|Indochron E-R®; Indocin®;
Indocin® I.V.; Indocin®
Indocid® SR; Novo-Methacin; Nu-Indo;
Indometacin; Indomethacin Sodium Trihydrate|
Nonsteroidal Anti-Inflammatory Agent (NSAID)
Management of inflammatory diseases and rheumatoid disorders; moderate pain;
acute gouty arthritis; I.V. form used as alternative to surgery for closure of
patent ductus arteriosus in neonates
B (D if used longer than 48 hours or after 34-week
Hypersensitivity to indomethacin, any component, aspirin, or other
nonsteroidal anti-inflammatory drugs (NSAIDs); active GI bleeding, ulcer
disease; premature neonates with necrotizing enterocolitis, impaired renal
function, active bleeding, thrombocytopenia
Use with caution in patients with cardiac dysfunction, dehydration,
hypertension, renal or hepatic impairment, epilepsy, history of GI bleeding,
patients receiving anticoagulants, and for treatment of JRA in children (fatal
hepatitis has been reported); may have adverse effects on fetus; may affect
platelet and renal function in neonates; elderly are a high-risk population for
adverse effects from nonsteroidal anti-inflammatory agents. As much as 60% of
elderly can develop peptic ulceration and/or hemorrhage asymptomatically.
CNS adverse effects such as confusion, agitation, and hallucination are
generally seen in overdose or high-dose situations; but elderly may demonstrate
these adverse effects at lower doses than younger adults.
Central nervous system: Dizziness
Gastrointestinal: Nausea, epigastric pain, abdominal pain, anorexia, GI
bleeding, ulcers, perforation, abdominal cramps, heartburn, indigestion
1% to 10%:
Central nervous system: Headache, nervousness
Endocrine & metabolic: Fluid retention
<1%: Hypertension, congestive heart failure, arrhythmias, tachycardia,
somnolence, fatigue, depression, confusion, drowsiness, hallucinations, aseptic
meningitis, urticaria, erythema multiforme, toxic epidermal necrolysis,
Stevens-Johnson syndrome, angioedema, hyperkalemia, dilutional hyponatremia
(I.V.), hypoglycemia (I.V.), polydipsia, hot flashes, gastritis, GI ulceration,
cystitis, polyuria, hemolytic anemia, bone marrow suppression, agranulocytosis,
thrombocytopenia, inhibition of platelet aggregation, anemia, leukopenia,
hepatitis, peripheral neuropathy, corneal opacities, blurred vision,
conjunctivitis, dry eyes, toxic amblyopia, decreased hearing, oliguria, renal
failure, shortness of breath, allergic rhinitis, epistaxis, hypersensitivity
Symptoms of overdose include drowsiness, lethargy, nausea, vomiting,
seizures, paresthesia, headache, dizziness, GI bleeding, cerebral edema,
tinnitus, leukocytosis, renal failure
Management of a nonsteroidal anti-inflammatory drug (NSAID) intoxication is
primarily supportive and symptomatic. Fluid therapy is commonly effective in
managing the hypotension that may occur following an acute NSAID overdose,
except when this is due to an acute blood loss. Seizures tend to be very
short-lived and often do not require drug treatment. Although, recurrent
seizures should be treated with I.V. diazepam.
CYP2C9 enzyme substrate
Increased toxicity: May increase serum potassium with potassium-sparing
diuretics; probenecid may increase indomethacin serum concentrations; other
NSAIDs may increase GI adverse effects; may increase nephrotoxicity of
Indomethacin may increase serum concentrations of digoxin, methotrexate,
lithium, and aminoglycosides (reported with I.V. use in neonates)
I.V.: Protect from light; not stable in alkaline solution; reconstitute just
prior to administration; discard any unused portion; do not use
preservative-containing diluents for reconstitution; suppositories do not
Inhibits prostaglandin synthesis by decreasing the activity of the enzyme,
cyclo-oxygenase, which results in decreased formation of prostaglandin
Onset of action: Within 30 minutes
Duration: 4-6 hours
Absorption: Prompt and extensive
Distribution: Vd: 0.34-1.57 L/kg; crosses the placenta; appears in
Protein binding: 90%
Metabolism: In the liver with significant enterohepatic cycling
Half-life: 4.5 hours, longer in neonates
Time to peak serum concentration: Oral: Within 3-4 hours
Elimination: Significant enterohepatic recycling; excreted in urine
principally as glucuronide conjugates
Patent ductus arteriosus: Neonates: I.V.: Initial: 0.2 mg/kg; followed with:
2 doses of 0.1 mg/kg at 12- to 24-hour intervals if age <48 hours at time of
first dose; 0.2 mg/kg 2 times if 2-7 days old at time of first dose; or 0.25
mg/kg 2 times if over 7 days at time of first dose; discontinue if significant
adverse effects occur. Dose should be withheld if patient has anuria or
Children: Oral: Initial: 1-2 mg/kg/day in 2-4 divided doses; maximum: 4
mg/kg/day; not to exceed 150-200 mg/day
Adults: Oral, rectal: 25-50 mg/dose 2-3 times/day; maximum dose: 200 mg/day;
extended release capsule should be given on a 1-2 times/day schedule
Food: May decrease the rate but not the extent of oral absorption. Drug may
cause GI upset, bleeding, ulceration, perforation; take with food or milk to
minimize GI upset.
