Indomethacin sodium trihydrate is available as a lyophilized powder in single-dose vials containing the equivalent of 1 mg of indomethacin.671 The formulation is not buffered and contains no preservatives.671 Reconstitute with 1 or 2 mL of preservative-free sterile water for injection or preservative-free sodium chloride 0.9% to yield a 1- or 0.5-mg/mL solution, respectively.671
pH
6 to 7.5.4
Trade Name(s)
Indocin I.V.
Indomethacin sodium trihydrate is administered by intravenous injection over 20 to 30 minutes.671 Dilution after reconstitution is not recommended.671 Extravasation should be avoided.671
Indomethacin sodium trihydrate is a white to yellow powder that forms a clear, slightly yellow solution upon reconstitution.671 Color variations have no relationship to indomethacin content.671 Intact vials should be stored at controlled room temperature in the original carton and protected from light.671 The manufacturer states reconstituted solutions should be prepared for immediate use and any unused portion discarded.671
Solutions of indomethacin sodium trihydrate (Abbott and Fujisawa) diluted in sodium chloride 0.9% to a concentration of 0.1 mg/mL were evaluated for visual and chemical stability stored in the original vials. Little or no loss was found after storage for 10 days at 25°C.2105
The stability of indomethacin sodium trihydrate (Merck Sharp & Dohme) 0.5 mg/mL reconstituted with sterile water for injection in the original vials and repackaged into 1-mL polypropylene syringes (Sherwood) was reported. The reconstituted solutions were stored at room temperature (about 23°C) exposed to fluorescent light for 12 hours daily and under refrigeration (about 4°C) in the dark. Little or no loss of indomethacin in the refrigerated solutions occurred after 14 days of storage. The solutions stored at room temperature exhibited 9% loss in 10 days. The solutions at both temperatures remained visually clear and colorless throughout the study.2228
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