Instructions for use VANCOMYCIN-TF

Instructions for use VANCOMYCIN-TF

Vancomycin-TF cannot be administered intramuscularly or intravenously as a bolus! Vancomycin-TF is used only by infusion. The following daily doses are recommended.

For adults

the dose is 500 mg IV every 6 hours or 1 g every 12 hours. The drug is administered as a slow infusion at a rate of no more than 10 mg/min over 60 minutes or more. The concentration of the prepared Vancomycin-TF solution should not exceed 5 mg/ml. The maximum daily dose is 2 g.

For newborns up to 7 days of life

the initial dose is 15 mg/kg, then 10 mg/kg every 12 hours.
Children under 1 month
should be administered 10 mg/kg body weight every 8 hours. For
children 1 month and older,
the recommended dose is 40 mg/kg body weight body/day, divided into individual administrations every 6 hours. It is not recommended to exceed the concentration of the prepared Vancomycin-TF solution more than 2.5-5 mg/ml. The infusion is given over 60 minutes or more. The maximum single dose for a child is 15 mg/kg body weight, the maximum daily dose is 60 mg/kg body weight.

For patients with renal failure

it is necessary to individually select the dose.

The initial dose should be 15 mg/kg body weight, then the interval between dosages is determined in accordance with creatinine clearance.

In elderly patients

and in
premature infants
, due to deterioration of renal function, a dose reduction or an increase in the interval between doses may be required.

For the treatment of staphylococcal enterocolitis and pseudomembranous colitis caused by Clostridium difficile, Vancomycin-TF is prescribed orally. Usual Daily Oral Dose for Adults

ranges from 500 mg to 1 g, for
children
- 40 mg/kg body weight, divided into 3-4 doses; course of treatment is 7-10 days. It is not recommended to exceed the daily dose of more than 2 g.

Rules for preparing and administering the solution

Preparation of solution for intravenous administration

. The solution is prepared immediately before administration of the drug. To prepare a solution of Vancomycin-TF with a concentration of 50 mg/ml, add the required volume of solvent to the bottle (10 ml to a bottle containing 500 mg of Vancomycin-TF and 20 ml to a bottle containing 1 g). The resulting solution must be further diluted in 100 ml or 200 ml of solvent to a concentration of no more than 5 mg/ml. As solvents, you can use water for injection, 0.9% sodium chloride solution for injection or 5% glucose solution for injection.

Preparation of a solution for oral administration.

The recommended dose of Vancomycin-TF is dissolved in 30 ml of water. The prepared solution can be prescribed for drinking or administered to the patient through a tube. Food syrups can be used to improve the taste of the solution.

Vancomycin, 1 piece, 500 mg, powder for solution for infusion

Vancomycin is a tricyclic glycopeptide antibiotic produced by Amycolatopsis orientalis. The bactericidal effect of vancomycin is manifested in the inhibition of bacterial cell wall biosynthesis and is capable of changing the permeability of the bacterial cell membrane and the synthesis of ribonucleic acid (RNA). Blocks the synthesis of the bacterial cell wall at a site different from that on which penicillins and cephalosporins act (without competing with them for binding sites), strongly binding to O-alanyl-O-alanine residues of peptidoglycan subunits (located on the outer surface of the cytoplasmic membrane) - a major component of the cell wall, which leads to cell lysis.

Shows a bactericidal effect against many gram-positive bacteria and a bacteriostatic effect against Enterococcus spp. Bactericidal effect on Enterococcus spp. achieved by the combined administration of vancomycin and aminoglycosides. There is no cross-resistance between vancomycin and other classes of antibiotics.

Active against gram-positive microorganisms: Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains), Streptococcus spp. (Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus agalactiae and others, including penicillin-resistant strains), Enterococcus spp. (including Enterococcus faecalis), Clostridium spp., Propionibacterium acnes, Actinomyces spp., some strains of Lactobacillus spp., Rhodococcus spp., Corynebacterium spp., Listeria monocytogenes, Bacillus spp.

In vitro, some isolated strains of Enterococcus spp. and Staphylococcus spp. may exhibit resistance to vancomycin.

In combination with aminoglycosides, in vitro synergism is observed against many strains of Staphylococcus aureus, group D streptococci that do not belong to enterococci, Enterococcus spp., Streptococcus viridans group. In combination with gentamicin, tobramycin, rifampicin, imipenem, a synergistic effect is observed against Staphylococcus aureus. In some cases, with a combination of vancomycin and rifampicin, antagonism of action is observed against strains of Staphylococcus spp., This combination of drugs also exhibits synergistic action against some strains of Streptococcus spp.

Vancomycin is inactive in vitro against gram-negative microorganisms, mycobacteria and fungi.

The optimum action is at pH 8; when the pH decreases to 6, the effect decreases sharply.

The development of resistance in staphylococci during therapy is very rare. The minimum inhibitory concentration (MIC) value for most antibiotic-sensitive microorganisms is less than 5 μg/ml; the MIC value for vancomycin-resistant Staphylococcus aureus strains reaches 10-20 mg/l.

