Label:
Refrigerate.
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Storage/Stability ---- |
Amikacin sulfate is
stable for 24 hours at room temperature and 2 days
at refrigeration at concentrations of 0.25 and 5.0
mg/mL in the following solutions:
5% Dextrose Injection, USP
5% Dextrose and 0.2% Sodium Chloride Injection,
USP
5% Dextrose and 0.45% Sodium Chloride Injection,
USP
0.9% Sodium Chloride Injection, USP
Lactated Ringer’s Injection, USP
Normosol®-M in 5% Dextrose Injection
Normosol®-R in 5% Dextrose Injection
Parenteral drug products should be inspected
visually for particulate matter and discoloration
prior to administration whenever the solution and
container permit.
Aminoglycosides administered by any of the above
routes should not be physically premixed with
other drugs but should be administered separately.
Because of the potential toxicity of
aminoglycosides, “fixed dosage”
recommendations which are not based upon body
weight are not advised. Rather, it is essential to
calculate the dosage to fit the needs of each
patient.
Therapeutic levels:
Peak:
Life-threatening infections: 25-30 mcg/mL
Serious infections: 20-25 mcg/mL
Urinary tract infections: 15-20 mcg/mL
Trough:
Serious infections: 1-4 mcg/mL
Life-threatening infections: 4-8 mcg/mL
Toxic concentration: Peak: >35 mcg/mL; Trough:
>10 mcg/mL
Timing of serum samples: Draw peak 30 minutes
after completion of 30-minute infusion or at 1
hour following initiation of infusion or I.M.
injection; draw trough within 30 minutes prior to
next dose
Dosing interval in renal
impairment: Some patients may require
larger or more frequent doses if serum levels
document the need (ie, cystic fibrosis or febrile
granulocytopenic patients)
Clcr >/=60 mL/minute: Administer every 8 hours
Clcr 40-60 mL/minute: Administer every 12 hours
Clcr 20-40 mL/minute: Administer every 24 hours
Clcr<20 mL/minute: Loading dose, then monitor
levels
Hemodialysis: Dialyzable (50% to 100%); administer
dose postdialysis or administer 2 /3 normal dose
as a supplemental dose postdialysis and follow
levels
Peritoneal dialysis: Dose as Clcr<20 mL/minute:
Follow levels
Continuous arteriovenous or venovenous
hemodiafiltration effects: Dose as for Clcr 10-40
mL/minute and follow levels
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