Composition, form of production and packaging
Lyophilizate for the preparation of a solution for infusions in the form of white or almost white lyophilized powder.
1 f.
vancomycin (in the form of hydrochloride) 500 mg (500,000 IU)
Vials (1) - packs of cardboard.
Lyophilizate for the preparation of a solution for infusions in the form of white or almost white lyophilized powder.
1 f.
vancomycin (in the form of hydrochloride) 1 g (1 000 000 IU)
Vials (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Tricyclic antibiotic from the glycopeptide group (isolated from Amycolatopsis orientalis). The drug has a bactericidal effect. Inhibits the synthesis of the bacterial cell wall, increases its permeability, changes the synthesis of RNA.
It is active against gram-positive microorganisms: Staphylococcus spp. (including Staphylococcus aureus and Staphylococcus epidermidis, including methicillin-resistant strains), Streptococcus spp. (including Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus pneumoniae, including strains resistant to penicillin), Enterococcus spp. (including Enterococcus faecalis), Listeria spp., Corynebacterium diphtheriae, Clostridium spp., Actinomyces spp.
Vancomycin in vitro is inactive against gram-negative microorganisms, fungi, mycobacteria.
There is no cross-resistance between vancomycin and other antibiotics. The development of resistance of staphylococci during therapy is rare.
The MIC value for most antibiotic-sensitive microorganisms is less than 5 Ојg / ml, the MIC value for tolerant Staphylococcus aureus within 10 Ојg / ml is 20 Ојg / ml.
PHARMACOKINETICS
Suction
Poorly absorbed from the digestive tract.
With iv injection of 500 mg of vancomycin, the average plasma concentration is about 33 Ојg / ml 1 h after the administration, with iv administration of vancomycin at a dose of 1 g, the average plasma concentration is 2 times higher. C max in blood plasma is achieved 1 hour after infusion and is 20-50 Ојg / ml. 12 hours after the infusion, the concentration of vancomycin is 5-10 Ојg / ml.
Distribution
Vancomycin easily penetrates into the body fluids (pleural, synovial, pericardial, ascites fluid). Through the BBB penetrates well only with inflamed meninges.
Excretion
75-90% of the drug is excreted by the kidneys through glomerular filtration, from 40 to 100% of the administered dose - in unchanged form. In a small amount is excreted with bile. T 1/2 is 4.7-11.2 hours.
In small amounts, it is excreted in hemodialysis or peritoneal dialysis.
Pharmacokinetics in special clinical cases
With violations of the kidney function, the elimination of vancomycin slows down.
INDICATIONS
Infectious-inflammatory diseases caused by microorganisms sensitive to vancomycin:
- endocarditis;
- sepsis;
- infections of bones and joints (including osteomyelitis);
- CNS infections (including meningitis);
- Infections of the lower respiratory tract (pneumonia);
- skin and soft tissue infections;
- in cases of allergy to penicillin, intolerance or lack of response to treatment with other antibiotics, including penicillins or cephalosporins.
For oral administration
- Staphylococcal enterocolitis;
- pseudomembranous colitis.
DOSING MODE
Edicyin can not be administered in / m and / in bolus.
Adults prescribe 500 mg every 6 hours or 1 g every 12 hours. The drug is administered as a slow intravenous infusion at a rate of not more than 10 mg / min for 60 minutes or more. The concentration of the prepared solution of vancomycin should not exceed 5 mg / ml.
Newborns up to 7 days of life - the initial dose of 15 mg / kg body weight, then - 10 mg / kg every 12 hours.
Children up to 1 month - 10 mg / kg every 8 hours.
Children from 1 month and older receive the drug at a daily dose of 40 mg / kg, divided into single injections, every 6 hours.
Infusion is carried out for 60 minutes or more. The concentration of the prepared solution of vancomycin should not exceed 2.5-5 mg / ml.
The maximum single dose for children is 15 mg / kg of body weight, the maximum daily dose is 60 mg / kg of body weight and should not be higher than the daily dose for adults (2 g).
In renal failure, the dose and / or interval between administrations should be adjusted according to the degree of renal failure. The initial dose is 15 mg / kg body weight, then the interval between administrations is determined in accordance with QC.
Creatinine clearance (ml / min) Vancomycin Dose Interval between administrations
more than 80 500 mg or 1 g of 12 h
80-50 1 g 24 h
50-10 1 g 3-7 days
less than 10 (anuria) 1 g 7-14 days
Older patients (over 60 years of age), infants and premature newborns require a dose reduction or an increase in the interval between administrations, as well as regular monitoring of plasma concentrations of vancomycin.
Rules for the preparation of a solution for intravenous administration
Dilute 500 mg of the contents of the vial into 10 ml of sterile water for injection or 1 g of the contents in 20 ml of sterile water for injection to obtain a solution concentration of 50 mg / ml.
The resulting solution is to be further diluted with a 5% solution of glucose for injection or 0.9% solution of sodium chloride for injection to a concentration of not more than 5 mg / ml. A solution containing 500 mg of vancomycin is diluted in 100 ml of an infusion solution; a solution containing 1 g of vancomycin is diluted in 200 ml of an infusion solution.
Solutions prepared based on 0.9% sodium chloride or 5% glucose can be stored in the refrigerator (2-8 В° C) for 14 days without significant loss of activity.