When used orally, it has a minimal systemic effect and acts locally on sensitive microflora in the gastrointestinal tract (GIT) (Staphylococcus aureus, Clostridium difficile).

Side effects of the drug Vancomycin

During or shortly after a rapid infusion of vancomycin, anaphylactoid reactions may occur, including hypotension, difficulty breathing, difficulty breathing, urticaria, and pruritus. Rapid infusion may also cause a rush of blood to the upper body, pain, and muscle spasms in the chest and back. These reactions usually disappear within 20 minutes, but may persist for several hours. Sometimes it is possible to develop renal failure in patients receiving vancomycin hydrochloride in high doses; rarely - interstitial nephritis. These are mainly patients who received concomitant treatment with aminoglycosides, or with previous renal dysfunction. Hearing loss may develop due to ototoxicity from vancomycin hydrochloride. The majority of these patients either had impaired renal function or pre-existing hearing loss, or were receiving concomitant treatment with ototoxic drugs. Occasionally, dizziness and tinnitus occur. Some patients experienced reversible neutropenia, which manifested itself a week or more after initiation of treatment with vancomycin or after administration of a total dose exceeding 25 g. The number of neutrophil leukocytes in the peripheral blood quickly recovered after discontinuation of vancomycin. Thrombocytopenia was rarely detected. Possible development of thrombophlebitis at the injection site, anaphylaxis, drug fever, nausea, chills, eosinophilia, rash (including exfoliative dermatitis), Stevens-Johnson syndrome, vasculitis.

Special instructions for the use of Vancomycin

Vancomycin can cause thrombophlebitis, the incidence and severity of which can be minimized by slow administration as a diluted solution (2.5–5 g/l) and by changing the site of infusion. Vancomycin is a tissue irritant and should only be administered intravenously. With intramuscular administration or extravasation during intravenous infusion, soft tissue necrosis may develop. In order to minimize the risk of nephrotoxicity when treating patients with impaired renal function or patients concomitantly receiving aminoglycosides, renal function should be monitored. During long-term treatment with vancomycin or in patients receiving concomitant therapy with drugs that can cause neutropenia, the white blood cell count should be checked periodically. In order to minimize the risk of ototoxicity when treating high doses of vancomycin or its combination with ototoxic drugs, as well as when using the drug in patients with hearing loss, it may be useful to conduct serial tests of hearing aid function. The incidence of infusion-related complications (including hypotension, flushing, flushing, urticaria, and pruritus) increases with concomitant administration of anesthetics. Complications from IV infusion can be minimized by administering a 60-minute infusion of vancomycin hydrochloride before anesthesia. Clinically significant vancomycin plasma concentrations have been observed in some patients following repeated oral administration of vancomycin for the treatment of active pseudomembranous colitis due to C. difficile . When administering vancomycin to young children (especially premature infants), it is advisable to ensure that the desired concentration of the drug is present in the blood serum. The simultaneous use of vancomycin and anesthetics in children is accompanied by hyperemia. Experimental studies have not revealed any evidence of a damaging effect of vancomycin on the fetus. There is no sufficient clinical data on the safety of the drug during pregnancy, especially in the first trimester. Vancomycin is prescribed to pregnant women only in cases of extreme necessity. Vancomycin passes into breast milk. Since there is a possibility of side effects in the child, breastfeeding should be avoided during treatment with vancomycin.

Indications for use of the drug Vancomycin

Severe infections caused by sensitive strains of methicillin-resistant staphylococci, with intolerance to penicillins, cephalosporins, as well as infections caused by microorganisms sensitive to vancomycin, resistant to other antimicrobial drugs or allergic to penicillin. Vancomycin is effective for staphylococcal endocarditis, sepsis, osteomyelitis, diseases of the lower respiratory tract, skin and soft tissues, as well as for antibacterial therapy during the surgical treatment of purulent processes caused by staphylococci. For endocarditis caused by Streptococcus viridans and S. bovis , monotherapy with vancomycin or a combination of the drug with aminoglycoside antibiotics is effective, and for endocarditis caused by enterococci (for example E. faecalis ), vancomycin is effective only in combination with aminoglycoside antibiotics. Vancomycin has been successfully used to treat patients with diphtheroid endocarditis, and in combination with aminoglycosides and/or rifampicin to treat patients with early endocarditis caused by S. epidermidis or diphtheroids after heart valve replacement. Vancomycin in the form of a parenteral solution can be used orally for the treatment (due to the use of antibiotics) of patients with pseudomembranous colitis caused by C. difficile and staphylococcal enterocolitis. For other types of infections, oral vancomycin hydrochloride is not effective. The American Heart Association and the American Dental Association have suggested vancomycin as a prophylactic agent for bacterial endocarditis in patients with penicillin allergy, congenital heart disease, rheumatic or other acquired heart valve disease, or undergoing upper respiratory surgery or dental surgery. .