Active substanceCeftazidimeCeftazidime
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  • Dosage form: & nbsp
    Powder for solution for intravenous administration.

    Composition:
    Active substance: ceftazidime pentahydrate 2.33 g

    in terms of ceftazidime - 2.0 g;

    Excipient: sodium carbonate - 0.236 g.

    Description:Powder from white to white with a yellowish hue of color.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.D.02   Ceftazidime

    Pharmacodynamics:

    Third-generation cephalosporin antibiotic. It has a bactericidal effect, disrupting the synthesis of the cell wall of microorganisms. A wide spectrum of pathogenic pathogens is sensitive to ceftazidime, including strains resistant to gentamycin and other aminoglycosides. Ceftazidime is resistant to the action of most β-lactamases of Gram-positive and Gram-negative bacteria.

    Active in vitro against the following microorganisms:

    Gram-negative: Pseudomonas aeruginosa, Pseudomonas spp. (including Pseudomonas pseudomallei), Klebsiella spp. (including Klebsiella pneumoniae), Proteus mirabilis, Proteus vulgaris, Morganella morganii, Proteus retlgeri, 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 strains resistant to ampicillin). Haemophilus parainfluenzae (including strains resistant to ampicillin). Gram-positive: Staphylococcus aureus (strains sensitive to methicillin), Staphylococcus epidermidis (strains sensitive to methicillin), Micrococcus spp., Streptococcus pyogenes (β-hemolytic group streptococcus A), Streptococcus group B (Streptococcus agalactiae), Streptococcus pneumoniae, Streptococcus mitis, Streptococcus spp. (excluding Streptococcus faecalis).

    Anaerobes: Peptococcus spp., Pcptostreptococcus spp., Propionibacterium spp., Clostridium perfringens, Fusobacterium spp., Bacteroides spp. (many strains Bacteroides fragilis are resistant).

    Inactive against the following microorganisms:

    Methicillin-resistant staphylococci, Streptococcus faecal is and many others Enterococci, Listeria monocytogenes, Campylobacter spp., Clostridium difficile. The prevalence of acquired resistance to ceftazidime varies depending on the region and over time, in certain types of microorganisms, resistance can be very high. It is preferable to have local sensitivity data, especially when treating severe infections.

    Pharmacokinetics:
    Five minutes after intravenous bolus administration at a dose of 0.5 g, 1 g and 2 g, the maximum concentration (C max) is 46 mg / L, 87 mg / L and 170 mg / L, respectively.
    Therapeutically effective concentrations of ceftazidime remain in the plasma 8-12 hours after intravenous administration.
    The connection with plasma proteins is about 10%.
    Concentrations of ceftazidime that exceed the minimum inhibitory concentrations for most common pathogens can be achieved in bone tissue, heart, bile, sputum, synovial fluid, intraocular fluid, pleural and peritoneal fluids. Ceftazidime easily penetrates the placenta and 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 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.
    The half-life period is about 2 hours. It is excreted unchanged by kidneys by glomerular filtration, about 80-90% of the administered dose is excreted within 24 hours. If renal function is impaired, the rate of excretion of ceftazidime decreases. Less than 1% of the drug is excreted with bile.In newborns, the half-life is longer than in adults 3-4 times.

    Indications:Infectious-inflammatory diseases caused by susceptible to ceftazidime pathogens:

    - severe infections, including intraepithelial (septicemia, bacteremia, peritonitis, meningitis, infections in patients with immunodeficiency, infected burns);

    - infections of the respiratory tract, including lung infections in patients with cystic fibrosis;

    - infection of ENT organs;

    - urinary tract infections;

    - infections of the skin and soft tissues;

    - infections of the gastrointestinal tract, biliary tract and abdominal cavity;

    - infection of bones and joints;

    - infections associated with dialysis.

    Preventive maintenance of infectious complications at operations on a prostate (transurethral resection).
    Contraindications:
    Hypersensitivity to ceftazidime or any other component of the drug. Pronounced reactions of hypersensitivity (eg, anaphylactic reactions) to other beta-lactam antibacterial drugs in the anamnesis.

    Carefully:Renal failure, gastrointestinal tract diseases (including history, ulcerative colitis), neonatal period, when combined with loop diuretics and aminoglycosides.patients with a symptom of malabsorption (increased risk of a decrease in prothrombin activity, especially in those with severe renal and / or liver failure), history of bleeding.
    Pregnancy and lactation:In pregnancy, the drug is used only if the intended benefit to the mother exceeds the potential risk to the fetus. When using the drug during lactation at the time of treatment should stop breastfeeding.
    Dosing and Administration:

    Intravenous (IV), jet or infusion. The dose of the drug is set individually, depending on the severity of the disease, the localization of the infection, the type of pathogen and its sensitivity to the drug, as well as the age of the patient and kidney function.

