The instruction for use
of medicine for experts
the Trade name
the International unlicensed
name Ceftazidime Dosage Form Powder for preparation of solution for injections, 500 mg, 1000 mg and
Active agent – a ceftazidime pentahydrate of 500 mg 1000 mg 2000 mg
(in terms of a ceftazidime),
excipient – sodium a carbonate 50 mg 100 mg 200 mg.
crystal powder, White or white with a creamy shade,
Antimicrobial drugs for system use.
Others beta laktamnye antibiotics. Cephalosporins of the third generation. ATC J01DD02 code
Pharmacokinetics properties After introduction drug is quickly distributed in a human body and reaches therapeutic concentration in the majority of fabrics and liquids, including synovial, pericardiac and peritoneal fluid and also in bile, a phlegm and urine. Distribution also happens in bones, a myocardium, a gall bladder, skin and soft tissues in the concentration sufficient for treatment of infectious diseases, especially at the inflammatory processes strengthening drug diffusion. Badly gets through the intact blood-brain barrier, but the therapeutic level reached by drug in cerebrospinal fluid is sufficient for treatment of meningitis. Reversibly contacts proteins of blood plasma (less than 15%), and possesses bactericidal action only in a free look. Extent of linking with blood proteins does not depend on concentration. The maximum concentration at intramuscular introduction of 0.5 g or 1 g in an hour is respectively equal in blood plasma 17 mkg/ml and 39 mkg/ml, at intravenous administration according to 42 mkg/ml and 69 mkg/ml. Time of achievement of the maximum concentration in blood plasma at intramuscular introduction – 1 h, at intravenous administration – by the end of infusion. Concentration of drug, equal 4 mkg/ml, remains during 6-8 h. Therapeutic concentration in blood plasma remains during 8-12 h. Elimination half-life at normal renal function – 1.8 h, at broken – 2.2 h. The volume of distribution is 0.21-0.28 l/kg. Drug collects in soft tissues, kidneys, lungs, bones and joints, serous cavities. Drug is not metabolized in a liver, the abnormal liver function is not reflected in a pharmacodynamics and pharmacokinetics of drug. The dose at such patients remains usual. It is removed in not changed look by kidneys up to 80-90% (70% of the entered dose are removed in the first 4 h) within a day by glomerular filtration and canalicular secretion equally. In a renal failure the dose decline is recommended.
The pharmacodynamics The drug Ceftazidime is antibacterial drug from group of cephalosporins III of generation, possesses a wide range and works bakteritsidno, breaks synthesis of a cell wall of microorganisms, is resistant to action of the majority beta laktamaz. Drug is active concerning gram-negative microorganisms: Haemophilus influenzae, Neisseria gonorrhoeae and other Neisseria spp. and most of representatives of the Enterobacteriaceae family (Citrobacter spp., Enterobacter spp., Escherichia coli, Klebsiella pneumoniae and other Klebsiella spp., Morganella morganii and other Morganella spp., Proteus mirabilis (including indolpositive), Proteus vulgaris and other Proteus spp., Providencia rettgeri and other Providencia spp. and Serratia spp.), Acinetobacter spp., Haemophilus parainfluenzae (including the strains resistant to ampicillin), Pasteurella multocida. Salmonella spp., Shigella spp. and Yersinia enterocolitica. The drug Ceftazidime has the highest activity among generation cephalosporins III concerning Pseudomonas aeruginosa and an intra hospital infection. Drug is active concerning gram-positive bacteria: Micrococcus spp., Streptococcus aureus, Streptococcus mitis, Streptococcus pneumoniae, Streptococcus pyogenes of group A, Streptococcus viridans and other Streptococcus spp. (excepting Streptococcus faecalis), the strains sensitive to Methicillinum: Staphylococcus aureus, Staphylococcus epidermidis. The drug Ceftazidime is active concerning anaerobic bacteria: Bacteroides spp. (the majority of strains of Bacteroides fragilis – a rezistentna), Clostridium perfringens, Peptococcus spp., Peplostreptococcus spp. and Propionobacterium spp. Drug is not active concerning metitsillinustoychivy strains of Campilobacter spp., Chlamydia spp., Clostridium difficile, Enterococcus spp., Listeria monocytogenes and other Lisleria spp., Staphylococcus aureus and Staphylococcus epidermidis, Streptococcus faecalis.
