INDOCIN SUSPENSION Rx
Generic Name and Formulations:
Indomethacin 25mg/5mL; pineapple-coconut mint flavor; alcohol 1%.
Iroko Pharmaceuticals, LLC
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.
Aspirin allergy. Coronary artery bypass graft surgery. Supp: history of proctitis or recent rectal bleeding.
Risk of serious cardiovascular and gastrointestinal events.
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. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.
NSAID (indole deriv.).
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, 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