Edicine

An antimicrobial drug for systemic use, an antibiotic of the glycopeptide group - Edicin shows good results in stopping infectious and inflammatory processes.

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Indications Edicine

Indications for the use of the drug Edicin are determined by the physicochemical characteristics of the active chemical compound vancomycin.

The main indications for the use of the drug Edicin are diseases developing on the basis of inflammation caused by various infections that exhibit increased sensitivity to vancomycin. This is especially relevant in case of intolerance or ineffective treatment with drugs of the cephalosporin or penicillin group.

• Infectious lesion of joint and bone tissue, such as osteomyelitis.
• Sepsis.
• Enterocolitis is a fairly common pathology of the gastrointestinal system, in which the inflammatory process affects both the large (colitis) and small (enteritis) intestines.
• Infectious lesions of the lower respiratory tract systems and organs, including pneumonia, bronchitis, etc.
• Endocarditis is an inflammation of the inner lining of the heart (endocardium).
• False membranous colitis caused by Clostridium difficile.
• Infections affecting the central nervous system, such as meningitis.
• Infectious lesion of the epidermis and other tissues.

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Release form

The main active chemical compound of the drug Edicin is vancomycin hydrochloride. One gram of this substance corresponds to 1,000,000 IU of vancomycin. Its content in a unit of the drug is determined by the numbers: 0.5 mg or 1.0 mg. The drug is released in a dried medicinal extract (lyophilisate) used in the manufacture of liquid medicine for droppers. The liquid is dispensed in dark glass bottles, subsequently packed in a classic-shaped box.

Pharmacodynamics

The main pharmacological properties of the drug under consideration are determined by the physicochemical properties of the active chemical compound, which is the basis of the medicinal unit, vancomycin. The pharmacodynamics of Edicin is aimed at inhibiting the development and distribution of pathogenic flora cells, increasing the permeability of existing structures. This fact allows blocking the development of new and eliminating existing units of invasive infection. This effect is achieved due to the ability of vancomycin to combine and penetrate into the mucopeptide alanine -D-acyl -D-alanine, leading to a failure in the unification of the ribonucleic acids of the "aggressor".

Pharmacodynamics of the drug Edicin is especially biologically active against aerobic gram-positive strains, as well as anaerobic gram-positive strains. These include:

1. Actinomyces spp.
2. Listeria monocytogenes, Streptococcus agalactiae.
3. Corynebacterium diphtheriae.
4. Streptococcus spp., including Streptococcus pyogenes, Streptococcus bovis, Streptococcus pneumonia, Streptococcus viridans, as well as strains resistant to the penicillin group.
5. Enterococcus faecalis.
6. Enterococcus spp.
7. Staphylococcus spp., including methicillin-resistant microorganisms, Staphylococcus epidermidis, strains of Staphylococcus aureus.
8. Clostridium spp.

Outside a living organism, vancomycin does not have any noticeable effect on gram-negative microscopic organisms, fungi, protozoa, microscopic bacteria and viruses.

There is no mutual opposition between Edicin and antibiotics of other groups. The pharmacodynamics of the drug Edicin shows maximum therapeutic effectiveness at an acid-base factor of pH 8. In case of its decrease to pH 6, the quality of the final result decreases sharply. The drug remains active only on pathogenic microscopic organisms undergoing the reproduction stage.

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Pharmacokinetics

The drug in question, when administered into the body, is rather weakly absorbed by the mucous membrane of the digestive system. In the case of intraperitoneal administration of the drug (administration through the peritoneum), the pharmacokinetics of the drug Edicin can show a result of systemic adsorption of about 60%.

When the drug is administered to the patient at a rate of 30 mg per kilogram of the patient's weight, its maximum amount in the blood is determined by a figure of approximately 10 mg/ml. This concentration level is recorded after six hours of administration. In the case of intravenous administration of Edicin, such a high component, providing a therapeutic effect, is observed in many human organs and systems: in the exudate and transudate of the pleura, in the ascitic fluid of the abdominal cavity, in the layers of the atrial appendage, exudate of the pericardial region, in the biological environment of the synovial (joint) zone, in the lubricating component of peritoneal filters, in urine.

