Active substanceCeftazidimeCeftazidime
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  • Dosage form: & nbspPowder for the preparation of solution for intravenous and intramuscular injection.
    Composition:
    Active substance:

    Ceftazidime Pentahydrate 0.5 g 1 g 2 grams

    (in terms of ceftazidime)

    Excipients:

    Sodium carbonate 0.05 g 0.1 g 0.2 g
    Description:White or white with a yellowish or yellowish-brownish tinge powder.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.D.02   Ceftazidime

    Pharmacodynamics:Cephalosporin antibiotic III generation for parenteral use. It acts bactericidal (it breaks the synthesis of the cell wall of microorganisms). Has a wide range of action. 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., Incl. Pseudomonas aeruginosa, Klebsiella spp., Incl.Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Escherichia coli, Enterobacter spp, including Enterobacter aerogenes, Enterobacter cloacae, Citrobacter spp, including Citrobacter diversus, Citrobacter freundii, meningitidis, Haemophilus influenzae (including the strains resistant to ampicillin)..;
    Gram-positive organisms: Staphylococcus aureus (and producing no penicillinase-producing strains that are sensitive to methicillin), Streptococcus pyogenes (group A beta-hemolytic streptococci), Streptococcus agalactiae (Group B), Streptococcus pneumoniae; anaerobic microorganisms: Bacteroides spp. (many strains of Bacteroides fragilis are resistant).
    Is inactive against methicillin-resistant Staphylococcus spp., Streptococcus faecalis, Enterococcus spp., Listeria monocytogenes, Campylobacter spp. and Clostridium difficile. It is active in vitro against most strains of the following organisms (the clinical significance of this activity is unknown): Clostridium perfringens not including Clostridium difficile, Acinetobacter spp., Haemophilus parainfluenzae, Morganella morganii, Neisseria gonorrhoeae, Peptococcus spp., Peptostreptococcus spp., Providencia spp., Providencia rettgeri , Salmonella spp .; Shigella spp., Staphylococcus epidermidis, Yersinia enterocolitica.
    Pharmacokinetics:The maximum concentration (Cmax) after intramuscular administration at doses of 0.5 and 1 g -17 and 39 mg / l, respectively, the time required to reach maximum concentration (TCmax) -1 hours. The Cmax after intravenous bolus administration in doses of 0.5, 1 and 2 g - 42, 69 and 170 mg / l, respectively. Therapeutically effective serum concentrations persist 8-12 hours after intravenous and intramuscular administration. The connection with plasma proteins is less than 10%. Concentrations of ceftazidime exceeding the minimum inhibitory concentrations for most commonpathogenic microorganisms, can be achieved in bone tissue, heart, bile, sputum, synovial fluid, intraocular, pleural and peritoneal fluids. It easily penetrates the placental barrier and is excreted in breast milk. In the absence of an inflammatory process in meningeal membranes ceftazidime poorly penetrates the blood-brain barrier, the concentration of the drug in the cerebrospinal fluid (CSF) is low. With meningitis in the cerebrospinal fluid, therapeutic concentrations of ceftazidime are achieved, which are 4-20 mg / l and higher. Ceftazidime not metabolized in the body. Half-life is about 2 hours, in newborns - 3-4 times more than in adults. Ceftazidime is excreted unchanged by the kidneys by glomerular filtration. Approximately 80-90% of the dose is excreted by the kidneys within 24 hours. Less than 1% of the drug is excreted with bile. If the renal function is impaired, the rate of excretion of ceftazidime is reduced. With hemodialysis, the half-life is 3-5 hours.
    Indications:

