Ceftazidime-Akos bottles, 1 g (ceftazidime)

Latin name

Ceftazidime-AKOS

Release form

Powder for solution for injection for injection

Pharmacological action

The drug Ceftazidime is an antibacterial drug from the group of third generation cephalosporins, has a wide spectrum and acts bactericidal, disrupts the synthesis of the cell wall of microorganisms, and is resistant to most beta-lactamases. The drug is active against gram-negative microorganisms: Haemophilus influenzae, Neisseria gonorrhoeae and other Neisseria spp. and most 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 indole-positive), Proteus vulgaris and other Proteus vulgaris and other Proteus vulgaris and other Proteus vulgaris ., Providencia rettgeri and other Providencia spp. And Serratia spp.), Acinetobacter spp., Haemophilus parainfluenzae (including ampicillin-resistant strains), Pasteurella multocida. Salmonella spp., Shigella spp. and Yersinia enterocolitica. Ceftazidime has the highest activity among generation III cephalosporins against Pseudomonas aeruginosa and nosocomial infection. The drug is active against gram-positive bacteria: Micrococcus spp., Streptococcus aureus, Streptococcus mitis, Streptococcus pneumoniae, Streptococcus pyogenes group A, Streptococcus viridans and other Streptococcus spp. (excluding Streptococcus faecalis) strains sensitive to methicillin: Staphylococcus aureus, Staphylococcus epidermidis. Ceftazidime is active against anaerobic bacteria: Bacteroides spp. (most strains of Bacteroides fragilis are resistant), Clostridium perfringens, Peptococcus spp., Peplostreptococcus spp. and Propionobacterium spp. The drug is not active against methicillin-resistant strains of Campilobacter spp., Chlamydia spp., Clostridium difficile, Enterococcus spp., Listeria monocytogenes and other Lisleria spp., Staphylococcus aureus and Staphylococcus epidermidis Streptococcus faecalis.

Pharmacokinetics

After administration, the drug is rapidly distributed in the human body and reaches therapeutic concentrations in most tissues and fluids, including synovial, pericardial and peritoneal fluid, as well as in bile, sputum and urine. Distribution also occurs in bones, myocardium, gall bladder, skin and soft tissues in concentrations sufficient to treat infectious diseases, especially in inflammatory processes that enhance the diffusion of the drug. It penetrates poorly through the intact blood-brain barrier, but the therapeutic level achieved by the drug in the cerebrospinal fluid is sufficient to treat meningitis. Reversibly binds to plasma proteins (less than 15%), and has a bactericidal effect only in free form. The degree of protein binding is independent of concentration. The maximum concentration with intramuscular administration of 0.5 g or 1 g after an hour, respectively, is 17 μg / ml and 39 μg / ml, with intravenous administration, respectively 42 μg / ml and 69 μg / ml. The time to reach maximum concentration with intramuscular injection is 1 hour, with intravenous administration, by the end of the infusion. The concentration of the drug, equal to 4 μg / ml, persists for 6-8 hours. The therapeutic plasma concentration is maintained for 8-12 hours. The elimination half-life with normal renal function is 1.8 hours with impaired 2.2 hours. The drug is not metabolized in the liver, impaired liver function does not affect the pharmacodynamics and pharmacokinetics of the drug. The dose in these patients remains normal. It is excreted unchanged by the kidneys up to 80-90% (70% of the administered dose is excreted in the first 4 hours) during the day by glomerular filtration and tubular secretion equally. In case of impaired renal function, a dose reduction is recommended. The volume of distribution is 0.21-0.28 l / kg. The drug accumulates in the soft tissues, kidneys, lungs, bones and joints, serous cavities.

Indications

Infectious and inflammatory diseases caused by drug-sensitive microorganisms: severe infections, including nosocomial infections (septicemia, bacteremia, peritonitis, meningitis, infections in immunocompromised patients, infected burns)

pyreitis, acute pyelitis, and , prostatitis, cystitis, urethritis (only bacterial /, kidney abscess)

lower respiratory tract infections (acute and chronic bronchitis, infected bronchiectasis, pneumonia caused by I Gram-negative bacteria, lung abscess, empyema, lung infection in cystic fibrosis patients)

skin and soft tissue infections (mastitis, wound infection, skin ulcers, cellulitis, erysipelas)

infections of bones and joints (septic arthritis, osteomyelitis, bacterial bursitis)

infections of the gastrointestinal tract, abdominal cavity and biliary tract (enterocolitis, retroperitoneal abscesses, diverticulitis, inflammation of the pelvic organs, cholecystitis, cholangitis, empyema of the gall bladder infection) srd pelvic and female genital organs

gonorrhea (especially with hypersensitivity to antibacterial drugs from the penicillin group)

infections of the ear, throat, nose (otitis media, sinusitis, mastoiditis).

Contraindications

hypersensitivity to the drug Ceftazidime-AKOS

hypersensitivity to cephalosporins and penicillins.

Precautions: renal failure, a history of colitis, malabsorption syndrome (increased risk of decreased prothrombin activity, especially in patients with severe renal and / or liver failure), simultaneous administration with a loop diuretic and aminoglycoside, as well as a newborn.

Use during pregnancy and lactation

During pregnancy, the drug is used only if the expected benefits to the mother outweigh the potential risk to the fetus and the baby. When using the drug during lactation, breast-feeding should be discontinued.

Composition

1 vial of powder for solution for injection contains:

active substance: 1.0 g ceftazidime sodium pentahydrate carbonate (in terms of ceftazidime)

Dosage and administration

Ceftazidime-AKOS is used only parenterally: intravenously (by stream or by drop) or intramuscularly. The dose of the drug is set individually, taking into account the severity of the disease, the localization of infection, the type and sensitivity of the pathogen, age and kidney function.

