
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 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. Patient Counselling This drug may cause blurred vision, drowsiness, dizziness, or headache, if affected, do not drive or operate machinery. Monitoring Parameters 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.
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).
ROUTE(S) : PO: C in 1st & 2nd trimesters
ROUTE(S) : IV: C prior to 30 weeks gestation
ROUTE(S) : Rectal: C prior to 30 weeks gestation
ROUTE(S) : PO: D in 3rd trimester
ROUTE(S) : IV / Rectal: D starting at 30 weeks gestation
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.
CIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) / Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories / Other Cardiovascular Drugs
ATC Classification
M01AB01 - indometacin ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
S01BC01 - indometacin ; Belongs to the class of non-steroidal antiinflammatory agents. Used in the treatment of inflammation of the eye.
C01EB03 - indometacin ; Belongs to the class of other cardiac preparations.
M02AA23 - indometacin ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 CIMS. All rights reserved. Powered by
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