    The maximum daily dose is 6 g, the maximum daily dose for adults

    of patients with cystic fibrosis is 9 g.

    Adults and children over 12 years of age: 1-6 g / day in 2 or 3 injections.

    Usually 1 g every 8 hours or 2 g every 12 hours.

    In severe disease, especially in patients with immunodeficiency (including patients with neutropenia), 2 g every 8 hours or 12 hours, or 3 g every 12 hours.

    For infections of the urinary tract and infections of the lung current, 0.5 g or 1 g every 12 hours.

    For the treatment of infectious complications in cystic fibrosis caused by Pseudomonas aeruginosa, 100-150 mg / kg / day in 3 injections.

    In operations on the prostate gland - 1 g during an introductory anesthesia, the second dose is administered after removal of the catheter.

    Children older than 2 months and up to 12 years: 30-100 mg / kg / day in 2-3 administration.

    Children with immunodeficiency, cystic fibrosis and meningitis - up to 150 mg / kg / day

    (maximum - 6 g / day) in 3 injections.

    Newborns and children from 28 days to 2 months: 25-60 mg / kg / day in 2 injections.

    Older patients: the recommended dose is no more than 3 g / day, especially in patients older than 80 years.

    Patients with renal insufficiency: ceftazidime is excreted by the kidneys unchanged, so patients with renal dysfunction should be reduced the dose of ceftazidime. 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

    Creatinine clearance (ml / min)

    Concentration of creatinine in blood plasma, μmol / l (mg / dL)

    Recommended single doses (g)

    Frequency of drug administration

    >50

    < 150 (<1,7)

    Standard doses

    50-31

    150-200(1,7-2,3)

    1,0

    every 12 hours

    30-16

    200-350 (2,3-4,0)

    1,0

    every 24 hours

    15-6

    350-500 (4,0-5,6)

    0,5

    every 24 hours

    <5

    > 500 (>5,6)

    0,5

    every 48 hours

    Patients with infections of severe course can increase the recommended single dose by 50% or the frequency of administration of the drug. In such patients should monitor the concentration of ceftazidime in blood plasma (should not exceed 40 mg / l).

    The drug can be used in children with impaired renal function, while the creatinine clearance is calculated in accordance with the ideal mass or surface area of ​​the body.

    Hemodialysis. During hemodialysis, the elimination half-life is 3-5 hours.

    After each hemodialysis session, maintenance doses of ceftazidime in

    according to the table above.

    Peritoneal dialysis. Ceftazidime can be used during peritoneal dialysis. Such patients are injected with 0.5 g of the drug every 24 hours.

    For patients with renal insufficiency in the intensive care unit

    therapy for continuous hemodialysis using an arteriovenous shunt and for patients on high-speed haemofiltration, the recommended dose is 1 g / day daily (in one or more administrations).

    For patients who are on hemofiltration at a low rate, the same doses of the drug are recommended, as in the case of impaired renal function.

    Patients on hemodialysis or haemofiltration using a venovenous shunt are recommended doses shown in the table.

    Doses of ceftazidime in patients on hemofiltration using a veno-venous shunt.

    Creatinine clearance (ml / ml)

    Maintenance dose (mg) depending on the rate of ultrafiltration (ml / min) *

    5

    16,7

    33,3

    50

    0

    250

    250

    500

    500

    5

    250

    250

    500

    500

    10

    250

    500

    500

    750

    15

    250

    500

    500

    750

    20

    500

    500

    500

    750

    * The maintenance dose is given every 12 hours.

    Doses of ceftazidime in patients on continuous hemodialysis using a veno-venous shunt.

    Creatinine clearance (ml / min)

    Maintenance dose (mg) depending on the rate of dialysis *

    1.0 l / h

    2.0 l / h

    Rate of ultrafiltration (l / h)

    Rate of ultrafiltration (l / h)

    0,5

    1,0

    2,0

    0.5

    1.0

    2.0

    0

    500

    500

    500

    500

    500

    750

    5

    500

    500

    750

    500

    500

    750

    10

    500

    500

    750

    500

    750

    1000

    15

    500

    750

    750

    750

    750

    1000

    20

    750

    750

    1000

    750

    750

    1000

    * The maintenance dose is given every 12 hours.

