Expiration date: 09/2025

Group affiliation: The antibiotic, glycopeptide

Description of the active substance (INN): vancomycin

Dosage Form: lyophilisate for solution for infusion

Composition:

lyophilisate  for solution 500 or 1000 mg vial

Pharmachologic effect:

The antibacterial agent, produced by Amycolatopsis orientalis, bactericidal effect on most of the microorganisms (in enterococci - bacteriostatic). Blocks the synthesis of the bacterial cell wall at a site different from that at wh ich are penicillins and cephalosporins (not compete with them for binding sites), firmly contacting the D-alanyl-D-alanine precursor part of the cell wall, which leads to cell lysis. Able also change the permeability of cell membranes of bacteria and selectively inhibit the synthesis of RNA. Active against gram-positive organisms: Staphylococcus spp. (Including methicillin-resistant strains and penitsillinazoobrazuyuschie), Streptococcus spp., Streptococcus pneumoniae (including strains resistant to penicillin), Corynebacterium spp., Enterococcus spp., Clostridium spp., Actinomyces spp. Optimum action - at pH 8, with a decrease in pH to 6 effect decreases sharply. It is active only on microorganisms which are in the stage of reproduction. Resistant almost all Gram-negative bacteria, Mycobacterium spp., Fungi, viruses, protozoa. It does not cross-resistant to others. Antibiotics.

Testimony:

Sepsis, endocarditis, pneumonia, lung abscess, bone and joint infections (including osteomyelitis), meningitis, pseudomembranous colitis (not associated with the use of antibiotics), caused by Clostridium difficile, enterocolitis, infections of the skin.

Contraindications:

Hypersensitivity, pregnancy (I trimester), lactation, neuritis of the auditory nerva.C caution. Hearing impairment (including history), renal failure, pregnancy (II-III trimesters).

Side effects:

Postinfuzionnye reaction (due to the rapid introduction): anaphylactoid reactions (lowering blood pressure, bronchospasm, dyspnea, skin rash, itching), the syndrome of "red man", associated with the release of histamine (chills, fever, heart palpitations, flushing of the upper body and face, spasm muscles of the chest and back). From the urinary system: renal toxicity (up to the development of renal failure) usually when combined with aminoglycosides or the appointment of more than 3 weeks in high concentrations, is manifested by increased serum creatinine and urea nitrogen concentrations. Rarely - interstitial nephritis. On the part of the digestive system: nausea, pseudomembranous colitis. From the senses: ototoxicity - hearing loss, vertigo, ringing in the ears. From the side of hematopoiesis: reversible neutropenia, transient thrombocytopenia, rarely - agranulocytosis. Local reactions (in violation of the rules of the infusion): phlebitis, injection site pain, tissue necrosis at the injection site. Allergic reactions: fever, nausea, chills, eosinophilia, rashes (including exfoliative dermatitis), malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), vasculitis.

Overdose:

Symptoms: increased severity of side effects. Treatment: symptoms, coupled with and hemoperfusion hemofiltration.

Dosage and administration:

Only I / (V / m painful injection) at a rate not exceeding 10 mg / min infusion duration should not be less than 60 minutes. Adults - 0.5 g or 7.5 mg / kg every 6 hours or 1 g or 15 mg / kg every 12 hours Newborn children -. 15 mg / kg followed by 10 mg / kg every 12 hours and children aged 1 month used the same dose every 8 hours for children older than 1 month -. 10 mg / kg every 6 hours or 20 mg / kg every 12 hours in patients with impaired renal excretory function of the initial dose -. 15 mg / kg, followed by mode correcting given dosing CC values ??(in uremia interval between injections - up to 10 days): QA 80 ml / min - the usual dose QA 50-80 ml / min - 1 g every 1-3 days, 10-50 ml / min - 1 g every 3-7 days, less than 10 ml / min - 1 g every 7-14 days. Creatinine clearance can be calculated according to the formula for men: body weight (kg) * (140 - age (years) / 72 * the concentration of serum creatinine (mg / dL) for women - the result is multiplied by 0.85 powder is dissolved in water for. injection:. 500 mg - 10 ml, 1 g - 20 ml (solution concentration of 50 mg / mL) The resulting solution was diluted with 0.9% solution of NaCl or 5% dextrose solution: to 500 mg - 100 ml for 1 g - 200 . When pseudomembranous colitis ml - inside, as a solution in 30 ml of water: adults - 0.5-2 times 3.4 g, children - 0.04 g / kg 3-4 times the duration of the treatment - 10.7 days..

Special instructions:

Application in II-III trimester of pregnancy is possible only by "real life" testimony. In appointing premature and normal newborns desirable control of the concentration in the blood serum. At simultaneous reception with general anesthetics increase the frequency of side effects, so better to vancomycin administered prior to general anesthesia. The treatment period is necessary to conduct the audiogram, the determination of renal function (urinalysis, creatinine and urea nitrogen). It is advisable to determine the concentration of vancomycin in the blood serum (in renal failure, in patients older than 60 years). The maximum concentration should not exceed 40 mg / mL, and the minimum - 10 mcg / mL. Concentrations above 80 mg / ml are considered toxic.

Interaction:

When concomitant administration of local anesthetics in children may appear erythematous rash and flushing of the skin face, in adults - a violation of intracardiac conduction. Not recommended simultaneous appointment with nephrotoxicity and ototoxic drugs (aminoglycosides, amphotericin B, ASA or others. Salicylates, bacitracin, bumetanide, capreomycin, carmustine, paromomycin, cyclosporine, "loop" diuretics, polymyxin B, cisplatin, ethacrynic acid). Cholestyramine reduces efficiency. Antihistamine drugs meklozin, phenothiazines, thioxanthenes may mask symptoms Valium actions vancomycin (tinnitus, vertigo). General anesthetics and vecuronium bromide - risk reduction in blood pressure or development of neuromuscular blockade. Infusion of vancomycin can be at least 60 minutes before their introduction.