Daunorubicin hydrochloride is available as a 5-mg/mL solution in single-use (preservative-free) 4- and 10-mL vials containing 20 and 50 mg of daunorubicin, respectively, as the base.2950; 3722 Each mL of solution contains 5 mg of daunorubicin hydrochloride (as the base) and also contains sodium chloride 9 mg and water for injection with hydrochloric acid and/or sodium hydroxide to adjust the pH.2950; 3722
CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs.
Equivalency
Daunorubicin hydrochloride 5.34 mg is equivalent to 5 mg of daunorubicin base.3722
pH
The pH of the injection solution ranges from 3 to 42950 or from 4 to 5,3722 depending on the specific product.
Trade Name(s)
Cerubidine
Daunorubicin hydrochloride is administered intravenously only.2950 The drug must not be given by intramuscular or subcutaneous injection.2950; 3722 Extravasation will result in severe local tissue necrosis.2950; 3722
The dose may be diluted by drawing the desired dose into a syringe containing 10 to 15 mL of sodium chloride 0.9% and injecting the contents into the sidearm or tubing of a rapidly flowing intravenous infusion of dextrose 5% or sodium chloride 0.9%.2950; 3722
In the event of spills or leaks, the use of sodium hypochlorite 5% (household bleach) in contact until a colorless liquid results has been recommended to inactivate daunorubicin hydrochloride.1200
CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs.
Daunorubicin hydrochloride is a deep red solution.3722 Intact vials of daunorubicin hydrochloride should be stored under refrigeration at 2 to 8°C in the original carton to protect from light.2950; 3722 The manufacturer states that the solution prepared for administration may be stored for up to 24 hours at controlled room temperature.2950; 3722
Immersion of a needle with an aluminum component in daunorubicin hydrochloride (Ives) 5 mg/mL resulted in a darkening of the solution, with black patches forming on the aluminum in 12 to 24 hours at 24°C with protection from light.988
pH Effects
Daunorubicin hydrochloride appears to have pH-dependent stability in solution.526; 1250 Solutions of daunorubicin hydrochloride are less stable at pH values above 8. Decomposition occurs, as indicated by a color change from red to blue-purple. The drug becomes progressively more stable as the pH of drug-infusion solution admixtures becomes more acidic, from 7.4 down to 4.5.526 The pH range of maximum stability was reported to be approximately 4.5 to 5.5. Below pH 4, decomposition increases substantially.1207
Light Effects
Protection from light is recommended.2950; 3722 Photoinactivation of daunorubicin hydrochloride exposed to radiation of 366 nm and fluorescent light has been reported.1094 One source indicates that significant losses due to light exposure for a sufficient time may occur at concentrations below 100 mcg/mL.1369 However, in clinical concentrations at or above 500 mcg/mL, no special light protection appeared to be necessary.1369
Syringes
Daunorubicin hydrochloride (Rhone-Poulenc) 2 mg/mL in polypropylene syringes exhibited little loss in 43 days at 4°C.1460
Filtration
Daunorubicin hydrochloride binds only slightly to cellulose acetate/nitrate (Millex OR) and polytetrafluoroethylene (Millex FG) filters.1249; 1415; 1416
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