indomethacin sodium trihydrate
Pregnancy Risk Category NR
How supplied
indomethacin
Capsules: 25 mg, 50 mg
Capsules (sustained-release): 75 mg
Oral suspension: 25 mg/5 ml
Suppositories: 50 mg
indomethacin sodium trihydrate
Injection: 1-mg vials
Action
Unknown. Produces anti-inflammatory, analgesic, and antipyretic effects, possibly by inhibiting prostaglandin synthesis.
Indications & dosage
Moderate to severe rheumatoid arthritis or osteoarthritis, ankylosing spondylitis--
Adults: 25 mg P.O. or P.R. b.i.d. or t.i.d. with food or antacids; increase daily dose by 25 or 50 mg q 7 days, up to 200 mg daily. Or, sustained-release capsules (75 mg): 75 mg P.O. to start, in morning or h.s., followed, if needed, by 75 mg b.i.d.
Acute gouty arthritis--
Adults: 50 mg P.O. t.i.d. Dose reduced as soon as possible; then discontinued.
Sustained-release capsules shouldn't be used for this condition.
Acute painful shoulders (bursitis or tendinitis)--
Adults: 75 to 150 mg P.O. daily in divided doses t.i.d. or q.i.d. for 7 to 14 days.
To close a hemodynamically significant patent ductus arteriosus in premature neonates (I.V. form only)--
Neonates under age 48 hours: 0.2 mg/
kg I.V.; then two doses of 0.1 mg/kg at 12- to 24-hour intervals.
Neonates ages 2 to 7 days: 0.2 mg/kg I.V.; then two doses of 0.2 mg/kg at 12- to 24-hour intervals.
Neonates over age 7 days: 0.2 mg/kg I.V.; then two doses of 0.25 mg/kg at 12- to 24-hour intervals.
Adverse reactions
P.O. and P.R.--
CNS: headache, dizziness, depression, drowsiness, confusion, somnolence, fatigue, peripheral neuropathy, psychic disturbances, syncope, vertigo.
CV: hypertension, edema.
EENT: blurred vision, corneal and retinal damage, hearing loss, tinnitus.
GI: nausea, anorexia, diarrhea, peptic ulceration, GI bleeding, constipation, dyspepsia, pancreatitis.
GU: hematuria.
Hematologic: iron deficiency anemia.
Metabolic: hyperkalemia.
Skin: pruritus, urticaria, Stevens-Johnson syndrome.
Other: hypersensitivity reactions (rash, respiratory distress).
I.V.--
GU: hematuria, proteinuria, interstitial nephritis.
Interactions
Drug-drug. Aminoglycosides, cyclosporine, methotrexate: indomethacin may enhance the toxicity of these drugs. Avoid concomitant use.
Anticoagulants: increased risk of bleeding. Monitor patient closely.
Antihypertensives: reduced antihypertensive effect. Monitor patient closely. Antihypertensives, furosemide, thiazide diuretics: impaired response to both drugs. Avoid using together if possible.
Aspirin: decreased blood levels of indomethacin. Avoid concomitant use.
Aspirin, corticosteroids: increased risk of GI toxicity. Don't use together.
Diflunisal, probenecid: decreased indomethacin excretion. Watch for increased incidence of indomethacin adverse reactions.
Digoxin: indomethacin may prolong half-life of digoxin. Use together cautiously.
Dipyridamole: enhanced fluid retention. Avoid concomitant use.
Lithium: increased plasma lithium levels. Monitor for toxicity.
Penicillamine: may increase bioavailability of penicillamine. Monitor closely.
Phenytoin: increased serum phenytoin levels may occur. Monitor closely.
Triamterene: possible nephrotoxicity. Monitor patient closely.
Drug-herb. Senna: blocked diarrheal effects. Avoid concomitant use.
Drug-lifestyle. Alcohol use: increased risk of GI toxicity. Don't use together.
Effects on diagnostic tests
Drug may interfere with results of dexamethasone suppression test. It may also interfere with urinary 5-hydroxyindoleacetic acid determinations.
Contraindications
Contraindicated in patients with hypersensitivity to drug or history of aspirin- or NSAID-induced asthma, rhinitis, or urticaria. Also contraindicated in pregnant or breast-feeding women and in infants with untreated infection, active bleeding, coagulation defects or thrombocytopenia, congenital heart disease in whom patency of the ductus arteriosus is needed, necrotizing enterocolitis, or impaired renal function. Suppositories are contraindicated in patients with history of proctitis or recent rectal bleeding.
Nursing considerations
I.V. administration
Patient teaching
*Liquid contains alcohol. **May contain tartrazine. †Canada ‡Australia §U.K. OTCOver the counter
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING