Vancorus - description of the drug, instructions for use, reviews

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Manufacturers: Synthesis

Active ingredients

• Vancomycin

Disease class

• Bacterial meningitis, not elsewhere classified
• Encephalitis, myelitis and encephalomyelitis
• Acute and subacute endocarditis
• Pneumonia without specifying the pathogen
• Local infection of skin and subcutaneous tissue, unspecified
• Pyogenic arthritis, unspecified
• Osteomyelitis
• Bone disease, unspecified
• Enterocolitis caused by Clostridium difficile
• Diarrhea and gastroenteritis of suspected infectious origin
• Septicemia, unspecified

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Antibacterial
• Bactericidal

Pharmacological group

• Glycopeptides

Indications for use

Vancorus is used to treat the following infectious and inflammatory diseases caused by microorganisms sensitive to vancomycin:

• lower respiratory tract infections (pneumonia, lung abscess);
• meningitis;
• sepsis;
• endocarditis;
• skin and soft tissue infections;
• infections of bones and joints, including osteomyelitis.

The solution is prescribed internally for diseases such as:

• enterocolitis caused by Staphylococcus aureus;
• pseudomembranous colitis caused by Clostridium difficile.

Directions for use and dosage

Intravenous administration

The solution is administered as a slow (at least 60 minutes) intravenous infusion at a rate of up to 10 mg/minute.

The injection solution is prepared immediately before administration: sterile water for injection is added to the bottle with the lyophilisate - 10 ml per dose of 500 mg, 20 ml per dose of 1000 mg. The concentration of the finished solution is 50 mg of vancomycin per 1 ml.

Before administration, the solution must be further diluted to a concentration of no more than 5 mg/ml.

As solvents, you can use a 0.9% sodium chloride solution or a 5% dextrose (glucose) solution: 100 ml for a dose of 500 mg, 200 ml for a dose of 1000 mg.

Recommended doses:

• newborns up to the 7th day of life - at the beginning of therapy, 15 mg/kg, then 10 mg/kg every 12 hours;
• children 2–4 weeks of age – 10 mg/kg every 8 hours;
• children from 1 month and older – 10 mg/kg every 6 hours;
• adults - 500 mg (7.5 mg/kg) every 6 hours or 1000 mg (15 mg/kg) every 12 hours.

If renal excretory function is impaired, the interval between administrations is increased or the dose of Vancorus is adjusted depending on creatinine clearance (CC, ml/minute).

Correction by increasing the intervals between administrations when prescribing a single dose of 1000 mg:

• CC > 80 ml/min – interval 12 hours;
• CC 50–80 ml/min – interval 1–3 days;
• CC 10–50 ml/min – interval 3–7 days;
• CC < 10 ml/min – interval 7–14 days.

Correction of a single dose of Vancorus:

• CC 100 ml/min – 1545 mg/day;
• CC 90 ml/min – 1390 mg/day;
• CC 80 ml/min – 1235 mg/day;
• CC 70 ml/min–1080 mg/day;
• CC 60 ml/min – 925 mg/day;
• CC 50 ml/min – 770 mg/day;
• CC 40 ml/min – 620 mg/day;
• CC 30 ml/min – 465 mg/day;
• CC 20 ml/min – 310 mg/day;
• CC 10 ml/min – 155 mg/day.

These dose adjustment recommendations cannot be followed in the presence of anuria. In such patients, the drug is prescribed at an initial dose of 15 mg/kg to quickly achieve therapeutic serum concentrations. Maintenance dose – 1.9 mg/kg per day.

In case of severe renal failure, it is advisable to use Vancorus in a maintenance dose of 250–1000 mg at intervals of several days.

For anuria, 1000 mg is usually prescribed every 7-14 days.

If only the serum creatinine concentration is known, the following formula is used to calculate clearance:

• for men: CC = body weight (kg) × [140 − age (years)]/ 72 × serum creatinine concentration (mg/dL);
• for women: the result should be multiplied by 0.85.

Oral administration

For pseudomembranous colitis caused by Clostridium difficile due to the use of antibiotics, as well as for staphylococcal enterocolitis, Vancorus is prescribed orally.

A solution for oral administration is prepared as follows: a single dose of the drug is dissolved in 30 ml of water. To improve the taste, it is possible to add food syrups. If it is impossible to take the drug orally, it is administered through a tube.

Recommended daily doses:

• adults – 500–2000 mg;
• children – 40 mg/kg.

The daily dose should be divided into 3-4 doses.

The highest daily dose for adults and children is 2000 mg.

Duration of therapy is 7–10 days.

Vancorus®

For intravenous (IV) infusion and oral administration.

The drug Vancorus® is administered only by intravenous drip!

The drug Vancorus® cannot be administered intramuscularly or intravenously as a bolus (bolus)!

When administered intravenously, the recommended concentration of vancomycin is no more than 5 mg/ml, the rate of administration is no more than 10 mg/min.

For adults and children over 12 years of age
with normal renal function,
the drug should be administered at a dose of 2.0 g per day (0.5 g every 6 hours or 1.0 g every 12 hours). Each dose should be administered at a rate of no more than 10 mg/min and over a period of at least 60 minutes. The maximum single dose is 1.0 g, the maximum daily dose is 2.0 g.

Children from 1 month to 12 years

the drug should be administered intravenously at a dose of 10 mg/kg every 6 hours. Each dose should be administered over at least 60 minutes. The recommended daily dose is 40 mg/kg.

For newborns

The initial dose is 15 mg/kg, then 10 mg/kg every 12 hours during the first week of life. Starting from the second week of life - every 8 hours until the age of 1 month. Each dose should be administered over at least 60 minutes. When prescribing to newborns, monitoring the concentration of vancomycin in the blood serum is desirable. The concentration of the prepared vancomycin solution should not exceed 5 mg/ml. The maximum single dose for newborns is 15 mg/kg body weight; the daily dose for a child should not exceed the daily dose for an adult (2.0 g).

Obese patients

the drug is prescribed in usual doses.

Patients with impaired renal function

it is necessary to select the dose individually. Creatinine clearance (CC) can be used to select the dose of vancomycin for this group of patients. Correction can be carried out by increasing the intervals between administrations, or reducing the single dose of the drug.

Dose adjustment by increasing the intervals between administrations

In elderly patients

vancomycin clearance is lower, the volume of distribution is larger. In this category of patients, it is advisable to select the dose based on the concentration of vancomycin in the blood plasma.

In premature infants and elderly patients

As a result of decreased renal function, a significant dose reduction may be required. Vancomycin plasma concentrations should be regularly monitored. The table below shows the doses of vancomycin depending on QC.

Vancomycin dose adjustment based on creatinine clearance

These calculations cannot be used to determine the dose of the drug for anuria. In such patients, vancomycin should be prescribed at an initial dose of 15 mg/kg body weight to quickly achieve therapeutic concentrations of the drug in the blood serum. The dose required to maintain a stable drug concentration is 1.9 mg/kg/day. For anuria, vancomycin is recommended to be administered 1.0 g every 7-10 days.

For patients with severe renal failure, it is advisable to adjust the dose by increasing the intervals between doses:

- with CC 10-50 ml/min - 1.0 g every 3-7 days.

- with CC <10 ml/min - 1.0 g every 7-14 days.

Based on the known concentration of creatinine in the blood serum, creatinine clearance is calculated using the formula:

for men

= body weight, kg x (140 - age, years) / [72 x serum creatinine concentration, mg/100 ml]

for women

= the result obtained is multiplied by 0.85.

Patients with liver failure

no dose adjustment required.

Hemodialysis patients

The initial dose is 20-25 mg/kg when using high permeability membranes. Maintenance doses are administered based on the residual concentration of the drug in the blood plasma and are adjusted to maintain a residual drug concentration of 15-20 mcg/ml. Vancomycin is effectively removed by hemodialysis using high-permeability membranes (such as polysulfone), but is poorly removed when using normal-permeability membranes.

