Index of drugs

Parenteral treatment of the following infections in adults and children from the moment of birth: skin and soft tissue infection with complications, infection of bones and joints, nosocomial pneumonia, community acquired pneumonia, complicated infections of the urinary tract, infective endocarditis, peritonitis associated with continuous ambulatory dialysis peritoneal (CAPD), bacteraemia occurring in connection with one of the above indications. The preparation is also indicated as an alternative oral treatment of diarrhea and colitis associated with infectionClostridium difficile. If appropriate, teicoplanin should be given in combination with other antimicrobials. The official guidelines for the proper use of antibacterial drugs should be taken into account.

1 vial contains 200 mg or 400 mg of teicoplanin, equivalent to not less than 200,000 IU or 400,000 IU After dissolving the powder, the solution will contain 200 mg or 400 mg of teicoplanin in 3 ml.

Glycopeptide antibiotic. Teicoplanin inhibits the growth of aerobic and anaerobic Gram-positive bacteria by affecting the biosynthesis of the cell wall in a place different from that of β-lactam antibiotics. Species usually sensitive: aerobic Gram-positive bacteria -Corynebacterium jeikeium, Enterococcus faecalis Staphylococcus aureus(including MRSA),Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis(C and G streptococci),Streptococcus pneumoniae, Streptococcus pyogenes,green streptococci; Anaerobic Gram-positive bacteria - Clostridium difficile, Peptostreptococcus spp. Species among which the problem of acquired resistance may occur: aerobic Gram-positive bacteria -Enterococcus faecium, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis. Species with innate resistance: all Gram-negative bacteria; other bacteria -Chlamydia spp., Chlamydophila spp., Legionella pneumophila, Mycoplasma spp. After intramuscular administration, the bioavailability of teicoplanin is approximately 90%. With human serum proteins, it binds in 87.6-90.8%. It is present mainly in the lungs, myocardium and bones; poorly penetrates into the cerebrospinal fluid. It is metabolized to a small extent. It is mainly excreted in urine in unchanged form. It is not removed during hemodialysis. T_0,5 in the final phase of elimination is 100-170 h.

Hypersensitivity to the active substance or excipient.

Caution should be used in patients with hypersensitivity to Vancomycin, because cross-sensitivity, including fatal anaphylactic shock, may occur. If a hypersensitivity reaction to teicoplanin occurs, treatment should be discontinued immediately and appropriate emergency measures instituted. The occurrence of "red human syndrome" after Vancomycin administration is not a contraindication to the use of the preparation, rarely (even when the first dose was given) a red human syndrome was observed. Stopping or slowing down the infusion may cause these reactions to disappear. if the daily dose is not given by injection, but by a 30-minute infusion If symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis occur, treatment with teicoplanin should be stopped immediately Teicoplanin is not suitable for use as monotherapy for certain types of infections, unless the pathogen it is already determined and its sensitivity is marked, or there is a strong suspicion that the most likely pathogen will be sensitive to teicoplanin treatment. The spectrum of antibacterial activity should be considered in the rational use of teicoplanin. the safety profile and suitability of standard antibacterial treatment in the treatment of a particular patient. On this basis, it can be expected that in most cases teicoplanin can be used to treat severe infections in patients for whom standard antibacterial activity is considered inappropriate. In the loading dose schedule - if teicoplanin is administered at doses of 12 mg / kg2 times daily, you should carefully monitor your patient for side effects because the safety data is limited. As part of this scheme, in addition to the recommended periodic haematological examination, blood creatinine values ​​should be monitored. Teicoplanin should not be administered intraventricularly. During treatment with teicoplanin, periodic haematological tests, including full blood counts, are recommended. Patients with renal insufficiency and / or who are receiving teicoplanin in combination with or sequentially with other medicines known to have nephrotoxicity (aminoglycosides, colistin, amphotericin B, ciclosporin and cisplatin) should be carefully monitored, including hearing testing. In patients with renal insufficiency, the dose of teicoplanin should be modified. Patients who develop symptoms of hearing disorder or damage to the inner ear during treatment with teicoplanina should be carefully studied and monitored, especially during long-term treatment and if there is kidney failure. Patients receiving teicoplanin in combination with or sequentially with other drugs known to have neurotoxic and ototoxic effects (aminoglycosides, cyclosporine, Cisplatin, Furosemide and ethacrynic acid) should be carefully monitored and if hearing loss occurs, the benefits of teicoplanin should be evaluated. Caution should be exercised when administering teicoplanin to patients in whom combination therapy with ototoxic and / or nephrotoxic drugs is required. Regular haematological tests, liver and kidney function tests are recommended.

