Universal reference book for medicines
Product name: VANCORUS ® (VANCORUS)

Active substance: vancomycin

Type: Antibiotic of the glycopeptide group

Manufacturer: SYNTHESIS (Russia)
Composition, form of production and packaging
Liofilizate for the preparation of a solution for infusions in the form of white to white powder with a pink or light brown hue.
1 f.
vancomycin (in the form of hydrochloride) 500 mg
Excipients: mannitol - 0.02 g.
Vials with a capacity of 10 ml (1) - packs of cardboard.
Vials with a capacity of 10 ml (50) - cardboard boxes.
Liofilizate for the preparation of a solution for infusions in the form of white to white powder with a pink or light brown hue.
1 f.
vancomycin (in the form of hydrochloride) 1 g
Excipients: mannitol - 0.04 g.
Vials with a capacity of 20 ml (1) - packs of cardboard.
Vials with a capacity of 20 ml (50) - carton boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Antibiotic is a glycopeptide. Amycolatopsis orientalis is produced.
It acts bactericidal on most sensitive microorganisms (on Enterococcus spp. - bacteriostatic). It blocks the synthesis of the bacterial cell wall in a region different from that of penicillins and cephalosporins (does not compete with them for binding sites), firmly binding to the D-alanyl-D-alanine part of the cell wall precursor, which leads to lysis of the bacterial cell.
It is active against Gram-positive microorganisms, including: Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains), Streptococcus spp., Enterococcus spp. (including Enterococcus faecalis), Clostridium spp. (including Clostridium difficile).
Vancomycin in vitro is sensitive to Listeria monocytogenes, Lactobacillus spp., Actinomyces spp., Bacillus spp.
Optimal action - at pH 8, with a decrease in pH to 6, the effect of vancomycin decreases dramatically.
Actively acts only on microorganisms, which are in the stage of reproduction.
Vancomycin is resistant to almost all Gram-negative bacteria, Mycobacterium spp., Fungi, viruses, protozoa.
Has no cross-resistance with antibiotics of other groups.
When administered orally, it has no systemic effect, acts locally on the sensitive microflora in the digestive tract (Staphylococcus aureus, Clostridium difficile).
PHARMACOKINETICS
Suction and distribution
C max after IV infusion 500 mg - 49 mcg / ml after 30 min and 20 mcg / ml after 1-2 h; after intravenous infusion of 1 g - 63 mcg / ml after 60 min and 23-30 mcg / ml after 1-2 h.
Binding to plasma proteins - 55%.
Widely distributed in most tissues and body fluids. Therapeutic concentrations are determined in ascites, synovial, pleural, pericardial and peritoneal fluids, in the urine, atrial auricle tissue. Does not penetrate intact GEB (when meningitis is detected in the cerebrospinal fluid in therapeutic concentrations).
Vancomycin penetrates the placenta. Excreted in breast milk.
With repeated introduction, cumulation is possible.
When ingestion is poorly absorbed and usually does not enter the systemic circulation. Determined plasma concentrations of vancomycin may be noted in isolated cases with repeated ingestion in patients with acute pseudomembranous colitis caused by Clostridium difficile.
Metabolism
Vancomycin is practically not metabolized in the body.
Excretion
T 1/2 with normal kidney function: adults - about 6 hours (4-11 hours), newborns - 6-10 hours, infants - 4 hours, children of older age - 2-3 hours.
75-90% of the drug is excreted by the kidneys by passive filtration in the first 24 hours.
In small and moderate amounts, vancomycin can be excreted with bile. In small amounts, it is excreted in hemodialysis or peritoneal dialysis.
Pharmacokinetics in special clinical cases
T 1/2 for chronic renal failure (oliguria or anuria) in adults - 6-10 days.
Patients with one kidney are slowly withdrawn and the removal mechanism is unknown.
INDICATIONS
Infectious-inflammatory diseases caused by microorganisms sensitive to vancomycin:
- endocarditis;
- sepsis;
- meningitis;
- Infections of the lower respiratory tract (pneumonia, lung abscess);
- infections of bones and joints (including osteomyelitis);
- infections of the skin and soft tissues.
In the form of a solution for oral administration:
- pseudomembranous colitis caused by Clostridium difficile;
- Enterocolitis caused by Staphylococcus aureus.
DOSING MODE
Vancomycin is administered as a slow intravenous infusion at a rate of no more than 10 mg / min for at least 60 minutes.
The drug should not be given in / m or intravenously.
The concentration of the prepared solution of vancomycin should not exceed 5 mg / ml.
Adults - 0.5 g (7.5 mg / kg) every 6 hours or 1 g (15 mg / kg) every 12 hours.
