Properties
What is it?
International Nonproprietary Name - amikacin sulfate Clinical-pharmacological group: Antibacterial agents → Aminoglycosides → For systemic use Composition 1 ml of solution for injection contains: Amikacin sulfate, equivalent to 50 mg or 250 mg of amikacin. Excipients: Sodium citrate, sodium metabisulfite, methylparaben, propylparaben, disodium edetate (100 mg/2 ml), propylene glycol (500 mg/2 ml). Main physical-chemical properties: Indications Infectious-inflammatory diseases caused by Gram-negative microorganisms (including strains resistant to gentamicin, sisomicin, and kanamycin) or by Gram-positive and Gram-negative associations: • Respiratory tract infections: bronchitis, pneumonia, lung abscess, pleural empyema; • Sepsis (including neonatal sepsis); • Septic endocarditis; • CNS infections (including meningitis); • Intra-abdominal infections (including peritonitis); • Genitourinary tract infections (pyelonephritis, cystitis, urethritis, prostatitis, gonorrhea); • Purulent infections of skin and soft tissues (including infected burns, infected ulcers and bedsores of various origins); • Biliary tract infections; • Bone and joint infections (including osteomyelitis); • Infected wounds; • Postoperative infections; • Otitis. Dosage and administration Before starting and during treatment with amikacin, kidney function should be assessed by determining serum creatinine concentration or creatinine clearance. For patients with normal kidney function (adults and children), intramuscular or intravenous administration of the drug: Amikacin is administered intramuscularly or intravenously (bolus over 2 minutes or by drip) at a dose of 5 mg/kg body weight every 8 hours or 7.5 mg/kg body weight every 12 hours. For uncomplicated bacterial infections of the urinary tract, 250 mg of amikacin is prescribed every 12 hours. An additional dose of 3–5 mg/kg body weight may be administered after a hemodialysis session. In case of burns, the drug can be administered at a dose of 5–7.5 mg/kg body weight every 4–6 hours due to the shortened half-life (1–1.5 hours). In adults, the maximum daily dose of the drug is 15 mg/kg body weight, which at the same time should not exceed 1.5 g (e.g., in patients with high body weight). The maximum dose for the course of treatment should not exceed 15 g. In newborns, the initial dose of amikacin is 10 mg/kg body weight, subsequent doses are 7.5 mg/kg body weight every 12 hours. In premature newborns, the recommended initial dose is 10 mg/kg body weight, subsequent doses are 7.5 mg/kg body weight every 18–24 hours. Single daily administration of the total daily dose of the drug is permissible (exceptions include treatment of endocarditis, meningitis, and the neonatal period). The single intravenous daily dose in adults (creatinine clearance > 50 ml/min) is 15 mg/kg body weight, and in children over 4 weeks of age – 20 mg/kg body weight (in children, a relatively higher dose per kg of body weight is prescribed due to increased volume of distribution (Vd)). Side effects Gastrointestinal system: nausea, vomiting, impaired liver function (increased activity of liver transaminases, hyperbilirubinemia); Hematopoietic system: anemia, leukopenia, granulocytopenia, thrombocytopenia, eosinophilia; Nervous system: headache, drowsiness, neurotoxic effects (muscle tremor, paresthesia, epileptic seizures), impaired neuromuscular transmission (respiratory arrest); Sensory organs: ototoxicity – hearing loss, vestibular (coordination disorders and others) and labyrinthine disorders, irreversible deafness; in isolated cases, intravitreal administration of amikacin may cause retinal hemorrhage in the macular area, which can lead to irreversible vision loss; Urinary system: nephrotoxicity – oliguria, proteinuria, microhematuria