Indomethacin

DEA Class; Rx

Common Brand Names; Indocin, Indocin SR, Tivorbex

NSAIDs

Indoleacetic acid NSAID; analgesic and antipyretic effects; used for RA and OA and in premature neonates to close a patent ductus arteriosus; increases risk of serious GI events; may increase risk of serious CV events; use lowest effective dose for shortest possible duration.

For the treatment of mild pain, moderate pain, or severe pain, such as arthralgia, myalgia, bursitis, or tendinitis.

For the treatment of moderate to severe pain.

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

>10%

Transient renal insufficiency (40%)

Jaundice (≤15%)

Elevated liver function test values (≤15%)

Headache (12%)

1-10%

Dizziness (3-9%)

Dyspepsia (3-9%)

Epigastric pain (3-9%)

Indigestion (3-9%)

Nausea (3-9%)

Symptomatic upper GI ulcers, gross bleeding/perforation (4% of patients treated for 1 year; 1% of patients treated for 3-6 months).

Abnormal pain/cramps/distress (<3%)

Constipation (1-3%)

Depression (1-3%)

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 (eg, exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis) reported; discontinue is symptoms occur

Pregnancy; 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

Lactation

Based on available published clinical data, drug may be present in human milk; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

200 mg/day PO of the immediate-release capsules (25 mg or 50 mg), oral suspension or suppositories; 120 mg of the immediate-release low strength capsules (20 mg or 40 mg, Tivorbex); or 150 mg/day PO of the sustained-release capsules.

200 mg/day PO of the immediate-release capsules (25 mg or 50 mg), oral suspension or suppositories; 120 mg of the immediate-release low strength capsules (20 mg or 40 mg, Tivorbex); or 150 mg/day PO of the sustained-release capsules.

15 years: Safety and efficacy have not been established; doses up to 100 mg/day PO have been used for pericarditis.
13—14 years: Safety and efficacy have not been established; 3 mg/kg/day (limited data support 4 mg/kg/day) or 150—200 mg/day PO of the immediate-release capsules or suspension, whichever is less, has been used.

>= 2 years: Safety and efficacy have not been established; 3 mg/kg/day (limited data support 4 mg/kg/day) or 150—200 mg/day PO of the immediate-release capsules or suspension, whichever is less, has been used.
< 2 years:Use not recommended.

> 7 days: 0.25 mg/kg IV.
< 7 days: 0.2 mg/kg IV.

capsule

• 20mg (Tivorbex)

• 25mg

• 40mg (Tivorbex)

• 50mg

capsule, extended-release

• 75mg

powder for injection

• 1mg

oral suspension

• 25mg/5mL

suppository

• 50mg