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indications:
intravenous: treatment of serious, life-threatening infections (which can not be effectively treated with other antibiotics) caused by methicillin-resistant strainsS. aureus or by Vancomycin susceptible bacteria in patients with hypersensitivity to penicillin and to patients who for various reasons can not take other medications or for which other medicines (including penicillins and cephalosporins) were ineffective, or the infection was caused by bacteria resistant to other drugs antibacterial drugs with the exception of vancomycin. The main indications are: staphylococcal endocarditis, staphylococcal sepsis and other infections caused by staphylococci, including infections of the lower respiratory tract, bones, skin and soft tissues.Orally: treatment of pseudomembranous colitis and staphylococcal enteritis.
Composition:
1 vial contains 500 mg or 1 g of vancomycin as hydrochloride.
Action:
A cyclic glycopeptide antibiotic. It has a strong bactericidal effect onStaphylococcus aureus and S. epidermidis (including methicillin-resistant strains),Streptococcus pneumoniae (also strains resistant to penicillin and other antibiotics),S. pyogenes, S. agalactiae, S. bovis, Clostridium spp. (includingCl. difficile), Corynebacterium spp., Listeria monocytogenes. BacteriostaticEnterococcus spp. (there are highly resistant strains), while in combination with aminoglycosides, it exerts a bactericidal effect on enterococci. It does not affect Gram-negative bacteria, mycobacteria and mycobacteria. Plasma protein binding is 55%. Vancomycin permeates, among others for peritoneal, pleural, pericardial, synovial, placental and maternal milk. It does not penetrate into the cerebrospinal fluid; in meningitis, penetration increases. It is not metabolised. It is excreted unchanged, mainly in the urine. T0,5 in the blood is usually 4-6 h, however, there are significant inter-individual differences.
Contraindications:
Hypersensitivity to vancomycin.
Precautions:
Do not use intramuscularly or by rapid intravenous injection (risk of hypotension, shock and cardiac arrest), strictly follow the method of administration. Caution should be used in patients with impaired renal function (dose modification required), hearing impairment, in patients treated concomitantly with ototoxic or nephrotoxic medicinal products and in newborns, infants and elderly patients. Renal function, liver function and blood picture should be monitored during treatment, and patients at risk should also monitor serum vancomycin and monitor their hearing. Avoid giving vancomycin to patients who have had deafness in the past. In patients with inflammatory mucositis of the gastrointestinal tract using vancomycin orally, it may be useful to monitor its serum concentration. Use with caution in patients with hypersensitivity to teicoplanin.
Pregnancy and lactation:
During pregnancy, use only if clearly necessary, when the anticipated benefits to the mother outweigh the potential risk to the fetus (blood vancomycin should be monitored then). Use with caution when breastfeeding.
Side effects:
Symptoms associated with too rapid drug administration: anaphylactoid reactions (hypotension, wheezing, shortness of breath, urticaria, pruritus), redness of the upper body, chest and back muscles pain and spasms, in addition pain at the injection site and thrombophlebitis, intramuscular - tissue necrosis. Nephrotoxicity: increased urea and serum creatinine, renal failure (especially at high doses), interstitial nephritis (in patients treated simultaneously with aminoglycosides or with pre-existing renal impairment), transient azotemia. Ototoxicity: hearing loss (usually after the simultaneous use of ototoxic drugs and in patients with pre-existing renal insufficiency or hearing disorders), rarely tinnitus, dizziness, disturbances of balance.Hematologic disorders: transient neutropenia, rare thrombocytopenia and transient agranulocytosis, eosinophilia. In addition, nausea, chills, drug-induced fever, skin rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, linear IgA dermatosis, rarely vasculitis were observed; very rarely pseudomembranous colitis.
Dosage:
intravenous (only in a drip infusion lasting at least 60 min, at a rate of not more than 10 mg / min and after appropriate dilution). Adults: 500 mg every 6 hours or 1 g every 12 hours (maximum daily dose - 2 g). Children: newborns under 7 days of age: I dose - 15 mg / kg, then 20 mg / kg / day in 2 doses every 12 hours; newborns over 7 days of life: 30 mg / kg / day in 3 doses every 8 hours; from 2 sq m 40 mg / kg / day in 4 doses every 6 hours. In patients with renal insufficiency, the doses depend on the creatinine clearance, i.e. in patients with a 70 ml / min clearance, the daily dose is 1080 mg; 50 ml / min - 770 mg; 40 ml / min - 620 mg; 30 ml / min - 465 mg; 20 ml / min - 310 mg. Patients with severe renal impairment may receive 250-1000 mg once a day instead of once daily doses.Orally or by gavage (after diluting the contents of the vial with 30 ml of water). Adults 0.5-2 g per day in 3-4 doses. Children 40 mg / kg / day in 3-4 doses. The maximum daily dose - 2 g. Duration of treatment: 7-10 days.
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