Active substanceCeftazidimeCeftazidime
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  • Dosage form: & nbsp
    Powder for the preparation of solution for intravenous and intramuscular injection.

    Composition:
    1 bottle contains:

    Active substance: ceftazidime pentahydrate in an amount equivalent to 1 g of ceftazidime.

    Excipient: sodium carbonate.
    Description:White or white with a yellowish hue of crystalline 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.

    Active in relation to:

    Gram-negative microorganisms: Pseudomonas spp. (including Pseudomonas aeruginosa), Klebsiella spp. (at Tom number of Klebsiella pneumoniae), Proteus mirabilis, Proteus vulgaris, Escherichia coli, Enterobacter spp. (at Tom number of Enterobacter aerogenes, Enterobacter cloacae), Citrobacter spp. (at Tom number of Citrobacter diversus, Citrobacter freundii), Neisseria mepngitidis, Haemophilus influenzae (including strains, sustainable to ampicillin); gram-positive microorganisms: Staphylococcus aureus (producing and non-reducing penicillinase strains, sensitive to methicillin), Streptococcus pyogenes (beta-hemolytic streptococcus groups A), Streptococcus agalactiae (beta- hemolytic streptococcus groups AT), Streptococcus pneumoniae;

    anaerobic microorganisms: Bacteroides spp. (many strains Bacteroides fragilis resistant).

    Inactive at respect sustainable to methicillin strains Staphylococcus spp., Streptococcus faecalis, Enterococcus spp., Listeria monocytogenes, Campylobacter spp. and Clostridium difficile.

    Active in vitro against the majority of strains of the following organisms (the clinical significance of this activity is unknown): Clostridium perfringens, Acinetobacter spp., Haemophilus parainfluenzae, Morganella morganii, Neisseria gonorrhoeae, Peptococcus spp., Peptostreptococcus spp., Providencia spp., Salmonella spp., Shigella spp., Staphylococcus epidermidis, Yersinia enterocolitica.

    Pharmacokinetics:
    The maximum concentration for intramuscular administration of 1 g is 39 μg / ml, with intravenous bolus administration of 69 μg / ml. Time to reach the maximum concentration, with intramuscular injection -1 h, with intravenous administration - by the end of infusion.
    Communication with plasma proteins is less than 10%. Concentrations of ceftazidime that exceed the minimum inhibitory concentrations for most common microorganisms can be achieved in bone tissue, heart, bile, sputum, synovial, intraocular,pleural and peritoneal fluids. It easily penetrates the placental barrier and is excreted in breast milk. In the absence of an inflammatory process, poorly penetrates the blood-brain barrier. When meningitis, the concentration in the cerebrospinal fluid reaches a therapeutic value (4-10 mg / L and higher). Therapeutic serum concentrations persist for 8-12 hours after intravenous and intramuscular administration. The drug is not metabolized in the liver, a violation of the liver does not affect the pharmacokinetics of the drug. The half-life period with normal renal function is 1.9 hours; in newborns - 3-4 times longer; with hemodialysis 3-5 hours. It is excreted unchanged in kidneys to 80-90% (70% of the administered dose is excreted in the first 4 hours) for 24 hours by glomerular filtration, with bile - less than 1%.
    Indications:
    Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:
    - Infection of the lower respiratory tract: bronchitis, infected bronchiectasis, pneumonia, lung abscess, pleural empyema, infections of the lungs in patients with cystic fibrosis;
    - LOP infekii: otitis media, mastoiditis, sinusitis;
    - Infusion of the genitourinary system: pyelonephritis, pyelitis, prostatitis, cystitis, urethritis, kidney abscess;
    - Infekii skin and soft tissues: phlegmon, erysipelas, wound infections, mastitis; infekiii bones and joints: osteomyelitis, septic arthritis;
    - Infection of the gastrointestinal tract, biliary tract and abdominal cavity: cholangitis, cholecystitis, gallbladder empyema, retroperitoneal abscesses, peritonitis, diverticulitis, enterocolitis;
    - infections of the pelvic organs;
    - Gonorrhea;
    - sepsis;
    - Meningitis.
    Preventive maintenance of infectious complications at operations on a prostate (transurethral resection).
    Contraindications:Hypersensitivity, including to other cephalosporins and penicillins.
    Carefully:
    - kidney failure;
    - the period of the newborn;
    bleeding history;
    - colitis in the anamnesis;
    - Malabsorption syndrome (increased risk of decreased prothrombin activity, especially in persons with severe renal and / or liver failure).
    Pregnancy and lactation:When pregnancy is used only if the intended benefit for the mother exceeds the potential risk to the fetus.If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.
    Dosing and Administration:

    Apply intravenously or intramuscularly.

