Active substanceCeftazidimeCeftazidime
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  • Dosage form: & nbspPPowder for solution for injection.
    Composition:

    Components

    Contents in the vial

    Active substance:

    Ceftazidime Pentahydrate, sterile in terms of ceftazidime

    90,91%2 (w / w)

    Dosage duration of 250 mg / bottle:

    250 mg

    For a dosage of 500 mg / bottle:

    500 mg

    Dosage time 1 g / bottle:

    1.0 g

    For dosage of 2 g / bottle:

    2.0 g

    Excipients:

    Sodium carbonate (anhydrous), sterile

    9.09% (w / w)

    For dosage of 250 mg / bottle:

    25 mg

    For a dosage of 500 mg / bottle:

    50 mg

    For a dosage of 1 g / bottle:

    100 mg

    For dosage of 2 g / bottle:

    200 mg

    Carbon dioxide

    qs

    Notes:

    1. The free volume in the vial is filled with 100% carbon dioxide.

    2. The filled masses in the vials for 250 mg, 500 mg, 1.0 g and 2.0 g of the package sizes are 333 mg, 666 mg, 1.333 g and 2.665 g respectively. The target masses are calculated taking into account the fact that ceftazidime penta hydrate has a theoretical water content of 14.1% and an average purity of 98.5% in terms of dry matter. 2.5% excess is included in the fill mass, taking into account the stability.

    Description:PPowder from white to light yellow.
    Pharmacotherapeutic group:antibiotic cephalosporin
    ATX: & nbsp

    J.01.D.D.02   Ceftazidime

    Pharmacodynamics:

    Mechanism of action

    Ceftazidime is a cephalosporin antibiotic III generation.

    Has a bactericidal effect, disrupting the synthesis of the bacterial cell wall.

    Pharmacodynamic effects

    The prevalence of acquired bacterial 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 sensory data, especially when treating severe infections.

    Below is the activity of ceftazidnum in vitro.

    Bacteria, usually sensitive to ceftazidime

    Gram-positive aerobes

    Beta-hemolytic streptococci1

    Staphylococcus aureus (strains sensitive to methicillin)1

    Coagulase-negative staphylococci (strains sensitive to methicillin)

    Gram-negative aerobes

    Haemophilus influenzae, including ampicillin resistant strains1

    Haemophilus parainfluenzae

    Neisseria gonorrhoeae

    Neisseria in eningitidis1

    Pasteurella multocida

    Proteus spp.1

    Providencia spp.

    Salmonella spp.

    Shigella spp.

    Bacteria for which acquired resistance to ceftazidime is likely

    Gram-negative aerobes

    Acinetobacter spp.

    ATurkholderia cepacia

    Citrobacter spp.1

    Enterobacter spp.1

    Escherichia coli1

    Klebsiella spp., including TO. pneumoniae1

    Pseudomonas spp., including P. aeruginosa1

    Serratia spp.1

    Morganella morganii

    Yersinia enterocolitica

    Gram-positive aerobes

    Streptococcus pneumoniae1

    Viridans group streptococci

    Gram-positive anaerobes

    Clostridium spp., not including FROM. difficile

    Peptostreptococcus spp.

    Propionibacterium spp.

    Gram-negative anaerobes

    Fusobacterium spp.

    Bacteria that have natural resistance to nitazidime

    Gram-positive aerobes

    Enterococcus spp., including E.faecalis and E. faecium

    Listeria spp.

    Gram-negative aerobes

    Campylobacter spp.

    Gram-positive anaerobes

    Clostridium difficile

    Gram-negative anaerobes

    Bacteroides spp., including B.fragilis

    Other

    Chlamydia spp.

    Mycoplasma spp.

    Legionella spp.

    1 - For these bacteria, the clinical efficacy of ceftazidime has been demonstrated in clinical studies.

    Pharmacokinetics:

    Suction

    After intramuscular administration of ceftazidime at a dose of 500 mg and 1 g in plasma, the maximum drug concentrations (18 mg / L and 37 mg / L, respectively) are quickly reached. Five minutes after intravenous bolus administration of the drug at a dose of 500 mg, 1 g or 2 g, its plasma concentrations are 46 mg / L, 87 mg / L and 170 mg / L, respectively.

    Distribution

    In plasma, the therapeutically effective concentrations of ceftazidime remain 8 to 12 hours after intravenous or intramuscular 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 blood-brain barrier, concentration of the drug in cerebrospinal fluid (CSF) low. With meningitis, CSF achieves therapeutic concentrations ceftazidime, which are 4-20 mg / l and higher.

