Posaconazole is available as an 18-mg/mL concentrate for injection in single-use vials containing 300 mg of the drug.2911 The concentrate for injection must be diluted prior to administration.2911 Also present in each vial are betadex sulfobutyl ether sodium 6.68 g, edetate disodium 3 mg, hydrochloric acid and sodium hydroxide to adjust the pH, and water for injection.2911
pH
The pH of the concentrate for injection is adjusted to 2.6.2911
Trade Name(s)
Noxafil
Single-use vials contain posaconazole concentrate for injection that is administered only by slow intravenous infusion after diluting 16.7 mL (300 mg) of the concentrate in an intravenous bag or bottle containing a sufficient volume of a compatible infusion solution to yield a solution containing posaconazole 1 to 2 mg/mL.2911 Prior to dilution, the vials should be allowed to come to room temperature.2911 The diluted solution must only be administered using a 0.22-µm polyethersulfone or polyvinylidene difluoride inline filter.2911
Posaconazole is administered by slow intravenous infusion over approximately 90 minutes through a central venous line (e.g., central venous catheter, peripherally inserted central catheter).2911 In certain circumstances (i.e., in anticipation of central venous line placement or while the central venous line is being replaced or is being used for another treatment), a single dose of posaconazole may be administered through a peripheral venous catheter over approximately 30 minutes.2911 If multiple doses of the drug are needed, a central line should be used; repeated administration of posaconazole through a peripheral venous catheter has been associated with thrombophlebitis.2911 Posaconazole should not be administered as a bolus intravenous injection.2911
Posaconazole concentrate for injection is a clear, colorless to yellow solution.2911 Intact vials of posaconazole should be stored under refrigeration at 2 to 8°C.2911 The concentrate for injection contains no preservatives and is for single use; any unused portions should be discarded.2911
After dilution, the resulting posaconazole solution also ranges from colorless to yellow; variations in color within this range do not affect product quality.2911 Diluted solutions should be visually inspected for particulate matter prior to administration.2911 Diluted solutions of posaconazole for infusion should be used immediately; admixtures not used immediately may be stored under refrigeration for up to 24 hours.2911
Filtration
The concentrate for injection diluted for infusion must be administered through a 0.22-µm polyethersulfone or polyvinylidene difluoride inline filter.2911
For a list of references cited in the text of this monograph, search the monograph titled References.