Adult Dosing
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
- 25 mg PR bid-tid; titrate the dose weekly by 25 or 50 mg daily up to 150-200 mg/day or until satisfactory response is obtained
- Max: 200 mg daily
- Persistent night pain and/or morning stiffness
- Max 100 mg qhs
- Max total daily dose: 200 mg
- Acute exacerbation of chronic rheumatoid arthritis
- Increase the initial dose by 25 or 50 mg PR qd if required
Acute painful shoulder (bursitis and/or tendinitis)
- Initial dose: 75-150 mg PR in 3-4 divided doses x 7-14 days
Acute gouty arthritis
- 50 mg PR tid; reduce the dose rapidly to complete cessation when symptoms subside
Note:
- Use lowest effective dose for shortest duration consistent with individual patient treatment goals
- Consider the risk and benefit of indomethacin before the start of therapy
- Suppositories should be retained in the rectum for at least 1 hour to ensure complete absorption
Pediatric Dosing
- Safety and effectiveness in pediatric patients <14 yrs of age have not been established
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
- 25 mg PR bid-tid; titrate the dose weekly by 25 or 50 mg daily up to 150-200 mg/day or until satisfactory response is obtained
- Max: 200 mg daily
- Persistent night pain and/or morning stiffness
- Max 100 mg qhs
- Max total daily dose: 200 mg
- Acute exacerbation of chronic rheumatoid arthritis
- Increase the initial dose by 25 or 50 mg PR qd if required
Acute painful shoulder (bursitis and/or tendinitis)
- Initial dose: 75-150 mg PR in 3-4 divided doses x 7-14 days
Acute gouty arthritis
- 50 mg PR tid; reduce the dose rapidly to complete cessation when symptoms subside
Note:
- Use lowest effective dose for shortest duration consistent with individual patient treatment goals
- Consider the risk and benefit of indomethacin before the start of therapy
- Suppositories should be retained in the rectum for at least 1 hour to ensure complete absorption
[Outline]
- NSAIDs may increase the risk of potentially fatal cardiovascular thrombotic events, MI, and stroke. Risk further increases with duration of use, and with presence of cardiovascular disease/risk factors for CV disease [US Black Box Warning]
- Use the lowest effective dose for the shortest duration possible in patients with known CV diseases or risk factors for CV diseases
- Indomethacin may cause GI adverse events such as inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine or large intestine; avoid use of indomethacin in patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding
- If a serious GI adverse event is suspected, discontinue the therapy and promptly institute an alternative therapy
- Other factors that increase the risk of GI bleeding in patients treated with indomethacin include long-term therapy, concomitant use of oral corticosteroids or anticoagulants, smoking, use of alcohol, older age, and poor general health status
- Severe hepatotoxicity can occur any time during treatment; closely monitor ALT and AST levels periodically in patients during therapy. Use the lowest effective dose for the shortest duration possible to minimize the potential risk of hepatotoxicity
- Avoid concomitant use with drugs known to be potentially hepatotoxic
- May cause new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to increased risk of CV events
- Use with caution in patients already taking thiazides or loop diuretics as it may hamper the therapeutic response to these therapies. Closely monitor BP during the therapy
- Use cautiously in patients with fluid retention or heart failure as it may lead to fluid retention and edema
- Long-term treatment may result in renal toxicity such as renal papillary necrosis and other renal injury. Patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, those with volume depletion, and the elderly are at greater risk for this toxicity
- Contraindicated in advanced renal disease
- Restrict administration in patients with aspirin triad, which occurs typically in asthmatic patients who experience rhinitis with or without nasal polyps, or in patients who exhibit potentially fatal bronchospasm after taking aspirin or other NSAIDs
- Discontinue the treatment at the first appearance of skin rash or any other signs of hypersensitivity like exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
- Do not administer in pregnant women after 30 weeks as it may cause premature closure of the ductus arteriosus in the fetus
- Corneal deposits and macular and retinal disturbances have been reported with therapy; discontinue the treatment if such changes occur. Do periodic ophthalmologic examination if the therapy is prolonged
- May aggravate depression or psychiatric disorders, epilepsy, or parkinsonism; use with caution in these situations; discontinue the treatment if the situation worsens
- Check hematologic profile at regular intervals in patients with long-term treatment of NSAIDs as it may cause anemia due to fluid retention and occult or gross GI blood loss
- Inhibits platelet aggregation and prolongs bleeding time in some patients; closely monitor patients with coagulation disorders or those receiving anticoagulants
- Cautiously administer in patients with preexisting asthma/aspirin-sensitive asthma as it may exacerbate the symptoms
- Use with caution in elderly patients, poor general health status, debilitated patients
Cautions: Use cautiously in
- Concurrent nephrotoxic agents
- Neurologic diseases
- Sepsis
- Dehydration
Pregnancy Category:C (caution in 3rd trimester)
Breastfeeding: Acceptable in nursing mothers because of low levels of indomethcin in breastmilk and therapeutic administration directly to infants; however, an alternate drug may be preferred if more information is available about the safe use of that agent while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 9 March 2011). As per manufacturer's data, use not recommended in nursing mothers.