    Metabolism

    Ceftazidime is not metabolized in the body.

    Excretion

    Parenteral administration allows achieve high concentrations in plasma blood for a long time, which decrease with a half-life of about 2 hours. Have newborns aged from 0 to 28 days and children between the ages of 28 days and up to 2 months, the half-life of ceftazidime can be 3-4 times higher than in adults. Ceftazidime excreted unchanged kidneys by glomerular filtration, with about 80-90% of the administered dose excreted by the kidneys within 24 hours. Less than 1% is excreted in bile, resulting in across intestine is allocated a limited amount of the drug.

    Patients with impaired renal function

    In patients with impaired function kidneys ceftazidime release rate decreases, therefore, the dose should be reduced (see the sections "Dosing and Administration" - "Patients with impaired renal function", "Special instructions").

    Indications:

    Fortum is indicated for treatment monoinfections or mixed infections caused by susceptible to ceftazidime by microorganisms, including:

    - severe infections, such as septicemia, bacteremia, infections in patients with immunodeficiency:

    - bacterial meningitis;

    - febrile neutropenia due to bacterial infection;

    - nosocomial pneumonia;

    - bronchopulmonary bacterial infection in mukonecidosis;

    - infection of ENT organs: chronic purulent otitis media, malignant external otitis;

    - complicated infection urinary tract;

    - complicated infections of the skin and soft tissues;

    - infections of the gastrointestinal tract, bile ducts;

    - complicated intra-abdominal infections;

    - infection of bones and joints;

    - peritonitis, Related carrying out hemo- and peritoneal dialysis and with continuous ambulatory peritoneal dialysis;

    - preventive maintenance of infectious complications at operations on Pthe rare gland (traMr.surretral resection).

    Fortum can be prescribed as a drug of choice before obtaining results for bacteriological sensitivity.

    Ceftazidime can be used in combination with most other beta-lactam antibiotics, as well as with aminoglycosides.

    Sensitivity of bacteria to ceftazidime varies depending on the region and over time. Where possible, local sensitivity data should be taken into account (see section "Pharmacological properties").

    Contraindications:

    - Increased sensitivity to ceftazidime pentahydrate or any other component of the drug;

    - increased sensitivity to other cephalosporin antibiotics in the anamnesis;

    - severe severe reactions hypersensitivity (for example, anaphylactic reactions) to other beta-lactam antibacterial drugs in anamnesis.

    Carefully:

    Use with caution in patients with impaired renal function, ulcerative colitis in the history, during the neonatal period, when combined with loop diuretics and aminoglycosides.

    Pregnancy and lactation:

    Pregnancy

    There is no data confirming embryotoxic or teratogenic effects of ceftazidime, but Fortum should be used with caution in women during the first months of pregnancy. If necessary, the use of Fortum during pregnancy should be commensurable the expected benefit to the length of the mother and the potential risk of fetal length.

    Breastfeeding period

    Ceftazidime is excreted in breast milk in small amounts, so care should be taken when applying the drug to nursing women. In the case of adverse effects in children on the breast breastfeeding, it is necessary to stop breastfeeding.

    Dosing and Administration:

    The dose of the drug is set individually depending on the severity of the course of the disease, localization, the type of pathogen and its sensitivity to the drug, as well as the patient's age and function of the nights.

    The drug is injected intravenously or deeply intramuscularly into the region of the upper-outer quadrant of the gluteus maximus or the lateral surface of the thigh.

    A solution of ceftazidime can be injected directly into the vein or into the tube of the infusion system if the patient receives infusion therapy.

    Adults and children with a body weight of 40 kg and more

    1-6 g / day in 2 or 3 injections intravenously or intramuscularly.

    - With bronchopulmonary bacterial infection in cystic fibrosis is prescribed by 100-150 mg / kg / day, in 3 administrations (the maximum daily dose is 9 g)1.

    - With febrile neutropenia due to bacterial infection, nosocomial pneumonia, bacterial meningitis, bacteremia appoint 2 g every 8 hours.

    - With infections of bones and joints, complicated infections of the skin and soft tissues, infections of the ENT organs, complicated intra-abdominal infections, peritonitis associated with holding hemo- and peritoneal dialysis and a continuous ambulatory peritoneal dialysis appoint 1-2 g every 8 hours.

    - With infections of the gastrointestinal tract and bile ducts - 1 g every 8 hours or 2 g every 12 hours.

