Edicin
Edicin: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Edicin
ATX code: J01XA01
Active ingredient: vancomycin (vancomycin)
Manufacturer: Hemofarm (Serbia), Lek d.d. (Slovenia)
Description and photo update: 28.11.2018
Prices in pharmacies: from 6000 rubles.
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Edicin is a glycopeptide, an antibacterial drug that has a bactericidal effect.
Release form and composition
The drug is available in the form of a lyophilisate for the preparation of a solution for infusion: lyophilized powder of white or almost white color (0.5 g or 1 g each in glass vials without color, in a cardboard box of 1 or 10 vials and instructions for the use of Edicin).
The active ingredient is vancomycin (in the form of hydrochloride), its content in 1 bottle is 0.5 g or 1 g [500,000 IU (international unit) or 1,000,000 IU, respectively].
Pharmacological properties
Pharmacodynamics
Edicin is an antibacterial drug with the active ingredient vancomycin, which is a tricyclic glycopeptide antibiotic isolated from Amycolatopsis orientalis. Vancomycin has bactericidal activity, manifested by the ability to inhibit the biosynthesis of the bacterial cell wall, increase the permeability of their cell membrane and alter the synthesis of RNA (ribonucleic acid).
Unlike penicillin and cephalosporin, vancomycin blocks the synthesis of the bacterial cell wall at other sites, so there is no competition for binding sites with these agents. Strong binding of vancomycin to D-alanyl-D-alanine residues of peptidoglycan subunits leads to cell lysis. Peptidoglycan is the main component of the cell wall, located on the outside of the cytoplasmic membrane.
Edicin has a bactericidal effect against many gram-positive bacteria, bacteriostatic against Enterococcus spp. (speciales). To achieve a bactericidal effect on Enterococcus spp. additional administration of aminoglycosides is required.
There is no cross-resistance between vancomycin and other classes of antibiotics.
Edicin is active against the following gram-positive microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus (including heterogeneous methicillin-resistant strains), Streptococcus spp. (including Streptococcus pneumonia, Streptococcus pyogenes, Streptococcus agalactiae, penicillin-resistant strains), Clostridium spp., Actinomyces spp., Enterococcus spp. (including Enterococcus faecalis), Propionibacterium acnes, some strains of Rhodococcus spp., Lactobacillus spp., Listeria monocytogenes, Corynebacterium spp.
In vitro, some isolated strains of Enterococcus spp. and Staphylococcus spp. shows resistance to vancomycin.
The combination with gentamicin, rifampicin, imipenem or tobramycin causes synergism against Staphylococcus aureus. In the combination of vancomycin with rifampicin, an antagonism of action against strains of Staphylococcus spp. and synergistic action against some strains of Streptococcus spp.
In vitro, vancomycin is not active against gram-negative microorganisms, fungi and mycobacteria.
The optimal effect of Edicin is achieved at a pH (acidity) of 8, if the pH drops to 6, then the effectiveness of vancomycin drops sharply.
Staphylococcal resistance develops very rarely. For most antibiotic-sensitive microorganisms, the minimum inhibitory concentration (MIC) is less than 0.005 mg / ml, for vancomycin-resistant Staphylococcus aureus strains - 0.01–0.02 mg / ml.
When taken orally, the drug has a local effect on sensitive microflora (Staphylococcus aureus, Clostridium difficile) in the gastrointestinal tract. The systemic effect of Edicin when administered orally is minimal.
Pharmacokinetics
After oral administration, vancomycin is absorbed in minimal amounts. The absorption of the drug may increase with inflammation of the intestinal mucosa. In such patients, the maximum plasma concentration is from 0.0024 to 0.003 mg / ml against the background of the use of 500 mg of Edicin at intervals of 6 hours.
In patients with normal renal function after intravenous (iv) administration of vancomycin at a dose of 500 mg, the highest concentration of the drug in the blood plasma (0.033 mg / ml) is noted immediately after administration, 1 hour after administration it is 0.0073 mg / ml. After intravenous administration of 1000 mg, the level of the drug in the blood plasma doubles. Immediately after administration, it is 0.02-0.05 mg / ml, and 12 hours after the end of the infusion - 0.005-0.01 mg / ml.
Plasma concentrations of vancomycin are similar for single and multiple administrations.
The volume of distribution can range from 0.2 to 1.25 l / kg, in children, including newborns, it can be 0.53-0.82 l / kg.
