Active substanceCeftazidimeCeftazidime
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  • Dosage form: & nbsppowder for solution for intravenous and intramuscular administration
    Composition:
    one vial contains
    active substance: ceftazidime pentahydrate (in terms of ceftazidime) 0.5 g 1.0 g 2, 0 g
    auxiliary substance: sodium carbonate 0.05 g 0.1 g 0.2 g
    Description:powder white or white with a yellowish hue.
    Pharmacotherapeutic group:Antibiotic-cephalosporin
    ATX: & nbsp

    J.01.D.D.02   Ceftazidime

    Pharmacodynamics:
    Ceftazidime is an antibacterial agent from the group of cephalosporins of the third generation, has a broad spectrum and acts bactericidal, disrupting the final stages of bacterial cell wall synthesis due to irreversible binding to transpeptidases (penicillin-binding proteins); resistant to the action of most beta-lactamases. Effects on many strains resistant to ampicillin and other cephalosporins.
    It is active against gram-negative microorganisms: Pseudomonas spp.(including Pseudomonas aeruginosa), Klebsiella spp. (including Klebsiella pneumoniae), Proteus mirabilis, Proteus vulgaris, Escherichia coli, Enterobacter spp. (including Enterobacter aerogenes, Enterobacter cloacae), Citrobacter spp. (including Citrobacter diversus, Citrobacter freundii), Neisseria meningitidis, Haemophilus influenzae (including strains resistant to ampicillin), Serratia spp .; Gram-positive microorganisms: Staphylococcus aureus (penicillinase-producing strains sensitive to methicillin), Steptococcus pyogenes (group A beta-hemolytic (group B), Streptococcus pneumoniae, anaerobic bacteria: Bacteroides spp. (most strains of Bacteroides fragilis are resistant). in vitro against most strains: Acinetobacter spp., Haemophilus parainfluenzae, Morganella morganii, Neisseria gonorrhoeae, Providencia spp. (including Providencia rettgeri), Salmonella spp., Shigella spp., Staphylococcus epidermidis, Yersinia enterocolitica, Clostridium spp. (excluding Clostridium difficile) , Peptococcus spp., Peptostreptococcus spp.
    Ceftazidime is inactive for methicillin-resistant Staphylococcus spp., Streptococcus faecalis and many other Enterococci, Listeria monocytogenes, Campylobacter spp. and Clostridium difficile.
    Pharmacokinetics:After an intravenous (iv) bolus injection of 0.5 g and 1 g of ceftazidime, the average values ​​of the maximum serum concentrations are 42 mg / l and 90 mg / l, respectively. After intramuscular (IM) administration of 0.5 g or 1 g, the maximum serum concentrations, an average of 17 mg / ml and 39 mg / L, respectively, are achieved 1 hour after administration. Therapeutically significant concentrations in the blood plasma persist for 8-12 hours. After IV or IM injection ceftazidime quickly distributed in the human body.Antibiotic concentrations exceeding the MIC for sensitive microorganisms are achieved in most tissues and fluids, including synovial, intraocular, pericardial and peritoneal fluids, bile, sputum, urine, bone tissue, myocardium, gall bladder, skin and soft tissues; the diffusion of the drug is increased in inflammatory processes. Badly penetrates unchanged shells of the brain. With meningitis, the permeability through the blood-brain barrier increases, while therapeutic concentrations of 4-20 mg / l and higher are achieved in the cerebrospinal fluid. Passes through the placenta; in low concentrations penetrates into breast milk. Reversibly binds to plasma proteins (less than 10%). The degree of binding does not depend on the concentration of the antibiotic. Ceftazidime Do not displace bilirubin from complexes with plasma proteins. The volume of distribution is 0.21 -0.28 l / kg.
    It is excreted by the kidneys (90% of the administered dose unchanged for 24 hours) by glomerular filtration and tubular secretion. In adults with normal renal function, the serum half-life is -1.9 h.In neonates, especially premature babies, the half-life of ceftazidime from serum may be 3-4 times higher than in adults. The half-life of the tissues is greater than from the blood serum. In patients with impaired renal function, the elimination half-life increases, which requires dose adjustment and administration regimens (if creatinine clearance is less than 50 ml / min). Less than 1% of the drug is excreted with bile. The drug is not metabolized in the liver, a violation of the liver does not affect the pharmacokinetics of the drug. The dose in such patients remains normal.
    Indications:
    Infectious-inflammatory diseases caused by microorganisms sensitive to ceftazidime:
    - infections of the central nervous system (bacterial meningitis and cerebral abscess);
    - infections of LOP-organs (otitis media, mastoiditis, sinusitis, etc.);
    - Lower respiratory tract infections (bronchitis, infected bronchiectasis, pneumonia, lung abscess, pleural empyema, infections of the lungs in patients with cystic fibrosis);
    - infections of the abdominal organs and bile ducts (cholangitis, cholecystitis, gall bladder empyema, retroperitoneal abscesses, peritonitis, diverticulitis);
    - infections of the gastrointestinal tract (enterocolitis);
    - skin and soft tissue infections, wound and burn infections;
    - infections of bones and joints (osteomyelitis, septic arthritis);
    - Infections of the kidneys and urinary tract (pyelonephritis, pyelitis, kidney abscess, prostatitis, cystitis, urethritis, kidney infections in patients with urolithiasis);
    - infectious and inflammatory diseases of the pelvic organs in women (endometritis, pelvioperitonitis, salpingitis, parametritis, pelvic cellulitis); sepsis;
    - Dialysis related infections.
    Contraindications:
    Hypersensitivity to ceftazidime and other cephalosporins, penicillins.
    Carefully:Renal failure; with a history of colitis; malabsorption syndrome (increased risk of decreased prothrombin activity); the period of the newborn; in combination with loop diuretics and aminoglycosides.
    Pregnancy and lactation:
    There is no evidence to confirm embryotoxic or teratogenic effects of ceftazidime, however, during pregnancy (I trimester) it is used only on strict indications, with the belief that the potential benefit from the use for the mother exceeds the possible risk to the fetus.
    Ceftazidime in low concentrations into breast milk, so if necessary, use during lactation should decide the issue of termination of breastfeeding.
    Dosing and Administration:

