International generic name
Drug form and composition
Solution for injection. One ampoule of 2 ml contains: 100 mg Amikacin sulfate
(50 mg/ml) equivalent to 100 mg Amikacin; 250 mg Amikacin sulfate (125 mg/ml) equivalent
to 250 mg Amikacin; or 500 mg Amikacin sulfate (250 mg/ml) equivalent to 500 mg
Amikacin is indicated for the treatment of infections of: central nervous system,
urogenital system, biliary and intestinal tracts, skin and subcutaneous tissues,
intraabdominal infections, pneumonia, caused by Gram-negative microorganisms, secondary
infections after combustion, bacterial septicemia, infections of the bones and joints
(caused by sensitive to Amikacin microorganisms).
Dosage and administration
In adults and children with normal renal function, Amikacin is administered intramuscularly
as an intravenous bolus or by slow intravenous infusion in a dose of 5 mg/kg body
weight given every 8 hours or 7.5 mg/kg body weight every 12 hours for a period
of 7 to 10 days. Before the infusion 500 mg Amikacin is dissolved in 200 mg saline
or other suitable solution. The infusion duration is 30 to 60 minutes. The maximum
daily dose should not exceed 15 mg/kg body weight, and the total dose for one treatment
course should be bellow 15 g. In newborn and prematurely born infants, the single
initial dose of Amikacin is 10 mg/kg body weight. After this dose the treatment
continues with a dose of 7.5 mg/kg body weight given every 12 hours during the following
7 to 10 days. Amikacin can be used in a single daily dose of 1 g intramuscularly
or 15 mg/kg body weight intravenously. In patients with disturbed renal function,
the dose should be reduced and Amikacin is injected at longer intervals to avoid
possible cumulation. In these cases, dosage should be determined based on the creatinine
clearance and the serum creatinine level.
Hypersensitivity to aminoglycoside antibiotics, pregnancy and breast-feeding.
Special warnings and precautions
In high plasma concentrations of the drug there is an increased risk of ototoxicity
and kidney toxicity, because of which a monitoring of the pick plasma concentration
is advised Amikacin should be prescribed with increased caution in patients suffering
from parkinsonism, diseases of the auditory nerve, myasthenia gravis, severe renal
and hepatic insufficiency. In cases of prolonged treatment, regular checks of the
state of hearing and creatinine clearance are advised. The treatment should be discontinued
in cases of loss of hearing of high frequency sounds.
Concurrent administration of Amikacin with myorelaxants leads to potentiation
of their effects and there is a possibility of cessation of the breathing. The combination
with other aminoglycoside antibiotics should be avoided because of the augmentation
of their ototoxic and nephrotoxic effects. Concurrent administration of Amikacin
with fast acting diuretics increases the risk of ototoxicity in patients with renal
failure. Combination with cefalosporins or polymixins increases the risk of nephrotoxicity.
After prolonged treatment with Amikacin the most common adverse effects are the
nephrotoxicity and the ototoxicity. The manifestations of ototoxicity are vestibular
toxic changes (in balance) and cochlear toxic changes (loss of hearing associated
with a sensation for pressure and noise in ears and decreased perception of high
frequency sounds). After concurrent administration of Amikacin and other nephrotoxic
drugs renal failure can be developed. Relatively rare the following adverse effects
can be seen: allergic reaction, nausea, vomiting, stomatitis, blood changes, depression
of respiration, and muscle pareses.
Amikacin is a semisynthetic antibiotic of the aminoglycoside group. It possesses
a broad antimicrobial spectrum, but the greatest activity is against the Gram-negative
bacteria (E. coli, Proteus, Klebsiella) etc. The drug is active also against some
staphylococcus strains (Staphylococcus epidermidis and aureus). Amikacin has a bactericidal
action which is due to the inhibition of the protein synthesis in the cells of the
microorganisms. It produces errors in genetic code reading during the process of
translation and interferes with the ordering of amine acids in the peptic chain
and leads to production of “useless proteins”. The presence of a remnant of -hydroxybutyrate
acid in the Amikacin’s molecule makes this drug insensitive to the enzymes, produced
by Pseudomonas and enterobacteria, resistant to the other aminoglycosides.
10 or 100 ampoules of 2 ml (100 mg). 10 or 100 ampoules of 2 ml (250 mg). 10
or 100 ampoules of 2 ml (500 mg).