    The dose of the drug is determined individually depending on the severity of the course of the disease, the localization of infection and the sensitivity of the pathogen, age and body weight, the function of the patient's kidneys.

    Usual dose for adults and children over 12 years of age

    In severe infections, especially in patients with reduced immunity (including patients with neutropenia) - 2 g every 8 hours.

    In cystic fibrosis, infections of the respiratory system caused by Pseudomonas spp. - 100-150 mg / kg / day, the frequency of administration - 3 times a day.

    With infections of the urinary tract and infections of the lung current - 0.5-1 g 2 times a day.

    With uncomplicated pneumonia and skin infections - 0.5-1 g every 8 hours. For infections of bones and joints - 2 g every 12 hours.

    When surgery on the prostate gland is prescribed at a dose of 1 g during an introductory anesthesia, repeat the introduction after removal of the catheter.

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

    If the kidney function is disturbed after the initial dose -1g correction of the dosing regimen is necessary. The maintenance dose is selected depending on the creatinine clearance: when creatinine clearance is 50-31 ml / min - 1 g 2 times a day, 30-16 ml / min - 1 g 1 time per day, 15-6 ml / min - 0.5 g once daily, less than 5 ml / min - 0.5 g every 48 hours.

    Against the background of hemodialysis, maintenance doses are calculated taking into account the clearance of creatinine, the administration of a suitable dose of the drug is carried out 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 L).

    Usual dose for children

    Newborns and infants under 2 months of age: intravenous infusion at a dose of 25-60 mg / kg / day in 2 divided doses.

    Children from 2 months to 12 years: intravenous infusion at a dose of 30-100 mg / kg / day in 2-3 divided doses. Children with reduced immunity, cystic fibrosis and meningitis: intravenous infusion up to 160 mg / kg / day, every 8 hours.

    The maximum daily dose for children should not exceed 6 g.

    Patients older than 80 years, the maximum daily dose should not be more than 3 g.

    Rules for the preparation of solution for injection

    To prepare a solution for injection, 1 g of the drug is dissolved in 3 ml of water for injection (with intramuscular injection) and 10 ml of water for injection (with intravenous administration).For IV injection, the resulting solution is diluted in 50-100 ml of the solvent. For the / m introduction ceftazidime can be diluted with a solution of lidocaine hydrochloride 1%.

    In the prepared solution, small bubbles of carbon dioxide may be present, which does not affect the effectiveness of the preparation. Use only freshly prepared solution. Light yellowing of the solution does not affect the efficiency.

    Side effects:

    · Allergic reactions: urticaria, fever, eosinophilia, rash, skin itch, toxic epidermal necrolysis (Lyell's syndrome), multiforme exudative erythema (including Stevens-Johnson syndrome), angioedema, bronchospasm, anaphylactic shock;

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

    · from the nervous system: headache, dizziness, paresthesia, convulsive seizures, encephalopathy, "fluttering" tremor;

    · from the genitourinary system: renal dysfunction, toxic nephropathy; oliguria, anuria, candidal vaginitis;

    · from the digestive system: nausea, vomiting, diarrhea or constipation, abdominal pain, colitis, cholestasis, oropharyngeal candidiasis;

    · from the hematopoiesis: leukopenia, neutropenia, thrombocytopenia, lymphocytosis, hemolytic anemia, hemorrhages;

    · laboratory indicators: hyperkreatininemia, increased urea concentration, false positive urine reaction to glucose, increased activity of "Hepatic" transaminases and alkaline phosphatase, hyperbilirubinemia, false positive Coombs reaction, increased prothrombin time;

    · other: nosebleeds; superinfection.