    The drug is given to adults and children for the treatment of the following infectious diseases caused by microorganisms that are sensitive to the drug:

    severe infections, including nosocomial (septicemia, bacteremia, peritonitis, meningitis, infections in patients with reduced immunity, infected burns); infection of bones and joints: septic arthritis, osteomyelitis, bacterial bursitis;

    infections of the respiratory tract: acute and chronic bronchitis, infected bronchiectasis, pneumonia caused by gram-negative bacteria, lung abscess, pleural empyema, infections of the lungs in patients with cystic fibrosis;

    urinary tract infections: acute and chronic pyelonephritis, pyelitis, prostatitis, cystitis, urethritis (bacterial only), kidney abscess;

    skin and soft tissue infections: mastitis, wound infections, skin ulcers, phlegmon, erysipelas; infections of the gastrointestinal tract, abdominal cavity and biliary tract: enterocolitis, retroperitoneal abscesses, diverticulitis, pelvic inflammatory disease, cholecystitis, cholangitis, empyema of the gallbladder;

    infection of female genital organs;

    infections of the ear, throat, nose: otitis media, sinusitis, mastoiditis, etc .;

    gonorrhea (especially with increased sensitivity to antibacterial drugs from the penicillin group).

    Contraindications:Hypersensitivity to ceftazidime and other components of the drug; increased sensitivity to other cephalosporin antibiotics and penicillins.
    Carefully:Renal failure, neonatal period, colitis in history, malabsorption syndrome (increased risk of decreased prothrombin activity, especially in those with severe renal and / or liver failure), simultaneous administration with loop diuretics and aminoglycosides.
    Pregnancy and lactation:When pregnancy is used only if the intended benefit for the mother exceeds the potential risk to the fetus. When using the drug during lactation, breast-feeding should be discontinued.
    Dosing and Administration:

    Ceftazidime is used only parenterally. The dose of the drug is determined individually, taking into account the severity of the disease, localization, type of pathogen and its sensitivity to the drug, the age of the patient and the function of the kidneys. The drug is administered intravenously or deeply intramuscularly into the region of the upper outer quadrant of the gluteus maximus or to the region of the lateral part of the thigh. The solution of ceftazidime can be injected directly into the vein or into the tube of the infusion system.

    Usual dose for adults and children over 12 years of age is 1 g intramuscularly or intravenously every 8-12 hours.

    - with uncomplicated infections of the urinary tract intramuscularly or intravenously, 250 mg every 12 hours;

    - with complicated infections of the urinary tract intramuscularly or intravenously, 500 mg-1 g every 8-12 hours;

    - with uncomplicated pneumonia infections of the skin and soft tissues intramuscularly or intravenously, 500 mg - 1 g every 8 hours;

    - in cystic fibrosis, respiratory tract infections caused by Pseudomonas spp. from 100 to 150 mg / kg / day, the frequency of administration - 3 times a day (dose up to 9 g / day in such patients did not cause complications);

    - for infections of bones and joints, intravenously, 2 g every 12 hours;

    - In severe infections, including intrahospital intravenously, 2 g every 8 hours;

    - with extremely severe or life-threatening infections, intravenously, 2 g every 8 hours. Older patients with a maximum daily dose should not exceed 3 g.

    Patients with renal insufficiency require a dose reduction, since ceftazidime is excreted by the kidneys unchanged.

    The initial dose is 1 g. The maintenance dose is selected depending on the rate of glomerular filtration.

    Supportive doses of ceftazidime in renal failure are presented in the table.

    CREATINE CREATININE

    DOSE

    > 50 ml / min (0.83 ml / s)

    See section "Usual dose for adults and children over 12 years"

    35-50 ml / min (0.52 - 0.83 ml / sec)

    1 g every 12 h

    16-30 ml / min (0.27-0.50 ml / s)

    1 g every 24 h

    6-15 ml / min (0.10-0.25 ml / s)

    500 mg every 24 hours h

    <5 ml / min (0.08 ml / s)

    500 mg every 48 hours

    Patients undergoing hemodialysis

    1 g after each hemodialysis session

    Patients undergoing peritoneal dialysis

    500 mg every 24 hours

    Patients with severe infections you can increase the maintenance dose by 50% or increase the frequency of administration of the drug. In this case, the level of ceftazidime should be monitored in serum, the serum concentration of ceftazidime should not exceed 40 mg / l.

