AHFS Class:

8:12.28.92 Other Miscellaneous Antibacterials

Fusidate sodium is available as a dry powder in vials containing 500 mg (equivalent to 480 mg of fusidic acid). It is packaged with a diluent vial containing 10 mL of phosphate-citrate buffer (pH 7.4 to 7.6). The drug should be reconstituted with the diluent and diluted further with sodium chloride 0.9% or other compatible diluent for administration.³⁸

Sodium and Phosphate Content

Each vial of fusidate sodium contains 3.1 mmol of sodium and 1.1 mmol of phosphate.³⁸

Trade Name(s)

Fucidin

Fusidate sodium is administered by slow intravenous infusion over not less than six hours if a superficial vein is employed. If a central venous line is used, the infusion should be given over two to four hours. The reconstituted fusidate sodium in 10 mL of buffer solution is diluted in 500 mL of sodium chloride 0.9% or other compatible infusion solution for administration. The drug must not be given by other routes.³⁸

Fusidate sodium should be stored below 25°C and protected from light. Reconstituted solutions that are added to 500 mL of compatible infusion solutions are stable for 24 hours at room temperature. Unused portions of the reconstituted solution should be discarded.³⁸

Fusidate sodium reconstituted with the buffer solution to 50 mg/mL is physically incompatible with infusion solutions containing amino acids solutions, dextrose 20% or greater, and lipid infusions.³⁸

Fusidate sodium (Leo) at a concentration of 0.125 mg/mL is stated to be physically incompatible with the following peritoneal dialysis solutions¹⁸⁰⁰:

• Dianeal PD2 with dextrose 1.36%
• Dianeal PD3 with dextrose 1.36%
• Dianeal with dextrose 3.86%
• Peritoneal Dialysis Solution 6.36%
• Peritoneal Dialysis Solution 6.36% + acetate
• Peritoneal Dialysis Solution with dextrose 2.27%

pH Effects

Precipitation may occur upon dilution if the resulting pH is less than 7.4.³⁸

Freezing Solutions

Fusidate sodium (Leo) 1 mg/mL in sodium chloride 0.9% and dextrose 5% is stated to be stable frozen at -20°C for 24 hours followed by thawing in a microwave oven.¹⁸⁰⁰

Fusidic acid (Leo) 500 mg, reconstituted in buffer and diluted to 550 mL in sodium chloride 0.9% in PVC bags, was stored frozen at -20°C. No loss was found after 12 months of storage followed by microwave thawing. Furthermore, the solution was physically compatible, with no increase in subvisible particles. In addition, there was no loss of fusidate sodium after six months of storage at -20°C followed by three freeze-thaw cycles.¹⁶¹²

Solution Compatibility

Additive Compatibility

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions March 13, 2017. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.