    - In severe infections, especially in patients with reduced immunity (including patients with neutropenia), 2 g every 8 or 12 hours, or 3 g every 12 hours.

    - With complicated infections urinary tract is recommended to inject 1-2 g every 8 or 12 hours.

    - For the prevention of operations on the prostate gland (transurethral resection), Fortum is prescribed at a dose of 1 g during anesthesia and a second dose is administered when the catheter is removed.

    Mode of prolonged infusion

    With febrile neutropenia due to bacterial infection, bronchopulmonary bacterial infection in cystic fibrosis, nosocomial pneumonia, bacterial meningitis, bacteremia, infections of bones and joints, complicated skin and soft tissue infections, complicated intra-abdominal infections, peritonitis associated with hemo- and peritoneal dialysis and with continuous outpatient peritoneal dialysis Fortum is administered as a loading dose of 2 g followed by the introduction of the drug in the regime of prolonged infusion in doses of 4 to 6 g every 24 hours.

    1 In adult patients with normal the kidney function with the administration of the drug in a dose of up to 9 grams per day, no side effects were observed.

    Special patient groups

    Children older than 2 months with a body weight of less than 40 kg

    - With infections of the gastrointestinal tract and bile ducts 30-100 mg / kg / day in 2 or 3 injections

    - With infections of the ENT organs: malignant external otitis, complicated infections of bones and joints, complicated infections of the skin and soft tissues, complicated intra-abdominal infections, peritonitis associated with hemo- and peritoneal dialysis and with continuous ambulatory peritoneal dialysis - 100-150 mg / kg / day in three injections, maximum - 6 g / day.

    - With febrile neutropenia, bronchopulmonary bacterial infection in mukonecidosis, bacterial meningitis, severe infections such as septicemia, bacteremia, infections in patients with immunodeficiency 150 mg / kg / day in three injections, maximum - 6 g / day.

    Mode of prolonged infusion

    With febrile neutropenia due to bacterial infection, bronchopulmonary bacterial infection in cystic fibrosis, nosocomial pneumonia, bacterial meningitis, bacteremia, infections of bones and joints, complicated infections of the skin and soft tissues, complicated intra-abdominal infections, peritonitis associated with hemo- and peritoneal dialysis and with continuous outpatient peritoneal dialysis Fortum is administered as a loading dose of 60-100 mg / kg followed by the administration of the drug in the regime of prolonged infusion at a dose of 100-200 mg / kg / day, maximum 6 g / day.

    Newborns aged 0 to 28 days and children between the ages of 28 days and up to 2 months

    25-60 mg / kg / day in 2 injections.

    Mode of prolonged infusion

    Safety and efficacy of Fortum in the regime of prolonged infusion in newborns from 0 to 28 days and children from 28 days to 2 months have not been studied.

    Elderly patients

    Given the reduced ground clearance ceftazidime in elderly patients age, the recommended dose of ceftazidime should not exceed 3 g / day, especially in patients older than 80 years.

    Patients with impaired renal function

    Ceftazidime is excreted by the kidneys unchanged. Therefore, in patients with impaired renal function, the dose of ceftazidime should be reduced. The initial dose is 1 g. Supporting doses are selected depending on the values ​​of creatinine clearance.

    Adults and children with a body weight of 40 kg and more

    Supportive doses of ceftazidime for patients with impaired renal function

    Clearance creatinine (ml / min)

    Concentration of creatinine and blood plasma, μmol / l (mg / dl)

    Recommended single doses of ceftazidime (g)

    Frequency administration of the drug

    >50

    < 150 (< 1,7)

    standard doses

    from 50 to 31

    150 to 200

    (from 1.7 to 2.3)

    1,0

    every 12 hours

    from 30 to 16

    from 200 to 350

    (2.3 to 4.0)

    1,0

    every 24 hours

    15 to 6

    from 350 to 500

    (4.0 to 5.6)

    0,5

    every 24 hours

    <5

    > 500 (> 5,6)

    0,5

    every 48 hours

    Patients with severe infections recommended one time dose should be increased by 50% or increased frequency of drug administration. These patients should be monitored concentration ceftazidime in plasma blood; the concentration of ceftazidime should not exceed 40 mg / l. For children, the clearance of creatinine is calculated according to fat-free body weight or body surface area.

