Symptomatic treatment of acute gouty arthritis (except ER capsules); acute painful shoulder (bursitis and/or tendonitis) and moderate to severe ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis.
PO (Adults): Antiarthritic — 25–50 mg 2–4 times daily or 75-mg extended-release capsule once or twice daily (not to exceed 200 mg or 150 mg of SR/day). A single bedtime dose of 100 mg may be used. Antigout — 100 mg initially, followed by 50 mg 3 times daily for relief of pain, then decreased further .
PO (Children >2 yr): 1–2 mg/kg/day in 2–4 divided doses (not to exceed 4 mg/kg/day or 150–200 mg/day).
Closure of Patent Ductus Arteriosus
IV (Neonates): 0.2 mg/kg initially, then 2 subsequent doses at 12–24 hr intervals of 0.1 mg/kg if age <48 hr at time of initial dose; 0.2 mg/kg if 2–7 days at initial dose; 0.25 mg/kg if age >7 days at initial dose.
Decreases fever, inflammation, and pain, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis; causes closure of a patent ductus arteriosus through inhibition of prostaglandin synthesis.
Treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; hypersensitivity to any component of the product.
Newborns with proven or suspected untreated infection; neonates who are bleeding; neonates with thrombocytopenia, coagulation defects, necrotizing enterocolitis, significant renal function impairment, and/or congenital heart disease (eg, pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta).
CNS: Headache (12%); dizziness (3% to 9%); depression, fatigue, somnolence, vertigo (less than 3%). EENT: Tinnitus (less than 3%). GI: Dyspepsia, GI bleeding (IV only), nausea with or without vomiting (3% to 9%); abdominal distress or pain, constipation, diarrhea (less than 3%). METAB: Elevated potassium, hyponatremia (3% to 9%; IV only). OTHER: Fulminating necrotizing fasciitis (particularly in association with group A beta-hemolytic streptococcus).