Arthritis/rheumatic disorders:

Indications for: INDOCIN SUSPENSION

Moderate to severe rheumatoid arthritis (including acute flares of chronic disease), osteoarthritis, ankylosing spondylitis. Acute painful shoulder (bursitis and/or tendinitis). Acute gouty arthritis.

Clinical Trials:

  • In clinical studies, indomethacin was found to be an effective anti-inflammatory agent, appropriate for long-term use in rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis. 

  • Indomethacin suppresses inflammation in rheumatoid arthritis as demonstrated by relief of pain, and reduction of fever, swelling and tenderness. Improvement in patients treated with indomethacin for rheumatoid arthritis has been demonstrated by a reduction in joint swelling, average number of joints involved, and morning stiffness; by increased mobility as demonstrated by a decrease in walking time; and by improved functional capability as demonstrated by an increase in grip strength.

  • Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.

Adult Dosage:

Use lowest effective dose for shortest duration. Initially 25mg 2–3 times daily. Increase if needed at weekly intervals by 25–50mg daily; max 200mg daily. Acute painful shoulder: 75–150mg/day in 3–4 divided doses until inflammation controlled (usually 7–14 days). Acute gouty arthritis: 50mg 3 times daily until pain tolerable; then rapidly reduce dose to discontinue.

Children Dosage:

≤14yrs: not established. If risk warranted, monitor and assess liver function periodically; ≥2yrs: 1–2mg/kg/day in divided doses; max 3–4mg/kg/day (or 150–200mg/day), whichever is less.

INDOCIN SUSPENSION Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery. Supp: history of proctitis or recent rectal bleeding.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

INDOCIN SUSPENSION Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. Epilepsy. Depression. Parkinsonism. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.

See Also:

INDOCIN SUSPENSION Classification:

NSAID (indole deriv.).

INDOCIN SUSPENSION Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Serum levels increased by probenecid. Caution with K+-sparing diuretics (eg, triamterene; avoid).

Adverse Reactions:

Headache, dizziness, dyspepsia, nausea, drowsiness; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), anemia. Supp: rectal irritation, tenesmus.

Note:

Formerly known under the brand names Indocin (caps, supps); Indocin SR (sust-rel caps).

Metabolism:

Indomethacin exists in the plasma as the parent drug and its desmethyl, desbenzoyl, and desmethyldesbenzoyl metabolites, all in the unconjugated form. Appreciable formation of glucuronide conjugates of each metabolite and of indomethacin are formed.

Drug Elimination:

Indomethacin is eliminated via renal excretion, metabolism, and biliary excretion. Indomethacin undergoes appreciable enterohepatic circulation. About 60% of an oral dose is recovered in urine as drug and metabolites (26% as indomethacin and its glucuronide), and 33% is recovered in feces (1.5% as indomethacin). The mean half-life of indomethacin is estimated to be about 4.5 hours.

How Supplied:

Caps, ER, supps—contact supplier; Susp—237mL