Indometacin information from DrugsUpdate
P - Caution when used during pregnancy
L - Caution when used during lactation
FI - Food *
LI - Lab *
Indometacin or indomethacin is a non-steroidal anti-inflammatory drug commonly used to reduce fever, pain, stiffness, and swelling. It works by inhibiting the production of prostaglandins, molecules known to cause these symptoms. It is marketed under many trade names, including Indocin, Indocid, Indochron E-R, and Indocin-SR.
Pharmacodynamics
Pharmacokinetics
Indometacin has anti-inflammatory, analgesic and antipyretic actions. It inhibits cyclooxygenase thus reducing prostaglandin synthesis.
Onset
30 minutes after oral admin.
Absorption
>90 % absorbed from the GIT (oral); peak plasma concentrations after 2 hours. Poor and incomplete (premature neonates). 80-90% absorbed after rectal admin.
Distribution
Synovial fluid, CNS, placenta; enters breast milk (small amounts). Protein-binding: 99%
Metabolism
Hepatic via glucuronidation and demethylation; undergoes enterohepatic recirculation.
Excretion
Urine: 60% as drug and metabolites, approximately 33% in faeces. Terminal half-life: 2.6-11.2 hours (adult) and 12-28 hours (neonate).
Indometacin Indications / Indometacin Uses
Information Not Available
Indometacin Adverse Reactions / Indometacin Side Effects
GI upsets, headache, dizziness, tinnitus, lightheadedness, depression, insomnia, psychiatric disturbances, peripheral neuropathy, blurred vision, confusion; hyperglycaemia, hyperkalaemia.
Potentially Fatal: Renal failure.
Precautions
Information Not Available
Special Precautions
Hypertension; congestive heart failure; fluid retention; epilepsy, parkinsonism, psychiatric disorders; may affect performance of skilled tasks. Prolonged treatment duration may increase risk of CV thrombotic events. Monitor ophthalmologic, blood, electrolytes and renal function regularly; lactation.
Other Drug Interactions
Increased risk of hyperkalaemia when used with ACE inhibitors or potassium sparing diuretics; increased risk of nephrotoxicity with ACE inhibitors, ciclosporin and tacrolimus; increased risk of bleeding with warfarin and other NSAIDs. Concurrent use may increase plasma concentration of digoxin, lithium and metrotrexate. Concurrent use with probenecid may cause indometacin toxicity. Aluminum- or magnesium-containing antacids may delay absorption.
Potentially Fatal: Concurrent use with diflunisal increases plasma concentrations of indometacin.
Other Interactions
Food Interaction
Rate of absorption delayed by food.
Dosage
Oral
Pain and inflammation associated with musculoskeletal and joint disorders
Adult: Initially, 25 mg bid-tid, increased if necessary by 25-50 mg daily at wkly intervals to 150-200 mg daily.
Oral
Acute gout
Adult: 150-200 mg daily in divided doses until signs and symptoms disappear.
Oral
Dysmenorrhoea
Adult: 75 mg daily.
Oral
Night pain and morning stiffness
Adult: Up to 100 mg/day, on retiring. May also be given as rectal suppository. Total combined oral and rectal doses should not exceed 200 mg/day.
Oral
Juvenile rheumatoid arthritis
Child: 2-14 years: start with 1-2 mg/kg/day in divided doses. Max: 3 mg/kg/day or 150-200 mg/day, whichever is lower.
Intravenous
Closure of patent ductus arteriosus
Child: Given as 3 IV doses at 12-24 hours intervals. First dose: start with 0.2 mg/kg. Second and third doses (based on neonatal age at first dose): if <48 hours old, use 0.1 mg/kg/dose; if 2-7 days old, use 0.2 mg/kg/dose; if >7 days old, use 0.25 mg/kg/dose. Withhold treatment if urine output is <0.6 ml/kg/hours. Infuse each dose over 20-30 minuntes. Second course of 1-3 doses may be repeated if ductus arteriosus remains open or re-opens 48 hours after the first course. Surgery may be required if neonate is unreponsive to 2 courses of treatment.
Ophthalmic
Prophylaxis of miosis during cataract surgery
Adult: As 0.5 or 1% solution: Instill 2 drops, repeat 2 hours later on the day before surgery, followed by 2 drops 3 hours before and 2 drops 1 hour before procedure. May instill up to 6 times/day post-operatively to prevent cystoid macular oedema, continue treatment until inflammatory signs have resolved.
Reconstitution
Add 1-2ml of preservative free 0.9% sodium chloride or water for injection. Further dilution of the reconstituted injection in IV infusions is not recommended. Reconstitution to be performed prior to injection and unused portion should be discarded.
Incompatibility
Glucose solution. Reconstituting in solutions
Food(before/after)
Information Not Available
List of Contraindications
Indometacin and Pregnancy
Caution when used during pregnancy
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
If used for > 48 hours or after 34 weeks' gestation or close to delivery:
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Indometacin and Lactation
Caution when used during lactation
Indometacin and Children
Information Not Available
Indometacin and Geriatic
Information Not Available
Indometacin and Other Contraindications
Active peptic ulcer; pregnancy (3rd trimester), hypersensitivity to aspirin and other NSAIDs; treatment of perioperative pain in CABG surgery; severe renal impairment; rectal admin in patients with proctitis and haemorrhoids; neonates with necrotizing enterocolitis, active bleeding, thrombocytopenia, coagulation defects and untreated infections.
Storage
Intravenous
Store below 30°C. Protect from light
Lab interference
Intravenous
Store below 30°C. Protect from light
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