    For children The creatinine clearance is calculated according to the ideal mass or surface area of ​​the body.

    The half-life of the drug during hemodialysis is 3-5 hours. The appropriate dose of the drug should be repeated after each period of dialysis.

    When peritoneal dialysis a drug ceftazidime can be included in the dialysis solution at a dose of 125 mg to 250 mg per 2 liters of dialysis solution.In patients with renal insufficiency, on continuous hemodialysis using an arteriovenous shunt, and in patients on high-speed haemofiltration in the intensive care unit, the recommended dose is 1 g daily for one or more injections.

    Patients on low-speed haemofiltration are prescribed doses recommended for renal dysfunction.

    Usual dose for children:

    Children under 2 months prescribe 25 - 60 mg / kg per day (in 2 injections).

    Children from 2 months to 12 years appoint 30-100 mg / kg per day (in 2-3 injections), children with reduced immunity, cystic fibrosis and meningitis - 150 mg / kg per day (in 3 injections).

    The maximum daily dose for children is 6 g.

    Duration of treatment

    The duration of treatment with ceftazidime is 7-14 days. In infections caused by Pseudomonas aeruginosa (pneumonia, cystic fibrosis, meningitis) treatment course can be increased up to 21 days.

    Preparation of solutions

    1. "PRIMARY "DISTRIBUTION

    DOSAGE

    VOLUME OF SOLVENT WHEN INTRINSICALLY INTRODUCED

    SOLVENT VOLUME IN INTRAVENOUS INTRODUCTION

    500 mg

    1.5 ml of water for injection or 0.5% or 1% solution of lidocaine hydrochloride

    5 ml of water for injection

    1.0 g; 2.0 g

    3 ml of water for injection or 0.5% or 1% solution of lidocaine hydrochloride

    10 ml of water for injection

    2. "SECONDARY "BREEDING

    For intravenous DROPS introduction, as described above the solution of the preparation is further diluted in 50 - 100 ml of one of the following solvents intended for intravenous administration:

    - 0.9% solution of sodium chloride,

    - Ringer's solution,

    - 5%, 10% glucose solution (dextrose),

    - 5% glucose solution (dextrose) with 0.9% sodium solution chloride.

    When the powder is dissolved, carbon dioxide is released. After the introduction of the solvent, the vial must be shaken to obtain a clear solution. In the final solution prepared, small bubbles of carbon dioxide may be present.

    The resulting solution may have a color from light yellow to dark yellow. If all the recommended rules for dilution of the drug are observed, then its effectiveness does not depend on the shade.

    Use only freshly prepared solution!

    Side effects:

    Allergic reactions: urticaria, chills or fever, rash, itching, bronchospasm, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), angioedema, anaphylactic shock.

    From the nervous system: headache, dizziness, paresthesia, convulsive seizures, encephalopathy, "fluttering" tremor.

    From the genitourinary system: candidiasis vaginitis.

    From the urinary system: renal dysfunction, toxic nephropathy.

    From the digestive system: nausea, vomiting, diarrhea, abdominal pain, colitis, cholestasis, oropharyngeal candidiasis, flatulence, dysbiosis, stomatitis, glossitis, pseudomembranous colitis.

    From the hematopoiesis: eosinophilia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, lymphocytosis, granulocytopenia, hemolytic anemia, hemorrhages.

    Laboratory indicators: hyperkreatininemia, increased urea concentration, false positive urine reaction to glucose, increased activity of "liver" transaminases and alkaline phosphatase, hyperbilirubinemia, false positive Coombs' reaction, an increase in prothrombin time.

    Local reactions: with intravenous phlebitis; when administered intramuscularly - soreness, burning, compaction at the injection site.

    Other: nosebleeds, superinfection.