When administered intravenously, vancomycin penetrates into many tissues (liver, kidneys, lungs, heart, tissues of the atrial appendage, vascular walls and abscesses) and fluid (pleural, pericardial, ascitic, peritoneal, synovial) of the body, as well as through the placental barrier. In addition, it is found in urine at concentrations that are capable of inhibiting the growth of sensitive microorganisms. Vancomycin penetrates into the cerebrospinal fluid slowly. It was found that with inflammation of the meninges, the rate of overcoming the blood-brain barrier increases in direct proportion.
Vancomycin is excreted in breast milk.
The active substance is almost not metabolized.
Plasma half-life (T 1/2): adults - on average 4-6 hours (from 3 to 9 hours), newborns - 6.7 hours, premature babies - 9.8 hours, children aged 4 months - 4 hours, children aged 3 - 2.4 hours, children aged 7 - 2.2 hours.
Through the kidneys unchanged by glomerular filtration, 80 to 90% of the administered dose of vancomycin is excreted within the first 24 hours.
A small amount (up to 5%) of the drug can be excreted in the bile. During hemodialysis or peritoneal dialysis, it is excreted in small quantities.
The total clearance of vancomycin in adults is 0.7–3.1 ml / s; in children, the clearance of vancomycin is higher - about 3 ml / s.
With impaired renal function, the rate of excretion of vancomycin decreases.
In patients with an absent (removed) kidney, T 1/2 on average is 180 hours.
In elderly patients, as a result of the natural slowing down of glomerular filtration, the total systemic and renal clearance of vancomycin can be reduced.
Indications for use
The use of Edicin in the form of an infusion is indicated for the treatment of the following infectious and inflammatory diseases and conditions caused by microorganisms sensitive to vancomycin:
- endocarditis: caused by Streptococcus viridans or Streptococcus bovis - monotherapy or in combination with aminoglycosides; caused by enterococci (including Enterococcus faecalis) - only in combination with aminoglycosides; caused by Staphylococcus epidermidis after valve replacement (early endocarditis) - in combination with rifampicin and / or aminoglycosides;
- prevention of endocarditis in patients with hypersensitivity reactions to penicillin antibiotics;
- sepsis;
- meningitis and other infectious pathologies of the central nervous system;
- osteomyelitis and other infections of the joints and bones;
- pneumonia, lung abscess and other infections of the lower respiratory system;
- infections of the skin and soft tissues;
- intolerance or lack of response to treatment with penicillins, cephalosporins or other antibiotics, allergy to penicillin.
In addition, Edicin in the form of an oral solution is prescribed for the treatment of pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus.
Contraindications
- neuritis of the auditory nerve;
- I trimester of pregnancy;
- breast-feeding;
- individual intolerance to vancomycin.
With caution, Edicin should be prescribed to patients with impaired hearing (including history), renal failure, established allergy to teicoplanin (increased likelihood of cross-allergy), in the II – III trimesters of pregnancy.
Edicin, instructions for use: method and dosage
Do not inject Edicin IV bolus (jet) or intramuscularly!
The ready-made solution of the lyophilisate is used by intravenous drip and inside.
To prepare a solution for intravenous administration, water for injection is added to a vial with a lyophilisate in the following volume: to 500 mg of vancomycin - 10 ml, to 1000 mg - 20 ml. The concentration of the resulting solution is 50 mg / ml (in 1 ml - 50 mg of vancomycin), it can be stored for 24 hours at temperatures up to 25 ° C or for 96 hours at a temperature of 2-8 ° C (in the refrigerator) and used for fractional intravenous administration.
Further dilution of the prepared solution is required!
The solution for infusion is prepared immediately before the procedure, its concentration should be no more than 5 mg / ml. To dilute the aqueous solution prepared in the above way, you can use 0.9% sodium chloride solution for injection or 5% dextrose (glucose) solution for injection in the following proportion: 500 mg of the drug - per 100 ml of solvent or 1000 mg - per 200 ml.
Duration of infusion - at least one hour, infusion rate - no more than 10 mg / min.
The ready-made solution for parenteral administration should be visually checked before administration, if the presence of mechanical impurities and / or color change is found, the drug cannot be used.
