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Ceftazidime Sanita

Ceftazidime Sanita

International Nonproprietary Name:

Ceftazidime

Pharmaceutical form:

Solution for injection powder
  • Properties

    Pharmacological properties:

    Cephalosporin antibiotic of III generation for parenteral use. Acts bactericidal. The mechanism of action is determined with the ability of ceftazidime to disrupt the synthesis of the cell wall of microorganisms. Has a wide range of action.  Resistant to the action of most beta-lactamases.

    Ceftazidime is effective against gram-negative bacteria: Pseudomonas aeruginosa, Pseudomonas spp. (including Pseudomonas pseudomallei), Klebsiella spp. (Including Klebsiella pneumoniae), Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia spp, Escherichia coli, Enterobacter spp., Citrobacter spp., Serratia spp., Salmonella spp., Shigella spp., Yersinia enterocolitica, Pasteurella multocida, Acinetobacter spp., Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae (including ampicillin resistant strains); Gram-positive bacteria: Staphylococcus aureus (strains susceptible to methicillin), Staphylococcus epidermidis (strains sensitive to methicillin), Micrococcus spp., Streptococcus pyogenes (group A beta-hemolytic streptococcus), Streptococcus group B (Streptococcus agalactiae), Streptococcus pneumoniae, Streptococcus mitis, Streptococcus Spp., (Excluding Streptococcus faecalis); Anaerobic bacteria: Peptococcus spp., Peptostreptococcus spp., Streptococcus spp., Propionibacterium spp., Clostridium perfringens, Fusobacterium spp., Bacteroides spp., (Many strains of Bacteroides fragilis are resistant).

    Ceftazidime is not effective against methicillin-resistant staphylococci, Streptococcus faecalis and many other Enterococci, Listeria monocytogenes, Campylobacter spp. And Clostridum difficile. 

     

    Pharmacokinetics

    After the drug administartion, ceftazidime is rapidly distributed in the body and reaches therapeutic concentrations in most tissues and body fluids, including synovial, pericardial and peritoneal fluid, bile, sputum and urine. Ceftazidime is also distributed in the bones, myocardium, gallbladder wall, skin and soft tissues, creating concentrations sufficient for the treatment of infectious diseases, especially in inflammatory processes that enhance the diffusion of the drug. Penetrates through the placenta, excreted with breast milk.

    Ceftazidime poorly penetrates to the intact blood-brain barrier. When meningitis is detected in therapeutic concentrations in the cerebrospinal fluid.  Binding (reversible) to plasma proteins is 15%, while the degree of binding to plasma proteins does not depend on the concentration.  The maximum concentration in the blood plasma after intramuscular injection in a dose of 0.5, 1 g is achieved after 1 hour and is 17 μg / ml and 39 μg / ml, respectively; When administered intravenously at the same doses of 42 μg / ml and 69 μg / ml.           

    Therapeutic concentrations of ceftazidime in the blood plasma persist for 8-12 hours, while for 6-8 hours the concentration is 4 μg / ml.         

    The volume of distribution is 0.21-0.28 l / kg. Cefazidime accumulates in soft tissues, kidneys, lungs, bones, joints, serous cavities.

    Ceftazidime is not metabolized in the liver, a violation of liver function does not affect the pharmacodynamics and pharmacokinetics of the drug.  The dose in such patients remains normal.    It is excreted unchanged by kidneys to 80-90% (70% of the administered dose is excreted in the first 4 hours) within a day by glomerular filtration and tubular secretion in equal measure.   The half-life in patients with normal renal function is 1.8 hours.  In patients with impaired renal function, the elimination half-life is 2.2 hours.  In case of impaired renal function, a dose reduction is recommended. 

  • Indications

    Treatment of infectious-inflammatory diseases (mono-or mixed infections) caused by microorganisms sensitive to the drug:

    Severe infections (sepsis, septicemia, bacteremia, peritonitis, meningitis, infections in patients with reduced immunity and in patients in critical care unit, for example, infected burns);

    • infection of bones and joints (septic arthritis, osteomyelitis, bacterial bursitis);

    • infection of the respiratory tract (acute and chronic bronchitis, infected bronchiectasis, pneumonia caused by gram-negative microorganisms, lung abscess, pleural empyema);

    • infection of the urinary tract (acute and chronic pyelonephritis, pyelitis, prostatitis, cystitis, urethritis / bacterial /, kidney abscess); 

    • infection of the skin and soft tissues (mastitis, wound infections, skin ulcers, cellulitis, erysipelas, infected burns); 

    • infection of the gastrointestinal tract, biliary tract and abdominal cavity (peritonitis, enterocolitis, retroperitoneal abscesses, diverticulitis, pelvic inflammatory disease, cholecystitis, cholangitis, gallbladder empyema); 

    • gynecological infections;

    • infection of the ear, throat and nose (otitis media, sinusitis, mastoiditis);

    • gonorrhea (especially in patients with hypersensitivity to penicillins).