    Doses of ceftazidime for patients with impaired renal function - extended infusion

    Clearance creatinine (ml / min)

    Creatinine concentrations in blood plasma, μmol / L (mg / dl)

    Frequency of drug administration

    from 50 to 31

    150 to 200

    (from 1.7 to 2.3)

    The loading dose of 2 g followed by 1-3 g for 24 hours in the regime of extended infusion

    from 30 to 16

    from 200 to 350

    (2.3 to 4.0)

    The loading dose of 2 g followed by 1 g for 24 hours in the regime of extended infusion

    ≤ 15

    >350

    (> 4,0)

    Not yet rated

    Care should be taken when selecting a dose. A thorough clinical monitoring of the safety and effectiveness of the therapy is recommended.

    Children with a body weight of less than 40 mg

    Supportive doses of ceftazidime for patients with impaired renal function

    Clearance creatinine (ml / min) **

    Concentration of creatinine and blood plasma * μmol / l (mg / dL)

    Featured single doses of ceftazidime mg / kg body weight

    Frequency introduction of preparation

    from 50 to 31

    150 to 200

    (from 1.7 to 2.3)

    25

    every 12 hours

    from 30 to 16

    from 200 to 350

    (2.3 to 4.0)

    25

    every 24 hours

    15 to 6

    from 350 to 500

    (4.0 to 5.6)

    12,5

    every 24 hours

    < 5

    >500 (> 5,6)

    12,5

    every 48 hours

    * Concentrations of creatinine in blood plasma are indicative values ​​that can not indicate the same degree of renal impairment for all patients.

    ** Calculated based on area body surface or measurements.

    Children with impaired renal function, the clearance of creatinine is calculated according to the surface area of ​​the body or the fat-free body weight.

    A thorough clinical monitoring of safety and effectiveness of the therapy.

    Extended infusion regimen for patients with impaired renal function

    The efficacy and safety of the Fortum drug, administered in the extended infusion regime in children with impaired function of noctums with a body weight of less than 40 kg, has not been studied. A thorough clinical monitoring of the safety and effectiveness of the therapy is recommended. If extended infusion is used in children with impaired renal function, creatinine clearance should be calculated according to body surface area or lean body mass.

    Hemodialysis

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

    After each hemodialysis session, maintenance doses of ceftazidime are administered in accordance with the table above.

    Peritoneal dialysis

    Ceftazidime can be used during peritoneal dialysis and continuous ambulatory peritoneal dialysis. In addition to intravenous introduction, ceftazidime can be added to the dialysis solution (usually at a dose of 125-250 mg per 2 liters of dialysate solution).

    For patients with renal failure who are on continuous hemodialysis using an arteriovenous shunt, or for patients on high-speed haemofiltration in the intensive care unit, the recommended dose is 1 g / day daily (one or more introductions).

    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 veno-venous shunt are recommended doses shown in the tables below.

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

    Creatinine clearance (ml / min)

    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

    * A 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

    * A maintenance dose is given every 12 hours.

    Patients with impaired hepatic function

    According to available data, there is no need for correction of the dosing regimen in patients with mild to moderate liver function impairment. There are no results of studies involving patients with impaired hepatic function.A thorough clinical monitoring of the safety and efficacy of the therapy is recommended.

    Instructions for preparing a solution

    Fortum powder in the form of a powder for injection solution is in vials under reduced pressure. When the powder is dissolved, carbon dioxide is liberated and the pressure in the vial is increased, so small bubbles of carbon dioxide may be present in the resulting prepared drug solution, which can be ignored.

    Number of ceftazidime in vial

    Method of administration

    Number of solvent (ml)

    Nearconcentration (mg / ml)

    250 mg

    at/m

    1.0 ml

    210

    in / in

    2.5 ml

    90

    500 mg

    at/m

    1.5 ml

    260

    in / in

    5.0 ml

    90

    1 g

    w / m

    3.0 ml

    260

    IV bolus

    10.0 ml

    90

    IV infusion

    50.0 ml *

    20

    2 grams

    IV bolus

    10.0 ml

    170

    IV infusion

    50.0 ml *

    40

    Adding solvent spend in 2 introduction.

    A drug Fortum is compatible with most of the most common solutions for intravenous administration, but sodium bicarbonate is not recommended at As a solvent (see section "Interaction from other medicinal products ").

    Depending on the concentration, type of solvent and storage conditions, the resulting solution preparation Fortum can have a color from light yellow to dark yellow. If the rules of dilution of the drug are observed, then its effectiveness does not depend on the shade of the solution.