The recommended dosage of Edicin for intravenous drip administration:
- Patients over the age of 12 years: 500 mg 4 times a day with an interval of 6 hours or 1000 mg 2 times a day with an interval of 12 hours (daily dose - 2000 mg). Dose adjustment is made individually, taking into account the age, degree of obesity of the patient and the concentration of vancomycin in serum;
- children from 4 weeks of age to 12 years: 10 mg per 1 kg of body weight 4 times a day with an interval of 6 hours (daily dose - 40 mg per 1 kg of body weight of a child). Infusion duration - at least 1 hour;
- newborns (up to 4 weeks of life): the initial dose is 15 mg per 1 kg of body weight, then 10 mg per 1 kg. During the first 7 days of life, the interval between infusions should be 12 hours (frequency of use - 2 times a day), starting from 8 days and until one month of age - 8 hours (frequency of use - 3 times a day). The duration of the infusion is at least one hour, the procedures are carried out under constant monitoring of the concentration of vancomycin in the serum.
The concentration of the solution should not exceed 2.5–5 mg / ml.
The maximum daily dose for children should not be higher than the daily dose for adult patients (2000 mg).
In case of impaired renal function, an individual selection of the dose of vancomycin is required, which should be carried out under the control of the concentration of serum creatinine. Correction is carried out by increasing the intervals between infusions or reducing a single dose of Edicin.
The recommended intervals between injections, taking into account the CC (creatinine clearance) of the patient:
- CC more than 80 ml / min: at a dose of 500 mg or 1000 mg every 12 hours;
- CC 80-50 ml / min: at a dose of 1000 mg every 24 hours (1 day);
- CC 50-10 ml / min: at a dose of 1000 mg after 72-168 hours (3-7 days);
- CC less than 10 ml / min (anuria): at a dose of 1000 mg after 168–336 hours (7–14 days).
The clearance of vancomycin in elderly patients is lower and the volume of distribution is greater. In this regard, the selection of the Edicin dose for this category of patients is advisable to carry out taking into account the level of vancomycin in the serum.
Premature infants and elderly patients may require a significant dose reduction due to impaired renal function.
Recommended correction of a single daily dose of Edicin based on individual QC:
- CC 100 ml / min: 1545 mg;
- CC 90 ml / min: 1390 mg;
- CC 80 ml / min: 1235 mg;
- CC 70 ml / min: 1080 mg;
- CC 60 ml / min: 925 mg;
- CC 50 ml / min: 770 mg;
- CC 40 ml / min: 620 mg;
- CC 30 ml / min: 465 mg;
- CC 20 ml / min: 310 mg;
- CC 10 ml / min: 155 mg.
In anuria, in order to quickly achieve the therapeutic concentration of vancomycin in serum, the initial dose should be 15 mg per 1 kg of the patient's body weight. A stable concentration of the drug is maintained by administering a dose of 1.9 mg per 1 kg of patient weight per day.
For hemodialysis using high-flow membranes, the initial dose of Edicin should be 0.02-0.025 mg per 1 kg of patient weight. The maintenance dose of vancomycin should maintain a residual drug concentration of approximately 0.015–0.02 mg / ml.
In hepatic impairment, dose adjustment is not required.
In the treatment of pseudomembranous colitis caused by Clostridium difficile, and staphylococcal enterocolitis, Edicin is administered orally, including through a tube.
For oral administration, the lyophilisate is dissolved in water: 500 mg of the drug requires 30 ml of water.
To improve the taste of the solution, you can use food syrups.
Recommended daily dosage for oral administration of Edicin:
- adults: 500-2000 mg each;
- children: at the rate of 40 mg per 1 kg of the child's weight.
The daily dose is divided into 3-4 doses.
The maximum daily dose is 2000 mg. The duration of the course of treatment is 7-10 days.
IV administration of vancomycin for the treatment of these diseases has no advantages.
In the treatment of other types of infections, oral administration of Edicin is ineffective.