    Overdose:
    Symptoms: pain, inflammation, phlebitis at the injection site, dizziness, paresthesia, headache, convulsions in patients with renal insufficiency, hypercreatininaemia, hyperbilirubinemia, thrombocytosis, thrombocytopenia, eosinophilia, leukopenia, lengthening prothrombin time.
    Treatment: symptomatic, in the case of renal failure - peritoneal dialysis or hemodialysis.
    Interaction:
    Pharmaceutically incompatible with heparin.
    It is pharmaceutically incompatible with aminoglycosides (significant mutual inactivation: with simultaneous use, these drugs should be administered to different parts of the body) and vancomycin (forms a precipitate depending on the concentration, if necessary, administer two drugs through a single tube, between their use of the system for intravenous administration should be washed) . Do not use sodium bicarbonate solution as a solvent (carbon dioxide is formed, this may require the gas to be discharged outside).
    "Loop" diuretics, aminoglycosides, vancomycin, clindamycin reduce the clearance of ceftazidime, as a result of which the risk of nephrotoxic action increases. Bacteriostatic antibiotics (incl. chloramphenicol) reduce the effect of the drug.Pharmaceutically compatible with the following solutions: at a concentration of up to 40 mg / ml - sodium chloride 0.9%, sodium lactate, Hartmann's solution, dextrose 5 %, sodium chloride 0.225% and dextrose 5 %, sodium chloride 0.45% and dextrose 5 %, sodium chloride 0.9% and dextrose 5 %, sodium chloride 0.18% and dextrose 4 %, dextrose 10 %, dextran 40:10% in a solution of sodium chloride 0.9%, dextran 40:10% in a solution of 5% dextrose, dextran 70: 6% in a solution of sodium chloride 0.9%, dextran 70: 6% in a 5% dextrose solution.
    At a concentration of 0.05 to 0.25 mg / ml ceftazidime compatible with the solution for intraperitoneal dialysis (lactate).
    For the / m introduction ceftazidime can be diluted with a solution of lidocaine hydrochloride 0.5% or 1%. Both components retain activity if added to the following solutions (concentration of ceftazidime 4 mg / ml): hydrocortisone (hydrocortisone sodium phosphate) 1 mg / ml in a 0.9% sodium chloride solution or 5% dextrose solution, cefuroxime (cefuroxime 3 mg / ml in a solution of sodium chloride 0.9%, cloxacillin (cloxacillin sodium) 4 mg / ml in a solution of sodium chloride 0.9%, heparin 10 IU / ml or 50 IU / ml in a solution of sodium chloride 0.9 %, potassium chloride 10 mEq / L or 40 mEq / L in a solution of sodium chloride 0.9%.When mixing ceftazidime solution (500 mg in 1.5 ml of water for injection) and metronidazole (500 mg / 100 ml), both components remain active.
    Special instructions:
    Patients who had a history of allergic reactions to penicillins may have increased sensitivity to cephalosporin antibiotics. During treatment can not be used ethanol.
    When using the drug and after 2-3 weeks after discontinuation of treatment, it is possible to develop diarrhea caused by Clostridium difficile. In mild cases, it is sufficient to cancel the treatment and apply the ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin, bacitracin or metronidazole. Do not use drugs that inhibit the intestinal motility.
    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions due to the risk of dizziness.
    Form release / dosage:
    Powder for solution for intravenous and intramuscular injection 0.5 g, 1 g, 2 g.


    Packaging:For 0.5 g, 1 g of active substance in bottles with a capacity of 10 ml or 20 ml, 2 g of active substance in bottles with a capacity of 20 ml.
    For 1, 5 or 10 vials with instructions for use are placed in a pack of cardboard. 50 bottles are placed in a carton box with an equal number of instructions for use for delivery to hospitals.
    Storage conditions:In a dry, protected from light 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 expiry date printed on the package!
    Terms of leave from pharmacies:On prescription
    Registration number:P N002274 / 01-2003
    Date of registration:22.04.2008
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp09.11.2015
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