    Vicef® is administered parenterally - intra / w and / m.

    In adults and children over 12 years of age Vitsefa® usual single dose of 1 g every 8-12 hours, or 2 g to 12 hours apart. The following doses, multiplicity and routes of administration are also recommended, which are determined by the localization and severity of the disease:

    - for uncomplicated urinary tract infections - 0.25 g every 12 hours in / in or / m;

    - with complicated infections of the urinary tract - 0.5 g every 8 or 12 hours in / in or / m;

    - with uncomplicated pneumonia, infections of the skin and soft tissues, infections of LOP-organ - 0.5-1 g every 8 hours iv or m;

    - with severe intra-abdominal or gynecological infections - 2 g every 8 hours IV;

    - with infections of bones and joints - 2 g every 12 hours in / in;

    - at a bacterial meningitis - on 2 g every 8 hours in / in;

    - in severe, life-threatening infections and febrile neutropenia - 2 g every 8 hours / in, or 3 g every 12 hours / in (maximum daily dose-d 6);

    - with severe pulmonary infection caused by Pseudomonas aeruginosa, in patients with cystic fibrosis and normal renal function - 30-50 mg / kg every 8 hours in / in.

    For the antibiotic prophylaxis of postoperative complications in operations on the prostate gland for Vitsefa®, when removing the urinary catheter, it is recommended to re-enter 1 g of Vitsef®.

    Children over 1 month. and up to 12 years usually administered at 30-50 mg / kg every 8 hours. For the treatment of bacterial meningitis, as well as treatment of infections in children with immunodeficiency or cystic fibrosis, the daily dose is 150 mg / kg (but not more than 6 g per day), which is divided into 3 injections.

    Newborns (children up to 1 month old) appoint 30 mg / kg every 12 hours in / in.

    Patients with impaired renal function require dose adjustment and administration regimens based on creatinine clearance. Treatment begins with the administration of 1 g of Vitsef® as the first loading dose. In the future, the supporting mode calculated as shown in the table:

    CK, ml / min

    50-31

    30-16

    15-5

    <5

    Mode

    1 g every 12 hours

    1 g every 24 h

    0.5 g every 24 hours

    0.5 g every 48 h

    For patients with severe infections in the background of chronic renal failure, the single doses indicated in the table (see above) can be increased by 50%, or the intervals between administrations can be shortened.In the future, correction of the dosing regimen is carried out based on sensitivity data of the isolated microorganisms, severity of the patient's condition and therapeutic monitoring data concentrations of ceftazidime in serum (the residual concentration should not exceed 40 mg / l).

    When hemodialysis: loading dose - 1 g, then 1 g after each hemodialysis procedures. When continuous hemodialysis using an arterio-venous shunt and with high-speed hemofiltration - 1 g / day daily (for one or more injections). When performing hemofiltration with a low rate, Vitsef® is prescribed in doses recommended for renal dysfunction (see table above). With peritoneal dialysis, 1 g (loading dose) is first administered, then 0.5 g once every 24 hours. In addition to intravenous or intravenous administration, it is possible to administer Vitsef® as part of a dialysis solution at the rate of 0.25 g of Vitsef® per 2 liters of dialysis solution. The introduction of Vitsef should be continued for another 2 days after the disappearance of the symptoms of infection. In cases of severe and complicated infections, a long course of treatment may be required.

