Management of inflammatory diseases and rheumatoid disorders; moderate pain; acute gouty arthritis

Use with caution in patients with cardiac dysfunction, 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. Use lowest effective dose for shortest period possible. Use of NSAIDs can compromise existing renal function especially when Clcr is <30 mL/minute. 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.

Hypersensitivity to indomethacin, aspirin, or other nonsteroidal anti-inflammatory drugs (NSAIDs); active GI bleeding, ulcer disease; premature neonates with necrotizing enterocolitis, impaired renal function, active bleeding, thrombocytopenia

>10% : Central nervous system: Dizziness Dermatologic: Rash Gastrointestinal: Nausea, epigastric pain, abdominal pain, anorexia, GI bleeding, ulcers, perforation, abdominal cramps, heartburn, indigestion
1% to 10%: Central nervous system: Headache, nervousness Dermatologic: Itching Endocrine & metabolic: Fluid retention Gastrointestinal: Vomiting Otic: Tinnitus

<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, 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 reactions

Decreased effect: May decrease antihypertensive effects of beta-blockers, hydralazine and captopril; indomethacin may decrease antihypertensive and diuretic effects of furosemide and thiazides Increased toxicity: May increase serum potassium with potassium-sparing diuretics; probenecid may increase indomethacin serum concentrations;

Symptoms of overdose include drowsiness, lethargy, nausea, vomiting, seizures, paresthesia, headache, dizziness, GI bleeding, cerebral edema, tinnitus, leukocytosis, renal failure Management of a nonsteroidal antiinflammatory 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. Rrecurrent seizures should be treated with I.V. diazepam.

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). 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.