Perioperative prevention of bacterial endocarditis in all age groups

: The recommended dose is an initial dose of 15 mg/kg before anesthesia. Depending on the length of the surgery, a second dose of vancomycin may be required.

Duration of therapy:

The duration of treatment depends on the type and severity of infection and individual clinical response.

The recommended duration of therapy is presented in the table below:

* Continue administration until the need for wound debridement has passed, until the patient's condition has clinically improved and there has been no fever for 48-72 hours.

**Longer courses of treatment with an oral drug should be considered for the treatment of prosthetic joint infections.

*** The duration and need for combination therapy depends on the type of valve and microorganism.

Rules for preparing a solution for intravenous administration

The solution for infusion is prepared immediately before administration of the drug. To do this, add the required volume of water for injection to a bottle with dry, sterile vancomycin powder: to obtain a solution with a concentration of 50 mg/ml, 0.5 g of vancomycin is diluted in 10 ml of water for injection or 1.0 g of vancomycin is diluted in 20 ml of water for injection . The solution prepared in this way can be stored at room temperature (up to 25 °C) for 24 hours or in the refrigerator at a temperature of 2 to 8 °C for 96 hours.

Further dilution of the prepared solution is required!

Prepared solutions of vancomycin must be further diluted before administration to a concentration of no more than 5 mg/ml. The required dose of the drug diluted in the above manner should be administered by divided intravenous infusions over at least 60 minutes. As solvents, you can use 5% dextrose (glucose) solution for injection or 0.9% sodium chloride solution for injection: for 0.5 g - 100 ml, for 1.0 g - 200 ml.

Before infusion, the prepared solution for parenteral administration should, if possible, be checked visually for the presence of mechanical impurities and color changes.

Preparation of oral solution and its use

Vancorus® can be used orally to treat pseudomembranous colitis caused by Clostridium difficile,

due to the use of antibiotics, as well as for the treatment of staphylococcal enterocolitis. Intravenous vancomycin has no benefit in treating these diseases.

The drug should be used in the following doses: adults 0.5-2.0 g 3-4 times a day, children 0.04 g/kg 3-4 times a day. The maximum daily dose should not exceed 2.0 g. The appropriate dose is prepared in 30 ml of water and given to the patient to drink or administered through a tube. To improve the taste of the solution, you can add regular food syrups to it. Duration of treatment is from 7 to 10 days.

Vancomycin is not effective when taken by mouth for other types of infections.

Side effects

• from the hematopoietic organs: transient thrombocytopenia, reversible neutropenia, agranulocytosis;
• from the gastrointestinal tract: nausea, pseudomembranous colitis;
• from the urinary system: interstitial nephritis, nephrotoxicity up to the development of renal failure [more often with long-term use (more than 3 weeks) in high doses or in combination with aminoglycosides; manifested by an increase in the concentration of creatinine and urea nitrogen in the blood];
• from the senses: ototoxicity – vertigo, hearing loss, ringing in the ears;
• allergic reactions: rash (including exfoliative dermatitis), chills, fever, eosinophilia, vasculitis, toxic epidermal necrolysis, malignant exudative erythema;
• local reactions (if infusion rules are violated): pain and tissue necrosis at the site of drug administration, phlebitis;
• post-infusion reactions (due to rapid administration): “red man” syndrome (hyperemia of the upper half of the body and face, rapid heartbeat, fever, chills, muscle spasms of the chest and back), anaphylactoid reactions (skin rash, itching, dyspnea, bronchospasm, decreased blood pressure, cardiac arrest).

