10:00 Antineoplastic Agents
Generic Name
| Special Alerts:
Temporary importation of non-FDA approved streptozocin to address shortage March 31, 2023: FDA is allowing temporary importation of non-FDA-approved Zanosar from Esteve Pharmaceutical SAS. The dosage schedules and therapeutic indications are the same for the imported and US approved Zanosar. It is important to note that although both the FDA-approved product and Esteve product share the same brand name Zanosar, there are key differences including shelf-life, indication, administration, and reconstitution. Please see the Dear Healthcare Professional letter on the FDA website for more information: www.fda.gov/media/166810/download. |
Streptozocin is available as a lyophilized powder in single-dose vials containing streptozocin 1 g and citric acid anhydrous 220 mg with sodium hydroxide for pH adjustment.1704 Reconstitute with 9.5 mL of sodium chloride 0.9% or dextrose 5% to provide a 100-mg/mL solution1704 The reconstituted solution may be further diluted in sodium chloride 0.9% or dextrose 5%.1704
pH
Reconstituted solutions have a pH between 3.5 and 4.5.1704
Trade Name(s)
Zanosar
Streptozocin may be administered by rapid intravenous injection or intravenous infusion.1704
Intact vials should be stored at 2 to 8°C and protected from light.1704 Stretozocin is a pale yellow powder that forms a pale gold solution upon reconstitution.1704 The product contains no preservatives; the manufacturer recommends a total storage time not exceeding 12 hours.1704
Streptozocin (Upjohn) 3 mg/mL in sodium chloride 0.9% did not support the growth of Staphylococcus aureus, Enterococcus faecium, Pseudomonas aeruginosa, and Candida albicans with loss of viability over 24 hours at room temperature. Even so, admixtures should be stored under refrigeration whenever possible, and the potential for microbiological growth should be considered when assigning expiration periods.2740
Filtration
Streptozocin 10 to 200 mcg/mL exhibited no loss due to sorption to either cellulose nitrate/cellulose acetate ester (Millex OR) or Teflon (Millex FG) filters.1415; 1416
For a list of references cited in the text of this monograph, search the monograph titled References.