International generic name
Drug form and composition
Solution for injection. One ampoule of 1 ml contains: 10 mg; 20 mg; or 40 mg
Gentamicin sulfate. One ampoule of 2 ml contains 80 mg Gentamicin sulfate (40 mg/ml).
Solution, eye drops. One ampoule eye collyrium of 10 ml contains 100 mg Gentamicin
sulfate (10 mg /ml).
Gentamicin-ampoules is indicated in: urinary tract infections (pyelitis, pyelonephritis,
cystitis, urethritis, prostatitis, infected nephrolithiasis); pulmonary infections;
peritonitis; biliary tract infections; infected wounds and burn injuries; nonspecific
meningitis; osteomyelitis. Gentamicin-collyrium is indicated in bacterial infections
of the eye surface structures, including conjunctivitis; blepharitis; keratitis;
episcleritis; hordeolum; injuries of the eye frontal segment; preoperative and postoperative
treatment in eye surgery.
Dosage and administration
Gentamicin-ampoules are applied parenterally (intravenously and intramuscularly).
In adult patients with normal renal function - 2-5 mg per kg body weight every 8-12
hours, intramuscularly. The medicine should not be used in daily doses higher than
8 mg per kg body weight. In elderly patients with disturbed renal function the dose
should be reduced depending on the creatine clearance. Gentamicin could be used
intravenously 3 mg per kg body weight, once daily. The single dose should be diluted
in 50-200 ml saline or in 5% dextrose and should be given as a slow intravenous
infusion for 1,5-2 hours. In newborns (up to 2 weeks after the birth) the preparation
is applied intramuscularly or intravenously, 2,5 mg per kg body weight every 12
hours. In older infants and children - 2-2.5 mg per kg body weight every 8 or 12
hours. Recommended maximal daily dose in children is up to 7.5 mg per kg body weight.
The treatment usually continues 7-10 days. Gentamicin - collyrium is applied in
the lachrymal sac - 1 drop, 4-6 times daily; in most severe cases - 1 drop every
Hypersensitivity to gentamicin and other aminoglycoside antibiotics; severe renal
diseases; auditory nerve dysfunction; myasthenia gravis; botulism in children; Parkinson’s
Special warnings and precautions
It is advisable before each therapeutic course a dermal allergy test to be made.
As a risk of ototxicity and nephrotoxicity exists, the dose should be individualized
in such a way, so the maximal plasma level to be lower than 10-12 μg/l.
Combined treatment with other aminoglycoside antibiotics enhances oto- and nephrotoxicity
of the preparation. Concomitant administration with furosemid and etacrynic acid
potentiates the risk of ototoxicity, whereas cephalosporines enhance the nephrotoxic
effect. Simultaneous administration of peripheral myorelaxants and Gentamicin the
time of the neuro-muscular block may be increased with consequent paralysis of the
respiration. In vitro mixing of Gentamicin and ampicillin leads to insoluble sediment
formation and inactivation of the medicine.
In parenteral treatment the most frequent adverse reactions are ototoxic and
nephrotoxic manifestations. Ototoxicity is manifested by dizziness, sound in the
ears, hearing loss. Nephrotoxicity is characterized by elevation of the serum urea
and creatine level, oliguria. In local application burning, irritation, and allergy
Gentamicine is an antibiotic belonging to the aminoglycosides. It possesses broad
antimicrobial spectrum with most prominent activity against the Gram-negative bacteria
(E. coli, Klebsiella, Proteus, Pseudomonas) and staphylococci. Gentamicin exerts
a bactericide effect on the splitting and no splitting microorganisms. It breaks
the 30 S-subunit of the ribosomes and depresses the protein synthesis in the bacterial
10 or 100 ampoules of 1 ml (10 mg, 20 mg, and 40 mg). 10 or 100 ampoules of 2
ml (80 mg). Ampoules of 10ml (100 mg), with sterile dropper.
Solution for injection and eye drops - 4 years