the Infectious and inflammatory diseases caused by microorganisms, sensitive to drug:
– sepsis (septicaemia), heavy it is purulent – septic states
– arthritis, osteomyelitis, a bursitis
– acute and chronic bronchitis, the infected bronchietasia,
the pneumonia caused by gram-negative bacteria, abscess of lungs,
a pleura empyema
– acute and chronic pyelonephritis, a pyelitis, prostatitis, cystitis, an urethritis
(only bacterial), kidney abscess
– the mastitis, wound fevers, trophic ulcers, phlegmon, an ugly face
– peritonitis, a coloenteritis, retroperitoneal abscesses, a diverticulitis, inflammation
of bodies of a small pelvis, cholecystitis, a cholangitis, an empyema of a gall bladder
– an infection of female genitals
– average otitis, sinusitis, a mastoiditis, etc.
– gonorrhea (especially at hypersensitivity to antibakterial-
to ny drugs from group of penicillin).
The route of administration and doses
apply the Ceftazidime only parenterally. The dose of drug is established individually, taking into account weight of a course of the disease, localization of an infection and sensitivity of the activator, age and body weight, function of kidneys. A usual dose for adults and teenagers: at the complicated infections of urinary tract intramusculary or intravenously on 500 mg – 1 g each 8-12 h, in uncomplicated pneumonia and infections of skin intramusculary or intravenously on 500 mg – 1 g each 8 h, in a mucoviscidosis, infections of the lungs caused by Pseudomonas spp., from 100 to 150 mg/kg/days, frequency rate of introduction – 3 times a day (use of a dose up to 9 g/days did not cause complications in such patients), in infections of bones and joints intravenously on 2 g each 12 h, in extremely heavy or zhizneugrozhayushchy infections intravenously on 2 g each 8 h. After an initial load dose of 1 g adult with a renal failure (including patients to whom carry out dialysis) the dose decline can be required, as shown below:
CLEARANCE of CREATININE
> 50 ml/min. (0.83 ml/sec.)
you Watch the section ‘Usual Dose for Adults and Teenagers’
of 35 – 50 ml/min. (0.52 – 0.83 ml/sec.)
On 1 g every the 12th
Part 16 – 30 ml/min. (0.27 – 0.50 ml/sec.)
On 1 g each 24
Parts 6 – 15 ml/min. (0.10 – 0.25 ml/sec.)
On 500 mg each 24 h
On 500 mg each 48 h
Patients to whom
Patients to whom
each 24 h carry out peritoneal dialysis On 500 mg carry out a hemodialysis On 1 g after each session of a hemodialysis
These indicators are approximate. At such patients it is recommended to control drug level in blood serum which should not exceed 40 mg/l. Elimination half-life of drug during a hemodialysis makes 3-5 h. The corresponding dose of drug should be repeated after every period of dialysis. At peritoneal dialysis the drug Ceftazidime can be included in dialysis liquid in a dose from 125 mg to 250 mg on 2 l of dialysis liquid.
A usual dose for children: Children aged up to 1st month – intravenous infusion of 30 mg/kg a day (frequency rate 2 introductions). Children from the 2nd month to 12 years – intravenous infusion of 30-50 mg/kg a day (frequency rate 3 introductions). Each 12th h appoint a dose up to 150 mg/kg/days to children with reduced immunity, a mucoviscidosis, meningitis. The maximum daily dose for children should not exceed 6 g.
Treatment needs to be continued for 2 more days after disappearance of symptoms of an infection. At the complicated infections the course of treatment, if necessary, can be continued.
PREPARATION of SOLUTIONS at dissolution of powder is allocated carbon dioxide. After administration of solvent the bottle needs to be stirred up that transparent solution turned out. At the received ready solution of drug there can be small vials of carbon dioxide. The received solution can have color from light yellow to dark yellow. If all recommended rules of cultivation of drug are followed, then its efficiency does not depend colors of the received solution.
1. ‘PRIMARY CULTIVATION’
mg 1 ml of water for injections at intramuscular introduction.
2.5 ml of water for injections at intravenous administration.
mg 1.5 ml of water for injections at intramuscular introduction.
5 ml of water for injections at intravenous administration.
1.0 g, 2.0
g 3 ml of water for injections at intramuscular introduction.
10 ml of water for injections at intravenous administration.
2.’ SECONDARY CULTIVATION’
For intravenous DROP administration the drug Ceftazidime solution received in the above way is in addition parted in 50-100 ml of one of the following solvents intended for intravenous administration: – 0.9% chloride sodium solution, – Ringera solution, – 5%, 10% solution of glucose (dextrose), – 5% solution of glucose (dextrose) from 0.9% chloride sodium solution, – 5% bicarbonate sodium solution. To use only freshly cooked solution!
