Indomethacin(in mdoe eth’ a sin)
Indomethacin
Indocid P.D.A. (CAN), Indocin
Indomethacin Sodium Trihydrate
Apo-Indomethacin (CAN), Indocin I.V.
PREGNANCY CATEGORY B
PREGNANCY CATEGORY D
(THIRD TRIMESTER)
Drug class
NSAID
Therapeutic Actions
Anti-inflammatory, analgesic, and antipyretic activities largely related to inhibition of prostaglandin synthesis; exact mechanisms of action are not known. Inhibits both cyclooxygenase (COX) 1 and 2. Indomethacin is mainly COX-1 selective.
Indications
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)
Parenteral use: 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
Unlabeled uses for oral form: Pharmacologic closure of persistent patent ductus arteriosus in premature infants; juvenile rheumatoid arthritis; prevention of premature labor
Unlabeled use of topical eyedrops: Cystoid macular edema
Unlabeled uses: To reduce incidence of patent ductus arteriosus in patients at risk for the condition.
Contraindications and Cautions
Oral and rectal
Contraindicated with allergy to indomethacin, salicylates, or other NSAIDs; history of proctitis or rectal bleeding (suppositories); pregnancy in the third trimester, lactation, labor; pain associated with coronary artery bypass graft surgery.
Use cautiously with CV dysfunction, hypertension, peptic ulceration, GI bleeding, impaired renal or hepatic function, pregnancy.
IV
Contraindicated with proven or suspected infection; bleeding, thrombocytopenia, coagulation defects; necrotizing enterocolitis; neonates with significant renal impairment, congenital heart disease when patency of ductus arteriosus is needed for blood flow.
Use cautiously with renal impairment.
Available Forms
Capsules—25, 50 mg; SR capsules—75 mg; oral suspension—25 mg/5 mL; suppositories—50 mg; powder for injection—1 mg
Dosages
Adults
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. SR dose may be used.
Acute painful shoulder: 75–150 mg/day PO, in three or four divided doses. Discontinue drug after inflammation is controlled, usually 7–14 days. SR dose may be used.
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 SR dose. In those who have persistent night pain or morning stiffness, a total daily dose of 100 mg may be given at bedtime. Do not exceed 200 mg.
Pediatric patients
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.
IV
Three IV doses given at 12- to 24-hr intervals.
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