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VANCOMICIN-PHARMEX lyophilisate for infusion solution 500 mg, lyophilisate for infusion solution 1000 mg

Instruction manual

For medical use of the drug

Vancomycin Pharmac

(vancomycin-pharmex)

Structure:

Active substance: vancomycin;

1 bottle contains vancomycin hydrochloride in terms of vancomycin 500 mg or 1000 mg;

excipients: sodium hydroxide / hydrochloric acid diluted (possibly due to the need for pH correction).

Dosage form.

Lyophilisate for solution for infusion.

Basic physical and chemical properties: lyophilized porous mass or powder from almost white to light brown in bottles. A pinkish tint is allowed.

Pharmacotherapeutic group.

Antibacterial agents for systemic use. glycopeptide antibiotics.

Code ATX J01X A01.

Pharmacological properties.

Pharmacodynamics

Vancomycin is a tricyclic glycopeptide antibiotic, which is obtained from Amycolatopsis orientalis, is effective against many gram-positive microorganisms. The bactericidal effect of vancomycin is to inhibit the synthesis of the bacterial wall by inhibiting the polymerization of glycopeptides and selectively inhibiting the synthesis of RNA bacteria. Cross-resistance between vancomycin and other antibiotics does not occur.

Vancomycin is especially effective against: staphylococci, including Staphylococcus aureus and S. epidermidis (including methicillin-resistant strains); streptococci, including Streptococcus pyogenes, S. agalactiae, Enterococcus faecalis (mainly Streptococcus faecalis), S. bovis, a group of hemolytic streptococci, Streptococcus pneumoniae (including penicillin-resistant strains); Clostridium difficile (including toxicogenic strains - causative agents of pseudomembranous enterocolitis); dipteroids.

In vitro sensitive to vancomycin are Listeria monocytogenes, Lactobacillus species, Actinomyces species, Clostridium species and Bacillus species. It is inactive in vitro against gram-negative bacteria, fungi and mycobacteria.

Pharmacokinetics

After intravenous administration of 1 g of vancomycin, the concentration in the blood plasma after 2 hours is 23 mg / l and 8 mg / l after 11 hours after administration. Almost 55% of the administered vancomycin binds to plasma proteins. After intravenous administration, the concentration of the drug inhibiting for microorganisms is found in pleural, pericardial, ascitic and synovial fluids, in urine, peritoneal dialysis fluid, in atrial tissues. Despite poor penetration through the pia mater under normal conditions, in the presence of inflammation, vancomycin penetrates well into the cerebrospinal fluid. The metabolism of this drug is negligible. The elimination half-life of the drug is on average 4-6 hours. In the first 24 hours, about 75% of the dose of vancomycin is excreted in the urine by glomerular filtration. In patients with impaired renal function, vancomycin excretion is slowed down. So, in patients with a removed kidney, the elimination half-life is 7.5 days.

Clinical characteristics.

Indications.

Treatment of infections caused by gram-positive microorganisms that are sensitive to the drug, including in patients with a history of penicillins and cephalosporins allergies:

  • endocarditis;
  • sepsis;
  • osteomyelitis;
  • infections of the central nervous system;
  • lower respiratory tract infections (pneumonia);
  • infections of the skin and soft tissues;
  • pseudomembranous colitis (for oral use).

Prevention of endocarditis in patients with hypersensitivity to penicillin antibiotics. Prevention of infections after surgical procedures in the oral cavity and ENT organs.

Contraindications

Hypersensitivity to vancomycin or to any other component of the drug.

Interaction with other drugs and other types of interactions.

With the simultaneous or sequential administration of vancomycin with other drugs with a neurotoxic and / or nephrotoxic effect, in particular with gentamicin, ethacrylic acid, amphotericin b, streptomycin, neomycin, kanamycin, amikacin, tobramycin, viiomycin, bacitracin, colimixin nephrotoxic and / or ototoxic effects of vancomycin.

Due to the synergistic effect with gentamicin, the maximum dose of vancomycin should be limited to 500 mg every 8 hours.

The simultaneous administration of vancomycin and anesthesia drugs increases the risk of hypotension, can cause erythema, histamine-like flushing, anaphylactoid reactions.

With the introduction of vancomycin during or immediately after surgery, the effect of muscle relaxants, such as succinylcholine, may increase or last.

Vancomycin should not be mixed with aminophylline or fluorouracil preparations, since the properties of vancomycin can weaken significantly over time.

The combination of vancomycin with aminoglycosides acts synergistically in vitro on Staphylococcus aureus, Streptococcus nonenterococcal group D, Enterococcus and Streptococcus species (various species).

