Idarubicin hydrochloride is available as a 1-mg/mL injection solution in single-dose vials containing 5, 10, and 20 mL.2964; 2965 Each mL contains idarubicin hydrochloride 1 mg (equivalent to 0.93 mg of idarubicin base) and glycerin 25 mg in water for injection;2964; 2965 hydrochloric acid2964 or hydrochloric acid and/or sodium hydroxide2965 is used to adjust pH.2964; 2965
pH
Tonicity
Idarubicin hydrochloride injection is isotonic.2964; 2965
Trade Name(s)
Idamycin PFS
Idarubicin hydrochloride should be administered undiluted by slow intravenous injection over 10 to 15 minutes into the tubing of a running infusion of sodium chloride 0.9% or dextrose 5%.2964; 2965 Extravasation may result in local tissue injury and necrosis may occur.2964; 2965 Labeling for some products states the intravenous catheter should be flushed prior to administration to ensure patency and to minimize the risk of extravasation.2964 Labeling for some products recommends that the tubing be attached to a butterfly needle or other suitable device, inserted preferably into a large vein.2965 The drug should not be given subcutaneously or intramuscularly.2965 Care should be exercised during dose preparation to avoid inadvertent skin contact with the drug.2965
Intact vials should be stored at 2 to 8°C and protected from light.2964; 2965 Retain in the original carton until time of use.2964; 2965
Idarubicin hydrochloride (Farmitalia) 0.07 mg/mL diluted in sodium chloride 0.9% and stored at 22°C did not exhibit an antimicrobial effect on the growth of 4 organisms (Enterococcus faecium, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) inoculated into the solution. Viability was maintained for periods of 48 to 120 hours. The author recommended that diluted solutions of idarubicin hydrochloride be stored under refrigeration whenever possible and that the potential for microbiological growth be considered when assigning expiration periods.2160
pH Effects
Idarubicin hydrochloride in prolonged contact with alkaline solutions will undergo decomposition.1368; 2964; 2965
Light Effects
Dilute solutions (0.01 mg/mL) of idarubicin hydrochloride are light sensitive, undergoing some degradation with exposure to light over periods greater than 6 hours.1368 However, the manufacturers suggest that no special precautions are necessary to protect freshly prepared solutions for administration.1369
Sorption
Idarubicin hydrochloride is compatible with PVC, glass, and polypropylene.1369
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