Indications for: INDOCIN SUSPENSION
Moderate to severe rheumatoid arthritis, osteoarthritis, ankylosing spondylitis. Acute painful shoulder. Acute gouty arthritis.
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.
≤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.
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.
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).
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.
Formerly known under the brand names Indocin (caps, supps); Indocin SR (sust-rel caps).
Caps, ER, supps—contact supplier; Susp—237mL