Generic Name : indomethacin, indomethacin sodium trihydrate acetate
Brand Name: Indocid P.D.A. (CAN), Indocin, Indocin-SR, ratio-Indomethacin (CAN) , Apo-Indomethacin (CAN), Indocin I.V., Rhodacine (CAN)
Pregnancy Category B (first and second trimesters
Pregnancy Category D (third trimester)
Dosage & Route
- Osteoarthritis or rheumatoid arthritis, ankylosing spondylitis: 25 mg PO bid or tid. If tolerated, increase dose by 25- or 50 mg increments if needed up to total daily dose of 150–200 mg/day PO.
- Acute painful shoulder: 75–150 mg/day PO, in three or four divided doses. Discontinue drug after inflammation is controlled, usually 7–14 days.
- Acute gouty arthritis: 50 mg PO, tid until pain is tolerable, then rapidly decrease dose until no longer needed, usually within 3–5 days. Do not use extended release. In those who have persistent night pain or morning stiffness, a total daily dose of 100 mg may be given hs. Do not exceed 200 mg.
- Safety and efficacy not established. When special circumstances warrant use in children older than 2 yr, initial dose is 2 mg/kg/day in divided doses PO. Do not exceed 4 mg/kg/day or 150–200 mg/day, whichever is less.
- Three IV doses given at 12- to 24-hr intervals.
- 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 SR 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
- IV: Closure of hemodynamically significant patent ductus arteriosus in premature infants weighing 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, recent history of coronary artery bypass surgery; peptic ulceration, GI bleeding; history of proctitis or rectal bleeding; impaired hepatic or renal function; pregnancy; labor and delivery. IV preparations: Proven or suspected infection; bleeding, thrombocytopenia, coagulation defects; necrotizing enterocolitis; renal impairment; local irritation if extravasation occurs
- Skin color, lesions; T; orientation, reflexes, ophthalmologic evaluation, audiometric evaluation, peripheral sensation; P, BP, edema; R, adventitious sounds; liver evaluation, bowel sounds; CBC, clotting times, urinalysis, LFTs, renal function tests, serum electrolytes, stool guaiac
Oral and rectal preparations
- BLACK BOX WARNING: Be aware that patient may be at increased risk for CV events, GI bleeding; monitor accordingly.
- Do not give SR tablets for gouty arthritis.
- Give drug with food or after meals if GI upset occurs.
- Arrange for periodic ophthalmologic examination during long-term therapy.
- WARNING: Discontinue drug if eye changes or symptoms of hepatic or renal impairment occur.
- WARNING: For overdose, use emergency procedures—gastric lavage, induction of emesis, support.
- WARNING: Test renal function between doses. If severe renal impairment is noted, do not give the next dose.
- Parents of infants receiving IV therapy for patent ductus arteriosus will need support and encouragement and an explanation of the drug’s action; this is best incorporated into the teaching about the disease.
- Use the drug only as suggested; avoid overdose. Take with food or after meals if GI upset occurs. Do not exceed the prescribed dosage. Do not use with over-the-counter analgesics; serious toxicity can occur.
- You may experience these side effects: Nausea, GI upset, dyspepsia (take drug with food); diarrhea or constipation; drowsiness, dizziness, vertigo, insomnia (use caution if driving or operating dangerous machinery).
- Report sore throat, fever, rash, itching, weight gain, swelling in ankles or fingers, changes in vision, black tarry stools.