Universal reference book for medicines
Name of the preparation: CEFTAZIDIME KABI (CEFTAZIDIME KABI)

Active substance: ceftazidime

Type: Third generation cephalosporin

Manufacturer: FRESENIUS KABI DEUTSCHLAND (Germany) manufactured by LABESFAL-LABORATORIOS ALMIRO (Portugal)
Composition, form of production and packaging
Powder for solution for iv and in / m introduction
white or white with a yellowish hue, crystalline.

1 f.

ceftazidime pentahydrate 1164.8 mg,

which corresponds to the content of ceftazidime 1000 mg

Excipients: sodium carbonate anhydrous 118 mg.

Vials with a capacity of 10 ml (1) - packs cardboard.

Vials with a capacity of 10 ml (10) - packs of cardboard.

Powder for solution for iv and in / m introduction white or white with a yellowish hue, crystalline.

1 f.

ceftazidime pentahydrate 582.4 mg,

which corresponds to the content of ceftazidime 500 mg

Excipients: sodium carbonate anhydrous 59 mg.

Vials with a capacity of 10 ml (1) - packs cardboard.

Vials with a capacity of 10 ml (10) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

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 β-lactamases. Effects on many strains resistant to ampicillin and other cephalosporins.
It is active against gram-negative microorganisms: Pseudomonas spp., Incl.
Pseudomonas aeruginosa, Klebsiella spp., Incl. Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Escherichia coli, Enterobacter spp., Including Enterobacter aerogenes, Enterobacter cloacae, Citrobacter spp., Including Citrobacter diversus, Neisseria gonorrhoeae, Citrobacter freundii, Pasteurella multocida, Neisseria meningitidis, Haemophilus influenzae (including strains resistant to ampicillin); Gram-positive microorganisms: Staphylococcus aureus (penicillinase-producing and susceptible methicillin-producing strains), Streptococcus pyogenes (group A beta-hemolytic streptococcus), Streptococcus agalactiae (group B), Streptococcus pneumoniae; anaerobic microorganisms: Bacteroides spp. (many strains of Bacteroides fragilis are resistant).
Inactive against methicillin-resistant Staphylococcus spp., Streptococcus faecalis, Enterococcus spp., Listeria monocytogenes, Campylobacter spp.
and Clostridium difficile.
It is active in vitro against most strains of the following organisms: Clostridium perfringens, not including Clostridium difficile, Acinetobacter spp., Haemophilus parainfiuenzae, Morganella morganii, Neisseria gonorrhoeae, Peptococcus spp., Peptostreptococcus spp., Providencia spp., Providencia rettger ,.
Salmonella spp., Shigella spp., Staphylococcus epidermidis, Yersinia enterocolitica.
PHARMACOKINETICS

C max after i / m administration in doses of 0.5 and 1 g - 17 and 39 mg / l, respectively, C max - 1 h. C max after iv bolus administration in doses of 0.5 and 1 g - 42 and 69 mg / l respectively .
Therapeutically effective serum concentrations persist 8-12 hours after IV and IM. The connection with plasma proteins is less than 10%.Concentrations of ceftazidime exceeding the minimum inhibitory concentration (MIC) for the most common pathogens can be achieved in bone tissue, heart, bile, sputum, synovial fluid, intraocular, pleural and peritoneal fluids. Easily penetrates the placenta and excretes in breast milk. In the absence of the inflammatory process, poorly penetrates the blood-brain barrier (BBB). When meningitis concentration in the cerebrospinal fluid (CSF) reaches a therapeutic value (4-20 mg / L and higher).T 1/2 - 1.9 h, in newborns - 3-4 times longer; with hemodialysis - 3-5 hours. It is not metabolized in the liver. It is excreted by the kidneys (80-90% unchanged by glomerular filtration) for 24 hours; with bile - less than 1%.
INDICATIONS

Infectious-inflammatory diseases caused by microorganisms sensitive to ceftazidime: lower respiratory tract (bronchitis, infected bronchiectasis, pneumonia, lung abscess, pleural empyema, infections of the lungs in patients with cystic fibrosis);
ENT organs (otitis media, sinusitis); urinary tract (pyelonephritis, pyelitis, cystitis, urethritis, kidney abscess, infections associated with urolithiasis); soft tissues (phlegmon, erysipelas, wound infections, mastitis, skin ulcer); infection of bones and joints (osteomyelitis, septic arthritis); gastrointestinal tract (GIT), bile ducts and abdominal cavity (cholangitis, cholecystitis, gall bladder empyema, retroperitoneal abscesses, peritonitis, diverticulitis, enterocolitis); pelvic organs, prostatitis, gonorrhea, sepsis, meningitis. Prevention of infectious complications in operations on the prostate gland.
DOSING MODE

In / in or / m.
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 are prescribed 1 g every 8-12 h or 2 g at intervals of 12 h.

