Ceftazidime - instructions for use, doses, side effects, contraindications

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.

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, Citrobacter freundii; Neisseria meningitidis; Haemophilus influenzae (including strains resistant to ampicillin);

Gram-positive microorganisms: Staphylococcus aureus (producing and not producing penicillinase strains sensitive to methicillin), Streptococcus pyogenes (group A beta-hemolytic streptococcus), Streptococcus agalactiae (group B beta-hemolytic streptococcus), 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 microorganisms (the clinical significance of this activity is unknown): Clostridium perfringens, Acinetobacter spp., Haemophilus parainfluenzae, Morganella morganii. Neisseria gonorrhoeae, Peptococcus spp., Peptostreptococcus spp., Providencia spp., Including Providencia rettgeri, Salmonella spp., Shigella spp., Staphylococcus epidermidis, Yersinia enterocolitica.

Pharmacokinetics:The maximum concentration in the blood plasma after intramuscular injection in doses of 0.5 and 1.0 g is 17 and 39 mg / l, respectively. The time required to reach the maximum concentration is 1 hour. The maximum concentration in the blood plasma after intravenous bolus at doses of 0.5, 1 and 2 g is 42, 69 and 170 mg / ml, respectively. Therapeutically effective serum concentrations persist 8-12 hours after intravenous and intramuscular administration. The connection with plasma proteins is less than 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, pleural and peritoneal fluids. Easily penetrates through the placenta and stands out with difficult 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 (4-20 mg / L and higher). The half-life is 1.9 hours, 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), within 24 hours; with bile - less than 1%.

Indications:

Lower respiratory tract infections (bronchitis, infected bronchiectasis, pneumonia, lung abscess, pleural empyema, lung infections in patients with cystic fibrosis);

ENT infections (otitis media, mastoiditis, sinusitis);

urinary tract infection (pyelonephritis, pyelitis, cystitis, urethritis, kidney abscess);

infections of soft tissues (phlegmon, erysipelas, wound infections, mastitis, skin ulcer);

infection of bones and joints (osteomyelitis, septic arthritis);

infections of the gastrointestinal tract, biliary tract and abdominal cavity (cholangitis, cholecystitis, gallbladder empyema, retroperitoneal abscesses, peritonitis, diverticularitis, enterocolitis); infections of the pelvic organs;

sepsis;

gonorrhea;

meningitis.

Prevention of infectious complications in operations on the prostate gland.

Contraindications:Hypersensitivity to ceftazidime and to preparations of the group of cephalosporins and penicillins.

Carefully:Renal failure, neonatal period, colitis in the anamnesis, 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:During pregnancy ceftazidime appoint only if the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be solved.

Dosing and Administration:

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

Adults and children over 12 years of age are prescribed 1 g every 8-12 hours or 2 g with an interval of 12 hours.

In severe infections, especially in patients with reduced munititis (including patients with neutropenia), - 2 g every 8 hours. For infections of the urinary tract - 0.25 g 2 times a day. In infections of bones and joints - 2.0 g every 12 hours. In cystic fibrosis, lung infections caused by Pseudomonas spp. - 0-50 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 should not exceed a maximum daily dose of 3 in

Newborns and infants up to 2 months of age are prescribed 25-60 mg / kg / day (multiplicity of 2 injections).

Children older than 2 months are prescribed 30-100 mg / kg / day (fold 2-3 injections), children with reduced immunity, cystic fibrosis and meningitis -50 mg / kg / day (multiplicity of 3 administration).

The maximum daily dose for children should not exceed 6 g. In patients with impaired renal function, (including patients undergoing dialysis), the dosing regimen of ceftazidime is set depending on the creatinine clearance.

Creatinine clearance (ml / min)

Dosing regimen

31-50

16-30

6-15

Less than 5

1.0 g every 12 h

for 1.0 g every 24 h

0.5 g every 24 hours

0.5 g every 48 h

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 on high-velocity haemofiltration in the intensive care unit, the recommended doses are 1.0 g / day daily (for one or more injections).

