VANZIMED [Vancomycin] 1 g Powder for the preparation of a solution for IV administration
VANZIMED
instructions for the medical use of the medicinal
product
Tradename
Vanzimed, Ванзимед
International
non-proprietary name or generic name
Vancomycin, Ванкомицин
Composition
Each bottle
contains:
Active substance: vancomycin (as vancomycin hydrochloride) 1 g.
Dosage form
Powder for preparation of
solution for injection.
Antibiotic, glycopeptide.
Pharmacodynamics
Antibiotic of the glycopeptide
group. Has a bactericidal effect. Violates the synthesis of the cell wall, the
permeability of the cytoplasmic membrane and the synthesis of RNA of bacteria.
Active against gram-positive bacteria: Staphylococcus spp. (including strains
producing penicillinase and methicillin-resistant strains), Streptococcus spp.,
Enterococcus spp., Corynebacterium spp., Listeria spp., Actinomyces spp.,
Clostridium spp. (including Clostridium difficile).
There was no cross-resistance
with antibiotics of other groups.
Pharmacokinetics
Distributed widely in
most tissues and body fluids. Poorly penetrates the BBB, however, with
inflammation of the meninges, permeability increases. Penetrates the placental
barrier. Plasma protein binding is 55%. T1 / 2 is 4-11 hours. 80-90% is excreted
in the urine, a small amount is excreted in the bile.
Indications for use
It is used for severe infections caused by sensitive
microorganisms; with an allergic reaction to penicillin; in case of intolerance
or lack of response to treatment with other antibacterial drugs, including
penicillins or cephalosporins; for infections caused by microorganisms
sensitive to vancomycin, but resistant to other antimicrobial drugs.
Endocarditis:
- caused by Streptococcus viridans or Streptococcus
bovis (as monotherapy or in combination with aminoglycosides);
- caused by enterococci, for example, Enterococcus
faecalis (only in combination with aminoglycosides);
- early endocarditis caused by Staphylococcus
epidermidis, Corynebacterium spp. after valve replacement (in combination with
rifampicin, aminoglycosides, or both);
- prevention of bacterial endocarditis in patients
with hypersensitivity reactions to antibacterial drugs of the penicillin series
and diseases of the heart valves (before dental and surgical procedures).
Sepsis.
Central nervous system infections (meningitis).
Bone and joint infections (including osteomyelitis).
Lower respiratory tract infections (pneumonia, lung
abscess).
Skin and soft tissue infections.
Contraindications
Hypersensitivity to vancomycin.
Acoustic neuritis.
Renal failure
Pregnancy (I trimester) and the period of breastfeeding.
Method of administration and dosage
For intravenous
administration. Cannot be administered as a bolus injection or intramuscularly
due to pain and possible necrosis at the injection site.
With the introduction
of Vanzimed, the recommended concentration is no more than 5 mg / ml and the
rate of administration is no more than 10 mg / min. In patients who are shown
to restrict fluid intake, a concentration of up to 10 mg / ml and an
administration rate not exceeding 10 mg / min can be used. However, in the case
of such concentrations, the likelihood of developing side effects associated
with infusion increases.
Adults:
The dose for patients with
normal renal function is 2 g IV (500 mg every 6 hours or 1 g every 12 hours).
Each dose should be administered at a rate not exceeding 10 mg / min and for at
least 60 minutes. The maximum single dose is 1 g, the maximum daily dose is 2
g.
Children:
Newborns up to 7 days: the initial dose is 15 mg / kg
of body weight, then 10 mg / kg of body weight every 12 hours.
Newborns from 7 days to 1 month: the initial dose is
15 mg / kg of body weight, then 10 mg / kg of body weight every 8 hours.
Children over 1 month of age: The usual dose of the
drug is 10 mg / kg of 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 for children should not exceed 2.5–5 mg / ml. The solution should be
administered for at least 60 minutes.
Patients with impaired renal
function and elderly patients
Patients with impaired renal
function need to individually select the dose. Serum creatinine levels can be
used to adjust the dose for this group of patients.
In elderly patients,
vancomycin has a lower clearance and a higher volume of distribution. In this
group, dose selection is appropriate based on serum vancomycin concentrations.
In premature infants and in elderly patients, a significant dose reduction may
be required as a result of reduced renal function. Serum vancomycin
concentrations should be monitored regularly.
Preparation of the solution
The solution for injection is
prepared immediately before the administration of the drug.
The powder is dissolved in
water for injection: 500 mg in 10 ml, 1 g in 20 ml (the concentration of the
solution is 50 mg / ml). The resulting solution is diluted with 0.9% sodium
chloride solution or 5% dextrose solution: for 500 mg - 100 ml and for 1 g -
200 ml.
Before using the diluted
solution, ensure that there is no sediment or discoloration.
Special instructions and precautions
During or shortly after a
rapid infusion of the drug, patients may develop anaphylactoid reactions
(lowering blood pressure, up to shock and cardiac arrest, breathing sounds,
shortness of breath, skin rash, itching). Rapid administration of the drug can also
cause the "red man" syndrome (chills, fever, palpitations, flushing
of the upper half of the trunk and face, spasm of the muscles of the chest and
back). After stopping the infusion, reactions usually resolve within 20
minutes, but can sometimes last up to several hours. To avoid adverse reactions
associated with infusion, Vanzimed should be administered as a diluted solution
for at least 60 minutes.