Vancorus 1g For Injection

Release form: Lyophilisate for the preparation of solution for infusion

Packaging: 1 bottle

Pharmacological action: Vancomycin is a tricyclic glycopeptide antibiotic, produced by Amycolatopsis orientalis, has a bactericidal effect on most microorganisms (bacteriostatic on Enterococcus spp.). Blocks the synthesis of the bacterial cell wall in a site different from that affected by penicillins and cephalosporins (does not compete with them for binding sites), strongly binding to the D-alanyl-D-alanine part of the cell wall precursor, which leads to cell lysis. 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). Listeria monocytogenes, bacterial genera Lactobacillus spp., Actinomyces spp., Bacillus spp. are sensitive to vancomycin in vitro. The optimum action is at pH 8; when the pH decreases to 6, the effect decreases sharply. Actively affects only microorganisms that are in the stage of reproduction. Almost all gram-negative bacteria, Mycobacterium spp., fungi, viruses, and protozoa are resistant. Does not have cross-resistance with other antibiotics. When used orally, it has no systemic effect; it acts locally on sensitive microflora in the gastrointestinal tract (Staphylococcus aureus, Clostridium difficile).

Indications: Infectious and inflammatory diseases caused by microorganisms sensitive to vancomycin: - endocarditis; - sepsis; - meningitis; - lower respiratory tract infections (pneumonia, lung abscess); - infections of bones and joints (including osteomyelitis); - infections of the skin and soft tissues;

In the form of an oral solution: - pseudomembranous colitis caused by Clostridium difficile; — enterocolitis caused by Staphylococcus aureus.

Contraindications: Hypersensitivity to vancomycin, auditory neuritis, pregnancy (first trimester), lactation period.

With caution: Patients with impaired hearing, renal failure due to the possible development of ototoxic and nephrotoxic effects, patients with an allergy to teicoplanin (possibility of cross-allergy), pregnancy (II and III trimester).

Use during pregnancy and breastfeeding: During pregnancy (II-III trimester), the drug is prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus. Vancomycin is excreted in breast milk. Breastfeeding should be stopped while taking the drug.

Special instructions : Use in the II-III trimester of pregnancy is possible only “for health reasons”. The drug is intended for use only in a hospital setting. When using the drug in infants and premature newborns, the concentration of vancomycin in the blood plasma should be regularly monitored. The drug should be administered slowly by infusion (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 sites of drug administration. With long-term use of vancomycin, it is necessary to conduct an audiogram, monitor the peripheral blood picture, kidney function (general urine analysis, creatinine and urea nitrogen levels). It is advisable to determine vancomycin serum concentrations in patients with renal failure in patients over 60 years of age, since high, long-term concentrations of the drug in the blood may increase the risk of drug toxicity (maximum concentrations should not exceed 40 mcg/ml, and minimum concentrations should not exceed 10 mcg/ml). ml, concentrations above 80 µg/ml are considered toxic). For patients with renal failure, doses of vancomycin should be individualized.

Composition: Active substance - vancomycin hydrochloride (in terms of vancomycin) 1.0 g, containing mannitol (mannitol).

Method of administration and dosage: Vancorus is administered as a slow intravenous infusion at a rate of no more than 10 mg/min for at least 60 minutes. The concentration of the prepared vancomycin solution should not exceed 5 mg/ml. Adults - 0.5 g or 7.5 mg/kg every 6 hours or 1 g or 15 mg/kg every 12 hours. Children: newborns up to 7 days of life - initial dose of 15 mg/kg body weight, then - 10 mg/kg every 12 hours; starting from the second 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 adjustment of the dosage regimen taking into account the values ​​of creatinine clearance (CC).