    Ceftazidime in a concentration of 1 mg / ml to 40 mg / ml is compatible with the following solvents:

    - 0.9% solution of sodium chloride;

    - Hartman's solution;

    - 5% dextrose solution;

    - 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;

    - dextran 40 for injection of 10% in a 0.9% solution of sodium chloride;

    - dextran 40 for injection of 10% in a 5% solution of dextrose;

    - dextran 70 for injection of 6% in a 0.9% solution of sodium chloride;

    - dextran 70 for injection of 6% in a 5% dextrose solution.

    Ceftazidime in a concentration of 0.05 mg / ml to 0.25 mg / ml is compatible with the solution for intraperitoneal dialysis (lactate).

    For intramuscular injection adults ceftazidime can be diluted with 0.5% or 1% lidocaine solution.

    If ceftazidime in a concentration of 4 mg / ml is mixed with the following solutions, both components retain activity:

    - hydrocortisone (hydrocortisone sodium phosphate) 1 mg / ml in a 0.9% solution of sodium chloride or 5% solution of dextrose;

    - cefuroxime (cefuroxime sodium salt) 3 mg / ml in 0.9% solution sodium chloride;

    - cloxacillin (cloxacillin sodium salt) 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 a solution of ceftazidime (500 mg in 1.5 ml of water for injection) and metronidazole (500 mg at 100 ml), both components remain active.

    Preparation of a solution for intramuscular or intravenous bolus administration

    1. Insert the syringe needle into the vial through the rubber stopper and add the recommended amount of solvent through it.

    2. Remove the syringe needle and shake the vial to get a clear solution.

    3. Flip the bottle. With a piston fully inserted into the syringe, pierce the rubber plug of the vial with a needle and move it forward needle in the bottle so that it is in solution. Collect the entire solution in a syringe. The solution in width can contain small bubbles of carbon dioxide.

    Preparation of a solution for intravenous infusions (vials of 1 g and 2 g)

    1. Insert the syringe needle into the vial through a rubber stopper and add 10 ml of solvent through it.

    2. Take out the needle of the syringe and shake the vial to make a clear solution.

    3. Insert the gas mist into the vial through the rubber stopper to reduce the internal pressure in the vial.

    4. Transfer cooked solution into the infusion system, bringing the total volume to at least 50 ml. Enter by intravenous infusion for 15-30 minutes.

    To ensure sterility, it is important not to inject the gas outlet needle into the bottle until the powder dissolves.

    Side effects:

    Undesirable reactions, presented below, are listed in accordance with the damage to organs and organ systems and frequency of occurrence.

    Frequency of occurrence is defined as follows: Often (> 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1 000 and <1/100), rarely (≥ 1/10 000 and <1/1 000), rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration surveillance.

    Frequency of occurrence undesirable reactions

    Infectious and parasitic diseases

    Infrequently: Candidiasis (including vaginitis and candidiasis of the oral cavity).

    Violations from the blood and lof the imphatic system

    Often: eosinophilia, thrombocytosis.

    Infrequently: leukopenia, neutropenia and thrombocytopenia.

    Rarely: lymphocytosis, hemolytic anemia, agranulocytosis.

    Immune system disorders

    Rarely: anaphylactic reactions (including bronchospasm and / or lowering of blood pressure).

    Disturbances from the nervous system

    Infrequently: headache and dizziness.

    Rarely: paresthesia,

    Cases reported neurological disorders such as tremor, myoclonia, convulsions, encephalopathy, coma, which were noted in patients with impaired renal function with an insufficient dose reduction of ceftazidime.

    Vascular disorders

    Often: phlebitis or thrombophlebitis with intravenous administration.

    Disorders from the gastrointestinal tract

    Often: diarrhea.

    Infrequently: nausea, vomiting, pain in abdomen and colitis.

    Very rarely: unpleasant taste in the mouth.

    Colitis can be caused Clostridium difficile and can manifest as pseudomembranous colitis (see section "Special instructions").

    Disturbances from the liver and bile ducts

    Often: transient rise one or more "hepatic" enzymes: alanine transferase (ALT), aspartate aminotransferase (ACT), lactate dehydrogenase (LDH), gamma-glutamyl transpeptidase (GGTP) and alkaline phosphatase (AF).

    Rarely: jaundice.

    Disturbances from the skin and subcutaneous tissues

    Often: patchy-papular rash or hives.

    Infrequently: itching.

    Rarely: angioedema, erythema multiforme, Stevens-Johnson syndrome and toxic epidermalth necrolysis.

    Disorders from the kidneys and urinary tract

    Very rarely: interstitial nephritis, acute renal failure.

