Amikacin Sulfate (Page 5 of 6)

Intramuscular Administration for Patients with Impaired Renal Function

Whenever possible, serum amikacin concentrations should be monitored by appropriate assay procedures. Doses may be adjusted in patients with impaired renal function either by administering normal doses at prolonged intervals or by administering reduced doses at a fixed interval.

Both methods are based on the patient’s creatinine clearance or serum creatinine values since these have been found to correlate with aminoglycoside half-lives in patients with diminished renal function. These dosage schedules must be used in conjunction with careful clinical and laboratory observations of the patient and should be modified as necessary. Neither method should be used when dialysis is being performed.

Normal Dosage at Prolonged Intervals

If the creatinine clearance rate is not available and the patient’s condition is stable, a dosage interval in hours for the normal dose can be calculated by multiplying the patient’s serum creatinine by 9, e.g., if the serum creatinine concentration is 2 mg/100 mL, the recommended single dose (7.5 mg/kg) should be administered every 18 hours.

Reduced Dosage at Fixed Time Intervals

When renal function is impaired and it is desirable to administer amikacin at a fixed time interval, dosage must be reduced. In these patients, serum amikacin concentrations should be measured to assure accurate administration of amikacin and to avoid concentrations above 35 mcg/mL. If serum assay determinations are not available and the patient’s condition is stable, serum creatinine and creatinine clearance values are the most readily available indicators of the degree of renal impairment to use as a guide for dosage.

First, initiate therapy by administering a normal dose, 7.5 mg/kg, as a loading dose. This loading dose is the same as the normally recommended dose which would be calculated for a patient with a normal renal function as described above.

To determine the size of maintenance doses administered every 12 hours, the loading dose should be reduced in proportion to the reduction in the patient’s creatinine clearance rate:

Maintenance Dose Every 12 hours = observed CC in mL/min X Calculated loading dose in mg
normal CC in mL/min
(CC — creatinine clearance rate)

An alternate rough guide for determining reduced dosage at 12-hour intervals (for patients whose steady state serum creatinine values are known) is to divide the normally recommended dose by the patient’s serum creatinine.

The above dosage schedules are not intended to be rigid recommendations but are provided as guides to dosage when the measurement of amikacin serum levels is not feasible.

Intravenous Administration

The individual dose, the total daily dose, and the total cumulative dose of amikacin sulfate are identical to the dose recommended for intramuscular administration. The solution for intravenous use is prepared by adding the contents of a 500 mg vial to 100 or 200 mL of sterile diluent such as 0.9% sodium chloride injection or 5% dextrose injection or any of the compatible solutions listed below.

The solution is administered to adults over a 30 to 60 minute period. The total daily dose should not exceed 15 mg/kg/day and may be divided into either 2 or 3 equally-divided doses at equally-divided intervals.

In pediatric patients the amount of fluid used will depend on the amount of amikacin ordered for the patient. It should be a sufficient amount to infuse the Amikacin Sulfate Injection over a 30 to 60 minute period. Infants should receive a 1 to 2 hour infusion.

Amikacin should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

Stability in IV Fluids

Amikacin sulfate is stable for 24 hours at room temperature at concentrations of 0.25 and 5 mg/mL in the following solutions:

5% Dextrose Injection

5% Dextrose and 0.2% Sodium Chloride Injection

5% Dextrose and 0.45% Sodium Chloride Injection

0.9% Sodium Chloride Injection

Lactated Ringer’s Injection

Normosol® M in 5% Dextrose Injection (or Plasma-Lyte 56 Injection in 5% Dextrose in Water)

Normosol® R in 5% Dextrose Injection (or Plasma-Lyte 148 Injection in 5% Dextrose in Water)

In the above solutions with Amikacin Sulfate Injection concentrations of 0.25 and 5 mg/mL, solutions aged for 60 days at 4°C and then stored at 25°C had utility times of 24 hours.

At the same concentrations, solutions frozen and aged for 30 days at -15°C, thawed, and stored at 25°C had utility times of 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever 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.

HOW SUPPLIED

Amikacin Sulfate Injection, USP is supplied as a colorless solution which requires no refrigeration. At times the solution may become a very pale yellow; this does not indicate a decrease in potency.

Amikacin Sulfate Injection, USP, 250 mg/mL, is supplied as follows:

NDC 0641-6167-10, 2 mL Single Dose Vial packaged in a carton of 10

NDC 0641-6166-10, 4 mL Vial packaged in a carton of 10

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

REFERENCES

  1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard — Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement. CLSI document M100-S25. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

Manufactured by:
WEST-WARD
PHARMACEUTICALS
Eatontown, NJ 07724 USA

Revised July 2015

462-711-00

PRINCIPAL DISPLAY PANEL

NDC 0641-6167-01
Rx only
Amikacin
Sulfate
Injection, USP
equivalent to amikacin
500 mg/2 mL
(250 mg/mL)
FOR IM OR IV USE
2 mL Single Dose Vial

NDC 0641-6167-01 Rx only Amikacin Sulfate Injection, USP equivalent to amikacin 500 mg/2 mL (250 mg/mL) FOR IM OR IV USE 2 mL Single Dose Vial

NDC 0641-6167-25
Rx only
Amikacin
Sulfate Injection, USP
equivalent to amikacin
500 mg/2 mL
(250 mg/mL)
For INTRAMUSCULAR or
INTRAVENOUS Use
25 x 2 mL Single Dose Vials
Each mL contains 250 mg amikacin (as
sulfate), 0.66% sodium metabisulfite, 2.5%
sodium citrate dihydrate with pH adjusted to
3.5 to 5.5 with sulfuric acid.
USUAL DOSAGE: 15 mg/kg/day
divided into 2 or 3 equal doses, IM.
Do not exceed 1.5 grams daily.
READ ENCLOSED INSERT for IV
and other uses.
Store at 20º to 25ºC (68º to 77ºF)
[See USP Controlled RoomTemperature].

º

NDC 0641-6167-25 Rx only Amikacin Sulfate Injection, USP equivalent to amikacin 500 mg/2 mL (250 mg/mL) For INTRAMUSCULAR or INTRAVENOUS Use 25 x 2 mL Single Dose Vials Each mL contains 250 mg amikacin (as sulfate), 0.66% sodium metabisulfite, 2.5% sodium citrate dihydrate with pH adjusted to 3.5 to 5.5 with sulfuric acid. USUAL DOSAGE: 15 mg/kg/day divided into 2 or 3 equal doses, IM. Do not exceed 1.5 grams daily. READ ENCLOSED INSERT for IV and other uses. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
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