Side effects
- from the gastrointestinal tract: often - nausea; very rarely - pseudomembranous colitis;
- on the part of the cardiovascular system: often - thrombophlebitis, lowering blood pressure; rarely - vasculitis; very rarely - cardiac arrest;
- on the part of the hematopoietic organs: often - neutropenia; rarely - agranulocytosis, thrombocytopenia, eosinophilia;
- from the respiratory system: often - wheezing noisy breathing (stridor), shortness of breath;
- on the part of the sensory organs: often - ototoxicity (temporary or permanent hearing loss, vertigo; mainly ototoxicity was observed while taking high doses of vancomycin or the simultaneous use of other drugs that cause ototoxicity, as well as in patients with severe hearing impairment or renal function); rarely - dizziness, tinnitus;
- on the part of the immune system: rarely - anaphylactic reactions [shortness of breath, bronchospasm, lowering blood pressure (BP), itching, skin rash], hypersensitivity reactions;
- from the urinary system: often - renal failure, the primary manifestation of which is due to an increase in plasma concentrations of urea nitrogen or creatinine; rarely - acute renal failure, interstitial nephritis;
- dermatological reactions: often - itching, urticaria, exanthema, "red man" syndrome (flushing of the face and upper half of the body, spasm of the muscles of the back and chest, palpitations, chills, fever), inflammation of the mucous membranes of the body; very rarely - Stevens-Johnson syndrome, linear dermatosis, Lyell's syndrome, exfoliative dermatitis;
- local reactions: frequency not established - phlebitis, pain, irritation and / or tissue necrosis at the injection site;
- others: rarely - chills, fever.
Overdose
Symptoms of an Edicin overdose: aggravation of dose-dependent side effects from the sensory organs and urinary system.
Treatment: the appointment of symptomatic and supportive therapy aimed at maintaining glomerular filtration, forced diuresis, accompanied by control of the concentration of vancomycin in plasma. There is no specific antidote.
If symptoms of overdose appear, it is necessary to cancel the use of Edicin or reduce the dose.
It should be borne in mind that vancomycin is effectively removed by hemodialysis using high-flux membranes. With hemofiltration and hemoperfusion through polysulfone ion exchange resin, an increase in vancomycin clearance occurs.
special instructions
The use of Edicin in the form of an intravenous infusion is indicated only in a hospital setting!
It should be borne in mind that the rapid introduction of vancomycin can cause a pronounced decrease in blood pressure, in rare cases - cardiac arrest.
The use of vancomycin in patients with renal failure who are older than 60 years should be accompanied by careful monitoring of the concentration of vancomycin in the blood plasma. With long-term preservation of a high concentration of the drug in the blood (over 0.08 mg / ml), the risk of toxic effects increases.
Patients with teicoplanin allergy may develop cross-allergy.
Long-term use of Edicin must be accompanied by an audiogram, careful monitoring of the peripheral blood picture and renal function, including a general urine test, creatinine and urea nitrogen.
Vancomycin is poorly cleared during hemodialysis using low-flux membranes.
The irritating effect of vancomycin when the drug solution diffuses through the vessel wall can cause necrosis of adjacent tissues. To prevent and reduce the risk of thrombophlebitis, the recommended infusion rate, the concentration (2.5–5 mg / ml) of the injected solution should be strictly observed and the sites of Edicin injection should be alternated.
Influence on the ability to drive vehicles and complex mechanisms
The effect of the components of Edicin on the patient's ability to drive vehicles or perform other potentially hazardous activities has not been established.
Application during pregnancy and lactation
The use of Edicin is contraindicated in the first trimester of the gestation period and during breastfeeding.
In the II and III trimesters of pregnancy, the appointment of the drug is allowed only for health reasons, when the expected benefit of therapy for the mother, according to the doctor, is higher than the potential risk to the fetus.
If Editsin is prescribed during lactation, breastfeeding should be discontinued for the period of treatment.
Pediatric use
The recommended dosage of Edicin for intravenous drip administration:
- newborns at the age of the first 7 days of life: initial dose - at the rate of 15 mg per 1 kg of body weight 2 times a day with an interval of 12 hours, then - 10 mg per 1 kg of body weight 2 times a day with an interval of 12 hours;
- newborns aged 1 to 4 weeks of life: initial dose - at the rate of 15 mg per 1 kg of body weight 2 times a day with an interval of 12 hours, then - 10 mg per 1 kg of body weight 3 times a day with an interval of 8 hours;
- children from 4 weeks of age to 12 years: 10 mg per 1 kg of body weight 4 times a day with an interval of 6 hours (daily dose - 40 mg per 1 kg of body weight of a child). Infusion duration - at least 1 hour;
- children aged 12 to 18 years: 500 mg 4 times a day with an interval of 6 hours or 1000 mg 2 times a day with an interval of 12 hours (daily dose - 2000 mg).
Recommended daily dosage for oral administration of Edicin: at the rate of 40 mg per 1 kg of child's weight (maximum daily dose - 2000 mg). The daily dose is divided into 3-4 doses. The duration of the course of treatment is 7-10 days.
