Indomethacin Injection 1 mg is a nonsteroidal antiinflammatory drug (NSAID). It is used to close a heart defect called patent ductus arteriosus (PDA) in a baby who was born early when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective.Indomethacin Injection 1 mg for intravenous administration is lyophilized indomethacin for injection. Each vial contains indomethacin for injection equivalent to 1 mg indomethacin as a white to yellow lyophilized powder or plug.
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Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as three intravenous doses of Indomethacin Injection given at 12-24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output < 0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Indomethacin Injection, no additional doses should be given until laboratory studies indicate that renal function has returned to normal
Renal: renal failure, renal dysfunction in 41 percent of neonates, including one or more of the following: reduced urinary output; reduced urine sodium, chloride, or potassium, urine osmolality, free water clearance, or glomerular filtration rate; elevated serum creatinine or BUN; uremia.