Active substanceCeftazidimeCeftazidime
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  • Dosage form: & nbspPowder for the preparation of solution for intravenous and intramuscular injection.
    Composition:
    per 1 bottle
    Active substance: ceftazidime pentahydrate is equivalent to ceftazidime 1000 mg
    Excipient: sodium carbonate-105 mg
    Description:
    White or white with a yellowish hue of crystalline powder.

    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.D.02   Ceftazidime

    Pharmacodynamics:

    Ceftazidime is a third generation cephalosporin antibiotic 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.

    The drug is active against gram-negative microorganisms: Pseudomonas spp., (ceftazidime has the highest activity among cephalosporins of the third generation in relation to Pseudomonas aeruginosa), Klebsiella spp., including Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Escherichia coli, Entembacter spp., including Enterobacter aerogenes, Enterobacter cloacae, Citrobacter spp., including Citrobacter diversus, Citrobacter freundii, Pasteurella multocida, Neisseria meningitidis, Haemophillus influenzae (including strains resistant to ampicillin).

    The drug is active against gram-positive microorganisms: Staphylococcus aureus (penicillinase-producing and penicillinase-producing strains sensitive to methicillin), Streptococcus pyogenes (group A beta-hemolytic streptococcus), Streptococcus agalactiae (group B), Streptococcus pneumoniae.

    The drug is active against anaerobic bacteria: Bacteroides spp. (most strains Bacterioides fragilis - resistant).

    The drug is not active against methicillin resistant strains Staphylococcus spp., Streptococcus faecalis., Enterococcus spp., Listeria monocytogenes, Campylobacter spp., Clostridium difficile

    A drug active in vitro against majority strains the following microorganisms: Clostridium perfringens, not including Clostridium difficile, Acinetobacter spp., Haemophilus parainfluenzae, Morganella morganii, Neisseria gonorrhoeae, Peptococcus spp., Peptostreptococcus spp., Providencia rettgeri, Salmonella spp., Shigella spp., Staphylococcus epidermidis, Yersinia enterocolitica.

    Pharmacokinetics:
    After administration, the drug is quickly distributed in the human body and reaches therapeutic concentrations in most tissues and liquids, including synovial, pericardial and peritoneal fluid, as well as in bile, sputum and urine.Distribution also occurs in the bones, myocardium, gall bladder, skin and soft tissues. Poor penetration through intact blood-brain barrier, but the drug reached in the cerebrospinal fluid therapeutic level is sufficient for the treatment of meningitis (4-20 mg / l and above). Easily penetrates the placenta and excretes in breast milk.
    The connection with plasma proteins is less than 10%. The maximum concentration with intramuscular injection (in / m) 0.5 g or 1 g in an hour (the time to reach the maximum concentration in the plasma), respectively, is 17 μg / ml and 39 μg / ml, with intravenous (w / v) 0.5 g, 1 g or 2 g, respectively, 42 μg / ml and 69 μg / ml and 170 mg / l.
    Time to reach the maximum concentration with intramuscular injection -1 hour, with intravenous administration - by the end of infusion. The therapeutic concentration in the blood plasma is maintained for 8-12 hours after IV and IM.
    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. Half-life with normal kidney function -1.9 h; in newborns - 3-4 times longer; with hemodialysis - 3-5 hours.
    It is excreted unchanged by kidneys to 80-90% (70% of the administered dose is excreted in the first 4 hours) during the day by glomerular filtration; with bile - less than 1%. In case of impaired renal function, a dose reduction is recommended.
    Indications:

    Infectious-inflammatory diseases caused by microorganisms sensitive to ceftazidime.

    Severe infections: peritonitis, sepsis, severe purulent-septic conditions, meningitis. Lower respiratory tract infections: pneumonia, lung abscess, empyema of the pleura, infected bronchiectasias, bronchitis.

    Infections LOP-organ: otitis media, mastoiditis, sinusitis.

    Urinary tract infections: pyelonephritis, pyelitis, prostatitis, cystitis, urethritis, kidney abscess.

    Infections of bones and joints: septic arthritis, osteomyelitis, bacterial bursitis.

    Infections of the skin and soft tissues: wound infections, infected burns, phlegmon, erysipelas, mastitis.