    The duration of treatment with ceftazidime is 7-14 days. In infections caused by Pseuchmonas aeruginosa (pneumonia, infectious complications of cystic fibrosis, meningitis) treatment course can be increased up to 21 days. Treatment with ceftazidime, like any other antibacterial therapy, should continue for at least 48-72 hours, after reducing the symptoms of acute inflammation and normalizing the temperature.

    Preparation of a solution for intravenous administration.

    In the solution of the preparation, small bubbles of carbon dioxide may be present, which does not affect the effectiveness of the preparation. Do not use sodium bicarbonate solution as a solvent.

    The amount of ceftazidime in the vial

    Method of administration

    Amount of solvent, ml

    Approximate concentration, mg / ml

    2 grams

    Intravenously, intravenously

    10

    170

    2 grams

    Intravenous infusion

    50

    40

    For intravenous bolus administration, the contents of the vial are dissolved in 10 ml of a solvent. For intravenous drip introduction, the resulting solution of the preparation is further diluted in 50-100 ml of solvent ("secondary" dilution). As a solvent, water for injections or compatible infusion solutions.

    Ceftazidime in a concentration of 1 to 40 mg / ml is compatible with infusion solutions: 0

    , 9% sodium chloride solution, Hartmann solution, 5% and 10% dextrose solutions, 0.225% sodium chloride solution and 5% dextrose solution, 0.45% sodium chloride solution and 5% dextrose solution, 0.9% sodium chloride solution and 5% dextrose solution, 0.18% sodium chloride solution and 4% dextrose solution, 10% Dextran 40 solution in 0.9% sodium chloride solution or 5% dextrose solution, 6% Dextran 70 solution in 0.9% sodium chloride solution or in a 5% solution of dextrose,a solution of metronidazole 5 mg / ml.

    In concentrations from 0.05 to 0.25 mg / ml ceftazidime compatible with the solution for intraperitoneal dialysis (lactate).

    Both components remain active if ceftazidime in a concentration of 4 mg / ml is added to the following solutions: hydrocortisone 1 mg / ml in 0.9% solution of sodium chloride or 5% solution of dextrose; cefuroxime 3 mg / ml in 0.9% solution of sodium chloride; cloxacillin 4 mg / ml in 0.9% sodium chloride solution; heparin 10 MP / ml or 50 IU / ml in a 0.9% solution of sodium chloride; potassium chloride 10 mEq / L or 40 mEq / L in a 0.9% solution of sodium chloride.

    Use only freshly prepared solution!

    Light yellowing of the solution does not affect the efficiency.

    Side effects:

    Local reactions: phlebitis or thrombophlebitis with intravenous administration.

    Allergic reactions: patchy-papular rash, urticaria, fever, itching, angioedema, bronchospasm, lowering of arterial pressure, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock.

    From the gastrointestinal tract: diarrhea, nausea, vomiting, abdominal pain, oropharyngeal candidiasis, pseudomembranous colitis.

    From the genitourinary system: candidiasis vaginitis, interstitial nephritis, impaired renal function, acute renal failure.

    From the hepatobiliary system and the pancreas: jaundice.

    From the central nervous system: headache, dizziness, paresthesia,

    unpleasant taste in the mouth; in patients with renal failure more often than in others,

    neurological disorders (tremor, myoclonia, seizures, encephalopathy,

    coma).

    Laboratory indicators: eosinophilia, false positive direct Coombs test, thrombocytosis, increased activity of "hepatic" enzymes - alanine aminotransferase (ALT), aspartate aminotransferase (ACT), lactate dehydrogenase (LDH), gamma-glutamyltranspeptidase (GGTP) and alkaline phosphatase (AFP), a transient increase in the concentration of urea, nitrogen and / or creatinine in the blood.

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

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:It often occurs in patients with renal insufficiency. Symptoms: neurological disorders (dizziness, parasthesia, headache, with the development of encephalopathy, seizures and coma), deviation in the results of laboratory tests (hypercreatininaemia, hyperbilirubinemia, thrombocytosis, thrombocytopenia, eosinophilia, leukopenia, prothrombin time lengthening). Treatment: symptomatic, supportive, hemodialysis, peritoneal dialysis.
    Interaction:
    It is pharmaceutically incompatible with aminoglycosides (significant mutual inactivation: with simultaneous use these drugs should be administered to different parts of the body), vancomycin (a precipitate is formed depending on the concentration, if necessary, two drugs are administered through a single tube, rinse) and chloramphenicol.
    At simultaneous application with "loop" diuretics, aminoglycosides, vancomycin, clindamycin, the risk of nephrotoxic action increases. Bacteriostatic antibiotics (including chloramphenicol) reduce the effectiveness of the drug.
    Ceftazidime, like other antibiotics, can disrupt the intestinal microflora,which can lead to a decrease in the reabsorption of estrogens and a decrease in the effectiveness of combined oral hormonal contraceptives.
    Do not use sodium bicarbonate solution as a solvent (carbon dioxide is formed).
    If you are taking other drugs, consult a doctor.

