Indometacin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Musculoskeletal and joint disorders Initial: 25 mg bid or tid. Increase if necessary by 25-50 mg at wkly intervals to 150-200 mg/day. Acute gout 150-200 mg/day in divided doses. Dysmenorrhoea 75 mg/day. Rectal Musculoskeletal and joint disorders As supp: 100 mg inserted at night and repeated in the morning if necessary. Ophth Inhibition of intraoperative miosis 4 drops 1 day pre-op and 4 drops 3 hr pre-op. Prophylaxis and reduction of post-op ocular inflammation 1 drop 4-6 times/day. Post-photorefractive keratectomy pain 1 drop 4 times/day for a few days post-op.
Dosage Details
Intravenous
Closure of patent ductus arteriosus
Child: Given as 3 IV doses at 12-24 hr intervals infused over 20-30 min. <48 hr old 0.2 mg/kg initially followed by 2 further doses of 0.1 mg/kg; 2-7 days old 3 doses of 0.2 mg/kg; >7 days old 0.2 mg/kg initially followed by 2 further doses of 0.25 mg/kg. 2nd course may be repeated if ductus remains open or re-opens 48 hr after the 1st course. Surgery may be required if neonate is unreponsive to 2 courses of treatment.

Ophthalmic
Inhibition of intraoperative miosis
Adult: 4 drops 1 day pre-op and 4 drops 3 hr pre-op.

Ophthalmic
Prophylaxis and reduction of postoperative ocular inflammation
Adult: 1 drop 4-6 times daily.

Ophthalmic
Post-photorefractive keratectomy pain
Adult: 1 drop 4 times daily for a few days post-op.

Oral
Pain and inflammation associated with musculoskeletal and joint disorders
Adult: Initially, 25 mg bid or tid, increased if necessary by 25-50 mg at wkly intervals to 150-200 mg daily.

Oral
Dysmenorrhoea
Adult: 75 mg daily.

Oral
Acute gout
Adult: 150-200 mg daily in divided doses until signs and symptoms subside.