    • infection associated with hemodialysis and peritoneal dialysis, as well as with continuous ambulatory peritoneal dialysis.
  • Contraindications

    • hypersensitivity to cephalosporins;

    • hypersensitivity to penicillins;

    • lactation period.

  • Dosage and Administration

    Ceftazidime is intended only for parenteral administration. The dose is set individually, depending on the severity of the course of the disease, the type of pathogen, age, body weight, kidney function. The drug is administered intravenously or deep intramuscularly into the zone of the upper outer quadrant of the gluteus muscle or to the zone 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.

    Adults are appointed 1-6 g per day intravenously or intramuscularly; The frequency of administration is 2-3 times a day.

    With infections of the urinary tract appoint 0.5-1 g every 12 hours.

    For most infections, a dose of 1 g is effective every 8 hours or 2 g every 12 hours.

    In severe disease, especially in patients with reduced immunity, including patients with neutropenia, 2 g every 8 or 12 hours or 3 g every 12 hours should be assigned.

    Patients with cystic fibrosis and lung infections caused by pseudomonas are prescribed at a dose of 100-150 mg / kg per day; Multiplicity of administration - 3 times a day.

    In severe or life-threatening infections, the drug is prescribed intravenously, 2 g every 8 hours.

    In infections of bones and joints, the drug is administered intravenously 2 g every 12 hours.

    The maximum daily intake for adults is 6 g.

    For older patients, taking into account the reduced clearance of ceftazidime in acute diseases, it is recommended to prescribe at a dose of not more than 3 g per day, especially for patients older than 80 years.

    For children older than 2 months, the drug is prescribed in a dose of 30-50 mg / kg per day; The frequency of administration is 2-3 times a day. For children with reduced immunity, in cystic fibrosis or meningitis appoint up to 150 mg / kg per day (maximum 6 g per day); Multiplicity of injections - 3 times a day.

    For newborns and infants under 2 months of age, the drug is prescribed at a dose of 30 mg / kg per day; Multiplicity of injections - 2 times a day.

    Treatment should be continued for another 2 days after the disappearance of of infection symptoms. In complicated infections, the course of treatment can be continued if necessary.

    Adults with impaired renal function (including patients on hemodialysis) after the initial loading dosage of 1 g, dose should be reduced depending on the creatinine clearance.

     


    Creatinine clearance

    Dosage

    More than 50 ml/min

    (0, 83 ml/sec)

    Average recommended dosage

    35-50 ml/min

    (0.52-0.83 ml/sec)

    1g every 24 hours

    16-30 ml/min

    (0.27-0.5 ml/sec)

    1g every 24 hours

    6-15 ml/min

    (0.1-0.25 ml/sec)

    0.5g every 24 hours

    Less than 5 ml/min

    (0.08 ml/sec)

    0.5g every 48 hours

    Patients on hemodialysis

    1g after each session

    Patients on peritoneal dialysis

    0.5 g every 24 hours


     

    The doses shown in the table are approximate. For patients of this category is recommended to control ceftazidime level in serum, which should not exceed 40 mg / ml.

    The half-life of ceftazidime during hemodialysis is 3-5 hours. The appropriate dose of the drug should be repeated at the end of each dialysis procedure.

    In peritoneal dialysis, the drug can be included in dialysis fluid at a dose of 125 mg to 250 mg per 2 liters of dialysis fluid.

     

    Solution preparation. When the powder is dissolved, carbon dioxide is released. After the solvent administration, the bottle should be shaken to obtain a clear solution. In the obtained ready solution of the drug, small bubbles of carbon dioxide may be present. The resulting solution can have a color from light yellow to dark yellow. If all the recommended dilution rules of the drug are observed, then its effectiveness does not depend on the color of the obtained solution.

     

     

    1. "PRIMARY DISTRIBUTION"

    250 mg

    1 ml of water for injection with intramuscular injection

    2.5 ml of water for injection with intravenous injection

    500 mg

    1.5 ml of water for injection with intramuscular injection

    5 ml of water for injection with intravenous injection

    1,0 g

    3 ml of water for injection with intramuscular injection

    10 ml of water for injection with intravenous injection

    2.0 g

    -

    10 ml of water for injection with intravenous injection

    2. "SECONDARY DISTRIBUTION"

    For intravenous DROP infusion, the solution of Ceftazidime prepared as described above 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 chloride solution, 5% sodium bicarbonate solution. Use only freshly prepared solution!
  • Drug form

    Powder for the preparation of an injection of 1.0 g in vials.