Children: newborns up to 7 days of life - the initial dose of 15 mg / kg body weight, then - 10 mg / kg every 12 hours; starting from the 2nd week of life - 10 mg / kg every 8 hours; children from 1 month and older - 10 mg / kg every 6 hours.
Patients with impaired renal excretory function require correction of the dosing regimen taking into account the values ​​of creatinine clearance (CK).
Correction can be carried out by increasing the intervals between administrations, or by reducing the single dose of the drug:
Correction by increasing the intervals between administrations
KK (ml / min) Vancomycin Dose Interval between administrations
more than 80 1 g 12 h
80-50 1 g 1-3 days
50-10 1 g 3-7 days
less than 10 1 g 7-14 days
Single dose adjustment
CK (ml / min) Vancomycin dose (mg / day)
100 1545
90 1390
80 1235
70 1080
60,925
50,770
40,620
30,465
20 310
10 155
This table can not be used to determine the dose of the drug in anuria. Such patients should be given an initial dose of 15 mg / kg body weight to quickly create therapeutic concentrations of the drug in the serum. The dose required to maintain a stable drug concentration is 1.9 mg / kg / day.
Patients with severe renal failure should be administered maintenance doses of 250-1000 mg once every few days.
With anuria , a dose of 1 g is recommended every 7-14 days.
When only the concentration of serum creatinine is known, the following formula can be used to calculate the creatinine clearance:
For men:
KK = body weight (kg)? (140 - age (years)) / 72? serum creatinine concentration (mg / dL).
For women: the result is multiplied by 0.85.
Preparation of solution for intravenous administration
Solution for injection is prepared immediately before the administration of the drug. To do this, 10 ml is added to the bottle with a dry, sterile drug of 0.5 g dosage, with a dosage of 1 g - 20 ml of sterile water for injection (concentration of the solution is 50 mg / ml).
Prepared solutions of vancomycin before administration are subject to further dilution to a concentration of not more than 5 mg / ml. The required dose of vancomycin diluted in the above manner should be administered by intravenous infusion for at least 60 minutes. As solvents, a 5% solution of dextrose (glucose) for injection or 0.9% solution of sodium chloride for injection can be used: for 0.5 g - 100 ml and for 1 g - 200 ml.
Before injection, the prepared parenteral solution should be visually inspected, if possible, for mechanical impurities and discoloration.
Solutions prepared on the basis of 5% dextrose (glucose) solution or 0.9% sodium chloride solution can be stored in the refrigerator (2-8 ° C) for 14 days without significant loss of activity.
Preparation of solution for oral administration and its use
For the treatment of pseudomembranous colitis caused by Clostridium difficile, due to the use of antibiotics, as well as for the treatment of staphylococcal enterocolitis , Vancorus ® is administered orally.
The daily dose for adults is 0.5-2 g, divided into 3-4 doses.
The daily dose for children is 40 mg / kg, divided into 3-4 doses.
The maximum daily intake for adults and children is 2 g.
The corresponding single dose is dissolved in 30 ml of water and the patient is given a drink or injected through a probe. To improve the taste of the solution, ordinary food syrups can be added to it. The duration of treatment is 7-10 days.
SIDE EFFECT
Post-fusion reactions (due to rapid administration): anaphylactoid reactions (decreased blood pressure, cardiac arrest, bronchospasm, dyspnoea, skin rash, itching); red man syndrome associated with the release of histamine (chills, fever, heart palpitations, hyperemia of the upper half of the trunk and face, spasm of the muscles of the chest and back).
From the side of the urinary system: nephrotoxicity (up to the development of renal failure) more often when combined with aminoglycosides or when administered for more than 3 weeks in high concentrations, manifested by increased concentrations of creatinine and urea nitrogen in the blood; interstitial nephritis.
On the part of the digestive system: nausea, pseudomembranous colitis.
From the sense organs: ototoxicity - hearing loss, vertigo, ringing in the ears.
On the part of the organs of hematopoiesis: reversible neutropenia, transient thrombocytopenia, agranulocytosis.
Allergic reactions: fever, chills, eosinophilia, rash (including exfoliative dermatitis), malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), vasculitis.
Local reactions (in violation of infusion rules): pain and necrosis of tissues at injection sites, phlebitis.
CONTRAINDICATIONS
- neuritis of the auditory nerve;
- I trimester of pregnancy;
- the period of lactation (breastfeeding);
- Hypersensitivity to vancomycin.
Caution should be applied to patients with impaired hearing, kidney failure due to the possible development of ototoxic and nephrotoxic effects, patients with allergies to teicoplanin (the possibility of cross-allergy), pregnancy (II and III trimester).
PREGNANCY AND LACTATION
In pregnancy (II and III trimester), the drug is prescribed only if the intended benefit to the mother exceeds the potential risk to the fetus and only to lifelong indications.
