Ceftazidime Cabi - instructions for use, dose, side effects, contraindications

Has a wide range of action. Resistant to the action of most beta-lactamases. Effects on many strains resistant to ampicillin and other cephalosporins.

It is active against gram-negative microorganisms: Pseudomonas spp., Including Pseudomonas aeruginosa, Klebsiella spp.,including 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 strains resistant to ampicillin); Gram-positive organisms: Staphylococcus aureus (and producing no penicillinase-producing strains that are sensitive to methicillin), Streptococcus pyogenes (group A beta-hemolytic streptococci), Streptococcus agalactiae (Group B), Streptococcus pneumoniae; anaerobic microorganisms: Bacteroides spp. (many strains of Bacteroides fragilis are resistant).

Is 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 parainfluenzae, Morganella morganii, Neisseria gonorrhoeae, Peptococcus spp., Peptostreptococcus spp., Providencia spp., Providencia rettgeri, Salmonella spp., Shigella spp., Staphylococcus epidermidis, Yersinia enterocolitica.

Pharmacokinetics:The maximum concentration after intramuscular (IM) administration in doses of 0.5 and 1 g is 17 and 39 mg / L, respectively, the maximum concentration is 1h. The maximum concentration after intravenous (iv) bolus administration in doses of 0.5 and 1 g is 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). The half-life (T1 / 2) 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) 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, gallbladder empyema, retroperitoneal abscesses, peritonitis, diverticulitis, enterocolitis); pelvic organs, prostatitis, gonorrhea, sepsis, meningitis. Prevention of infectious complications in operations on the prostate gland.

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

Carefully:Renal failure, newborn babies, pregnancy (I trimester), 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: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.

Dosing and Administration:

Intravenous or intramuscular. 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 is 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 kidney function is disturbed, the initial dose is 1 g.The maintenance dose is selected depending on the rate of release of creatinine: for creatinine clearance (CK) 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 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 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 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.

Duration of treatment.

The duration of treatment with ceftazidime is 7-14 days. In infections caused by Pseudomonas aeruginosa (pneumonia, cystic fibrosis, meningitis) treatment course 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 intramuscular injection	Volume of solvent for intravenous administration
500 mg	1.5 ml of water for injection or 0.5% or 1% solution of lidocaine hydrochloride	5 ml of water for injection
1000 mg	3 ml of water for injection or 0.5% or 1% solution of lidocaine hydrochloride	10 ml of water for injectionactivities

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, tenderness along the vein; when administered intramuscularly - soreness, burning, compaction at the injection site.

From 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: renal dysfunction, toxic nephropathy.

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

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

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

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, as well as 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.

Interaction:

Pharmaceutically incompatible with aminoglycosides (significant mutual inactivation: when used simultaneously, these drugs should be injected into different veins or parts of the body with intramuscular injection) and vancomycin (forms a precipitate depending on the concentration, if necessary, administer two drugs through onetube, between their use of the system for intravenous administration should be washed). Do not use sodium bicarbonate solution as a solvent (carbon dioxide is formed). "Loop" diuretics, aminoglycosides, vancomycin, clindamycin reduce the clearance of creatinine, which increases the risk of nephrotoxic effects of ceftazidime.

Bacteriostatic antibiotics (incl. 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 mass of about 40 thousand Daltons 10% in a solution of sodium chloride 0.9% or in a solution of 5% dextrose; 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 compatible with the solution for intraperitoneal 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 a solution of sodium chloride 0.9% or a solution of dextrose 5%; 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 solution of 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:

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, subject to 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).

Effect on the ability to drive transp. cf.and fur:Patients receiving ceftazidime, care should be taken when driving a car and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:Powder for the preparation of solution for intravenous and intramuscular injection of 500 mg and 1000 mg.

Packaging:500 mg of the active ingredient in a 10 ml glass injection bottle capped with a rubber stopper and an aluminum cap with a plastic cover to control the first opening. For 1 or 10 vials together with the instruction for use are put in a cardboard pack.

By 1000 mg of active ingredient in a 10 ml glass injection bottle capped with a rubber stopper and an aluminum cap with a plastic cover to control the first opening. For 1 or 10 vials together with the instruction for use are put in a cardboard pack.

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 expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-000057

Date of registration:26.11.2010

Date of cancellation:2015-11-26

The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany

Manufacturer: & nbsp

LABESFAL-LABORATORIOS ALMIRO, S.A. Portugal

Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany

Information update date: & nbsp08.11.2015

Illustrated instructions

Instructions

Ceftazidime Kabi (Ceftazidime Kabi)