Development of ototoxicity is
possible. Signs of ototoxicity can be temporary or permanent. Usually, ototoxicity
is observed in patients receiving high doses of the drug, as well as in
patients with a history of hearing impairment and renal failure, or in patients
receiving concomitant treatment with other drugs with possible development of
ototoxicity, for example, aminoglycosides.
It should be used with caution
in patients with renal insufficiency (Vanzimed doses should be set
individually; it is recommended to monitor vancomycin plasma concentrations in
patients over 60 years of age), since at high concentrations of the drug in the
blood that persist for a long time, the risk of ototoxic and nephrotoxic action
of the drug; the maximum concentration should not exceed 40 μg / ml, the minimum - 10 μg / ml, concentrations over 80 μg / ml are considered toxic.
Patients receiving Vanzimed
need to periodically conduct a blood test and monitor kidney function (general
urinalysis, creatinine and urea nitrogen).
When the drug is prescribed,
thrombophlebitis can be observed, the likelihood of their development can be reduced
by slowly introducing diluted solutions (2.5-5 g / l) and alternating the
injection sites.
Long-term use of the drug can
lead to the emergence of resistant strains of bacteria and the development of
superinfection.
When used in newborns
(including premature infants), it is recommended to control the concentration
of vancomycin in the blood plasma.
Influence on the ability to drive
vehicles and mechanisms
During the period of drug
treatment, the ability to concentrate may decrease, which should be taken into
account when driving vehicles or performing work that requires an increased
concentration of attention and speed of psychomotor reactions.
Application during pregnancy and during breastfeeding
Application during pregnancy is possible only for "vital"
indications if the expected benefit to the mother outweighs the potential risk
to the fetus. If it is necessary to use the drug during lactation,
breastfeeding should be discontinued for the period of drug treatment.
Interaction with other medicinal products
With the simultaneous use of
vancomycin and anesthetics, erythema and anaphylactoid reactions were noted
(including a decrease in blood pressure, rash, urticaria, and itching).
Administration of vancomycin as a 60-minute infusion prior to induction of
anesthesia may reduce the likelihood of these reactions.
If vancomycin is administered
on time or immediately after surgery, with the simultaneous use of muscle
relaxants (for example, suxamethonium iodide), then their effects
(neuromuscular blockade) can be enhanced and prolonged.
With the simultaneous and / or
sequential systemic or local use of other potentially ototoxic and / or
nephrotoxic drugs (aminoglycosides, amphotericin B, acetylsalicylic acid or
other salicylates, bacitracin, paromomycin, capreomycin, carmustine,
cyclosporine, "loop" diuretics, including ethacrynic acid , polymyxin
B, cisplatin) requires careful monitoring of the possible development of these
symptoms.
Cholestyramine reduces the
activity of vancomycin when taken orally.
Antihistamines, meclosine,
phenothiazines, thioxanthenes can mask the symptoms of the ototoxic effect of
vancomycin (tinnitus, vertigo).
Vancomycin solution has a low
pH, which can cause physical or chemical instability when mixed with other
solutions.
It is not recommended to mix
or simultaneously use a solution of vancomycin with chloramphenicol,
glucocorticosteroids, methicillin, aminophylline, cephalosporins and
phenobarbital.
Mixing with alkaline solutions
should be avoided.
Solutions of vancomycin and
beta-lactam antibiotics are pharmaceutically incompatible when mixed. The
likelihood of precipitation increases with increasing vancomycin concentration.
It is recommended to reduce the concentration of vancomycin to 5 mg / ml or
less.
Side effect
From the side of the cardiovascular system: lowering blood pressure,
shock, vasculitis, cardiac arrest.
From the gastrointestinal tract: nausea, pseudomembranous
colitis.
On the part of the organ of hearing and labyrinth
disorders: transient
or permanent hearing loss, hearing loss, dizziness, tinnitus.
From the respiratory system, chest and mediastinal
organs: shortness of breath,
breathing sounds.
Skin and subcutaneous tissue disorders: rash, itching, urticaria,
exfoliative dermatitis, benign (IgA) blistering dermatosis, pruritic
dermatosis, malignant exudative erythema (Stevens-Johnson syndrome), toxic
epidermal necrolysis.
From the side of the kidneys and urinary tract: renal failure, manifested
by an increase in the concentration of creatinine and urea nitrogen in the
blood serum, interstitial nephritis, acute renal failure.
From the side of the blood and lymphatic system: leukopenia, reversible
neutropenia, transient thrombocytopenia, agranulocytosis, eosinophilia,
pancytopenia, anemia.
From the immune system: anaphylactic reactions.
General disorders and disorders at the injection site:
phlebitis, hyperemia of the
upper half of the trunk and face, spasm of the muscles of the chest and back,
chills, drug fever, pain at the injection site, tissue necrosis at the
injection site.
If any of the side effects
indicated in the instructions are aggravated, or you notice any other side
effects not listed in the instructions, inform your doctor.
Overdose
Symptoms: side
effects may increase.
Treatment: symptomatic
therapy aimed at maintaining glomerular filtration. There is no specific
antidote. It is removed poorly during dialysis.
Storage conditions
Store at a
temperature not exceeding 25°C.
Keep out of the reach
of children!
Shelf life
2 years. Do not use
after the expiration date printed on the package.
Vacation conditions
Dispensed by prescription.
Release form
1 bottle with instructions for use in a cardboard box.