Trade Names:Indocin IV- Powder for Injection 1 mg
Trade Names:Indocin SR- Capsules, sustained-release 75 mg
Trade Names:Indocin- Suppository 50 mg
Trade Names:Indocin- Suspension, oral 25 mg per 5 mL
Trade Names:Indomethacin- Capsules 25 mg- Capsules 50 mgApo-Indomethacin (Canada)Nu-Indo (Canada)ratio-Indomethacin (Canada)
Decreases fever, inflammation, and pain, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis; causes closure of a patent ductus arteriosus through inhibition of prostaglandin synthesis.
C max is approximately 1 to 2 mcg/mL (dose-dependent). T max is approximately 2 h. Bioavailability is approximately 100%.
99% is protein bound. Crosses blood-brain barrier and placenta.
Undergoes appreciable enterohepatic circulation. The metabolites are desbenzoyl, desmethyl, and desmethyl-desbenzoyl.
Eliminated via biliary excretion, metabolism, and renal excretion. The mean t ½ is approximately 4.5 h. Approximately 60% is excreted in urine and 33% in feces.
Symptomatic treatment of acute gouty arthritis (except sustained-release capsules); acute painful shoulder (bursitis and/or tendonitis) and moderate to severe ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis.IV
Closure of patent ductus arteriosus.
Treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; hypersensitivity to any component of the product.IV
Newborns with proven or suspected untreated infection; neonates who are bleeding; neonates with thrombocytopenia, coagulation defects, necrotizing enterocolitis, significant renal function impairment, and/or congenital heart disease (eg, pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta).
PO/PR 75 to 150 mg/day in divided doses for 7 to 14 days (or 75 to 150 mg sustained-release capsules 1 to 2 times daily).Ankylosing Spondylitis, Osteoarthritis, Rheumatoid ArthritisAdults
PO/PR 25 mg twice daily or 3 times daily up to max of 200 mg/day (or 75 mg sustained-release capsules 1 to 2 times daily).Gouty ArthritisAdults
PO/PR 50 mg 3 times daily; do not use sustained-release capsules.Patent Ductus Arteriosus
IV 3 doses total.Infants younger than 2 days of age
IV 0.2 mg/kg followed by 2 doses of 0.1 mg/kg 12 to 24 h apart.Infants 2 to 7 days of age
IV 3 doses of 0.2 mg/kg separated by 12 to 24 h.Infants older than 7 days of age
IV 0.2 mg/kg followed by 2 doses of 0.25 mg/kg separated by 12 to 24 h.
Store at 68° to 77°F. Protect from light.Sustained-release capsules
Store at 59° to 86°F. Protect from moisture.IV injection
Store below 86°F. Protect from light.Oral suspension
Store below 86°F. Avoid temperatures above 122°F. Protect from freezing.Suppositories
Store below 86°F. Avoid temperatures above 104°F.
Antihypertensive effects may be decreased.Aminoglycosides (eg, gentamicin)
Aminoglycoside levels may be elevated, increasing the risk of toxicity.Anticoagulants
May increase risk of gastric erosion and bleeding.Aspirin
Protein binding of indomethacin may be reduced; in addition, the risk of gastric erosion and bleeding may be increased. Concurrent use is not recommended.Cyclosporine
Risk of cyclosporine toxicity may be increased, possibly caused by decreased synthesis of renal prostaglandin.Diflunisal
Diflunisal may decrease renal Cl and significantly increase indomethacin plasma concentrations that may produce toxicity. Concurrent use is not recommended.Digoxin
May increase digoxin levels. Monitor levels closely.Diuretics
May decrease diuretic effects. Do not administer with triamterene.Lithium
May decrease lithium Cl, resulting in toxicity.Methotrexate
May increase methotrexate levels.NSAIDs (eg, ibuprofen)
Concurrent use of other NSAIDs is not recommended because of increased risk of GI toxicity.Potassium-sparing diuretics
Additive increase in serum potassium levels.Probenecid
Plasma concentrations of indomethacin may be increased, necessitating a lower dose.SSRIs (eg, fluoxetine)
Increased risk of GI bleeding.
False-negative test results may occur in dexamethasone suppression test.
Headache (12%); dizziness (3% to 9%); depression, fatigue, somnolence, vertigo (less than 3%).
Tinnitus (less than 3%).
Dyspepsia, GI bleeding (IV only), nausea with or without vomiting (3% to 9%); abdominal distress or pain, constipation, diarrhea (less than 3%).
Elevated potassium, hyponatremia (3% to 9%; IV only).
Fulminating necrotizing fasciitis (particularly in association with group A beta-hemolytic streptococcus).
NSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke, which can be fatal. This risk may increase with length of therapy. Patients with CV disease or risk factors for CV disease may be at greater risk. Indomethacin is contraindicated for the treatment of perioperative pain in the setting of surgery. NSAIDs cause an increased risk of serious GI adverse reactions, including bleeding, inflammation, perforation of the stomach or intestines, and ulceration, which can be fatal. These events can occur any time during use and without warning symptoms. Elderly patients are at greater risk of serious GI reactions.
Follow chronically treated patients for signs and symptoms of GI tract ulceration and bleeding. Monitor CBC, chemistry profile, and LFTs periodically during long-term therapy. Monitor renal function in patients with compromised kidney function. Monitor Hgb or Hct in patients with signs or symptoms of anemia. Perform eye examinations if patient experiences visual disturbances. Closely monitor BP during the initiation of treatment and throughout the course of therapy. Carefully monitor patients who may be adversely affected by alterations in platelet function (eg, patients with coagulation disorders or receiving anticoagulant therapy). Determine serum electrolytes during therapy in newborns. Monitor urinary output in newborns.
Category C . Avoid use in late pregnancy.
Excreted in breast milk.
Safety and efficacy not established in children younger than 14 yr of age, except use of IV form in infants.
Use with caution.
Not recommended in patients with advanced renal disease. Use with caution in patients with renal function impairment and closely monitor renal function.
Do not administer to patients with aspirin triad, which occurs typically in patients with asthma who experience rhinitis with or without nasal polyps, or patients who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.
Patients with asthma may have aspirin-sensitive asthma, which may be associated with severe and sometimes fatal bronchospasm. Do not administer indomethacin to patients with this type of aspirin-sensitivity because of possible cross-reactivity.
May aggravate depression or other psychiatric disorders, epilepsy, or Parkinsonism; use with caution.
Fluid retention and edema have been reported. Use with caution in patients with fluid retention or heart failure.
Anemia may occur, possibly caused by fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis.
Borderline elevations of 1 or more LFT may occur in patients taking indomethacin.
New hypertension or worsening of preexisting hypertension, either of which may contribute to increased risk of CV events, may occur.
May mask the usual signs and symptoms of infection.
Corneal deposits and retinal disturbances, including those of the macula, have been reported.
NSAIDs inhibit platelet aggregation and have been reported to prolong bleeding time.
Long-term administration has resulted in renal papillary necrosis and other renal injury.
Serious and sometimes fatal skin adverse reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, may occur.
Disorientation, dizziness, headache, lethargy, mental confusion, nausea, numbness, paresthesias, seizures, vomiting.
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