Edicin ,1 g x 1 powder for solution for infusion
1 vial contains: 1000 mg vancomycin hydrochloride
Indications for use:
Sepsis, endocarditis, pneumonia, lung abscess, bone and joint infections (including osteomyelitis), meningitis, pseudomembranous colitis caused by Clostridium difficile, enterocolitis, skin infections.
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In individuals with normal renal function, multiple IV infusions of 1 g of vancomycin (15 mg / kg) (infusion over 60 minutes) created average plasma concentrations of about 63 mg / l immediately after completion of the infusion; 2 hours after the infusion, the average plasma concentration is about 23 mg / L, and 11 hours after the infusion it is about 8 mg / L. Multiple infusions of 500 mg (administration over 30 min) created an average plasma concentration of about 49 mg / L after completion of the infusion; 2 hours after infusion, the average plasma concentration is about 19 mg / L, and after 6 hours - about 10 mg / L. Concentrations in plasma with repeated administration are similar to plasma concentrations in single administration.
The average plasma T1 / 2 of vancomycin is 4–6 hours in patients with normal renal function. About 75% of the administered dose of vancomycin is excreted in the urine due to glomerular filtration in the first 24 hours. The average Cl from plasma is about 0.058 l / kg / h, and the average renal Cl is about 0.048 l / kg / h. The renal clearance of vancomycin is quite constant and ensures its excretion by 70–80%. The volume of distribution ranges from 0.3 to 0.43 l / kg. The drug is practically not metabolized. As shown by ultrafiltration, when the concentration of vancomycin in serum is from 10 to 100 mg / l, 55% of vancomycin is found in a protein-bound state.
After iv administration of vancomycin, hydrochloride is found in pleural, pericardial, ascitic, synovial fluids and in the tissue of the atrial ear, as well as in urine and peritoneal fluid in concentrations that inhibit the growth of microorganisms. Vancomycin slowly penetrates into the cerebrospinal fluid. With meningitis, the drug penetrates into the cerebrospinal fluid. Vancomycin passes through the placental barrier and into breast milk.
Impaired renal function slows the elimination of vancomycin. In patients with missing kidneys, the average T1 / 2 is 7.5 days. The total systemic and renal clearance of vancomycin can be reduced in elderly patients as a result of the natural slowdown of glomerular filtration.
The bactericidal effect of vancomycin is manifested as a result of inhibition of cell wall biosynthesis. In addition, vancomycin can alter the permeability of the bacterial cell membrane and alter RNA synthesis. There is no cross-resistance between vancomycin and other classes of antibiotics.
In vitro, vancomycin is active against gram-positive microorganisms, including: Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains), Streptococcus pyogenes, Streptococcus pneumoniae, penicillin-resistant, Streptococcus bacillus, Streptococcus bacillus, Streptococcus enterococci (e.g. Enterococcus faecalis); Clostridium difficile (for example, toxigenic strains involved in the development of pseudomembranous enterocolitis) and dipteroids. Other microorganisms that are sensitive to in vitro vancomycin are: Listeria monocytogenes, the bacterial genera Lactobacillus, Actinomyces, Clostridium, and Bacillus.
In vitro, some isolated strains of enterococci and staphylococci are resistant to vancomycin. Vancomycin and aminoglycosides act as synergists in vitro against many strains of Staphylococcus aureus, non streptococcus streptococci, enterococci and bacteria of the Streptococcus group (viridans group).
Vancomycin is inactive in vitro against gram-negative microorganisms, mycobacteria and fungi.
Hypersensitivity, lactation, auditory nerve neuritis.
The body as a whole: anaphylactoid reactions.
Cardiovascular system: cardiac arrest, hot flashes, decreased blood pressure, shock (these symptoms are mainly associated with rapid infusion of the drug).
Gastrointestinal tract: nausea, pseudomembranous colitis.
Blood system: agranulocytosis, eosinophilia, neutropenia, thrombocytopenia.
Effect on the kidneys: interstitial nephritis, changes in functional renal tests, impaired renal function.
Skin: exfoliative dermatitis, hypersensitivity reactions, benign (IgA) vesiculate dermatosis, pruritic dermatosis, rash, "red man" syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, vasculitis.
Sense organs: vertigo, tinnitus, ototoxic effects.
In a number of patients receiving vancomycin, an ototoxic effect was observed. It may be transient or permanent. It is reported that most of these cases were observed among patients who received excessive doses of vancomycin, with a history of hearing loss, or in patients who received simultaneous treatment with other drugs with the possible development of ototoxicity, for example, aminoglycosides.
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