Solutions prepared on the basis of the following infusion liquids can be stored in the refrigerator for 96 h: 5% glucose solution and 0.9% sodium chloride solution, Ringer's lactate solution, Ringer's acetate solution, Ringer's lactate solution and 5% glucose solution.
Vancomycin is poorly absorbed after ingestion, so it can be administered orally only for the treatment of staphylococcal enterocolitis and pseudomembranous colitis caused by Clostridium difficile.
Oral administration
Adults daily dose is 0.5-1 g, children daily dose is set at the rate of 40 mg / kg body weight. Multiplicity of admission 3-4 times / day. The duration of treatment is 7-10 days. The maximum daily dose should not exceed 2 g.
Rules for the preparation of oral solution
Before taking the contents of the vial (500 mg), dissolve in 30 ml of water and then taken or injected through a naso-gastric tube. To improve the taste of the solution, it is possible to add usual food syrups and perfumes.
SIDE EFFECT
On the part of the digestive system: nausea, vomiting, diarrhea (severe diarrhea can be a sign of superinfection with resistant microorganisms or the development of pseudomembranous colitis).
From the hemopoietic system: reversible neutropenia, leukopenia, eosinophilia, thrombocytopenia; rarely - agranulocytosis.
From the urinary system: nephrotoxicity, manifested in increased plasma concentrations of creatinine and urea nitrogen (up to renal insufficiency - in the case of taking large doses of vancomycin); rarely - interstitial nephritis (in patients taking aminoglycoside antibiotics simultaneously, and in case of a history of renal dysfunction). With the abolition of vancomycin, renal function normalized and azotemia disappeared in most patients.
From the side of the central nervous system: vertigo, hearing loss.
Local reactions: for violations of infusion rules - thrombophlebitis, necrosis of tissues at the site of administration.
Allergic reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, vasculitis, skin rash.
As a result of rapid administration of the drug, postinfusion reactions may occur: anaphylactoid reactions (decreased blood pressure, dizziness, palpitations, bronchospasm, fever), skin rash, red man syndrome (hyperemia of the upper body), muscle spasms in the neck and back. After cessation of the infusion, such reactions may disappear within 20 minutes, but sometimes persist for several hours.
CONTRAINDICATIONS
- Hypersensitivity to vancomycin.
With caution should be used in patients with impaired hearing, kidney failure due to the possible development of ototoxic and nephrotoxic effects.
PREGNANCY AND LACTATION
In pregnancy, Edicin is prescribed only if the intended benefit to the mother exceeds the potential risk to the fetus.
Vancomycin is excreted in breast milk. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped for the period of taking the drug.
APPLICATION FOR FUNCTIONS OF THE LIVER
In renal failure, the dose and / or interval between administrations should be adjusted depending on the degree of renal failure. The initial dose is 15 mg / kg body weight, then the interval between administrations is determined in accordance with the creatinine clearance.
Creatinine clearance (ml / min) Vancomycin Dose Interval between administrations
more than 80 500 mg or 1 g of 12 h
80-50 1 g 24 h
50-10 1 g 3-7 days
less than 10 (anuria) 1 g 7-14 days
In view of the possible development of nephrotoxic effects, edicycin should be administered with caution to patients with renal insufficiency.
APPLICATION FOR CHILDREN
Newborns up to 7 days of life - the initial dose of 15 mg / kg body weight, then - 10 mg / kg every 12 hours.
Children up to 1 month - 10 mg / kg every 8 hours.
Children from 1 month and older receive the drug at a daily dose of 40 mg / kg, divided into single injections, every 6 hours.
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
Older patients (over 60 years of age) require a dose reduction or an increase in the interval between administrations, as well as regular monitoring of plasma concentrations of vancomycin.
SPECIAL INSTRUCTIONS
The drug is intended for use only in a hospital.
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 drug is not used in / m because of the painful injection and the possible development of necrosis.
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, the kidney function (general urinalysis, creatinine and urea nitrogen).
Vancomycin can be administered orally only for the treatment of staphylococcal enterocolitis and pseudomembranous colitis caused by Clostridium difficile.
Use in Pediatrics
When using the drug in infants and preterm infants , the concentration of vancomycin in the blood plasma should be monitored regularly.
OVERDOSE
Treatment: the drug should be canceled or lowered. 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 the simultaneous use of vancomycin and other potentially neurotoxic and / or nephrotoxic drugs (including ethacrynic acid, aminoglycoside antibiotics, muscle relaxants, cisplatin) careful monitoring of the patient's condition is necessary.
With the simultaneous administration of vancomycin and anesthesia, the risk of arterial hypotension, erythema, urticaria, pruritus, and the development of anaphylactoid reactions is likely to increase.
It is not recommended simultaneous use of vancomycin with chloramphenicol, corticosteroids, methicillin, heparin, aminophylline, cephalosporins and phenobarbital.
With simultaneous use with vancomycin, antihistamines can mask the symptoms of the ototoxic effect of vancomycin (tinnitus, vertigo).
It is not recommended simultaneous application of Edicine with ototoxic drugs in connection with possible enhancement of the ototoxic effect.
Pharmaceutical incompatibility
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.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years. Do not use after the expiry date printed on the package.
