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.

Creatinine clearanceDose of Vancomycin-TFInterval between infusions
>80 ml/min500 mg or 1 g12 h
80-50 ml/min1 g24 hours
50-10 ml/min1 g3-7 days
<10 ml/min (anuria)1 g7-14 days

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.

Pharmacological properties of the drug Vancomycin

Tricyclic glycopeptide antibiotic obtained from Amycolatopsis orientalis . Vancomycin inhibits the biosynthesis of cell membranes of microorganisms, changes their permeability and disrupts RNA synthesis. There is no cross-resistance between vancomycin and other antibiotics. Staphylococci are sensitive to vancomycin, including Staphylococcus aureus and Staphylococcus epidermidis (including methicillin-resistant strains), streptococci, including Streptococcus pyogenes, Streptococcus pneumoniae (including penicillin-resistant strains), Streptococcus agalactiae, viridans group, Streptococcus bovis and enterococci, Clostridium diffic ile , diphtheroids , Listeria monocytogenes, Lactobacillus spp., Actinomyces spp., Clostridium spp. and Bacillus spp . Gram-negative bacilli, mycobacteria and fungi are insensitive to vancomycin in vitro When combined with aminoglycoside antibiotics, vancomycin exhibits a synergistic effect against many strains of S. aureus , non-enterococcal group D streptococci, enterococci, and Streptococcus spp . ( viridans ). Vancomycin is poorly absorbed after oral administration; to treat systemic infections it is administered intravenously. IM injections are painful. In patients with normal renal function after intravenous infusion of 1 g of vancomycin for 60 minutes, its concentration in the blood plasma immediately after administration is 63 mg/l, after 2 hours - about 23 mg/l, 10 hours after the end of the infusion - 8 mg/l. With repeated infusion administration of 500 mg of the drug over 30 minutes, the concentration in the blood plasma immediately after administration is 49 mg/l, after 2 hours - 19 mg/l, after 6 hours - 10 mg/l. The average half-life of vancomycin from blood plasma for patients with normal renal function is 4-6 hours. 75% of the administered dose of vancomycin is excreted in the urine by glomerular filtration in the first 24 hours. The average plasma clearance is about 0.058 l/kg/h, and the average renal clearance is about 0.048 l/kg/h. Impaired renal function slows down the elimination of vancomycin. In patients with anuria, the average half-life is 7.5 days. Distribution coefficient - 0.3–0.43 l/kg. About 60% of a dose of vancomycin administered intraperitoneally during peritoneal dialysis undergoes systemic adsorption after 6 hours. Serum concentrations of about 10 mg/l are achieved with an intraperitoneal injection of 30 mg/kg body weight of vancomycin. Vancomycin is not effectively removed by hemodialysis and peritoneal dialysis; it is possible to increase the clearance of vancomycin during hemoperfusion. The total systemic and renal clearance of vancomycin may be reduced in the elderly. About 55% of vancomycin is bound to plasma proteins. After IV administration of vancomycin, it is detected in inhibitory concentrations in pleural, pericardial, peritoneal, ascitic and synovial fluids, in urine and atrial appendage tissue. Vancomycin does not readily diffuse through intact meninges into the CSF, but its concentration in the CSF increases during meningitis.

Side effects

With rapid administration, post-infusion reactions are formed: the “red” man symptom (caused by excessive release of histamine), which is manifested by rapid heartbeat, chills, fever , spasm of muscle tissue, hyperemia of the skin in the upper half of the body; anaphylactic reactions in the form of skin itching, rash, dyspnea, bronchospasm and a drop in blood pressure.

Digestive tract: pseudomembranous colitis , nausea.

Urinary tract: increased levels of urea nitrogen and creatinine, nephrotoxicity (manifests itself with long-term therapy, in combination with aminoglycosides); interstitial nephritis is rarely reported .

Sense organs: ringing in the ears, hearing loss, vertigo . Hematopoietic organs: agranulocytosis, thrombocytopenia (transient form), reversible neutropenia is rarely formed.

The most common local reactions are rash, pain at the injection site, phlebitis , and necrosis in the area where the drug was administered.

Allergic reactions may develop in the form of rash, eosinophilia, chills, nausea, fever, vasculitis , exudative erythema maligna, Lyell's syndrome .

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.

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. .

Pharmacodynamics and pharmacokinetics

The main component is produced by Amycolatopsis orientalis . Vancomycin has a bactericidal effect (the exception is enterococci - the drug has a bacteriostatic effect on them). The mechanism of antibacterial action is aimed at blocking the synthesis chain in the bacterial cell wall, inhibiting the synthesis of ribonuclease, and changing the permeability of bacterial cell membranes. The drug affects staphylococci , corynobacteria, streptococci, clostridia, enterococci, actinomycetes.

Optimal efficiency is observed at a pH of 8; a decrease in the effectiveness of the drug is observed when the pH decreases to 6. The antibiotic Vancomycin has an active effect on microorganisms that are in the reproduction stage.

Almost all gram-negative microorganisms, protozoa, viruses , fungi, and mycobacteria are resistant to the action of the drug. Cross-resistance between vancomycin and other antibacterial drugs has not been reported.

Vancomycin price, where to buy

The price of Vancomycin is approximately 200 rubles. You can buy the drug in Moscow for about the same price.

  • Online pharmacies in RussiaRussia
  • Online pharmacies in UkraineUkraine

ZdravCity

  • Vancomycin Elfa por.
    ready r-ra d/inf. 1000 mg bottle Elfa Laboratories RUB 231 order
  • Vancomycin por. ready sol. for info. and for internal reception fl. 1 State Public Joint Stock Company Kraspharma

    RUB 276 order

  • Vancomycin powder for injection solution. 1gPJSC Kraspharma

    RUB 287 order

  • Vancomycin powder for injection solution. 500 mg PAO Kraspharma

    RUB 203 order

Pharmacy Dialogue

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Pharmacy24

  • Vancomycin-Vokate 500 mg No. 10 lyophilisate Anfarm Hellas S.A., Greece
    1985 UAH.order

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.

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