Drug Name:
INDOCIN SUSPENSION Rx

Generic Name and Formulations:
Indomethacin 25mg/5mL; pineapple-coconut mint flavor; alcohol 1%.
Company:
Iroko Pharmaceuticals, LLC
Therapeutic Use:
Indications for INDOCIN SUSPENSION:
Moderate to severe rheumatoid arthritis, osteoarthritis, ankylosing spondylitis. Acute painful shoulder. Acute gouty arthritis.
Adult:
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:
≤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.
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.
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. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.
See Also:
Pharmacological Class:
NSAID (indole deriv.).
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, anemia. Supp: rectal irritation, tenesmus.
Note:
Formerly known under the brand names Indocin (caps, supps); Indocin SR (sust-rel caps).
How Supplied:
Caps, ER, supps—contact supplier. Susp—237mL
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