Vero-Vancomycin lyophilizate for infusion solution 1 g

The bactericidal effect of vancomycin results from the inhibition of cell wall biosynthesis. In addition, vancomycin can change the permeability of the bacterial cell membrane 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 viridans, Enterococcus spp. (including Enterococcus faecalis), Clostridium difficile (including toxigenic strains involved in pseudomembranous enterocolitis) and Corinebacterium spp. 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 viridans.

Vancomycin is inactive in vitro against Gram-negative microorganisms, mycobacteria and fungi.

Indications

Active ingredient

Composition

1 vial contains vancomycin (in the form of hydrochloride) 1000 mg.

How to take, the dosage

When administering vancomycin, the recommended concentration is no more than 5 mg/ml and the rate of administration is no more than 10 mg/min. In patients indicated for fluid restriction, concentrations up to 10 mg/ml and an infusion rate not exceeding 10 mg/min may be used. However, with such concentrations, there is an increased likelihood of adverse events associated with rapid infusion of the drug.

Adults

The drug should be administered 2 g by IV (500 mg every 6 h/ 1 g every 12 h). Each dose should be given at a rate of no more than 10 mg/min and for at least 60 minutes.

The patient’s age and obesity may require modification of the usual dose based on determination of serum vancomycin concentrations.

Children

The drug should be administered at 10 mg/kg by IV every 6 hours. Each dose should be administered for at least 60 minutes.

For newborns, the starting dose is 15 mg/kg, followed by 10 mg/kg every 12 hours for the first week of life. From the second week of life, every 8 hours until one month of age. Each dose should be administered for at least 60 minutes.

Interaction

Errhyma, skin redness and anaphylactoid reactions have been reported with concomitant intravenous administration of vancomycin and anesthetics, and there may be a risk of BP decrease or development of neuromuscular block. Administration of vancomycin as a 60-minute infusion prior to anesthetic administration may reduce the likelihood of these reactions.

. When other potentially ototoxic and/or nephrotoxic drugs (aminoglycosides, amphotericin B, acetylsalicylic acid or other salicylates, bacitracin, capreomycin, carmustine, paramomycin, cyclosporine, loop diuretics, polymyxin B, cisplatin, etacrynic acid) are used concurrently and/or sequentially systemically or topically, close monitoring of the possible development of these symptoms is required.

Colestyramine decreases the activity of vancomycin.

Antihistamines, meclosine, phenothiazines, thioxanthenes may mask the symptoms of ototoxic effects of vancomycin (tinnitus, vertigo).

The 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 physically incompatible when mixed. The likelihood of precipitation increases with increasing vancomycin concentration. The IV system should be adequately flushed between applications of these antibiotics. In addition, it is recommended that the concentration of Vero-vancomycin be reduced to 5 mg/ml or less.

Special Instructions

The rapid administration of vancomycin (within a few minutes) may be accompanied by a marked decrease in BP 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.

Vancomycin should be administered with caution to patients with an allergy to teicoplanin because cross-allergies have been reported.

Patients receiving vancomycin intravenously should have periodic blood tests and monitor renal function.

Vancomycin should be used with caution in patients with renal impairment (determine vancomycin serum concentrations in patients over 60 years of age with renal impairment) because high, long lasting concentrations of the drug in the blood may increase the risk of toxic effects of the drug (Cmax should not exceed 40 µg/mL and minimum 10 µg/mL, concentrations >80 µg/ml are considered toxic). For patients with renal insufficiency, vancomycin doses should be adjusted individually.

Vancomycin is an irritant and therefore diffusion of the dissolved drug through the vascular wall may cause necrosis of adjacent tissue. Thrombophlebitis may occur; this can be reduced by slow administration of dilute solutions (2.5-5 g/l) and by alternating the points of administration
of the drug.

Contraindications

With caution, the drug should be used in case of hearing impairment (including history), in the second and third trimesters of pregnancy.

Side effects

Urinary system disorders: interstitial nephritis, changes in functional renal 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 concomitant treatment with other drugs with possible development of ototoxicity, such as aminoglycosides.

Cardiovascular system: cardiac arrest, flushes, decreased BP, shock (symptoms mainly associated with rapid infusion of the drug), vasculitis, thrombophlebitis.

Digestive system disorders: nausea, pseudomembranous colitis.

Hematopoietic system: agranulocytosis, eosinophilia, neutropenia, thrombocytopenia.

Dermatological reactions: exfoliative dermatitis, rash.

Allergic reactions: Urticaria, anaphylactoid reactions (associated with rapid infusion of drug), hypersensitivity reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, itchy dermatosis, benign (IgA) bullous dermatosis, diffuse exfoliative erythroderma (red man syndrome – upper body redness, chest and back pain and muscle spasm; reactions usually go away within 20 minutes after stopping the infusion, but can sometimes last up to several hours)

Other: Drug fever, pain, and tissue necrosis at injection sites.

Overdose

Symptoms: increased severity of side effects.

Treatment: corrective therapy to maintain glomerular filtration. Vancomycin is poorly removed by dialysis. There is evidence that hemofiltration and hemoperfusion via polysulfone ion-exchange resin leads to increased clearance of vancomycin.

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