Adult Dosing
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
- 25 mg (5 mL) PO bid-tid, alt: 75 mg ECAPS qd-bid; titrate the dose weekly by 25-50 mg (5-10 mL) daily up to 150-200 mg (30–40 mL) daily or until satisfactory response is obtained
- Max: 200 mg (40 mL) daily
- Persistent night pain and/or morning stiffness
- Max 100 mg (20 mL) qhs
- Max total daily dose: 200 mg (40 mL)
- Acute exacerbations of chronic rheumatoid arthritis
- Increase the initial dose by 25 mg or 50 mg PO qd if required
Acute painful shoulder (bursitis and/or tendinitis)
- Initial dose: 75-150 mg (15-30 mL) daily PO in 3-4 divided dose x 7-14 days
- ECAPS: 75mg qd-bid daily x 7-14 days
Acute gouty arthritis
- 50 mg (10 mL) PO tid; once the pain is tolerable, rapidly decrease the dose to complete cessation of drug
Mild-to-moderate acute pain
- 20 mg PO tid or 40 mg PO bid/tid
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
- ECAPS is not recommended for acute gouty arthritis
Pediatric Dosing
- Safety and effectiveness in pediatric patients <14 yrs of age have not been established
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
- 25 mg (5 mL) PO bid-tid, alt: 75 mg ECAPS qd-bid; titrate the dose weekly by 25-50 mg (5-10 mL) daily up to 150-200 mg (30–40 mL) daily or until satisfactory response is obtained
- Max: 200 mg (40 mL) daily
- Persistent night pain and/or morning stiffness
- Max 100 mg (20 mL) qhs
- Max total daily dose: 200 mg (40 mL)
- Acute exacerbations of chronic rheumatoid arthritis
- Increase the initial dose by 25 mg or 50 mg qd if required
Acute painful shoulder (bursitis and/or tendinitis)
- Initial dose: 75-150 mg (15-30 mL) daily PO in 3-4 divided dose x 7-14 days
- ECAPS: 75 mg qd-bid daily x 7-14days
Acute gouty arthritis
- 50 mg (10 mL) PO tid, once the pain is tolerable, rapidly decrease the dose to complete cessation of drug
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
- ECAPS is not recommended for acute gouty arthritis
[Outline]
- NSAIDs may increase the risk of serious and 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 disease or with risk factors for CV disease
- Indomethacin may cause serious GI adverse events such as inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine or large intestine. Restrict use 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
- Factors that increase the risk of GI bleeding in patients treated with NSAIDs include long-term therapy, concomitant use of oral corticosteroids or anticoagulants, smoking, use of alcohol, older age, and poor general health status
- Use with caution in patients with a prior history of ulcer disease or gastrointestinal bleeding
- Severe hepatotoxicity can occur any time during treatment; closely monitor ALT and AST levels periodically in patients receiving long-term therapy. Use the lowest effective dose for the shortest duration possible to minimize the potential risk of hepatotoxicity
- Avoid concomitant use of drug known to be potentially hepatotoxic
- May develop onset of new 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 of thiazides or loop diuretics; closely monitor BP during the therapy
- Use cautiously in patients with fluid retention or heart failure
- Long-term treatment may cause 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 of this toxicity
- Contraindicated in advanced renal disease
- Restrict administration in patients with aspirin triad, and in patients who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs
- Discontinue the treatment at the first appearance of a 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 causes 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 including hemoglobin or hematocrit at regular intervals in patients on long-term treatment with NSAIDs as it may cause anemia due to fluid retention and occult or gross GI blood loss
- Indomethacin 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 pre-existing asthma/aspirin-sensitive asthma as it may exacerbate the symptoms
- Use with caution in elderly patients, poor general health status, or debilitated patients
- Concomitant use of ACEI increases the risk of renal toxicity
- Indomethacin cannot be substituted for corticosteroids or to treat corticosteroid insufficiency. The anti-inflammatory and antipyretic actions of indomethacin may diminish the use of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions
Cautions: Use cautiously in
- Concurrent nephrotoxic drugs
- Dehydration
- Sepsis
- Neurologic diseases
Pregnancy Category:C (caution in 3rd trimester)
Breastfeeding: It is acceptable in nursing mothers due to low levels of indomethacin in breastmilk and therapeutic administration directly to infants. However, an alternate drug with more information about safe use in nursing mothers may be preferred, especially during 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.
US Trade Name(s)
US Availability
indomethacin (generic)
- CAPS: 25, 50 mg
- ECAPS: 75 mg
Indocin
Tivorbex
Canadian Trade Name(s)
- Novo-Methacin
- Nu-Indo
- Pro-Indo
Canadian Availability
indomethacin (generic)
Novo-Methacin, Nu-Indo, Pro-Indo
UK Trade Name(s)
UK Availability
indometacin (generic)
Indolar SR, Pardelprin MR
Australian Trade Name(s)
Australian Availability
Arthrexin, Indocid
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Indomethacin 25 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $15.99
60 mg = $20.99 - Indomethacin 50 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $15.99
60 mg = $21.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