In severe disease, especially in patients with reduced immunity, including patients with neutropenia, should be prescribed 2 g every 8 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 g - 1 g 2 times a day. In cystic fibrosis, patients with respiratory system infections caused by Pseudomonas spp. - 100-150 mg / kg / day, the frequency of administration - 3 times a day.
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.Older patients, taking into account the lowered clearance of ceftazidime in acute diseases, the maximum daily dose is 3 g, especially for patients older than 80 years.

Children older than 2 months and up to 12 years of age are prescribed 30-100 mg / kg / day (2-3 administrations), children with reduced immunity, cystic fibrosis and meningitis -150 mg / kg / day in 3 injections, the maximum daily dose is 6 Newborns and infants up to 2 months of age are prescribed 25-60 mg / kg / day in 2 injections.

If the renal function is impaired, the initial dose is 1 g. The maintenance dose is selected depending on the rate of creatinine release: when creatinine clearance is 50-31 ml / min - 1 g 2 times a day, 30-16 ml / min -1 g 1 once a day, 15-6 ml / min - 0.5 g once a day;
less than 5 ml / min - 0.5 g once every 48 hours. For patients with infections of severe course, a single dose can be increased by 50%, while they should control the concentration of ceftazidime in the blood 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 (CC), the administration is performed after each hemodialysis session.
Against the background of peritoneal dialysis, in addition to intravenous administration, ceftazidime can be included in a 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.

Duration of treatment.

The duration of treatment with ceftazidime is 7-14 days.
In infections caused by Pseudomonas aeruginosa (pneumonia, cystic fibrosis, meningitis), treatment can be increased up to 21 days.
Rules for the preparation of solution for injection.

Use only freshly prepared solution!
After adding the solvent, the vial should be vigorously shaken until the powder is completely dissolved.
In the prepared solution, small bubbles of carbon dioxide may be present, which does not affect the effectiveness of the preparation.
Light yellowing of the solution does not affect the effectiveness of the preparation.
Dosage Volume of solvent with / m introduction Volume of solvent with / in the introduction

500 mg 1.5 ml water for injection or 0.5% or 1% lidocaine hydrochloride solution 5 ml water for injection

1000 mg 3 ml water for injection or 0.5% or 1% lidocaine hydrochloride solution 10 ml water for injection

SIDE EFFECT

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

Local reactions: with intravenous injection - phlebitis, tenderness along the vein;
with the / m introduction - soreness, burning, compaction at the injection site.
From the side of the nervous system: headache, dizziness, paresthesia, in patients with impaired renal function with improper dose selection - convulsions, encephalopathy, fluttering tremor, coma, neuromuscular excitability.

On the part of the reproductive system: candidiasis vaginitis.

From the urinary system: a violation of kidney function, toxic nephropathy.

On the part of the digestive system: nausea, vomiting, diarrhea, abdominal pain, pseudomembranous colitis, cholestasis, oropharyngeal candidiasis.

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

Laboratory indices: hypercreatininemia, azotemia, increased urea concentration, false positive urine reaction to glucose, increased activity of "liver" transaminases and alkaline phosphatase (ALF), hyperbilirubinemia, false-positive direct Coombs test without hemolysis, thrombocytosis, increased prothrombin time, pancytopenia.

CONTRAINDICATIONS

Hypersensitivity to the components of the drug, including other cephalosporins, penicillins.

Carefully.
Renal failure, newborn babies, pregnancy (I trimester), history of colitis, patients with malabsorption syndrome (increased risk of decreased 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 for the mother exceeds the potential risk for the fetus, with the drug during lactation, breast-feeding should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution: kidney failure.
In case of impaired renal function, a dose reduction is recommended.
APPLICATION FOR CHILDREN

With caution: newborn children.