Potassium: Hyperkalemia has been reported. The elderly and those with renal
insufficiency are at greatest risk. Monitor potassium serum concentration in
those at greatest risk. Avoid salt substitutes.
Sodium: Hyponatremia from sodium retention. Suspect secondary to suppression
of renal prostaglandin. Monitor serum concentration and fluid status. May need
to restrict fluid.
Monitor response (pain, range of motion, grip strength, mobility, ADL
function), inflammation; observe for weight gain, edema; monitor renal function
(serum creatinine, BUN); observe for bleeding, bruising; evaluate
gastrointestinal effects (abdominal pain, bleeding, dyspepsia); mental
confusion, disorientation, CBC, liver function tests
Positive direct Coombs'; increased sodium, chloride, prolonged bleeding
|Mental Health: Effects
on Mental Status|
Dizziness is common; may cause nervousness; may rarely cause sedation,
confusion, depression, and hallucinations
Effects on Psychiatric
May cause bone marrow suppression; use caution with clozapine and
carbamazepine; may decrease lithium clearance resulting in an increase in serum
lithium levels and potential lithium toxicity; monitor serum lithium
|Dental Health: Local
No information available to require special precautions
Effects on Dental Treatment|
NSAID formulations are known to reversibly decrease platelet aggregation via
mechanisms different than observed with aspirin. The dentist should be aware of
the potential of abnormal coagulation. Caution should also be exercised in the
use of NSAIDs in patients already on anticoagulant therapy with drugs such as
Oral: Take this medication exactly as directed; do not increase dose without
consulting prescriber. Do not crush, break, or chew capsules. Take with food or
milk to reduce GI distress. Maintain adequate fluid intake (2-3 L/day of fluids
unless instructed to restrict fluid intake).
Rectal: Suppositories do not need to be refrigerated. Wash hands before
inserting unwrapped suppository high up in rectum. Wearing glove is recommended.
(Use caution to avoid damage with long fingernails.)
Do not use alcohol, aspirin, or aspirin-containing medication, and all other
anti-inflammatory medications without consulting prescriber. You may experience
drowsiness, dizziness, nervousness, or headache (use caution when driving or
engaging in tasks requiring alertness until response to drug is known);
anorexia, nausea, vomiting, or heartburn (frequent small meals, frequent oral
care, sucking lozenges, or chewing gum may help); fluid retention (weigh
yourself weekly and report unusual (3-5 lb/week) weight gain). May discolor
stool (green). GI bleeding, ulceration, or perforation can occur with or without
pain; discontinue medication and contact prescriber if persistent abdominal pain
or cramping, or blood in stool occurs. Report breathlessness, difficulty
breathing, or unusual cough; chest pain, rapid heartbeat, palpitations; unusual
bruising/bleeding; blood in urine, stool, gums, or vomitus; swollen extremities;
skin rash, irritation, or itching; acute fatigue; or changes in hearing or
ringing in ears. Pregnancy/breast-feeding precautions: Inform prescriber
if you are or intend to be pregnant. Consult prescriber if breast-feeding.
Extended release capsules must be swallowed intact
Capsule: 25 mg, 50 mg
Indocin®: 25 mg, 50 mg
Capsule, sustained release (Indocin® SR): 75 mg
Powder for injection, as sodium trihydrate (Indocin®
I.V.): 1 mg
Suppository, rectal (Indocin®): 50 mg
Suspension, oral (Indocin®): 25 mg/5 mL (5 mL, 10 mL,
237 mL, 500 mL)
Brooks PM and Day RO,
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Clinch D, Banerjee AK, Ostick G,
"Absence of Abdominal Pain in Elderly Patients With Peptic Ulcer," Age
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Clive DM, Stoff JS,
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"Effects of Indomethacin in Premature Infants With Patent Ductus Arteriosus: Results of a National Collaborative Study,"
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Gastroenterology, 1989, 96(2 Pt 2 Suppl):675-81.
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"Nonsteroidal Anti-Inflammatory Drug-Associated Azotemia in the Very Old,"
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