ASHP INJECTABLE DRUG INFORMATION Amikacin Sulfate  37

Amikacin Sulfate
AHFS 8:12.02

Products Stability
Amikacin sulfate is available in a concentration of 250 mg/ Amikacin sulfate is supplied as a colorless to pale yellow or light
mL. Also present are sodium metabisulfite, sodium citrate, and straw-colored solution.4 It was reported that aqueous solu-
sulfuric acid to adjust pH.1(12/07) tions of amikacin sulfate in concentrations of 37.5 to 250 mg/
mL retained greater than 90% for up to 36 months at 25°C,
pH 12 months at 37°C, and 3 months at 56°C.291 Aqueous solu-
4.5.291 The range is 3.5 to 5.5.4 tions of amikacin sulfate are subject to color darkening because
Osmolality of air oxidation. However, this change in color has no effect on
potency.291
The osmolality of amikacin sulfate 500 mg was calculated for
the following dilutions:1054 Syringes
  Osmolality (mOsm/kg) Amikacin sulfate (Bristol) 750 mg diluted with 1 mL of sodium
chloride 0.9% to a final volume of 4 mL was stable, showing
Diluent 50 mL 100 mL about a 2% loss when stored in polypropylene syringes
Dextrose 5% 353 319 (Becton Dickinson) for 48 hours at 23°C under fluorescent
light.1159
Sodium chloride 0.9% 383 349
Sorption
Sodium Content Amikacin sulfate was shown not to exhibit sorption to polyvinyl
chloride (PVC) bags or sets and multilayer bags composed of
The sodium content of amikacin sulfate 50 mg/mL is 0.064 polyethylene, polyamide, and polypropylene.2269
mEq/mL; for the 250-mg/mL concentration, the sodium content
is 0.319 mEq/mL.291 Central Venous Catheter
Amikacin sulfate (Apothecon) 1 mg/mL in dextrose 5% was
Administration found to be compatible with the ARROWg+ard Blue Plus (Arrow
Amikacin sulfate may be administered by intramuscular injec- International) chlorhexidine-bearing triple-lumen central cath-
tion and intravenous infusion; for intravenous infusion, 500 mg eter. Delivery of the amikacin sulfate ranged from 92 to 98%
may be diluted in 100 to 200 mL of compatible infusion solution of the initial concentration among the 3 lumens. Furthermore,
and administered to adults over 30 to 60 minutes. The diluent chlorhexidine delivered from the catheter remained at trace
volume should be sufficient for drug infusion over 1 to 2 hours in amounts with no substantial increase due to the delivery of the
infants and over 30 to 60 minutes in older children.1(12/07) 4 drug through the catheter.2335

Compatibility Information
Solution Compatibility
Amikacin sulfate
Test Soln Name Mfr Mfr Conc/L or % Remarks Ref C/I

Dextrose 5% in Ringer’s injection BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Dextrose 5% in Ringer’s injection, BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
lactated days at −15°C

Dextrose 2.5% in sodium chloride 0.45% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Dextrose 2.5% in sodium chloride 0.9% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Dextrose 5% in sodium chloride 0.225% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Dextrose 5% in sodium chloride 0.45% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

DOI: 10.37573/9781585286850.014
38  Amikacin Sulfate ASHP INJECTABLE DRUG INFORMATION

Solution Compatibility (Cont.)

Test Soln Name Mfr Mfr Conc/L or % Remarks Ref C/I

Dextrose 5% in sodium chloride 0.9% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Dextrose 10% in sodium chloride 0.9% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Dextrose 5% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Dextrose 5% TRa BR 5g Physically compatible and potency retained for 24 hr at 518 C

room temperature

Dextrose 5% TRa BR 20 g Physically compatible. 4% loss in 24 hr at room tempera- 555 C

ture and 6% loss frozen for 30 days at −20°C

Dextrose 5% MGb BR 4g Stable for 48 hr at 25°C in light 981 C

Dextrose 5% ABa BR 5g Visually compatible. Stable for 48 hr at 25°C in light and 1541 C
4°C in dark

Dextrose 10% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Dextrose 10% SO BR 11.9 gc Visually compatible with no loss in 30 days at 5°C 1731 C

Dextrose 10% SO BR 22.7 gc Visually compatible with no loss in 30 days at 5°C 1731 C

Dextrose 20% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Normosol M in dextrose 5% AB BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Normosol R AB BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Normosol R in dextrose 5% AB BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Ringer’s injection BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Ringer’s injection, lactated BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Sodium chloride 0.225% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Sodium chloride 0.45% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Sodium chloride 0.9% BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

Sodium chloride 0.9% TRa BR 5g Physically compatible. Stable for 24 hr at room temperature 518 C

Sodium chloride 0.9% MGb BR 4g Stable for 48 hr at 25°C in light 981 C

Sodium chloride 0.9% AB a

BR 5g Visually compatible. Stable for 48 hr at 25°C in light and 1541 C
4°C in dark

Sodium lactate 1⁄6 M BA BR 250 mg and 5 g Compatible and stable for 24 hr at 25°C, 60 days at 4°C, 30 292 C
days at −15°C

TPN #107d 150 mg Activity retained for 24 hr at 21°C 1326 C

a
Tested in PVC containers.
b
Tested in glass containers.
c
Tested as a concentrate in glass vials.
d
Refer to Appendix for the composition of parenteral nutrition solutions. TPN indicates a 2-in-1 admixture.