Medicines that reduce intestinal motility are contraindicated in pseudomembranous colitis.

Cholestyramine reduces the effectiveness of vancomycin.

Features of the application.

Rapid administration of the drug in the form of a bolus injection (within a few minutes) can cause significant arterial hypotension, including shock, sometimes with cardiac arrest, therefore, to reduce the risk of hypotensive reactions, the patients blood pressure should be monitored during drug administration.

Vancomycin should be used only intravenously because of the danger of developing soft tissue necrosis.

To prevent the development of adverse reactions, a solution of vancomycin should be administered for at least 60 minutes. The risk of thrombophlebitis can be reduced by slow administration of a diluted solution (2.5–5 mg / ml) and a change in the injection site.

It should be noted that adverse reactions associated with the rate of administration of the drug can occur at any concentration and rate of administration of the drug and disappear after completion of drug administration.

Use with caution in elderly patients, patients with impaired hearing or during the concomitant use of other ototoxic drugs, such as aminoglycosides.

With prolonged treatment with vancomycin, blood, urine, and kidney function should be periodically monitored.

Monitoring of liver function should be carried out continuously, since liver diseases when taking vancomycin can be exacerbated due to an increase in bilirubin, AST, ALT, alkaline phosphatase and, occasionally, an increase in lactate dehydrogenase and gamma-glutamine transferase.

The frequency of complications associated with infusion (including arterial hypotension, hot flashes, hyperthermia, urticaria, and pruritus) increases with the concomitant administration of anesthetics, so it is recommended that anesthesia be started after the completion of the vancomycin infusion.

Vancomycin should be used with caution in patients with allergic reactions to teicoplanin, since cases of cross allergic reactions have been described.

In some patients with inflammatory diseases of the intestinal mucous membranes, significant systemic absorption is possible when ingesting vancomycin, therefore, there is a risk of developing adverse reactions associated with parenteral use of vancomycin.

With special care, vancomycin should be used in premature infants due to the immaturity of the renal system, which may result in an increase in serum concentration of vancomycin.

It is recommended to control the level of concentration of vancomycin in the blood serum of premature infants and infants.

When treating with vancomycin, there is a risk of developing an ototoxic effect, therefore, the drug should be used with caution in patients with hearing impairment or during the concomitant use of other ototoxic drugs, such as aminoglycosides.

Long-term use of vancomycin can lead to the development of resistant microorganisms and fungi. Careful monitoring of the patient is of great importance. If superinfection occurs during therapy (secondary infection due to an infectious disease, which continues), appropriate measures should be taken.

There are reports of cases of pseudomembranous colitis caused by Clostridium difficile among patients who used intravenous vancomycin.

It was reported that patients with burns have higher rates of total clearance of vancomycin, so they need more frequent use with increasing doses. During the use of vancomycin, such patients are advised to individually determine the dose and carefully monitor the condition.

Use during pregnancy or lactation.

There is no data on the safety of the drug during pregnancy. the use of vancomycin in the first trimester of pregnancy is contraindicated. the appointment of vancomycin in the third and third trimesters of pregnancy is possible only for health reasons, when the expected benefit to the mother outweighs the risk to the fetus, while it is necessary to control the concentration of vancomycin in the blood serum.

The drug passes into breast milk, so if it is necessary to use it, you should stop breast-feeding.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

During the period of treatment with the drug, the ability to concentrate may decrease, which should be taken into account when driving a car or performing work that requires increased attention.

Dosage and administration.

Vancomycin is used for intravenous administration in the treatment of life-threatening infections. in no case should be administered as a bolus injection or intramuscularly due to soreness and possible necrosis at the injection site.

Reactions to the administration of the drug may depend both on the concentration of the solution, and on the speed of its administration. For the treatment of adults, it is recommended that the concentration during administration does not exceed 5 mg / ml, and the rate of administration does not exceed 10 mg / min. Individual patients who need to limit the amount of liquid administered can be given a drug with a concentration of up to 10 mg / ml, but the rate of administration should not exceed 10 mg / min. A high concentration of the drug administered increases the risk of adverse reactions.

The duration of treatment depends on the therapeutic indications for which the drug is used.

Intravenous use of the drug.

Dilute the contents of the bottle of 500 mg in 10 ml or the contents of the bottle of 1 g in 20 ml of water for injection.

After dilution, the drug solution in vials remains stable for 24 hours at a temperature of 25 ° C or for 96 hours in a refrigerator at a temperature of + 2 ° C to + 8 ° C.