Pharmacokinetics Edicin shows a low level of binding to blood plasma proteins. This figure is about 55%. The drug does not show the ability to overcome the blood-brain barrier, but placental invasion and penetration into breast milk are high. In case of inflammation of the membranes of the brain and/or spinal cord (meningitis), the therapeutic concentration of the drug is observed in the cerebrospinal or spinal fluid (liquor).

Vancomycin hydrochloride is practically not subject to biotransformation. If an adult patient has healthy kidneys, the half-life (T _1/2 ) of the drug falls within the time interval from four to six hours. If the patient's medical history is burdened with chronic renal failure or in the case of cessation of urine flow into the bladder (anuria), the rate of utilization and excretion of the drug from the patient's body is slowed down and can reach seven to eight days.

In case of therapeutic treatment involving multiple administration of the drug, accumulation of vancomycin is possible.

During the first day after taking the medicine, about 75% of Edicin is excreted from the body by glomerular filtration, with urine through the kidneys. If the patient has undergone nephrectomy (kidney removal), the excretion procedure is somewhat slower, and the excretion mechanism itself is currently unknown. It is only known that a moderate amount is excreted with bile. If the medicine is ingested orally, it is almost completely excreted with feces and in small doses during peritoneal dialysis or hemodialysis.

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Dosing and administration

To obtain the necessary medicinal effect, the method of application and doses should be prescribed only by a specialist. Vancomycin is administered to the patient only intravenously, intramuscular administration is not allowed. Any bolus injections are not recommended, except for infusion into the body through a vein.

For adult patients, the starting dose is usually 0.5 g, slow intravenous infusion of the substance is carried out every six hours, and when administering a double dose of the drug (1 g), then twice a day with an interval of twelve hours. The drip rate is no more than 10 mg / min, for the introduction of the basic dose (0.5 g) it will take at least an hour. The concentration of vancomycin in the infusion solution should not be higher than 5 mg / ml.

For young patients, the dosage of the drug directly depends on the child’s age.

1. For newborns under seven days old, the starting dosage is calculated as 15 mg per kilogram of the patient's weight, subsequently the dosage is reduced to 10 mg/kg. The drug is administered every twelve hours.
2. For infants less than one month old, the starting dosage is calculated as 10 mg per kilogram of the patient's weight, administered by infusion every eight hours.
3. For children aged one month and older, the starting daily dosage is calculated as 40 mg per kilogram of the patient's weight, divided into three infusions at eight-hour intervals.

The concentration of vancomycin in the infusion solution should not be higher than 2.5 – 5 mg/ml. The drip rate should not exceed 10 mg/min; at least an hour is required to administer the basic dose (0.5 g).

The maximum acceptable single dose for a small patient should not exceed 15 mg/kg. The same daily figure corresponds to 60 mg per kilogram of body weight for a child and should not exceed the same figure for an adult patient - no more than 2 g per day.

For patients with renal dysfunction, it is necessary, depending on the level of insufficiency, to adjust the administered amount of Edicin and/or the time interval between infusions. In this situation, the starting amount is prescribed at the rate of 15 mg per kilogram of the patient's weight. To determine an effective, but safe, interval between the administered drug, regular monitoring of creatinine clearance is carried out.

In order to obtain the required concentration of the solution (50 mg/ml), 500 mg of Edicin should be dissolved in 10 ml of special clean water used for medical procedures. If the drug is 1 g, then the amount of water taken is, accordingly, twice as much.

If it is necessary to obtain lower therapeutic concentrations, 500 mg of vancomycin is diluted with 100 ml of a special diluent. 1 g, respectively, is diluted with 200 ml. As a diluent, a 0.9% sodium chloride solution is mainly taken, the second, frequently used drug is a 5% glucose solution. The quantitative component of vancomycin in the prepared solution should not exceed 5 mg / ml.

