Index of drugs

Treatment of the following severe infections due to tobramycin sensitive bacteria if less toxic antibacterial agents are ineffective: nosocomial infections of the lower respiratory tract, including severe pneumonia; exacerbation of lower respiratory tract infection in patients with cystic fibrosis; complicated and recurrent urinary tract infections; infection inside the abdominal cavity; infection of the skin and soft tissues, including severe burns. Tobramycin is usually used in combination with β-lactam antibiotics or antibiotics acting on anaerobic bacteria, particularly in life-threatening infections caused by unknown bacteria, in mixed infections caused by aerobic and anaerobic bacteria, in systemic bacterial infectionsPseudomonas spp. and in immunocompromised patients - mainly with neutropenia. The official guidelines for the appropriate use of antimicrobial agents should be taken into account.

1 ml of solution contains 1 mg or 3 mg of tobramycin; medicine contains sodium.

Hypersensitivity to tobramycin or other aminoglycosides or to any of the excipients. Myasthenia gravis.

Aminoglycosides may adversely affect the fetus (eg congenital deafness and nephrotoxicity) if their concentration in the serum of a pregnant woman is high. Tobramycin is not indicated for use in pregnant women unless the benefit to the mother outweighs the risk to the fetus. If there is exposure to tobramycin during the fetal period, it is recommended to test the hearing and renal function of the newborn. Tobramycin is excreted in small amounts into breast milk. Due to the risk of ototoxicity and nephrotoxicity in newborns, breast-feeding or tobramycin should be discontinued. Tobramycin may adversely affect the intestinal flora of the child. If gastrointestinal disturbances occur in a breastfed infant (intestinal candidiasis, diarrhea), breast-feeding should be discontinued or tobramycin discontinued.

Common: eosinophilia, damage to the vestibule and cochlea (in patients with impaired renal function, thrombophlebitis, increased AST and ALT, renal dysfunction (in patients with renal impairment), pain and local reactions at the injection site. Uncommon: leukopenia , headache, damage to the vestibule and cochlea (in patients with normal renal function), nausea, vomiting, increased alkaline phosphatase, lactate dehydrogenase, increased bilirubin in the blood, allergic skin rash, renal dysfunction (in patients with normal renal function) Rare: anemia, granulocytopenia, thrombocytopenia, leukocytosis, hypersensitivity reactions (including pruritus, drug-induced fever and skin changes), confusion, confusion, diarrhea, redness of the skin, fever, lethargy, decrease in Calcium, Magnesium, sodium, potassium in the blood. Very rare: severe reaction hypersensitivity (including cutaneous), toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, alopecia, acute renal failure (symptoms may include progressive increases in blood creatinine, increased levels of nitrogen and residual nitrogen in the urine, oliguria, and tubulin eruption) and progressing proteinuria). Not known: pseudomembranous colitis, superinfection with tobramycin resistant organisms, paresthesia, skin ache, muscle tremors, convulsions (symptoms of neurotoxicity), drowsiness, neuromuscular blockade.

Intravenously, infusion.Adults and youth from 12 y. Severe infections: 3 mg / kg / day in a single daily dose or in 3 divided doses (ie 1 mg / kg every 8 hours). Life-threatening infections: up to 5 mg / kg / day in a single daily dose or in divided doses (ie 1.66 mg / kg every 8 hours), sometimes dosing every 6 hours; if the clinical condition improves, the dose should be reduced.Cystic fibrosis: 8-10 mg / kg / day, in order to achieve a therapeutic concentration in the blood; due to the high individual variability, the concentration of tobramycin in the blood should be monitored.Children (> 1 week of age): 6-7,5 mg / kg / day in a single daily dose or 2-2.5 mg / kg every 8 h or sometimes 1.5-1, 9 mg / kg every 6 hours. The medicine is not recommended for children at birth. <12 kg (once a day dosing) and <32 kg (several (three) times a day dosing). Due to the higher doses recommended for patients with respiratory tract infection and cystic fibrosis (8-10 mg / kg / day), the drug can be used in these patients if their body temperature is increased. is at least 25 kg (multiple doses per day).Special groups of patients. Patients with impaired renal function: after an initial dose of 1 mg / kg it is necessary to modify the dosage (ie maintenance doses) by reducing the dose administered every 8 hours (diagram 1.) or increasing the intervals between the usual doses (diagram 2.), according to the schemes described below. In life-threatening infections, additional doses may be administered at half the recommended doses; after observing an improvement in the patient's condition, the dose should be reduced to normal values.Scheme 1. - modified doses, given every 8 hours: CCr ≥70 ml / min - body weight 50-60 kg: 60 mg; mc. 60-80 kg: 80 mg; CCr 69-40 ml / min - month 50-60 kg: 30-60 mg, body weight 60-80 kg: 50-80 mg; CCr 39-20 ml / min - month 50-60 kg: 20-25 mg, body weight 60-80 kg: 30-45 mg; CCr 19-10 ml / min - month 50-60 kg: 10-18 mg, body mass 60-80 kg: 15-24 mg; CCr 9-5 ml / min - month 50-60 kg: 5-9 mg, month 60-80 kg: 7-12 mg; CCr ≤4 ml / min - mc. 50-60 kg: 2.5-4.5 mg, body mass 60-80 kg: 3.5-6 mg. An alternative way to calculate the reduced dose, given every 8 hours (in patients with stable and known creatinine levels), is to divide the usual recommended dose by serum creatinine (mg / 100 mL) in a given patient.Scheme 2. - fixed doses, administered at modified intervals (50-60 kg: 60 mg, 60-80 kg: 80 mg): CCr ≥ 70 ml / min - every 8 h; CCr 69-40 ml / min - every 12 hours; CCr 39-20 ml / min - every 18 h; CCr 19-10 ml / min - every 24 hours; CCr 9-5 ml / min - every 36 h; CCr ≤4 ml / min - every 48 h. In order to calculate the frequency of dosing, expressed in h, it is usually enough to multiply the serum creatinine concentration (mg / 100 ml) of a given patient by 6. If high doses are repeatedly used in infants and young children with impaired renal function and in patients with additional risk factors for toxic reactions, the dosages should be monitored for serum tobramycin levels and adjusted if necessary. To avoid toxic side effects, the maximum serum concentration should be 4-10 μg / ml and the minimum concentration should be before the Next dose <2 μg / ml.Hemodialysis. After each dialysis session, the dose should be individually adjusted according to the serum concentration of tobramycin; usually the recommended dose of tobramycin after dialysis equals half of the loading dose.Elderly patients. Supportive doses may be lower than in younger adult patients.Overweight patients: body weight, forming the basis for calculating the daily dose expressed in mg / kg, can be calculated as follows: + 40% of excess mc.Way of giving. Traditionally, tobramycin is administered in divided doses, e.g. every 8 hours, but studies have shown that once a day dosing is more beneficial, both in terms of efficacy and safety. It is recommended to administer the drug at a single daily dose, except in patients with impaired immunity (eg neutropenia), severe renal failure, cystic fibrosis, ascites, and in patients with extensive burns (> 20% of the skin area) and pregnant women. The drug should be administered as an intravenous infusion; recommended time of administration is 30 minutes, but it can be extended up to 60 minutes.Duration of treatment: usually 7-10 days; in the treatment of refractory or complicated infections, long-term administration of the drug may be necessary. Monitoring of renal function, hearing and atrium is recommended because the occurrence of nephro- and neurotoxicity is more likely during treatment> 10 days.