Do not use during pregnancy unless clearly necessary. The risk of damage to the inner ear and kidneys can not be ruled out. It is not known if teicoplanin is excreted in breast milk - a decision should be made to continue or terminate breastfeeding or continue or discontinue teicoplanin, taking into account the benefits of breastfeeding and the benefits of teicoplanin to the mother.

Common: erythema, rash, pruritus, pain, fever. Uncommon: eosinophilia, thrombocytopenia, leukopenia, anaphylaxis, dizziness, headache, deafness, hearing loss, tinnitus, vestibular disorders, phlebitis, bronchospasm, nausea, vomiting, diarrhea, increased transaminases and alkaline phosphatase in the blood, increased blood creatinine. Rare: abscess, red-red syndrome (redness of the upper body). Not known: abscess at the injection site, superinfection, agranulocytosis, neutropenia, anaphylactic shock, convulsions, thrombophlebitis, angioneurotic edema, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, urticaria, renal failure (including acute renal failure), chills.

Intravenously or intramuscularly. The solution can be injected intravenously over 3 to 5 minutes or in a 30-minute infusion. In neonates, use only in infusion. Teicoplanin concentrations should be monitored at steady-state after the end of the loading dose to confirm that the minimum serum concentration has been reached: in most Gram-positive infections, the minimum teicoplanin concentrations are at least 10 mg / l, if measured by high-performance chromatography liquid (HPLC) or at least 15 mg / l if polarized immunofluorescence (FPIA) was used; in endocarditis and other severe infections, the minimum teicoplanin concentrations are 15-30 mg / l when measured by HPLC or 30-40 mg / l if measured by FPIA. To ensure stability of these concentrations during maintenance therapy, control of the minimum plasma concentrations of teicoplanin can be performed at least once a week.Adults (including the elderly) and children> 12 years. Target minimum concentrations on days 3-5 and target minimum concentrations during maintenance treatment were measured using FPIA. In infective endocarditis, at least 21 days of treatment are usually appropriate. Treatment should not be continued for more than 4 months. Combination therapy - Teicoplanin has a limited spectrum of antibacterial activity (Gram-positive bacteria).It is not suitable for use as monotherapy in certain types of infections, unless the pathogen is already determined and its sensitivity is determined or there is a strong suspicion that the most likely pathogen (s) will be sensitive to teicoplanin treatment.Infections of the skin and soft tissues with complications. Pneumonia. Urinary tract infections with complications. Loading dose: 400 mg intravenously or intramuscularly (corresponding to approximately 6 mg / kg) 3 times, every 12 hours; the target minimum concentrations on days 3-5 should be> 15 mg / l. Maintenance dose: 6 mg / kg intravenously or intramuscularly once a day; target minimum concentrations should be> 15 mg / l once a week.Infections of bones and joints. Loading dose: 800 mg intravenously (corresponding to approximately 12 mg / kg) 3-5 times, every 12 hours; the target minimum concentrations on days 3-5 should be> 20 mg / l. Maintenance dose: 12 mg / kg intravenously or intramuscularly once a day; the target minimum concentrations should be> 20 mg / l.Infective endocarditis. Loading dose: 800 mg intravenously (corresponding to approximately 12 mg / kg) 3-5 times, every 12 hours; the target minimum concentrations on days 3-5 should be 30-40 mg / l. Maintenance dose: 12 mg / kg intravenously or intramuscularly once a day; the target minimum concentrations should be> 30 mg / l.Diarrhea and colitis associated with infectionClostridium difficile100-200 mg orally administered twice daily for 7-14 days.Patients with renal insufficiency. Dose modification is not necessary until the 4th day of treatment, when dosing should be adjusted to maintain the minimum serum concentration (10 mg / l). After the fourth day of treatment: in slight and moderate renal impairment (creatinine clearance 30-80 ml / min), the maintenance dose should be halved, giving the entire dose every other day or half of this dose once a day; in severe renal impairment (creatinine clearance <30 ml / min) and hemodialysis patients: the dose should be reduced to 1/3 of the usual dose, starting with a starting dose every third day or 1/3 of that dose once a day.Continuous ambulatory peritoneal dialysis. After intravenous administration of a single 6 mg / kg saturating dose, 20 mg / l in the bag with dialysis solution is administered in the first week, in the second week 20 mg / l to every second bag, and then in 3 20 mg / l per week to the bag left overnight.Children. Newborns and infants up to 2 months: loading dose - a single dose of 16 mg / kg administered intravenously as an infusion on the first day of treatment; maintenance dose - a single dose of 8 mg / kg intravenously in infusion once a day. From 2 months to 12 years: loading dose - a single dose of 10 mg / kg administered intravenously every 12 hours, repeated 3 times; maintenance dose - a single dose of 6-10 mg / kg administered intravenously once a day.