Amikacin Sulfate (Page 4 of 4)

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:

Chemical Structure
(click image for full-size original)

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 other 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 sulfate ordered for the patient. It should be a sufficient amount to infuse the amikacin 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 USP

5% Dextrose USP and 0.2% Sodium Chloride Injection USP

5% Dextrose USP and 0.45% Sodium Chloride Injection USP

0.9% Sodium Chloride Injection USP

Lactated Ringer’s Injection USP

Normosol® M in 5% Dextrose Injection USP
(or Plasma-Lyte 56 injection in 5% Dextrose USP in water).

Normosol® R in 5% Dextrose Injection USP
(or Plasma-Lyte 148 injection in 5% Dextrose USP in water).

In the above solutions with amikacin sulfate 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 is supplied as follows:

NDC Number Strength

0703-9032-03

500 mg per 2 mL

0703-9040-03

1 gram per 4 mL

2 mL and 4 mL vials are packaged in shelf packs of 10.

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

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. D 7/2018

Package/Label Display Panel

1
(click image for full-size original)

Amikacin Sulfate Injection USP 250 mg/mL, 10 x 2 mL Single Dose Vial, Carton Label Text

NDC 0703-9032-03 Rx only

Amikacin

Sulfate Injection USP

Equivalent to amikacin

500 mg/2 mL

(250 mg/mL)

For Intramuscular or

Intravenous Use

Contains

10 x 2 mL Single Dose Vials

TEVA

Package/Label Display Panel

2
(click image for full-size original)

Amikacin Sulfate Injection USP 250 mg/mL, 10 x 4 mL Vial, Carton Label Text

NDC 0703-9040-03 Rx only

Amikacin

Sulfate Injection USP

Equivalent to amikacin

1 gram/4 mL

(250 mg/mL)

For Intramuscular or Intravenous Use

Contains 10 x 4 mL Vials

TEVA

AMIKACIN SULFATE
amikacin sulfate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-9032
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIKACIN SULFATE (AMIKACIN) AMIKACIN 500 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
TRISODIUM CITRATE DIHYDRATE
SODIUM METABISULFITE
WATER
SULFURIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0703-9032-03 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0703-9032-01)
1 NDC:0703-9032-01 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0703-9032-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064045 10/01/1993
AMIKACIN SULFATE
amikacin sulfate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-9040
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIKACIN SULFATE (AMIKACIN) AMIKACIN 1 g in 4 mL
Inactive Ingredients
Ingredient Name Strength
TRISODIUM CITRATE DIHYDRATE
SODIUM METABISULFITE
WATER
SULFURIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0703-9040-03 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0703-9040-01)
1 NDC:0703-9040-01 4 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0703-9040-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064045 10/01/1993
Labeler — Teva Parenteral Medicines, Inc. (794362533)

Revised: 07/2018 Teva Parenteral Medicines, Inc.

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