Vancomycin J Lyophilizate for infusion solution 1 g
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Antibiotic of tricyclic glycopeptide group, isolated from Amycolatopsis orientalis, effective against many Gram-positive microorganisms.
Bactericidal effect of vancomycin is manifested by the inhibition of cell wall biosynthesis. In addition, vancomycin can change the permeability of the cell membrane of bacteria and RNA synthesis. There is no cross-resistance between vancomycin and antibiotics of other classes.
In vitro vancomycin is active against Gram-positive microorganisms, including Staphylococcus aureus, Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains), Streptococcus pyogenes, Streptococcus pneumoniae (including penicillin-resistant strains), Streptococcus agalactiae, Streptococcus bovis, Streptococcus spp. viridians, Clostridium difficile (including toxigenic strains involved in the development of pseudomembranous colitis) and Corynebacterium spp. Acts bacteriostatic on Enterococcus spp. (including Enterococcus faecalis and Enterococcus faecium (most strains of E. faecium have intermediate sensitivity to vancomycin)). Optimum action is at pH 8, at lowering pH to 6 the effect decreases sharply. It is active only against microorganisms at the stage of reproduction. Other microorganisms that are sensitive to vancomycin in vitro include Listeria monocytogenes, Lactobacillus spp., Actinomyces spp., Clostridium spp., Bacillus spp.
In vitro some isolated strains of enterococci and staphylococci show resistance to vancomycin. The combination of vancomycin and aminoglycosides shows synergism in vitro against many strains of Staphylococcus aureus, Streptococcus spp. (not belonging to enterogroup D), Enterococcus spp, Streptococcus spp. viridians.
Vancomycin is inactive in vitro against Gram-negative microorganisms, mycobacteria, viruses, protozoa and fungi.
Vancomycin is used for serious or severe infections caused by susceptible microorganisms, including Staphylococcus spp. (including penicillin- and methicillin-resistant strains), Streptococcus spp., (including penicillin-resistant strains), in allergic reaction to penicillin, in intolerance to other antimicrobials.
1 vial contains:
- Active ingredient: vancomycin hydrochloride (activity 900 µg/mg) 1025.4 mg* equivalent to vancomycin 1000.0 mg
* Each vial contains 0.02% edetic acid (EDTA), which is part of the substance.
- Solvent: water for injection – 10.0 ml.
How to take, the dosage
Vancomycin is not intended for intramuscular and bolus injections and is administered intravenously by infusion.
When administered intravenously, vancomycin recommended concentration is no more than 5 mg/ml and the rate of administration is no more than 10 mg/min.
Adults should administer the drug 2 g intravenously per day (500 mg every 6 hours and/or 1 g every 12 hours). Each dose should be given at a rate not exceeding 10 mg/min for at least 60 min. The maximum single dose is 1000 mg, the maximum daily dose is 2000 mg.
In children over 1 month old the drug should be administered 10 mg/kg v/v every 6 hours. Each dose should be administered for at least 60 minutes.
For newborns the initial dose is 15 mg/kg and 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 one month. Each dose should be administered for at least 60 minutes. When administering to newborns it is advisable to monitor serum concentration.
The maximum single dose for children is 15 mg/kg of body weight, the daily dose for a child should not exceed the daily dose for an adult (2 g).
In patients with obesity the drug is used in usual doses.
Patients with renal dysfunction should choose the dose individually. The serum creatinine clearance (CK) can be used to adjust the dose of vancomycin for this group of patients.
Correction by increasing the intervals between the injections
It is reasonable to correct the dose for patients with significant renal insufficiency by increasing the intervals between the injections: at CK 10-50 ml/min – 1 g every 3-7 days, at CK < 10 ml/min – 1 g every 7-14 days.
In premature infants and elderly patients as a result of decreased renal function a significant dose reduction may be required.
When concomitant use of vancomycin with local anesthetics in children erythema, skin redness and anaphylactoid reactions were noted, in adults – disorders of intracardiac conduction.
Concurrent use with general anesthetics and vecuronium bromide increases the frequency of adverse effects (risk of reduced blood pressure, development of neuromuscular blockade). Administration of vancomycin at least 60 min before anesthetic administration may reduce the likelihood of these reactions.
