International generic name

Gentamicin

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).

Indications

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 hour.

Contraindications

Hypersensitivity to gentamicin and other aminoglycoside antibiotics; severe renal diseases; auditory nerve dysfunction; myasthenia gravis; botulism in children; Parkinson’s disease; pregnancy.

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.

Drug interactions

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.

Adverse reactions

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 were seen.

Pharmacological mechanisms

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 cell.

Supplied

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.

Expiry

Solution for injection and eye drops - 4 years