    Infections of the gastrointestinal tract, abdominal cavity and biliary tract:

    retroperitoneal abscesses, cholangitis, gallbladder empyema, cholecystitis, peritonitis,

    diverticulitis, enterocolitis.

    Infections of the pelvic organs: endometritis. Gonorrhea.

    Prevention of infectious complications in operations on the prostate gland.

    Contraindications:Hypersensitivity to ceftazidime, to other cephalosporins, penicillins.
    Carefully:impaired renal function; newborns; hemorrhages in the anamnesis; colitis in history; malabsorption syndrome (increased risk of decreased prothrombin activity, especially in persons with severe renal and / or liver failure), combination with loop diuretics, aminoglycosides.
    Pregnancy and lactation:
    Use in pregnancy is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus.
    If you need to use the drug during lactation, you should decide whether to stop breastfeeding.
    Dosing and Administration:

    The drug is administered intravenously or intramuscularly. The dose of the drug is determined individually, taking into account the severity of the disease, localization of infection and sensitivity of the pathogen, age and body weight, kidney function.

    Adults and children over 12 years of age appoint 1 g every 8-12 hours or 2 g at intervals of 12 hours.In severe infections, especially in patients with reduced immunity (including patients with neutropenia), - 2 g every 8 hours or 3 g every 12 hours. In uncomplicated urinary tract infections - 0.25 g 2 times a day. With complicated infections of the urinary tract - 0.5-1 g 2 times a day. In cystic fibrosis, patients with respiratory infections caused by pseudomonas spp. - 30-50 mg / kg every 8 hours. In operations on the prostate gland, prophylaxis is administered before the induction of anesthesia, 1 g, the administration is repeated after removal of the catheter.

    Elderly patients with a maximum daily dose of 3 g.

    Children over 2 months. and up to 12 years appoint 30-100 mg / kg / day (for 2-3 injections), the maximum dose - 6 g / day; children with reduced immunity, cystic fibrosis and meningitis - 150 mg / kg / day in 3 injections, the maximum daily dose - 6 g.

    Newborns and infants under 2 months of age. prescribe 25-60 mg / kg / day in 2 injections.

    If the kidney function is disturbed, the initial dose is 1 g. The maintenance dose is selected depending on the rate of excretion as indicated below.

    CREATINE CREATININE DOSE

    31-50 ml / min. 1 g every 12

    16-30 ml / min. 1 g every 24 h

    5-15 ml / min. 500 mg every 24 hours

    <5 ml / min, 500 mg every 48 hours

    For patients with severe infections, a single dose can be increased by 50%, while they should control the concentration of ceftazidime in the serum (should not exceed 40 mg / l).

    For children, the clearance of creatinine is calculated in accordance with the ideal body weight or surface area of ​​the body.

    Against the background of hemodialysis, maintenance doses are calculated taking into account the clearance of creatinine, the administration is performed after each hemodialysis session. Against the background of peritoneal dialysis, in addition to intravenous administration ceftazidime can be included in the dialysis solution (125-250 mg per 2 liters of dialysis solution). In patients with renal insufficiency, on continuous hemodialysis using an arteriovenous shunt, and in patients who are on high-speed haemofiltration in the intensive care unit, the recommended dose is 1 g / day daily (for one or more injections).

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

    The maximum daily intake for adults and children should not exceed 6 g. The duration of treatment with ceftazidime is 7-14 days. In infections caused by Pseudomonas aeruginosa (pneumonia, infectious complications of cystic fibrosis, meningitis) treatment course can be increased up to 21 days.

    Preparation of solutions

    1 . "Primary" breeding

    1.0 g 3 ml water for injection with 10 ml water for injection at

    intramuscular administered. intravenous administration.

    2. "Secondary" breeding

    Day of intravenous drip The preparation solution obtained in the above described way is further diluted in 50-100 ml of one of the following solvents intended for intravenous administration:

    - 0.9% solution of sodium chloride,

    - solution of Hartmann,

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

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

    Use only freshly prepared solution!

    Side effects:

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

    From the digestive system: nausea, vomiting, diarrhea, abdominal pain, dysbiosis, impaired liver function (transient increase in activity of "liver" transaminases, alkaline phosphatase, hyperbilirubinemia), pseudomembranous colitis, cholestasis.

    From the hematopoiesis: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, thrombocytosis, hemolytic anemia, lymphocytosis, pancytopenia, hypocoagulation.