Rectal
Pain and inflammation associated with musculoskeletal and joint disorders
Adult: As supp: 100 mg to be inserted at night and repeated in the morning if necessary.
Administration
Should be taken with food.
Reconstitution
Intravenous:
Add 1 or 2 mL of sterile water for inj or NaCl 0.9% inj to indometacin 1 mg to provide soln containing approx 1 or 0.5 mg/mL respectively. Further dilution of the reconstituted inj in IV infusions is not recommended.
Incompatibility
Y-site: Amino acid inj, Ca gluconate, cimetidine, dobutamine, dopamine, gentamicin, levofloxacin, pantoprazole, tobramycin.
Contraindications
Known hypersensitivity to indometacin, aspirin or other NSAIDs. Neonates w/ congenital heart disease when patency of the ductus arteriosus is needed for adequate pulmonary or systemic blood flow (e.g. neonates w/ pulmonary atresia, severe tetralogy of Fallot or severe coarctation of the aorta). Neonates w/ proven or suspected untreated infection, necrotising enterocolitis, impaired renal function, active bleeding (e.g. intraventricular haemorrhage or GI bleeding), thrombocytopenia or underlying coagulation defect. Patient w/ history of proctitis or recent rectal bleeding. History of asthma, urticaria, allergic-type reactions. Treatment of perioperative pain in the setting of CABG surgery. Concurrent use w/ diflunisal.
Special Precautions
Patient w/ known CV disease or risk factors for CV disease, fluid retention, history of GI disease (e.g. bleeding or ulcers), history of mental depression or other psychiatric disorder, epilepsy, or parkinsonian syndrome; existing infection that is adequately controlled. May mask signs and symptoms of infection. Hepatic and renal impairment. Elderly, childn. Pregnancy and lactation.
Adverse Reactions
CHF, tachycardia, chest pain, arrhythmia, palpitations, HTN, pulmonary HTN, oedema; GI disturbances (e.g. nausea, vomiting, dyspepsia, indigestion, heartburn, epigastric pain); headache, frontal throbbing, apparent swelling of the temporal vessels, tinnitus, ataxia, tremor, dizziness, insomnia, vertigo, lightheadedness, confusion, psychiatric disturbances; haemolytic anaemia, bone marrow depression, agranulocytosis, leucopenia, thrombocytopenic purpura; corneal deposits and retinal disturbances, acute interstitial nephritis w/ haematuria, proteinuria, pruritus, urticaria, rash, macular and morbilliform eruptions, apnoea and exacerbation of pulmonary infection.
Potentially Fatal: Anaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, aplastic anaemia, jaundice and fatal fulminant hepatitis, liver necrosis, hepatic failure, fulminant necrotising fasciitis, renal failure, MI, stroke, GI ulceration, perforation and haemorrhage.
IV/PO/Rectal: C (prior to 30 weeks gestation), D (starting at 30 weeks gestation)
Patient Counseling Information
May impair ability to perform activities requiring mental alertness or physical coordination (e.g. operating machinery, driving).
MonitoringParameters
BP should be monitored closely during initiation and throughout therapy. Perform periodic ophthalmologic examinations at least once a year. Closely monitor renal function and serum electrolytes. Periodically perform CBC and chemistry profile in patients receiving long-term therapy.
Overdosage
Symptoms: Nausea, vomiting, intense headache, dizziness, mental confusion, disorientation, lethargy, paraesthesia, numbness, convulsions. Management: Symptomatic and supportive treatment. If ingestion is recent, the stomach should be emptied immediately by inducing emesis, or gastric lavage followed by admin of activated charcoal. Consider correction of severe electrolyte abnormalities.
Drug Interactions
May increase plasma levels of methotrexate. Increased risk of GI bleeding w/ warfarin. May reduce hypotensive effects of hydralazine, furosemide, β-blockers (e.g. atenolol, propranolol, oxprenolol), or thiazide diuretics. Increased risk of hyperkalaemia w/ K-sparing diuretics, ACE inhibitors, K supplements. May increase nephrotoxic effects of ciclosporin or triamterene. Increase plasma concentration w/ probenecid. May increase plasma levels of aminoglycoside (e.g. amikacin, gentamicin) in premature neonates. May enhance antipsychotic effect (e.g. severe drowsiness and confusion) of haloperidol. Al- or Mg-containing antacids may reduce GI disorders of indometacin.
Potentially Fatal: Diflunisal decreases renal clearance and increases plasma concentrations of indometacin which leads to fatal GI haemorrhage.
Food Interaction
Absorption may be delayed by food.
Lab Interference
May augment the hypothalamic-pituitary-adrenal (HPA) axis response to the dexamethasone suppression test, potentially causing false normal results in patients w/ depression.
Action
Description: Indometacin, an indole acetic acid derivative has anti-inflammatory, analgesic and antipyretic actions. It reversibly inhibits cyclooxygenase-1 and -2 (COX-1 and -2) enzymes, thus resulting in reduced synthesis of prostaglandin precursors.
Onset: Approx 30 min.
Duration: 4-6 hr.
Pharmacokinetics:
Absorption: Readily absorbed from the GI tract. Absorption may be slowed by food. Bioavailability: 100%. Time to peak plasma concentration: Approx 2 hr.
Distribution: Distributed into synovial fluid, CNS and placenta; enters breast milk (small amounts). Plasma protein binding: Approx 99%.
Metabolism: Undergoes hepatic metabolism to its glucuronide conjugate and to desmethylindomethacin, desbenzoylindomethacin, desmethyl-desbenzoylindomethacin, and their glucuronides.
Excretion: Via urine as glucuronide conjugates (60%); faeces as metabolites (33%). Terminal half-life: 2.6-11.2 hr.
Storage
Store between 15-30°C. Protect from light.
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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