Indomethacin

Indomethacin is a prescription medication used to treat Inflammatory/Rheumatoid Disorders, Bursitis/Tendinitis, Acute Gouty Arthritis, Nephrogenic Diabetes Insipidus and Pain. 

• Indomethacin is available under the following different brand names: Indocin, Indocin SR, Tivorbex

Adult and pediatric dosage

Capsule

• 20mg (Tivorbex)
• 25mg
• 40mg (Tivorbex)
• 50mg

Capsule, extended-release

• 75mg

Powder for injection

• 1mg

Oral suspension

• 25mg/5mL

Suppository

• 50mg

Inflammatory/Rheumatoid Disorders

Adult dosage

• Immediate release: 25-50 mg orally/rectally every 8-12 hours; not to exceed 200 mg/day
• Extended-release: 75-150 mg/day orally in single daily dose or divided every 12 hours; not to exceed 150 mg/day

Pediatric dosage

• Children younger than 2 years of age: Safety and efficacy not established
• Children 2-14 years of age: 1-2 mg/kg/day orally divided every 6-12 hours; not to exceed 4 mg/kg/day or 150-200 mg day
• Children older than 14 years of age: 25-50 mg immediate release orally/rectally every 8-12 hours; not to exceed 200 mg/day; 75-150 mg/day extended release orally in single daily dose or divided every 12 hours; not to exceed 150 mg/day 

Bursitis/Tendinitis

Adult dosage

• Immediate release: 75-150 mg/day orally/rectally divided every 6-8 hours
• Extended-release: 75-150 mg/day orally in single daily dose or divided every 12 hours

Acute Gouty Arthritis

Adult dosage

• 50 mg orally/rectally every 8 hours for 3-5 days; reduced once pain is under control

Nephrogenic Diabetes Insipidus

Adult dosage

• 2 mg/kg/day orally divided every 8 hours

Pain

Adult dosage

• 20 mg orally three times daily or 40 mg orally twice/three times daily
• Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Closure of Ductus Arteriosus

Pediatric dosage

• Neonates younger than 28 days: 0.2 mg/kg IV over 20-30 minutes initially, then 2 subsequent doses, depending on postnatal age
• Doses 2 and 3 (less than 48 hours): 0.1 mg/kg IV over 20-30 minutes at 12- and 24-hour intervals
• Doses 2 and 3 (2-7 days): 0.2 mg/kg IV over 2-30 minutes at 12- and 24-hour intervals
• Doses 2 and 3 (over 7 days): 0.25 mg/kg IV over 20-30 minutes at 12- and 24-hour intervals
• After dose 3 (infants less than 1.5 kg): 0.1-0.2 mg/kg IV over 20-30 minutes once daily for 3-5 days

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Indomethacin include:

• indigestion, 
• nausea, 
• headache, and 
• dizziness

Serious side effects of Indomethacin include:

• hives, 
• difficult breathing, 
• swelling in the face or throat, 
• fever, 
• sore throat, 
• burning eyes, 
• skin pain, 
• red or purple skin rash with blistering and peeling, 
• chest pain spreading to the jaw or shoulder, 
• sudden numbness or weakness on one side of the body, 
• slurred speech, 
• leg swelling, 
• shortness of breath, 
• skin rash (no matter how mild), 
• changes in the vision, 
• swelling, 
• rapid weight gain, 
• loss of appetite, 
• upper stomach pain (that may spread to the back), 
• nausea, 
• vomiting, 
• diarrhea, 
• unusual tiredness, 
• itching, 
• flu-like symptoms, 
• dark urine, 
• yellowing of the skin or eyes (jaundice), 
• bloody or tarry stools, 
• coughing up blood, 
• vomit that looks like coffee grounds, 
• little or no urination, 
• swelling in the feet or ankles, 
• tiredness, 
• pale skin, 
• unusual tiredness, 
• lightheadedness, and 
• cold hands and feet

Rare side effects of Indomethacin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Indomethacin has severe interactions with no other drugs.
• Indomethacin has serious interactions with at least 22 other drugs. 
• Indomethacin has moderate interactions with at least 245 other drugs.
• Indomethacin has minor interactions with at least 82 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

Absolute

• History of hypersensitivity (anaphylactic or serious skin reactions)
• History of urticaria, asthma, or allergic type reactions with aspirin
• Preoperative pain associated with CABG surgery
• History of proctitis or recent rectal bleeding (suppositories)

Relative

• Bleeding disorder
• Duodenal/gastric/peptic ulcer
• Stomatitis
• Ulcerative colitis
• Upper GI disease
• Late pregnancy (may cause premature closure of ductus arteriosus)

Neonates

• Renal impairment
• Untreated infection
• Necrotizing enterocolitis
• Active bleeding (GI bleeding or intracranial hemorrhage)
• Thrombocytopenia
• Congenital heart disease where patent ductus arteriosus is necessary

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Indomethacin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Indomethacin?”

Cautions

• Use caution in patients with history of bronchospasm, cardiac disease, CHF, hypertension, hepatic or renal impairment
• Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers
• Prolonged use may cause corneal deposits and retinal disturbances; discontinue if visual changes observed
• Risk of aggravation of psychiatric disturbances, epilepsy, fluid retention, or Parkinson disease
• Reduction in cerebral blood flow associated with rapid IV infusion
• Serious skin adverse events (e.g., exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis) reported; discontinue is symptoms occur
• Platelet adhesion and aggregation may decrease; may prolong bleeding time; monitor closely patients receiving anticoagulants; patients on long-term NSAID therapy should be monitored for anemia; agranulocytosis, aplastic anemia, thrombocytopenia reported (rarely)
• Transaminase elevations reported with use; patients with abnormal liver function test should be monitored closely; discontinue immediately if signs or symptoms of liver disease develop
• NSAID use may increase risk of hyperkalemia, particularly in the elderly, renal disease, diabetics, when administered concomitantly with agents that can induce hyperkalemia
• May increase risk of meningitis with patients with systemic lupus erythematosus and mixed connective tissue disorders being a at higher risk
• Heart Failure (HF) risk
  • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
  • NSAIDS should be avoided or withdrawn whenever possible
  • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134
• Drug reaction with eosinophilia and systemic symptoms
• Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
• Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
• Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
• Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately

Pregnancy and Lactation

• Use of NSAIDs, including indomethacin capsules, can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment; because of these risks, limit dose and duration of therapy to between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy
• Premature closure of fetal ductus arteriosus use of NSAIDs, including indomethacin capsules, at about 30 weeks gestation or later in pregnancy increases risk of premature closure of fetal ductus arteriosus; avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy
• Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment
• Data from observational studies regarding other potential embryofetal risks of NSAID use in women in first or second trimesters of pregnancy are inconclusive
• If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to lowest effective dose and shortest duration possible; if treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue therapy and follow up according to clinical practice
• There are no studies on effects during labor or delivery; in animal studies, NSAIDS, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth
• Reproductive potential
  • Based on mechanism of action, the use of prostaglandin-mediated NSAIDs, including indomethacin capsules, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women
  • Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation
  • Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation; consider withdrawal of NSAIDs, including, in women who have difficulties conceiving or who are undergoing investigation of infertility
  • Based on available published clinical data, drugs may be present in human milk; the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for therapy and any potential adverse effects on breastfed infants from drug or from underlying maternal condition.