Further dilution is necessary: ​​to a solution containing 500 mg or 1 g of vancomycin, add at least 100 ml or 200 ml of 0.9% sodium chloride solution for injection or 5% glucose solution for injection, respectively. The resulting solution remains stable for 48 hours in the refrigerator at a temperature of + 2 ° C to + 8 ° C or for 24 hours at a temperature of 25 ° C.

From a microbiological point of view, it is desirable to introduce the solution immediately after dilution.

The final concentration of the resulting solution of vancomycin should not exceed 5 mg / ml.

An aqueous solution of vancomycin can also be diluted with such infusion solvents:

  • Ringer’s lactate solution,
  • Ringers solution lactate and 5% glucose solution,
  • Ringers acetate solution.

Vancomycin solutions obtained using the above solvents can be stored in a refrigerator at a temperature of + 2 ° C to + 8 ° C for 96 hours.

Before using the diluted solution, make sure that there is no precipitate or discoloration.

The drug is administered continuously intravenously drip for 60 minutes.

Patients with normal renal function.

Adults: 500 mg every 6 hours or 1000 mg every 12 hours. The solution is administered intravenously infusion for at least 60 minutes. The maximum single dose is 1000 mg, the maximum daily dose is 2 g.

Children.

Newborns up to 7 days: the initial dose is 15 mg / kg body weight, then 10 mg / kg body weight every 12 hours.

Newborns from 7 days to 1 month: the initial dose is 15 mg / kg body weight, then 10 mg / kg body weight every 8 hours.

Children over 1 month of age: The usual dose of vancomycin is 10 mg / kg body weight every 6 hours.

The maximum single dose for children is 15 mg / kg of body weight, the maximum daily dose is 2 g.

The concentration of the prepared solution of vancomycin for children should not exceed 2.5-5 mg / ml. The solution should be administered for at least 60 minutes.

Elderly patients: a dose reduction may be necessary due to age-related decline in renal function.

Overweight patients: a standard daily dose adjustment may be required.

Patients with liver failure: does not require daily dose adjustment.

Patients with impaired renal function.

The dosage should be adjusted according to creatinine clearance in accordance with the table below.

When the concentration of creatinine in the blood serum is known, the following formula should be used (taking into account the gender, body weight and age of the patient) to determine creatinine clearance. The calculated creatinine clearance (ml / min) is only determined, and the exact creatinine clearance should be measured.

Men: Body weight (kg) x (140 - age (in years)) / (72 x serum creatinine concentration (mg / dl))

Women: 0.85 x value obtained by the above formula.

Creatinine clearance (ml / min) Dose of vancomycin (mg / day)
100 1545
90 1390
80 1235
70 1080
60 925
50 770
40 620
30 465
20 310
10 155

The initial dose of the drug should be 15 mg / kg of body weight, including for patients with mild to moderate renal failure.

In anuria, the initial dose of vancomycin 15 mg / kg of body weight should be prescribed until the serum concentration is reached. The maintenance dose is 1.9 mg / kg / day.

For patients with significant renal failure, it is recommended to prescribe 250-1000 mg of the drug 1 time per day with a break of several days.

Dosing regimen during hemodialysis

For patients who are on dialysis, the saturation dose is 1000 mg, and the maintenance dose is 1000 mg every 7–10 days. When using polysulfone membranes for hemodialysis, an increase in the maintenance dose of vancomycin is necessary.

Serum creatinine should be a constant indicator of kidney function. Otherwise, the creatinine clearance values ​​obtained are invalid. Monitoring the concentration of vancomycin in the blood serum in cases where the risk of toxicity exceeds the indicated parameters is recommended: 2 hours after infusion of 1 g of the drug, the peak concentration is 20-50 mg / l and the minimum concentration before the next dose is 5-10 mg / l. In the case when these indicators are exceeded, it is recommended to review the dosage.

Intro

Vancomycin is poorly absorbed after oral administration, so it can be prescribed in this way only for the treatment of pseudomembranous colitis caused by Clostridium difficile.

A solution for oral administration is prepared by adding 500 mg of 30 ml of water to the contents of the vial of vancomycin. The resulting solution can be administered orally or administered through a nasal tube. To improve the taste, sweet syrup with flavoring agents can be added to the solution.

Adults: The usual daily dose is 500-1000 mg, divided into 3-4 doses for 7-10 days. The maximum daily dose should not exceed 2 g.

Children: the usual daily dose is 40 mg / kg body weight, divided into 3-4 doses for 7-10 days. The maximum daily dose should not exceed 2 g.

Children.

Drug mo

Tags: Vancomycin