Indomethacin

Aka: Indomethacin, Indocin

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II. Indications: FDA Approved

  1. Adults
    1. Rheumatoid Arthritis
    2. Osteoarthritis
    3. Acute Gouty Arthritis
    4. Ankylosing Spondylitis
  2. Children
    1. Patent Ductus Arteriosus in the newborn

III. Indications: Off-Label (Not FDA approved)

  1. Adults
    1. Pericarditis
    2. Bartter's Syndrome
    3. Cluster Headache
    4. Preterm Labor (Tocolysis)
    5. Polyhydramnios
    6. Primary Dysmenorrhea
  2. Children
    1. Juvenile Rheumatoid Arthritis

IV. Contraindications

  1. Peptic Ulcer Disease
  2. Aspirin Sensitivity
  3. Renal Disease
  4. Coagulopathy
  5. Pregnancy beyond 30 weeks
  6. Childhood (except Patent Ductus Arteriosus)
  7. Dementia

V. Mechanism

  1. NSAID in the acetic acid class (indole)

VI. Pharmacokinetics

  1. Half life: 2 hours

VII. Medications

  1. Immediate Release Capsules: 25 mg, 50 mg
  2. Sustained Release Capsules: 75 mg
    1. Do not open or crush sustained release capsules
  3. Oral suspension: 25 mg/5 ml
  4. Suppository: 50 mg
    1. Only NSAID available in suppository form

VIII. Dosing: Adults

  1. Precautions
    1. Limit to lowest effective dose and for least time needed
    2. See other references for dosing and indications for use in polyhydramnios
  2. Immediate Release
    1. Typical dosing range (acute musculoskeletal pain, Dysmenorrhea)
      1. Start 25 mg orally three times daily with food or milk
      2. May advance to 50 mg orally three times daily if needed
    2. Arthritis (RA, OA)
      1. Start: 25 mg orally twice to three times daily
      2. May advance to 150 to 200 mg/day divided three to four times daily)
    3. Acute Gouty Arthritis
      1. Start 50 mg orally three times daily for 2 to 3 days (until pain is controlled)
      2. Next 25 mg orally three times daily for 7 to 10 days
  3. Sustained Release (Cluster Headache, acute Gouty Arthritis)
    1. Dose 75 mg orally daily to twice daily
  4. Maximum: 200 mg/day (divided three to four times daily)

IX. Dosing: Children

  1. Juvenile Rheumatoid Arthritis (not FDA approved)
    1. Start 1 to 3 mg/kg/day divided 3 to 4 times daily
    2. May advance as needed to 4 mg/kg/day (up to max: 200 mg/day)

X. Dosing: Preterm Labor

  1. Precautions
    1. Associated with risk of significant maternal and fetal complications when used in Preterm Labor (see below)
    2. Confirm with other references and consult maternal fetal medicine before using Indomethacin in pregnancy
  2. Protocol 1
    1. Loading dose: 100 mg suppository rectally
    2. Maintenance: 25 mg PO every 6 hours for 24 hours
    3. Repeat for an additional 24 hours maximum
  3. Protocol 2
    1. Loading dose: 50 mg PO
    2. Maintenance: 25 mg PO every 4 hours for 24 hours
    3. Repeat for an additional 24 hours maximum
  4. Monitoring
    1. Amniotic Fluid Index biweekly for use >48 hours

XI. Adverse Effects: General (more than other NSAIDs)

  1. See NSAID
  2. See NSAID Gastrointestinal Adverse Effects
  3. See NSAID Renal Adverse Effects
  4. Headache
  5. Peptic Ulcer
  6. Gastrointestinal upset
  7. Fluid retention
  8. Prolonged Bleeding Time
  9. Nausea or Vomiting
  10. Pruritus
  11. Bowel changes
  12. Mood disturbance
    1. May worsen Major Depression
  13. Nephrotoxic
    1. See Nephrotoxicity due to NSAIDs

XII. Adverse Effects: Maternal and Fetal

  1. See NSAID
  2. Maternal effects
    1. Postpartum Hemorrhage
  3. Fetal effects
    1. Early ductus arteriosus closure
    2. Fetal Pulmonary Hypertension
    3. Oligohydramnios
    4. Not linked to Intraventricular Hemorrhage
      1. Suarez (2001) Obstet Gynecol 97:921-5 [PubMed]

XIII. Safety

  1. Considered safe in Lactation
  2. Avoid NSAIDs in pregnancy outside the first part of the second trimester (13 to 20 weeks)
    1. Teratogenic in first trimester
    2. Risk of premature ductus arteriosus closure in the fetus in third trimester
    3. Most NSAIDs carry a legacy system Pregnancy Category B or C designation (aside from third trimester)
      1. However, many obstetricians avoid NSAIDs entirely in pregnancy (even in second trimester)

XIV. Drug Interactions

  1. Lithium

XV. Efficacy

  1. Most potent NSAID (however this carries renal and GI risks)

XVI. Resources

  1. Indomethacin (DailyMed)
    1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ce9c3c5-0cf7-4760-988d-2559adcfb200
  2. Indomethacin (StatPearls)
    1. https://www.ncbi.nlm.nih.gov/books/NBK555936/

XVII. References

  1. Hamilton (2020) Tarascon Pocket Pharmacopoeia

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Related Studies

Cost: Medications

indomethacin (on 12/21/2022 at Medicaid.Gov Survey of pharmacy drug pricing)
INDOMETHACIN 25 MG CAPSULE Generic $0.10 each
INDOMETHACIN 50 MG CAPSULE Generic $0.09 each
INDOMETHACIN ER 75 MG CAPSULE Generic $0.26 each
FPNotebook does not benefit financially from showing this medication data or their pharmacy links. This information is provided only to help medical providers and their patients see relative costs. Insurance plans negotiate lower medication prices with suppliers. Prices shown here are out of pocket, non-negotiated rates. See Needy Meds for financial assistance information. GoodRx is another tool for finding lower drug prices.

Related Topics in Analgesic Medications

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