Vancomycin is excreted in breast milk. For the period of treatment the drug should stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with impaired renal excretory function require correction of the dosing regimen taking into account the values ​​of creatinine clearance (CK).
Correction can be carried out by increasing the intervals between administrations, or by reducing the single dose of the drug:
Correction by increasing the intervals between administrations
KK (ml / min) Vancomycin Dose Interval between administrations
more than 80 1 g 12 h
80-50 1 g 1-3 days
50-10 1 g 3-7 days
less than 10 1 g 7-14 days
Single dose adjustment
CK (ml / min) Vancomycin dose (mg / day)
100 1545
90 1390
80 1235
70 1080
60,925
50,770
40,620
30,465
20 310
10 155
This table can not be used to determine the dose of the drug in anuria. Such patients should be given an initial dose of 15 mg / kg body weight to quickly create therapeutic concentrations of the drug in the serum. The dose required to maintain a stable drug concentration is 1.9 mg / kg / day.
Patients with severe renal failure should be administered maintenance doses of 250-1000 mg once every few days.
With anuria , a dose of 1 g is recommended every 7-14 days.
When only the concentration of serum creatinine is known, the following formula can be used to calculate the creatinine clearance:
For men:
KK = body weight (kg) x (140 - age (years)),
72 x serum creatinine concentration (mg / dL).
For women: the result is multiplied by 0.85.
APPLICATION FOR CHILDREN
When using the drug in infants and preterm infants, the concentration of vancomycin in the blood plasma should be monitored regularly.
APPLICATION IN ELDERLY PATIENTS
It is desirable to determine the concentration of vancomycin in the serum in patients with renal insufficiency in patients older than 60 years, since high, persistent concentrations of the drug in the blood can increase the risk of toxic effects of the drug (maximum concentrations should not exceed 40 μg / ml, and minimal - 10 μg / ml, concentrations above 80 μg / ml are considered toxic). For patients with renal insufficiency, doses of vancomycin should be selected individually.
SPECIAL INSTRUCTIONS
The drug is intended for use only in a hospital.
When using the drug in infants and preterm infants, the concentration of vancomycin in the blood plasma should be monitored regularly.
The drug should be infusion slowly (at least 60 minutes). Rapid administration (eg, within a few minutes) of vancomycin may be accompanied by a marked decrease in blood pressure and, in rare cases, cardiac arrest.
The incidence and severity of thrombophlebitis can be reduced by properly diluting the original solution and alternating the injection site.
With prolonged use of vancomycin, an audiogram should be performed, the peripheral blood picture should be monitored, kidney function (general urine analysis, creatinine and blood urea nitrogen measurements).
It is desirable to determine the concentrations of vancomycin in the serum in patients with renal insufficiency in patients older than 60 years, since high, long-term concentrations of vancomycin in the blood may increase the risk of toxic effects of the drug (maximum concentrations should not exceed 40 μg / ml, and minimal - 10 μg / ml, concentrations above 80 μg / ml are considered toxic). For patients with renal insufficiency, doses of vancomycin should be selected individually.
OVERDOSE
Symptoms: increased severity of side effects from the urinary and sensory systems.
Treatment: conduct symptomatic therapy. It is recommended to administer the liquid and monitor the plasma concentrations of vancomycin. To quickly remove excess vancomycin from the body, hemofiltration is more effective than hemodialysis.
DRUG INTERACTION
With simultaneous intravenous administration of vancomycin and local anesthetics, erythematous rashes and hyperemia of the skin of the face may appear, and in adults - violation of intracardiac conduction.
With simultaneous and / or sequential systemic or topical application of other potentially ototoxic and / or nephrotoxic drugs (aminoglycosides, amphotericin B, aminosalicylic acid or other salicylates, capreomycin, carmustine, cyclosporine, loop diuretics, including ethacrylic acid, polymyxin B, cisplatin) requires careful monitoring of the possible development of these symptoms.
Kolestiramin reduces the activity of vancomycin when it is ingested.
Antihistamines, meclosin, phenothiazines, thioxanthenes can mask the symptoms of the ototoxic action of vancomycin (tinnitus, vertigo).
Pharmaceutical interaction
The solution of vancomycin has a low pH, which can cause physical or chemical instability when mixed with other solutions. Avoid mixing with alkaline solutions.
Solutions of vancomycin and beta-lactam antibiotics are physically incompatible when mixed.
The probability of precipitation increases with increasing concentration of vancomycin. It is necessary to adequately rinse the IV in the system between the applications of these antibiotics. In addition, it is recommended to reduce the concentration of vancomycin to 5 mg / ml or less.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C. Shelf life - 2 years.
Solutions prepared on the basis of 5% dextrose (glucose) solution or 0.9% sodium chloride solution can be stored in the refrigerator (2-8 ° C) for 14 days without significant loss of activity.
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