– urticaria, a fever, fever, rash, an itching, it is rare – a bronchospasm,
an eosinophilia, Stephens-Johnson’s syndrome, a toxic epidermal
necrolysis (Lyell’s disease), a Quincke’s disease, an acute
– nausea, vomiting, diarrhea or a constipation, a meteorism, an abdominal pain, dysbacteriosis,
an abnormal liver function (increase in activity of “hepatic”
transaminases, alkaline phosphatase), is rare – stomatitis,
a glossitis, a pseudomembranous coloenteritis
– a leukopenia, a neutropenia, a granulocytopenia, thrombocytopenia,
hemolytic anemia, hypocoagulation
– a renal failure (an azotemia, increase in content of urea and creatinine in blood), an oliguria, an anury
– a headache, dizziness
– phlebitis, morbidity on the vein course, morbidity and infiltrate in the place
in oil of introduction
– nasal bleedings, candidiasis, superinfection.
– hypersensitivity to cephalosporins
– hypersensitivity to penicillin
Pharmaceutical it is incompatible with aminoglycosides, heparin, Vancomycinum. It is impossible to use bicarbonate sodium solution as solvent. Loopback diuretics, aminoglycosides, Vancomycinum, clindamycin reduce clearance of a ceftazidime therefore the risk of nephrotoxic action increases. Pharmaceutical we will combine with the following solutions: at concentration from 1 to 40 mg/ml – sodium chloride of 0.9%, Dextrosum of 5%, sodium chloride of 0.45% and Dextrosum of 5%. For introduction in oil the ceftazidime can be divorced with solution of lidocaine of a hydrochloride of 0.5% or 1%. At ceftazidime solution mixing (500 mg in 1.5 ml of water for injections) and metronidazole (500 mg / 100 ml) both components keep the activity.
in the presence of the following diseases or states it is necessary to weigh carefully ratios of advantage and risk for the patient: newborns and children up to 1 month, bleedings in the anamnesis, digestive tract diseases in the anamnesis, especially, nonspecific ulcer colitis. At patients with the allergy to penicillin registered in the anamnesis the cross hypersensitivity to cephalosporins at 3-7% of patients is noted. Though at many patients with the allergy to penicillin which is shown in the form of rash, cephalosporins applied without undesirable consequences, it is recommended to be careful when prescribing the drug Ceftazidime. The ceftazidime can interfere with synthesis of vitamin K owing to suppression of indestinal flora that can cause decrease in level of blood-coagulation factors, dependent on vitamin K, and in rare instances lead to a gipotrombinemiya and bleeding. Prescribing of vitamin K quickly eliminates a gipotrombinemiya. At the heavy, elderly and weakened patients, at patients with an abnormal liver function and at persons poor nutrition risk of developing bleedings is highest. At some patients the pseudomembranous colitis caused by Clostridium difficile toxin can develop in time or after use of a ceftazidime. In mild cases there is enough drug withdrawal, at heavier – recovery of water-salt and proteinaceous balance is recommended if the listed measures do not help, appoint metronidazole, bacitracin, Vancomycinum.
Pregnancy and a lactation
At pregnancy apply only according to strict indications (especially in the I trimester). The ceftazidime is allocated with breast milk in low concentration therefore in need of use in the period of a lactation it is necessary to stop breastfeeding.
Features of influence of medicine on the ability to run the vehicle or potentially dangerous mechanisms
does not influence
Symptoms: introduction of inadequately high doses of the drug Ceftazidime can cause dizziness, paresthesias, a headache, convulsive attacks, deviations in results of laboratory analyses.
Treatment: as specific antidote is absent, symptomatic treatment and supporting. In case of heavy overdose when conservative therapy is unsuccessful, the concentration of drug in blood can be reduced by means of a hemodialysis.
A form of release and packing
Powder for preparation of solution for injections on 500 mg, 1000 mg and 2000 mg in bottles with a capacity of 10 or 15 ml.
To store storage conditions in the dry, protected from light place, at a temperature not above 25 °C.
To store out of children’s reach!
An expiration date
After an expiration date not to use drug.
According to the prescription
the Producer: JSC Khimfarm, Shymkent, REPUBLIC OF KAZAKHSTAN, Rashidov St.,/N, ph.: 560882