Indomethacin for Injection, USP Description | Pfizer Medical Information

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DESCRIPTION

Sterile Indomethacin for Injection, USP for intravenous administration is lyophilized indomethacin for injection. Each vial of indomethacin for injection contains indomethacin sodium, USP equivalent to 1 mg indomethacin; 3 mg sodium citrate dihydrate, USP and 0.13 mg citric acid anhydrous, USP as a white to yellow lyophilized powder or plug. Variations in the size of the lyophilized plug and the intensity of color have no relationship to the quality or amount of indomethacin present in the vial.

Indomethacin for injection is designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid, sodium salt, trihydrate. Its molecular weight is 433.82. Its empirical formula is C19H15ClNNaO4•3H2O and its structural formula is:

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INDICATIONS AND USAGE

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 usual medical management...