Side effects: Post-infusion reactions (due to rapid administration): anaphylactoid reactions (low blood pressure, cardiac arrest, bronchospasm, dyspnea, skin rash, itching), “red man” syndrome associated with histamine release (chills, fever, rapid heartbeat, hyperemia upper half of the body and face, spasm of the muscles of the chest and back). From the urinary system: nephrotoxicity (up to the development of renal failure), more often when combined with aminoglycosides or when prescribed for more than 3 weeks in high concentrations, manifested by an increase in the concentration of creatinine and urea nitrogen; interstitial nephritis. From the gastrointestinal tract: nausea, pseudomembranous colitis. From the senses: ototoxicity – hearing loss, vertigo, tinnitus. From the hematopoietic organs: reversible neutropenia, transient thrombocytopenia, agranulocytosis. Allergic reactions: fever, chills, eosinophilia, rash (including exfoliative dermatitis), erythema malignant exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), vasculitis. Local reactions (if the infusion rules are violated): pain and tissue necrosis at the injection sites, phlebitis.

Drug interactions: With simultaneous intravenous administration of vancomycin and local anesthetics, erythematous rashes and hyperemia of the skin of the face may appear; in adults, intracardiac conduction disturbances may occur. With simultaneous and/or sequential systemic or local use of other potentially ototoxic and/or nephrotoxic drugs (aminoglycosides, amphotericin B, aminosalicylic acid or other salicylates, capreomycin, carmustine, cyclosporine, loop diuretics, including ethacrynic acid, polymyxin B, cisplatin) requires careful monitoring of the possible development of these symptoms. Cholestyramine reduces the activity of vancomycin when taken orally. Antihistamines, meclozine, phenothiazines, thioxanthenes can mask the symptoms of vancomycin ototoxicity (tinnitus, vertigo). Vancomycin solution has a low pH, which may cause physical or chemical instability when mixed with other solutions. Mixing with alkaline solutions should be avoided. Solutions of vancomycin and beta-lactam antibiotics are physically incompatible when mixed. The likelihood of precipitation increases with increasing concentrations of vancomycin. The intravenous system should be adequately flushed between uses of these antibiotics. In addition, it is recommended to reduce vancomycin concentrations to 5 mg/ml or less.

Overdose: Symptoms: increased severity of side effects from the urinary system and sensory organs. Treatment: Carry out symptomatic therapy. Fluid administration and monitoring of vancomycin plasma concentrations is recommended. To quickly remove excess vancomycin from the body, hemofiltration is more effective than hemodialysis.

Storage conditions: In a dry place, protected from light, at a temperature not exceeding 25 ° C.

Shelf life: 2 years.

Conditions for dispensing from pharmacies: Dispensed with a doctor's prescription

special instructions

The drug should only be used in a hospital setting.

Vancorus cannot be administered intravenously or intramuscularly.

The incidence and severity of thrombophlebitis can be reduced by properly diluting the original solution and alternating the sites of drug administration.

During long-term treatment, monitoring of renal function (general urinalysis, creatinine and blood urea nitrogen levels), monitoring of peripheral blood patterns, and an audiogram are indicated.

In infants and premature infants, the concentration of vancomycin in the blood plasma must be constantly monitored during treatment.

Serum levels of the drug should be monitored in patients over 60 years of age with renal failure, since this category of patients is at high risk of developing toxic effects of the drug.

Drug interactions

Vancomycin has a low pH, which may cause physical or chemical instability when mixed with other solutions. The drug should not be mixed with alkaline solutions.

Vancorus is physically incompatible with beta-lactam antibiotics. Between uses of these antibiotics and vancomycin, the intravenous system should be thoroughly flushed because the likelihood of precipitation increases with increasing concentrations of vancomycin.

Meclozine, phenothiazines, antihistamines, and thioxanthenes may mask symptoms of vancomycin ototoxicity (vertigo and tinnitus).

With simultaneous and/or sequential use (both systemic and local) of other potentially nephrotoxic and/or ototoxic drugs, the patient's condition must be carefully monitored for the development of these symptoms. This includes, but is not limited to, the following drugs: aminosalicylic acid or other salicylates, cyclosporine, capreomycin, aminoglycosides, carmustine, amphotericin B, loop diuretics, including ethacrynic acid, cisplatin, polymyxin B.

Cholestyramine reduces the effectiveness of vancomycin when taken orally.

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Vancorus, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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