    General reactions and reactions at the site of administration

    Often: pain and / or inflammation after intramuscular injection.

    Infrequently: fever.

    Laboratory and instrumental data

    Often: positive direct reaction of Coombs.

    Infrequently: transient increases in urea, urea nitrogen in the blood and / or serum creatinine.

    A positive Coombs reaction is observed in about 5% of patients, with a corresponding change laboratory indicators of blood.

    Overdose:

    Symptoms

    Overdose can lead to neurological complications with the development of encephalopathy, seizures and coma.

    Treatment

    The content of ceftazidime in blood plasma can be reduced by hemodialysis or peritoneal dialysis. Symptomatic therapy.

    Interaction:

    Simultaneous administration of high doses of ceftazidime and nephrotoxic drugs may have an adverse effect on kidney function (see section "Special instructions").

    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.

    A drug Fortum is compatible with most solutions for intravenous administration. but ceftazidime less stable in sodium bicarbonate solution, so it is not recommended to use it as a solvent.

    Pharmaceutically incompatible with aminoglycosides, vancomycin, chloramphenicol. Ceftazidime and aminoglycosides should not be mixed in one infusion system or syringe. Chloramphenicol current in vitro as an antagonist of ceftazidime and other cephalosporins. The clinical significance of this phenomenon is not known, but with simultaneous administration it is necessary to take into account the possible antagonism of the action.

    When vancomycin is added to the solution of ceftazidime, precipitation is noted, so it is recommended to wash the infusion system between the administrations of these two drugs.

    Special instructions:

    Before starting treatment with Fortum, you need to collect a detailed history of previous reactions of hypersensitivity to ceftazidime, cephalosporins, penicillins or other drugs. Particular attention should be given to patients with a previous mild allergic reaction to penicillins or other beta-lactam antibiotics.

    When developing an allergic reaction to ceftazidime, the drug should be immediately discontinued, in severe cases, epinephrine, hydrocortisone, antihistamines, or other emergency measures may be required.

    The simultaneous use of cephalosporins in a high dose with nephrotoxic drugs, such as aminoglycosides or diuretics with a pronounced effect (for example, furosemide), can have a negative impact on kidney function.

    Because the ceftazidime is excreted by the kidneys, in patients with renal insufficiency, its dose should be reduced in accordance with the degree of impaired renal function.Neurological disturbances were reported in patients with renal insufficiency in cases when the dose was not reduced (see sections "Dosing and Administration", "Side effect").

    Cases of pseudomembranous colitis occur with antibiotics, the severity of which can range from mild to life-threatening. Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after antibiotic use. If diarrhea is long or severe, or the patient experiences abdominal cramps, treatment should be stopped immediately and the patient should be examined. Drugs that inhibit the intestinal peristalsis are contraindicated.

    Prolonged use of broad-spectrum antibiotics, including ceftazidime, can lead to an increase in the growth of insensitive microorganisms (mainly delivery Candida and Enterococcus), and may require discontinuation of treatment or appropriate therapy. During treatment it is necessary to constantly assess the patient's condition.

    As with the treatment of other cephalosporins and penicillins of a wide range of effects, when using ceftazidime in some initially sensitive strains Enterobacter spp. and Serratia spp. may develop resistance, so in the treatment of infections caused by these microorganisms, should periodically conduct a study on the sensitivity to antibiotics.

    Ceftazidime does not affect the results of the determination of glucose in urine by enzymatic methods, but can cause a slight distortion of the results of the analysis based on the reduction of copper (Benedikt, Feding, Klinist).

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

    Effect on the ability to drive transp. cf. and fur:

    Because the drug may cause dizziness, warn patients about precautions when driving a vehicle or working with moving machinery.

    Form release / dosage:PPowder for solution for injection, 250 mg, 500 mg, 1 g or 2 g.
    Packaging:

    Vials of 250 mg, 500 mg, 1 g or 2 g of ceftazidime; 1 bottle is placed in a cardboard box together with instructions for use.

    Storage conditions:

    Store at a temperature of no higher than 25 ° C, in a place protected from light.

    After reconstitution, store the solutions for 24 hours at room temperature (not above 25 ° C) or 7 days in the refrigerator.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015707 / 01
    Date of registration:25.05.2009
    Expiration Date:Unlimited
    The owner of the registration certificate: GlaxoSmithKline SpA GlaxoSmithKline SpA Italy
    Manufacturer: & nbsp
    Information update date: & nbsp08.01.2017
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