    Overdose:
    Symptoms: Pain, inflammation, phlebitis at the injection site, dizziness, paresthesia, headache, convulsions in patients with renal insufficiency, hypercreatininemia, hyperbilirubinemia, thrombocytosis, thrombocytopenia, eosinophilia, leukopenia, prolongation of prothrombin time.
    Treatment: Because there is no specific antidote, overdose treatment is symptomatic and supportive. In the case of renal failure, peritoneal dialysis or hemodialysis.
    Interaction:
    Pharmaceuticallyincompatible with aminoglycosides (significant mutual inactivation: simultaneous use of 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 one system for intravenous administration, the system should be washed between their use).
    Do not use sodium bicarbonate solution as a solvent (carbon dioxide is formed).
    "Loop" diuretics, aminoglycosides, vancomycin, clindamycin reduce clearance, which increases the risk of nephrotoxic action.
    Bacteriostatic antibiotics (including chloramphenicol) reduce the effect of the drug.
    Pharmaceutically compatible with the following solutions: at a concentration of 1 to 40 mg / ml - sodium chloride (NaCl) 0.9%; sodium lactate; Hartmann solution; dextrose 5%; NaCl 0.225% and thunderstorm thunderstorm 5%; NaCl 0.45% and dextrose 5%; NaCl 0.9% and dextrose 5%; NaCl 0.18% and dextrose 4%; dextrose 10%; dextran with a molecular mass of about 40,000 Daltons (Da) 10% in a NaCl solution of 0.9% or in a 5% dextrose solution; dextran with a molecular mass of about 70,000 Da 6% in a NaCl solution of 0.9% or in a 5% dextrose solution.
    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 (hydrocortisone sodium phosphate) 1 mg / ml in 0.9% NaCl solution or 5% dextrose solution; cefuroxime (cefuroxime sodium) 3 mg / ml in NaCl solution 0,9%; cloxacillin (cloxacillin sodium) 4 mg / ml in NaCl solution 0,9%; heparin 10 IU / ml or 50 IU / ml in NaCl solution 0,9%; potassium chloride 10 mEq / L or 40 mEq / L in a NaCl solution of 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 with a history of an allergic reaction to penicillins may have increased sensitivity to cephalosporins.
    Ceftazidime may interfere with the synthesis of vitamin K, due to the suppression of intestinal flirus, which can cause a decrease in the activity of vitamin K-dependent clotting factors and in rare cases lead to hypoprothrombinemia and bleeding. The appointment of vitamin K quickly eliminates hypothrombinemia.In elderly and weakened patients, in patients with impaired liver function and in persons with malnutrition, the risk of developing bleeding is highest.
    Some patients may develop pseudomembranous colitis caused by Clostridium difficile during or after the administration of ceftazidime. In mild cases, it is sufficient to cancel the drug, in more severe cases, it is recommended to restore the water-salt and protein balance; appoint metronidazole, vancomycin. During treatment with ceftazidime, disulfiramoid-like effects are possible.
    Effect on the ability to drive transp. cf. and fur:During treatment, care must 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 solution for intravenous and intramuscular injection 1 g.



    Packaging:
    1 g of ceftazidime in a glass bottle of hydrolytic class I of transparent colorless glass with a capacity of 20 ml, sealed with a rubber stopper under running in with aluminum caps and covered with a plastic lid.Each bottle together with instructions for use is placed in a cardboard pack.
    The solvent is "Water for Injection", 5 ml or 10 ml produced by OJSC "Pharmasintez", Russia (RU No. LP-001844).

    1. One bottle with 1 g of the drug, together with the instruction for use, is placed in a cardboard pack.

    2. One bottle with 1 g of preparation and one ampoule with 5 ml of solvent together with instructions for use are placed in a cardboard box with septa.

    3. One bottle with 1 g of preparation and one ampoule with 10 ml of solvent together with instructions for use are placed in a cardboard box with septa.
    Storage conditions: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 the product after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N012310 / 01
    Date of registration:24.03.2010
    The owner of the registration certificate:FARMGID CJSCFARMGID CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp08.11.2015
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