Protamine sulfate is available as a 10-mg/mL solution in 5- and 25-mL single-dose (preservative-free) vials.3437 Each mL contains protamine sulfate 10 mg with sodium chloride 9 mg in water for injection.3747 Sulfuric acid and/or dibasic sodium phosphate may be used to adjust the pH.3747
pH
From 6 to 7.3747
Tonicity
Protamine sulfate injection is isotonic.3437
Osmolality
The osmolality of protamine sulfate 10 mg/mL was determined to be 290 mOsm/kg by freezing-point depression and 292 mOsm/kg by vapor pressure.1071
Protamine sulfate is administered undiluted by slow intravenous injection over 10 minutes.3747 No more than 50 mg should be administered in any 10-minute period.3747 Protamine sulfate may also be administered intravenously following dilution in sodium chloride 0.9% or dextrose 5%.3747
Intact vials of protamine sulfate should be stored at controlled room temperature and protected from freezing.3747
Because the product contains no preservatives, the manufacturer states that diluted solutions of protamine sulfate should not be stored.3747
Filtration
Protamine sulfate (Fournier Freres) 0.2 mg/mL in dextrose 5% and sodium chloride 0.9% was filtered through a 0.22-µm cellulose ester membrane filter (Ivex-HP, Millipore) over 6 hours. No significant drug loss due to binding to the filter was noted.1034
Drugs in Syringe Compatibility
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Other Drugs
Protamine sulfate is stated to be incompatible with some antibiotics, including cephalosporins and penicillins.3747 Immediate precipitation has been observed when protamine sulfate is mixed with ceftriaxone sodium.3748
For a list of references cited in the text of this monograph, search the monograph titled References.