. If other potentially ototoxic and/or nephrotoxic drugs (aminoglycosides, amphotericin B, acetylsalicylic acid or other salicylates, bacitracin, bumetanide, capreomycin, carmustine, paramomycin, cyclosporine, “loop” diuretics, polymyxine B, cisplatin, etacrynic acid) are used concurrently and/or sequentially, close monitoring for the possible development of these symptoms is required.
Colestiramine reduces the effectiveness of vancomycin (when taken orally). Antihistamines, meclosine, phenothiazines, thioxanthenes may mask the symptoms of ototoxic effects of vancomycin (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.
Vancomycin and beta-lactam antibiotic solutions are pharmaceutically incompatible when mixed. The likelihood of precipitation increases with increasing vancomycin concentration. The IV system should be thoroughly flushed between applications of these antibiotics. In addition, it is recommended to reduce the vancomycin concentration to 5 mg/ml or less.
Rapid administration of vancomycin (within a few minutes) may be accompanied by a marked decrease in blood pressure and, in rare cases, cardiac arrest. Vancomycin should be administered as a diluted solution for at least 60 minutes to avoid adverse reactions associated with rapid infusion.
Patients receiving vancomycin by IV should periodically perform blood tests and monitor renal function.
When prescribing the drug to newborn children (especially premature infants), it is desirable to monitor the concentration of vancomycin in the blood serum.
Vancomycin is used in severe or severe infections caused by susceptible microorganisms, including Staphylococcus spp. (including penicillin- and methicillin-resistant strains), Streptococcus spp. (including penicillin-resistant strains) with allergic reaction to penicillin and intolerance to other antimicrobials.
Vancomycin should be used with caution in patients with renal insufficiency (determine vancomycin serum concentrations in patients older than 60 years), because high, long-lasting concentrations of the drug in the blood may increase the risk of manifestation of toxic effects of the drug (maximum serum vancomycin concentrations (Cmax) should not exceed 40 microgram/ml and minimum – 10 microgram/ml, concentration >80 µg/ml is considered toxic).
For patients with renal insufficiency, vancomycin doses should be adjusted individually.
Thrombophlebitis may occur when the drug is prescribed; the likelihood of their development can be reduced by slow administration of dilute solutions (2.5-5 g/L) and alternation of drug administration sites.
During the drug treatment ability to concentrate may decrease, which should be taken into account when driving vehicles or performing works requiring high concentration and quick psychomotor reactions.
- high sensitivity to vancomycin;
- hearing nerve neuritis.
Hearing impairment (including history. In the anamnesis), renal failure, pregnancy (I, II and III trimester), patients with an allergy to teicoplanin (possibility of cross-allergy).
Cardiovascular system: cardiac arrest, blood “flushes”; decreased blood pressure, shock (symptoms are mainly associated with rapid infusion of the drug), vasculitis, thrombophlebitis.
Digestive system: nausea, pseudomembranous colitis.
Blood system: agranulocytosis, eosinophilia, neutropenia, thrombocytopenia.
Urinary system: interstitial nephritis, altered renal function tests, renal dysfunction.
Sensory organs: vertigo, tinnitus, ototoxic effects (transient/permanent). In most cases ototoxic effects were observed among patients who received excessive doses of vancomycin, with a history of hearing loss or in patients who received simultaneous treatment with other drugs with possible development of ototoxicity, such as aminoglycosides.
Dermatological reactions: exfoliative dermatitis, rash.
Allergic reactions: Urticaria, anaphylactoid reactions (associated with rapid infusion of the drug), hypersensitivity reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, itchy dermatosis, benign vesicular dermatosis, diffuse exfoliative erythroderma (red man syndrome – upper body redness, pain and muscle spasm in chest and back; After cessation of the infusion, reactions usually subside within 20 minutes, but may sometimes last up to several hours)
Other: drug fever, injection site phlebitis, injection site necrosis, dyspnea, stridor, injection site pain; drug rash accompanied by eosinophilia and systemic manifestations (DRESS syndrome), increased “liver” transaminase activity, pancytopenia, anemia, leukopenia.
Symptoms: increased severity of dose-dependent adverse events.
Treatment: symptomatic therapy to maintain glomerular filtration. Vancomycin is poorly removed by dialysis. There is evidence that hemofiltration and hemoperfusion through polysulfone ion exchange resin leads to increased clearance of vancomycin.
Jodas Expoim Pvt. Ltd, India
Jodas Expoim Pvt. Ltd
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