    Vicef® is administered intravenously (by jet, drip) and by intramuscular injection.

    The dissolution of Vitsef® is accompanied by a slight exothermic reaction, in which carbon dioxide is released and a positive pressure is created in the vial. Carbon dioxide bubbles can be present in the finished solution, which does not affect the effectiveness of the drug. Light yellowing of the solution does not affect the efficiency.

    Intramuscular injection

    For intravenous administration, sterile Vietsef® powder is dissolved in sterile water for injection or a 0.5-1% solution of lidocaine hydrochloride (in the absence of indications of intolerance to local anesthetics of the amide type). The following minimum amounts of solvent are added directly to the bottle with a dry antibiotic powder:

    into a vial containing 0.5 g of Vitsef® 1.5 ml

    into a vial containing 1.0 g of Vitsef® 3.0 ml

    The resulting solution, an approximate concentration of ceftazidime in which 260 mg / ml, is administered intramuscularly to areas of the body with a pronounced muscular layer (upper to outer quadrant of the buttock or lateral surface of the thigh). It is recommended that an aspiration test be carried out to avoid undesirable introduction of the solution into the blood vessel.

    Intravenous administration

    For intravenous administration, Vitsef® is dissolved in sterile water for injection. The following amounts of solvent are added directly into the bottle with a dry powder of antibiotic:

    in a vial containing 0.5 g of Vitsef® 5.0 ml

    in a vial containing 1.0 g of Vitsef® 10 ml

    in a vial containing 2.0 g of Vitsef® 20 ml

    The resulting solution, an approximate concentration of ceftazidime in which 90 mg / ml, is administered ip slowly, for 3-5 minutes; it is possible to administer through a special node or port for injection of a system for intravenous infusions if the patient receives parenterally-compatible liquids with Vitsef®. For IV infusion, Vitsef® is dissolved, as for IV injections (see above). The resulting solution is added to a vial containing 50-100 ml of a compatible infusion medium. Enter through the system for IV infusions for at least 30 minutes. Vitsef® is compatible with 5% dextrose solution, 0.9% sodium chloride solution, 10% dextrose solution, an aqueous solution containing 0.225% sodium chloride and 5% dextrose; an aqueous solution containing 0.45% sodium chloride and 5% dextrose; an aqueous solution containing 0.9% sodium chloride and 5% dextrose; Ringer's solution;lactated Ringer's solution; 1/6 M sodium lactate solution; 10% solution of invert sugar; solution of "Normozol-M" with 5% glucose.

    Side effects:

    Allergic reactions: in 2% and less - a maculopapular rash, an itch, a fever; very rarely - angioedema, polymorphic erythema, Stevens-Johnson syndrome and toxic epidermal necrolysis.

    From the digestive system: in 2% or less - diarrhea, nausea, vomiting, abdominal pain, colitis, cholestasis; very rarely - jaundice, pseudomembranous colitis associated with Clostridium difficile.

    From the nervous system: in 1% and less - dizziness, headache; paresthesia; very rarely - convulsive seizures. Cases of neurological complications such as tremor, myoclonia, convulsions, encephalopathy and coma have been reported in patients with renal insufficiency, for which the dose of ceftazidime has not been correspondingly reduced.

    From the hematopoiesis: in 2% and less - eosinophilia, thrombocytosis; very rarely - transient leukopenia, neutropenia, thrombocytopenia, lymphocytosis, hemolytic anemia and agranulocytosis.

    From the urinary system: very rarely - interstitial nephritis, impaired renal function, renal failure.

    From the laboratory indicators: in 2% and less - a transient increase in the activity of "liver" transaminases (ACT, AJIT), alkaline phosphatase, LDH, false positive Coombs reaction without hemolysis; less than 1% - transient hypercreatininaemia, increased levels of urea and / or plasma creatinine.

    Local reactions: in 2% or less - pain and / or inflammation at the site of intravenous injection; with the / m introduction of soreness and compaction at the injection site.

    Other: less than 1% - fever, candidiasis of the oral cavity and candidal vaginitis.