    From the urinary system: renal dysfunction (azotemia, hypercreatininaemia, increased urea in the blood), oliguria, anuria, toxic nephropathy.

    From the nervous system: headache, dizziness, paresthesia, seizures, encephalopathy, "fluttering" tremor, coma, neuromuscular excitability.

    Local reactions: phlebitis, pain along the veins; morbidity and infiltration at the site of intramuscular injection.

    Other: nosebleeds, candidiasis (candidal vaginitis, oropharyngeal candidiasis), superinfection, false-positive direct Coombs test, increased prothrombin time, false positive urine reaction to glucose.

    Overdose:

    Symptoms: dizziness, paresthesia, headache, convulsions, abnormalities in the results of laboratory tests.

    Treatment: since there is no specific antidote, the treatment is symptomatic and supportive. In case of severe overdose, when conservative therapy is unsuccessful, the concentration of the drug in the blood can be reduced by hemodialysis.

    Interaction:
    Pharmacologically 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 IV system should be Rinse).
    Do not use sodium bicarbonate solution as a solvent!
    "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 effectiveness of the drug. Pharmaceutically compatible with the following solutions: at a concentration of 1 to 40 mg / ml - 0.9% solution of sodium chloride; sodium lactate solution; Hartmann solution; 5% solution dextrose; 0.225% sodium chloride solution and 5% dextrose solution; 0.45% sodium chloride solution and 5% dextrose solution; 0.9% solution of sodium chloride and 5% solution of dextrose; 0.18% sodium chloride solution and 4% dextrose solution; 10% dextrose solution; 10% dextran solution with a molecular weight of 40 thousand daltons in a 0.9% solution of sodium chloride or in 5%a solution of dextrose; 6% dextran solution with a molecular weight of 70 thousand daltons in a 0.9% solution of sodium chloride or in a 5% solution of dextrose. 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 remain active if ceftazidime is added to the following solutions (concentration of ceftazidime 4 mg / ml): hydrocortisone (hydrocortisone sodium phosphate) 1 mg / ml in a 0.9% solution of sodium chloride or in a 5% solution of dextrose; cefuroxime (cefuroxime sodium) 3 mg / ml in a 0.9% solution of sodium chloride; cloxacillin (cloxacillin sodium) 4 mg / ml in a 0.9% solution of sodium chloride; heparin 10 IU / 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.
    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:
    In 3-7% of patients with an allergy to penicillins, a history of cross-sensitivity to cephalosporins was noted.
    Ceftazidime may interfere with the synthesis of vitamin K due to suppression of the intestinal microflora,which can cause a decrease in the level of vitamin K-dependent clotting factors, and in rare cases lead to hypothrombinemia and bleeding. The appointment of vitamin K eliminates hypothrombinemia. In elderly and weakened patients, in patients with impaired, liver function and in persons with malnutrition, the risk of bleeding is highest.
    Some patients may develop pseudomembranous colitis during or after the administration of ceftazidime, caused by toxins produced by Clostridium difficile. In mild cases, it is sufficient to cancel the drug, and in more severe cases it is recommended to restore the water-salt and protein balance. If these measures do not help, appoint metronidazole, bacitracin or vancomycin. Possible false positive test Coombs and false positive urine reaction to glucose.
    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, dyspnea).
    When developing an allergic reaction to ceftazidime, the drug should be immediately discontinued.
    Effect on the ability to drive transp. cf. and fur:
    Care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular administration of 1000 mg.


    Packaging:
    The amount of the preparation containing 1000 mg of ceftazidime is placed in a vial of colorless glass, sealed with a stopper of chlorobutyl rubber, crimped with an aluminum ring with a safety plastic cap. 1 bottle with instructions for use in a cardboard box.
    For hospitals:
    10,25,48 or 100 bottles together with an equal number of instructions for use in a cardboard box.
    Storage conditions:Store in a dry, 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 expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-002537
    Date of registration:22.12.2011
    The owner of the registration certificate:Jodas Expo Pvt.LtdJodas Expo Pvt.Ltd India
    Manufacturer: & nbsp
    Representation: & nbspJodas Expoim, Open CompanyJodas Expoim, Open Company
    Information update date: & nbsp07.11.2015
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