APPLICATION IN ELDERLY PATIENTS

Older patients need a dose adjustment.
It is advisable during the treatment to monitor kidney function.
SPECIAL INSTRUCTIONS

In case of severe or life-threatening infections, especially in patients with weakened immunity (including patients with neutropenia), the drug can be used with other antibiotics, such as aminoglycosides, vancomycin and clindamycin, under the condition of separate administration.

In 3-7% of patients with a history of an allergy to penicillins, cross-sensitivity to cephalosporins was noted.
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 quickly 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.
Some patients may develop pseudomembranous colitis during or after ceftazidime, caused by toxins produced by Clostridium difficile.
In this case, the treatment is stopped and pseudomembranous colitis therapy is prescribed in accordance with the clinical picture.
In case of impaired renal function, a dose reduction is recommended.

For elderly patients, it is advisable to monitor kidney function during treatment.

During treatment, it is not recommended to drink alcohol because of the possibility of disulfiram-like reactions (sudden rush of blood to the face, abdominal cramps, nausea, vomiting, headache, tachycardia, dyspnea).

Impact on the ability to drive vehicles and manage mechanisms.
Patients taking ceftazidime should be careful when driving a car and doing other potentially dangerous activities that require increased attention and speed of psychomotor reactions.
OVERDOSE

It often occurs in patients with renal insufficiency.

Symptoms: dizziness, paresthesia, headache, a deviation in the results of laboratory tests (increased urea and serum creatinine in the blood, hyperbilirubinemia, thrombocytosis, thrombocytopenia, eosinophilia, leukopenia, prothrombin time lengthening), in patients with renal insufficiency - seizures encephalopathy, "fluttering "tremor, coma, neuromuscular excitability.

An overdose of ceftazidime can cause pain, inflammation, phlebitis at the injection site.

Since there is no specific antidote, the treatment is symptomatic and supportive.

In patients with impaired renal function, and also in case of severe overdose, when conservative therapy is unsuccessful, the concentration of ceftazidime in the blood can be reduced by peritoneal dialysis or hemodialysis.

DRUG INTERACTION

Pharmacologically incompatible with aminoglycosides (significant mutual inactivation: with simultaneous use, these drugs should be injected into different veins or parts of the body with intramuscular injection) and vancomycin (forms a precipitate depending on concentration, if necessary, administer two drugs through a single tube, between their use of the system for intravenous administration should be rinsed).
Do not use sodium bicarbonate solution as a solvent (carbon dioxide is formed)."Loopback" diuretics, aminoglycosides, vancomycin, clindamycin lower the creatinine clearance, which increases the risk of nephrotoxic action of ceftazidime.
Bacteriostatic antibiotics (including chloramphenicol) reduce the effectiveness of ceftazidime.

Pharmaceutically compatible with the following solutions: at a concentration of 1 to 40 mg / ml - sodium chloride 0.9%;
sodium lactate; Hartmann solution; dextrose 5%; sodium chloride 0.225% and dextrose 5%; sodium chloride 0.45% and dextrose 5%; sodium chloride 0.9% and dextrose 5% sodium chloride 0.18% and dextrose 4%; dextrose 10%, dextran with a molecular weight of about 40 thousand Daltons 10% in a solution of sodium chloride 0.9% or in a solution of dextrose 5%; dextran with a molecular mass of about 70 thousand Daltons 6% in a solution of sodium chloride 0.9% or in a solution of 5% dextrose.
In concentrations from 0.05 to 0.25 mg / ml, ceftazidime is compatible with the solution for intraperitoneal dialysis (lactate).

For the / m administration ceftazidime can be diluted with a solution of lidocaine hydrochloride 0.5-1%.
Both components remain active if ceftazidime at a concentration of 4 mg / ml is added to the following solutions: hydrocortisone (hydrocortisone sodium phosphate) 1 mg / ml in 0.9% sodium chloride solution or 5% dextrose solution; cefuroxime (cefuroxime sodium) 3 mg / ml in a solution of sodium chloride 0.9%; cloxacillin (cloxacillin sodium) 4 mg / ml in a solution of sodium chloride 0.9%; heparin 10 IU / ml or 50 IU / ml in a solution of sodium chloride 0.9%; Potassium chloride 10 mEq / L or 40 mEq / L in a 0.9% sodium chloride solution. When mixing a solution of ceftazidime (500 mg in 1.5 ml of water for injection) and metronidazole (500 mg / 100 ml), both components remain active.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Store in a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life.
2 years. Do not use after the expiration date printed on the package.
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