Treatment of premature infants and infants should be accompanied by regular monitoring of the concentration of vancomycin in blood plasma.
With impaired renal function
Due to the high risk of developing nephrotoxic effects, it is recommended to prescribe Edicin to patients with renal insufficiency with caution.
With renal failure, a dosage regimen adjustment is required. The dose selection is carried out individually, accompanied by the control of serum creatinine. Correction is carried out by increasing the intervals between infusions or reducing a single dose of Edicin.
The recommended intervals between infusions, taking into account the patient's CC:
- CC more than 80 ml / min: at a dose of 500 mg or 1000 mg every 12 hours;
- CC 80-50 ml / min: at a dose of 1000 mg every 24 hours (1 day);
- CC 50-10 ml / min: at a dose of 1000 mg after 72-168 hours (3-7 days);
- CC less than 10 ml / min (anuria): at a dose of 1000 mg after 168–336 hours (7–14 days).
Recommended correction of a single daily dose of Edicin based on individual QC:
- CC 100 ml / min: 1545 mg;
- CC 90 ml / min: 1390 mg;
- CC 80 ml / min: 1235 mg;
- CC 70 ml / min: 1080 mg;
- CC 60 ml / min: 925 mg;
- CC 50 ml / min: 770 mg;
- CC 40 ml / min: 620 mg;
- CC 30 ml / min: 465 mg;
- CC 20 ml / min: 310 mg;
- CC 10 ml / min: 155 mg.
For violations of liver function
In hepatic insufficiency, Edicin dose adjustment is not required.
Use in the elderly
When treating patients over the age of 60, due to the natural deterioration of renal function, a dose adjustment of Edicin is required, which is produced by reducing a single dose or increasing the intervals between injections, taking into account the patient's CC. Plasma concentrations of vancomycin should be monitored regularly.
Drug interactions
Possible drug interactions with simultaneous intravenous administration of Edicin:
- anesthetics: the use of anesthetics increases the risk of facial flushing, erythematous rashes, lowering blood pressure, anaphylactoid reactions, and neuromuscular blockade. The likelihood of developing these reactions can be reduced if the IV administration of vancomycin is performed before the administration of the anesthetic;
- aminoglycosides, amphotericin B, salicylates (including aminosalicylic acid), carmustine, bacitracin, capreomycin, paromomycin, loop diuretics, cisplatin, polymyxin B, ethacrynic acid, cyclosporin: systemic or topical application of these or other drugs that have non-toxic and / or non-toxic effects (including with sequential use), it is necessary to be accompanied by careful monitoring of the patient's condition for the timely diagnosis of the development of symptoms of their negative influence;
- chloramphenicol, phenobarbital, glucocorticosteroids, cephalosporins, methicillin, aminophylline: these drugs are not recommended to be prescribed;
- beta-lactam antibiotics: do not mix vancomycin solution with beta-lactam antibiotics, their pharmaceutical incompatibility causes precipitation. The drugs should be administered sequentially, thoroughly flushing the IV system after each antibiotic. The concentration of the vancomycin solution should be 5 mg / ml;
- antihistamines, thioxanthenes, meclosine, phenothiazines: these agents can mask the manifestation of symptoms of the ototoxic effect of vancomycin, including tinnitus or vertigo.
In addition, the lyophilisate must not be mixed with alkaline solutions. It should be borne in mind that the low acidity of a vancomycin solution can cause both physical and chemical instability when mixed with other solutions.
Concomitant therapy with cholestyramine causes a decrease in the activity of vancomycin when the solution is taken orally.
Analogs
Editsin's analogs are: Vankorus, Vancadicin, Vankocin, Vankogen, Vancomabol, Vankomek, Vancomycin, Tankofeto, Lykovanum.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Editsin
The few reviews about Editsin are positive. Along with the effectiveness of the drug, they note the possibility of its use in all age groups of patients, including those with concomitant pathologies of the kidneys or liver.
Price for Edicin in pharmacies
The price of Edicin for a package containing 10 vials of 1000 mg lyophilisate can range from 6,000 rubles, 10 vials of 500 mg lyophilisate - from 4067 rubles.
Edicin: prices in online pharmacies
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Drug name Price Pharmacy |
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Edicin 1000 mg lyophilisate for preparation of solution for infusion 10 pcs. RUB 6000 Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