    Overdose:An overdose of ceftazidime was observed in patients with renal insufficiency. Symptoms: increased convulsive activity, "fluttering" tremor, encephalopathy, neuromuscular excitability, coma. Treatment: symptomatic and supportive therapy. In case of severe overdose, the concentration of the drug in the blood can be reduced by hemodialysis.
    Interaction:With the simultaneous administration of Vitsef® with aminoglycosides, synergistic and additive effects are observed. In solution, it is pharmaceutically incompatible with aminoglycosides (significant mutual inactivation: with simultaneous application) and vancomycin (forms a precipitate depending on the concentration).If used simultaneously, do not mix them in a single syringe or one infusion medium; with the / m introduction to enter into different parts of the body; when administered intravenously, it is advisable to administer separately, observing a certain sequence with a time interval between injections (infusions), or use separate intravenous catheters. Do not use sodium bicarbonate solution as a solvent.
    Chloramphenicol and beta-lactam antibiotics, incl. ceftazidime, act antagonistically, therefore, their simultaneous application should be avoided.
    A solution of ceftazidime at a concentration of 4 mg / ml, prepared using a 5% dextrose solution or 0.9% sodium chloride solution, is compatible with a solution of cefuroxime sodium 3 mg / ml; heparin solution 10 IU / ml and 50 IU / ml, potassium chloride solution 10 mEq / l and 40 mEq / l. When mixing Vitsef® solution at a concentration of 20 mg / ml and metronidazole 5 mg / ml, both components remain active. In a concentration of 0.05 to 0.25 mg / ml ceftazidime compatible with a solution for peritoneal dialysis (lactate).
    Special instructions:When administered intramuscularly to patients with intolerance to local anesthetics of the amide type, 0.5% or 1% lidocaine solution can not be used as a solvent.
    If diarrhea occurs during treatment, Vitsef® should be alert to the possible development of pseudomembranous colitis. If a diagnosis of antibiotic-associated diarrhea or pseudomembranous colitis is established, discontinue Vietsef® immediately and prescribe appropriate treatment. As with other antibiotics, the use of Vitsef® can lead to colonization by an insensitive microflora and the development of superinfection. When determining glucose in urine by the method of Benedict or Felling, and also with the use of Klinist® is rare may false positive results are observed.
    Effect on the ability to drive transp. cf. and fur:Studies on the effect of ceftazidime on the performance of potentially hazardous activities requiring special attention and rapidity of reactions have not been conducted. Given the possible development of dizziness, when using ceftazidime, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular injection of 0.5 g, 1.0 g and 2.0 g.
    Packaging:
    0.5 g or 1.0 g of active substance into glass bottles with a capacity of 10 ml;
    2.0 g of active substance into glass bottles with a capacity of 20 ml.
    1. 1 bottle with the drug and instructions for use are put in a pack of cardboard.
    2. Five vials of the drug are packed in contour mesh packages from polyvinyl chloride film and aluminum foil foil or without foil. One contour mesh package and instructions for use are put in a pack of cardboard. The solvent is "Water for Injection" in ampoules of 5 ml or 10 ml.
    For a dosage of 0.5 g
    1. 1 bottle with the preparation and 1 ampoule with a solvent of 5 ml is packed in a contour mesh box made of polyvinylchloride film and foil of aluminum lacquered or without foil. One contour mesh package and instructions for use are put in a pack of cardboard.
    2. Five vials of the preparation complete with 5 ampoules of a 5 ml solvent are packed in contour Packaging of PVC film and aluminum foil lacquered or foil-free.One contour mesh package with the preparation, one circuit pack with a solvent and instruction for use is put in a pack of cardboard.
    For a dosage of 1.0 g
    1. 1 bottle of preparation and 1 ampoule with a solvent of 5 ml or 2 ampoules with a solvent of 5 ml, or 1 ampoule with a 10 ml solvent are packed in a contoured cell packaging made of polyvinylchloride film and foil, aluminum lacquered or without foil. One contour mesh package and instructions for use are put in a pack of cardboard.
    2. Five vials of the preparation complete with 5 ampoules of a 5 ml solvent or 10 ampoules of a 5 ml solvent or 5 ampoules of a 10 ml solvent are packaged in contoured cell packs made of polyvinyl chloride film and foil of aluminum lacquered or foil-free. One contour mesh package with the preparation, one circuit pack with a solvent and instruction for use is put in a pack of cardboard.
    For a dosage of 2.0 g:
    1. 1 vial of preparation and 1 ampoule with a 5 ml solvent or 4 ampoules with a 5 ml solvent or 2 ampoules with a 10 ml solvent are packaged in a contour mesh box made of polyvinyl chloride film and foil of aluminum lacquered or foil-free.One contour mesh package and instructions for use are put in a pack of cardboard.
    2. For 5 vials with the preparation complete with 5 ampoules of a solvent of 5 ml or 10 ampoules
    solvent in a volume of 10 ml is packed in contoured cell packs made of polyvinyl chloride film and foil of aluminum lacquered or without foil. One contour mesh package with the preparation, one circuit pack with a solvent and instruction for use is put in a pack of cardboard.
    Storage conditions:
    List B. In a dry, the dark place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000653 / 01
    Date of registration:20.12.2007 / 01.10.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:PREBAND PFC, LLCPREBAND PFC, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.02.2017
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