    Special instructions:

    Do not use sodium bicarbonate solution as a solvent (carbon dioxide is formed).

    If you are taking other drugs, consult a doctor. Special instructions. Patients who had a history of allergic reactions to cephalosporins, penicillins and other beta-lactam antibacterials, may have increased sensitivity to cephalosporin antibiotics. With the development of allergic reactions, the drug should be immediately discontinued, in severe cases, it may be necessary to use epinephrine, hydrocortisone, antihistamines and other emergency measures.

    During treatment can not be used ethanol because of the possibility of disulfiram-like reactions (sudden rush of blood to the face, spastic pain in the abdomen, nausea, vomiting, headache, tachycardia, shortness of breath).

    With the simultaneous administration of ceftazidime in a high dose with nephrotoxic drugs, such as aminoglycosides and diuretics (furosemide), it is necessary to monitor kidney function.

    In patients with renal insufficiency, the dose of ceftazidime should be reduced in accordance with the degree of impaired renal function. For elderly patients, it is advisable to monitor kidney function during treatment.

    Some patients may develop pseudomembranous colitis during or after the administration of ceftazidime, caused by toxins produced by Clostridium difficile. Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after use of the drug. In this case, stop treatment and carry out appropriate therapy; drugs that inhibit the intestinal peristalsis are contraindicated.

    The drug may interfere with the synthesis of vitamin K due to suppression of the intestinal flora, which can cause a decrease in the level of vitamin K-dependent clotting factors and in rare cases lead to hypoprothrombinemia and bleeding. The appointment of vitamin K eliminates hypoprothrombinemia.The risk of developing bleeding is highest in patients with severe disease, in patients with impaired liver function, in elderly and weakened patients, in those with malnutrition. Long-term use of broad-spectrum antibiotics, including ceftazidime, can lead to an increase in the growth of insensitive microorganisms (for example Candida, Enierococci), and may require discontinuation of treatment or appropriate therapy. During treatment it is necessary to constantly assess the patient's condition.

    In the treatment of ceftazidime in some initially sensitive strains Enterobacler spp. and Serratia spp. resistance can develop, therefore, in the treatment of infections caused by these microorganisms, periodic studies should be conducted on sensitivity to antibiotics.

    Ceftazidime does not affect the results of the determination of glucose in urine using enzymatic methods, but can cause a slight distortion of the results of the analysis, based on the restoration of copper (Benedict, Feling, Klinist).

    Ceftazidime does not affect the quantitative determination of creatinine by alkaline citrate method.

    Effect on the ability to drive transp. cf. and fur:
    Care should be taken when driving a car and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:
    Powder for solution for intravenous injection, 2.0 g.
    Packaging:
    Powder for the preparation of a solution for intravenous administration of 2.0 g of active substance in glass bottles with a capacity of 10 ml, 20 ml. 1 bottle with instructions for use in a pack of cardboard. 10 bottles with instructions for use in a cardboard box.

    For hospitals:

    - 50 bottles with an equal number of instructions for use in a cardboard box;

    - from 1 to 50 bottles with an equal number of instructions for use in a cardboard box.

    Complete with solvent

    Solvent: 5 ml or 10 ml of water for injection in ampoules of glass. 1 bottle and 1 ampoule 10 ml (or 2 ampoules of 5 ml each) in a contoured cell package (NLC) made of a PVC film with instructions for use in a pack of cardboard; 5 bottles and 5 ampoules of 10 ml (or 10 ampoules of 5 ml each) in separate PEA from PVC film with instructions for use in a pack of cardboard.
    In the pack put a knife to open the ampoules or a scarifier ampoule. When using ampoules with notches, rings or break points, the ampoule opener opener or ampoule scarifier is allowed not to be inserted.

    Storage conditions:
    In the dark place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.

    Shelf life:
    2 years. Do not apply but the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002920
    Date of registration:20.03.2015
    Date of cancellation:2020-03-20
    The owner of the registration certificate:KRASFARMA, JSC KRASFARMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.11.2015
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