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Amikacin

Amikacin
Solution for injection for intramuscular and intravenous administration 500 mg/2 ml
ATC J01G B06
Prescription only medicine
Reimburse by Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION


Whenever possible, amikacin concentrations in serum should be measured to assure adequate but not excessive levels. It is desirable to measure both peak and trough serum concentrations intermittently during therapy. Peak concentrations above 35 mg/mL and trough concentrations above 10 mg/mL should be avoided. The dosage should be adjusted as indicated.

The patient`s pretreatment body weight should be obtained for calculation of correct dosage.

Adults and Children

15 mg/Kg of weight per day in two or three divided doses (adults usually 500 mg twice daily). Total daily dose for adults should not exceed 15 mg/kg and never totally exceed 1.5g/day.

Prematures

7.5 mg/kg every 12 hours.

Newborns

Initially 10 mg/Kg of weight, then 7.5 mg/Kg every 12 hours.

Infants (older than 2 weeks)

7.5 mg/kg every 12 hours or 5 mg/kg every 8 hours.

The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate. The blood urea nitrogen (BUN) is much less reliable for this purpose. Reassessment of renal function should be made periodically during therapy.

When amikacin is indicated in uncomplicated urinary tract infections, a dose of 250 mg twice daily or 500 mg once daily may be used.

The usual duration of treatment is 7-10 days. In difficult and complicated infections where treatment beyond 10 days is considered, the use of amikacin should be reevaluated. If continued, amikacin serum levels and renal, auditory and vestibular functions should be monitored.

At the recommended dosage level, uncomplicated infections due to amikacin-sensitive organisms should respond in 24-48 hours. If definite clinical response does not occur within 3-5 days, therapy should be stopped and the antibiotic susceptibility pattern of the invading organism should be rechecked. Failure of infection to respond may be due to resistance of the organism or to the presence of septic foci requiring surgical drainage.

Intramuscular and intravenous administration in patients with normal renal function

Administration in 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.

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 creatinine concentration is 2 mg/100mL, the recommended single dose (7.5 mg/kg) should be administered every 18 hours.

Reduced Dosage at Fixed Time Intervals

First, initiate therapy by administering a normal dose, 7.5 mg/kg, as a loading dose. 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 (CC): Maintenance dose every 12 hours = observed CC in mL/min X calculated loading dose in mg normal CC in mL/min 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.

Route of Administration

Intramuscular administration: Intramuscular route is preferred for most of the infections, for maximum levels are achieved 1 hour after administration. In threatening infections or when intramuscular administration is not possible, intravenous administration can be used.

Intravenous administration: In adults and children the drug can be administered either unchanged (2-3 min) or by slow infusion within 30-60 min. In infants, it should be administered by infusions lasting 1-2 hours. Amikacin should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route. A physiological solution of NaCl, 5% dextrose or Ringer`s solution with lactose for the infusion are recommended. The solutions must be stored in a refrigerator and should be used within a period of 12 hours after the preparation.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

COMPOSITION

Each ml solution contains amikacin sulphate equivalent to amikacin 250 mg.

THERAPEUTIC INDICATIONS

Serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species and Acinetobacter (Mima-Herellea) species.
Clinical studies have shown amikacin sulphate injection to be effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, CNS (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and post-operative infections (including post-vascular surgery). Clinical studies have shown amikacin also to be effective in serious complicated and recurrent urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.
Bacteriologic studies should be performed to identify causative organisms and their susceptibilities to amikacin. Amikacin may be considered as initial therapy in suspected Gram-negative infections, and therapy may be instituted before obtaining the results of susceptibility testing. Clinical trials demonstrated that amikacin was effective in infections caused by gentamicin- and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens and Pseudomonas aeruginosa. The decision to continue therapy with the drug should be based on results of the susceptibility tests, the severity of the infection and the response of the patient, as well as important additional considerations.
Amikacin has also been shown to be effective in staphylococcal infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus, infections due to susceptible strains of staphylococci in patients allergic to other antibiotics and in mixed staphylococcal/Gram-negative infections.
In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin-type drug may be indicated, because of the possibility of infections due to Gram-positive organisms, such as streptococci or pneumococci.

CONTRAINDICATIONS

Known hypersensitivity to this medicine. A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any other aminoglycoside, because of the known cross-sensitivities of patients to drugs in this class.

PACKAGING

500 mg/2 ml solution for injection 2 ml/vial/box