If the solution was diluted to the required concentration without any deviations from the requirements, using 0.9% sodium chloride or 5% glucose, then the prepared medicine can be stored without the risk of losing its effectiveness for two weeks in the refrigerator at a temperature of 2–8 °C.

It is important to remember that before any infusion, the administered solution must be visually checked for the absence of foreign bodies and impurities, as well as the possibility of a change in the color of the liquid.

The prepared solution may be prescribed for internal administration through the mouth (orally) or, if necessary, through a nasogastric tube.

For oral administration, the solution is prepared slightly differently: 0.5 g of the composition of the vial is diluted with 30 ml of clean sterile water for injection.

Special food additives in the form of syrups and flavors are used to improve the taste characteristics of Edicin when it is prescribed as a drink.

For adult patients, the starting dosage is usually 0.5 g - 1 g, diluted into three to four oral doses. If medically necessary, the amount of the drug can be increased, but the daily amount should not exceed 2 g. The duration of the therapeutic course is from seven to ten days.

For small patients, the daily dosage is calculated as 40 mg, taken per kilogram of the baby's weight and divided into three to four doses. The duration of the therapy is from seven to ten days.

People with liver problems (enzyme deficiency) do not need to adjust the dose of Edicin.

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Use Edicine during pregnancy

Based on the fact that vancomycin shows quite good placental invasion and easily penetrates into breast milk, the use of the drug Edicin during pregnancy, especially in the first trimester, when all organs and systems of the body of the future human are being laid and formed, is strictly contraindicated. The use of arresting therapy in the second and third trimesters of gestation is possible only in the case of serious vital indicators, when real help for the woman's health significantly outweighs the expected complications that may arise during the development of the embryo.

Edicin is classified as a Group C fetal risk category by the FDA for use by pregnant women. This means that animal studies have shown the drug to have a negative effect on the fetus, and no studies have been conducted in pregnant women, but the potential benefit associated with the drug in the expectant mother may justify its use despite the risk to the baby.

If there is a therapeutic need to treat a young mother during the period when she is breastfeeding her newborn baby, then it is recommended to stop breastfeeding the child for the duration of therapy.

Contraindications

The drug in question does not have any special systemic effects that would result in negative symptoms. Therefore, contraindications to the use of Edicin are minor and are limited to the following pathologies:

• Increased individual intolerance to the components of the drug.
• An inflammatory process in the nerve that provides hearing function is auditory neuritis.
• First trimester of pregnancy.
• Time to breastfeed a newborn.

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Side effects Edicine

Each organism is individual and has its own level of sensitivity. Therefore, the introduction of a chemical compound in dosages necessary to obtain the expected therapeutic effect can sometimes cause side effects of Edicin.

• It could be vertigo, which manifests itself with the following symptoms:
  • Hearing loss.
  • The appearance of unpleasant constant noise.
  • Nausea, which, if severe, provokes a vomiting reflex.
  • Increased functioning of the sweat-producing glands.
  • Increased heart rate.
• Neutropenia is reversible.
• Diarrhea.
• Eosinophilia is an increase in the quantitative level of eosinophils in the blood plasma.
• Pseudomembranous colitis is a severe pathology of the colon that develops as a complication of antibacterial therapy.
• Rashes, itching.
• Thrombocytopenia is a decrease in the platelet count to less than 150 x 109/l, which is accompanied by increased bleeding and problems with stopping bleeding.
• Leukopenia is a decrease in the quantitative level of leukocytes below 4.0 * 109/l.
• There are rare cases of agranulocytosis - a sharp decrease in the content of granulocytes in the blood (less than 1x109/l, neutrophilic granulocytes less than 0.5x1x109/l).
• Post-infusion reactions of the body with rapid administration of the drug.
• Nephrotoxicity, in rare cases including provoking renal failure.
• With prolonged use of large doses or in combination with aminoglycosides, an increase in urea nitrogen, as well as plasma creatinine concentrations, is possible.
• Very rarely, interstitial nephritis may develop. This result can be obtained if the patient has impaired renal function or if one of the aminoglycosides was administered in parallel.
• Exfoliative dermatitis.
• Dizziness.
• Spasm of the muscles of the bronchi and muscle tissue of the back and neck.
• Inflammation that leads to destruction of the walls of blood vessels (vasculitis).
• Hyperemia.
• Toxic epidermal necrolysis is the body's response to the administration of a drug.
• Drop in blood pressure.
• Fever.
• If the infusion requirements are not met, a local reaction to the introduction may occur:
  • Thrombophlebitis is an inflammatory process affecting the walls of veins with their blockage by a blood clot (thrombus).
  • Pain symptoms in the injection area.
  • The process of necrosis of tissue cells in the infusion area.