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

The duration of the course of therapy is 7-14 days. In infections caused by Pseudomonas aeruginosa (pneumonia, complications caused by infection of the lungs with cystic fibrosis, meningitis) treatment course can be increased up to 21 days.

Preparation of solutions for injections:

Dosage	Method of administration	Volume of solvent (ml)
0.5 g	intramuscularly	1,5
	intravenously bolus	5,0
1 g	intramuscularly	3,0
	intravenously bolus	10
	intravenously infusion	50

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: Rash, fever, eosinophilia, pruritus, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme (including Stevens-Johnson syndrome), angioedema, bronchoconstriction, 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, candidal vaginitis.

From the digestive system: nausea, vomiting, diarrhea, constipation, abdominal pain, colitis, cholestasis, oropharyngeal candidiasis.

On the part of the organs of hematopoiesis: leukopenia, neutropenia, thrombocytopenia, lymphocytosis, hemolytic anemia, hemorrhages.

Laboratory indicators: hypercreatininaemia, increased urea concentration, false positive urine reaction to glucose, increased activity of "liver" 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, hypercreatininaemia, hyperbilirubinemia, thrombocytosis, thrombocytopenia, eosinophilia, leukopenia, lengthening prothrombin time.

Treatment: symptomatic, in the case of renal failure-peritoneal dialysis or hemodialysis.

Interaction:

Pharmaceutically incompatible with aminoglycosides, vancomycin. Do not use sodium bicarbonate solution as a solvent.

"Loop" diuretics, aminoglycosides, vancomycin, clindamycin reduce clearance, which increases the risk of nephrotoxic action.

Bacteriostatic antibiotics (incl. chloramphenicol) reduce the effect of the drug.

Pharmaceutically compatible with the following solutions: at a concentration of 1 to 40 mg / ml - sodium chloride 0.9%; sodium lactate; Hartman's 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 ), 18% and dextrose 4 %; dextrose 10 %; dextran with a molecular mass of about 40 kDa 10% in a solution of sodium chloride 0.9% or in a solution of 5% dextrose; dextran with a molecular weight of about 70 kDa of 6% in a solution of sodium chloride of 0.9% or in a solution of 5% dextrose.

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

For intramuscular injection ceftazidime can be diluted with a solution of lidocaine hydrochloride 0.5-1%. 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 solution sodium chloride 0.9% or a dextrose solution of 5%; cefuroxime (cefuroxime sodium) 3 mg / ml in solution sodium chloride 0.9%; cloxacillin (cloxacillin sodium) 4 mg / ml in solution sodium chloride 0.9%; heparin 10 IU / ml or 50 IU / ml in solution sodium chloride 0.9%; potassium chloride1 10 mEq / l or 40 mEq / l in solution sodium chloride 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 who had a history of allergic reactions to penicillins, may have increased sensitivity to cephalosporin antibiotics.

Ceftazidime may interfere with the synthesis of vitamin K due to suppression of 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. In severe, 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 toxin during or after the administration of ceftazidime. In mild cases, it is enough to cancel the drug, with more severe - it is recommended to restore the water-salt and protein balance, if necessary, metronidazole, vancomycin inside.

During treatment can not be used ethanol - Disulfiramoid-like effects are possible.

Effect on the ability to drive transp. cf. and fur:When using ceftazidime, care must be taken when driving and using other equipment.

Form release / dosage:

Powder for solution for intravenous and intramuscular injection 0.5 g and 1.0 g.

Packaging:

For 0.5 g and 1.0 g of ceftazidime in glass vials with a capacity of 10 ml.

1 a bottle with instructions for use in a cardboard box. 50 bottles with instructions for use in the amount of 10 pieces in a cardboard box (for hospitals).

Storage conditions:List B. In a dry, 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 use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-003633/10

Date of registration:30.04.2010

The owner of the registration certificate:Company DEKO, LLC Company DEKO, LLC Russia

Manufacturer: & nbsp

Company DEKO, LLC Russia

Information update date: & nbsp08.11.2015

Illustrated instructions

Instructions

Ceftazidime (Ceftazidime)