Brand Name: Indocid P.D.A. (CAN), Indocin, Indocin-SR, Novo-Methacin (CAN)
indomethacin sodium trihydrate, Apo-Indomethacin (CAN), Indocid (CAN), Indocin I.V., Indotec (CAN), Novomethacin (CAN), Rhodacine (CAN)
Pregnancy Category B, Pregnancy Category D (third trimester)
Drug class: Nonsteroidal anti-inflammatory drug (NSAID)
Anti-inflammatory, analgesic, and antipyretic activities largely related to inhibition of prostaglandin synthesis; exact mechanisms of action are not known.
Oral, topical, suppositories
· Relief of signs and symptoms of moderate to severe rheumatoid arthritis and moderate to severe osteoarthritis, moderate to severe ankylosing spondylitis, acute painful shoulder (bursitis, tendinitis), acute gouty arthritis (not sustained-release form)
· Unlabeled uses for oral form: pharmacologic closure of persistent patent ductus arteriosus in premature infants; juvenile rheumatoid arthritis
· Unlabeled use of topical eye drops: cystoid macular edema
· Closure of hemodynamically significant patent ductus arteriosus in premature infants weighing between 500–1,750 g, if 48 hr of usual medical management is not effective
· Oral and rectal preparations: allergy to indomethacin, salicylates, or other NSAIDs; CV dysfunction, hypertension; peptic ulceration, GI bleeding; history of proctitis or rectal bleeding; impaired hepatic or renal function; pregnancy; labor and delivery; lactation.
· IV preparations: proven or suspected infection; bleeding, thrombocytopenia, coagulation defects; necrotizing enterocolitis; renal impairment; local irritation if extravasation occurs.
Headache, dizziness, somnolence, insomnia, fatigue, tiredness, dizziness, tinnitus, ophthalmologic effects
Rash, pruritus, sweating, dry mucous membranes, stomatitis
Nausea, dyspepsia, GI pain, diarrhea, vomiting, constipation, flatulence
Dysuria, renal impairment
Bleeding, platelet inhibition with higher doses, neutropenia, eosinophilia, leukopenia, pancytopenia, thrombocytopenia, agranulocytosis, granulocytopenia, aplastic anemia, decreased Hgb or Hct, bone marrow depression, mennorhagia
Dyspnea, hemoptysis, pharyngitis, bronchospasm, rhinitis
· Increased toxic effects of lithium
· Decreased diuretic effect with loop diuretics: bumetanide, furosemide, ethacrynic acid
· Potential decrease in antihypertensive effect of beta-adrenergic blocking agents, captopril, lisinopril, enalapril
Oral and rectal preparations
· Give drug with food or after meals if GI upset occurs.
· Do not give sustained-release tablets for gouty arthritis.
· Arrange for periodic ophthalmologic examination during long-term therapy.
· Discontinue drug if eye changes, symptoms of liver or renal dysfunction occur.
· Institute emergency procedures if overdose occurs: gastric lavage, induction of emesis, support.
· Test renal function between doses. If severe renal impairment is noted, do not give the next dose.