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Overdose

If the requirements and recommendations were not violated during the preparation of the solution for intravenous or oral administration and during the infusion itself, the probability of receiving high doses of the drug is reduced to a minimum. But if an overdose, for whatever reason, occurs, then an increase in the intensity of the manifestation of side effects can be observed.

In this situation, symptomatic therapy is prescribed. Parallel hemofiltration and hemoperfusion can also bring positive results.

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Interactions with other drugs

When performing complex therapy unskilled, one can often observe the induction or, conversely, activation of the characteristics of a particular drug. To avoid unexpected results and achieve maximum expected effectiveness, it is necessary to know the consequences of Edicin interaction with other drugs. Otherwise, irreparable damage can be caused to the patient's health.

Concomitant administration of vancomycin with drugs and drug groups such as aminoglycoside antibiotics, loop diuretics, polymyxins, amphotericin B, cyclosporine, bacitracin or cisplatin may cause hearing problems and kidney damage.

If the complex treatment includes drugs related to nephrotoxic or neurotoxic pharmacological drugs, mostly viomyocin, ethacrynic acid, polymyxin B, colistin, as well as neuromuscular blocking agents, there is a medical need for closer monitoring of the patient's condition during the therapy period.

Colestyramine reduces the pharmadynamic characteristics of Edicin. Tandem use of anesthetics dramatically increases the likelihood of hypotension, allergic symptoms in the form of itching and urticaria. Further mutual use can also lead to the development of abnormal reddening of the skin, histamine-like flushes, anaphylactoid reaction of the body and anaphylactic shock. But the frequency and intensity of such negative manifestations can be reduced by introducing vancomycin at a very low rate (taking 0.5 g of the drug is extended for more than an hour) and before taking the anesthetic.

It is worth warning that special precautions are necessary when administering Edicin to newborn babies, especially if they are premature. Regular monitoring of the level of the active substance in the blood plasma is necessary here.

Throughout the therapy, it is necessary to periodically conduct control studies:

• A comparative audiogram, a graph that allows you to monitor the state of a person's hearing.
• Monitoring of kidney function:
  • Urine test.
  • Urea nitrogen values.
  • Determination of creatinine level.
• It would be useful to determine the quantitative indicator of vancomycin in the blood serum. This is especially important for elderly patients and patients with a history of renal failure.

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Storage conditions

To maintain high pharmacodynamic and pharmacokinetic characteristics of the drug in question, it is necessary to strictly follow all storage conditions of Edicin, because this directly affects the duration of the effective operation of the drug.

Storage conditions for Edicin are very often found in the instructions for use of many other drugs, because they are quite standard.

1. The temperature in the room where Edicin is stored should not exceed 25 degrees Celsius.
2. The preparation should not be exposed to direct sunlight.
3. The drug should not be accessible to young researchers.
4. The medicine must be stored in a room with low humidity.

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Shelf life

If all storage requirements for the medicinal product Egilok have been met, the shelf life and effective use for therapeutic purposes extends to two years (or 24 months) from the date of manufacture. If at least one of the storage conditions has been violated, the time interval for effective use of the medicine in question is reduced. After the expiration of the final shelf life, further use of the medicine is unacceptable.

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