Indocin® I.V.
(indomethacin for injection)

• Indocin I.V. is a lyophilized powder supplied as single dose vials containing indomethacin for injection, equivalent to 1 mg indomethacin.

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Indications and Usage
INDOCIN®  I.V. (indomethacin for injection) is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours of usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective.   Clear-cur clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive pericardium, cardiomegaly and pulmonary plethora on chest X-ray.

Important Safety Information
INDOCIN I.V. should not be used in neonates with proven or suspected infection that is untreated; neonates who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; neonates with thrombocytopenia; neonates with congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow. INDOCIN  I.V. has been shown to cause minor gastrointestinal bleeding in neonates, it may inhibit platelet aggregation and cause a significant reduction in urine output (50% or more) with concomitant elevations of BUN and creatinine and reductions in GRF and creatinine clearance.  The most frequent side effects associated with INDOCIN I.V. in a randomized placebo-controlled trial of neonates treated with indomethacin (n=206) were bleeding problems including including gross or microscopic bleeding in the intestinal tract, pulmonary hemorrhage, and disseminated intravascular coagulopathy; transient oliguria and elevations of serum creatinine (≥ 1.8 mg/dL). 

For more information, please see Full Prescribing Information.

® Registered trademark of Merck, Sharp & Dohme, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, U.S.A.