The drug is administered intravenously (stream or drip) or deeply intramuscularly into the region of the upper outer quadrant of the gluteus maximus muscle or into the lateral region of the thigh. A solution of ceftazidime can be injected directly into a vein or into the tube of the infusion system.

The usual dose for adults and children over 12 years of age is 1 g intramuscularly or intravenously every 8-12 hours.

For uncomplicated urinary tract infections, intramuscularly or intravenously, 250 mg every 12 hours.

For complicated urinary tract infections - i / m or intravenously 0.5-1 g every 8-12 hours.

For uncomplicated pneumonia, infections of the skin and soft tissues - intramuscularly or intravenously 0.5-1 g every 8 hours.

For cystic fibrosis, respiratory tract infections caused by Pseudomonas spp. - intravenously in a dose of 100-150 mg / kg / day, the frequency of administration is 3 times / day (the use of a dose of up to 9 g / day in such patients did not cause complications).

For infections of bones and joints - intravenously, 2 g every 12 hours.

In severe infections, including nosocomial infections, 2 g intravenously every 8 hours.

For extremely severe or life-threatening infections, take 2 g intravenously every 8 hours.

In elderly patients, the maximum daily dose should not exceed 3 g.

In patients with renal failure, a dose reduction is required, as ceftazidime is excreted by the kidneys unchanged. The initial dose is 1 g. A maintenance dose is selected depending on the glomerular filtration rate.

Creatinine clearance Dose

> 50 ml / min (> 0.83 ml / sec) Usual dose for adults and children over 12 years old

35-50 ml / min

(0.52-0. 83 ml / s) 1 g every 12 hours

16-30 ml / min

(0.27-0.5 ml / s) 1 g every 24 hours

6-15 ml / min

(0.1-0.25 ml / s) 500 mg every 24 hours

500 mg every 48 hours

Patients on hemodialysis 1 g after each hemodialysis session

Patients on peritoneal dialysepo 500 mg every 24 hours

Patients with severe infections can increase the maintenance dose by 50% or increase frequency of drug administration. In this case, the level of ceftazidime in the blood serum should be monitored, while the serum concentration of ceftazidime should not exceed 40 mg / l.

For children, creatinine clearance is calculated according to the ideal weight or body surface area.

T1 / 2 of the drug during hemodialysis is 3-5 hours. The appropriate dose of the drug should be repeated after each period of dialysis.

With peritoneal dialysis, ceftazidime can be included in the dialysis solution at a dose of 125 mg to 250 mg per 2 L of dialysis solution.

In patients with renal failure undergoing continuous hemodialysis using an arteriovenous shunt, and in patients undergoing high-speed hemofiltration in the intensive care unit, the recommended dose is 1 g / day daily (in 1 or several administrations).

In patients undergoing low-speed hemofiltration, the recommended doses for impaired renal function are prescribed.

Children under the age of 2 months are prescribed 25-60 mg / kg / day (in 2 doses).

Children from 2 months to 12 years of age are prescribed 30-100 mg / kg / day (in 2-3 administrations).

Immunocompromised Children, cystic fibrosis and meningitis - 150 mg / kg / day (in 3 doses).

The maximum daily dose of ceftazidime for children is 6 g.

Duration of treatment with

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

Rules for the preparation of

solutions When the powder dissolves, carbon dioxide (carbon dioxide) is released. After the introduction of the solvent, the vial must be shaken to obtain a clear solution. In the resulting prepared solution of the drug, small bubbles of carbon dioxide (carbon dioxide) may be present.

The resulting solution may vary in color from light yellow to dark yellow. If all the recommended rules for diluting the drug are met, then its effectiveness does not depend on the shade.

Primary dilution

Dose Volume

of the

preservative for intramuscular injection Volume

of the

preservative intravenously

500 mg 1.5 ml of water for injection

or 0.5% or 1% lidocaine hydrochloride solution 5 ml srlk or 2 ml of grdl injection

or 0.5% or 1% lidocaine hydrochloride solution 10 ml

water for injection

Secondary dilution

For intravenous drip, the solution of the drug Ceftazidime-AKOS obtained as described above is additionally diluted in 50-100 ml of one of the following x solvents intended for intravenous administration (0.9% sodium chloride solution, Ringer's solution, 5% or 10% dextrose (glucose) solution, 5% dextrose (glucose) solution with 0.9% sodium chloride solution. For secondary dilution, only freshly prepared solution should be used.

Side effects

Allergic reactions: urticaria, chills or fever, rash, itching, bronchospasm, eosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, anaphylactic.

From the digestive system: nausea, vomiting, diarrhea, flatulence, abdominal pain, dysbiosis, increased activity of hepatic transaminases, alkaline phosphatase, hyperbilirubinemia, stomatitis, glossitis, pseudomembranous enterocolitis, oropharyngeal candidiasis, cholestasis.

From the hemopoietic system: eosinophilia, leukopenia, neutropenia, agranulocytosis, granulocytopenia, thrombocytopenia, hemolytic anemia, lymphocytosis, hemorrhage.

From the reproductive system: candidal vaginitis.

From the urinary system: impaired renal function, toxic nephropathy.

From the side of the central nervous system: headache, dizziness, paresthesia, dizziness, convulsive seizures, encephalopathy, fluttering tremor.

Laboratory indicators: hypercreatininemia, an increase in urea concentration, a false positive urine reaction to glucose, a false positive direct Coombs reaction, an increase in prothrombin time.

Local reactions: with intravenous administration - phlebitis with intramuscular administration - pain, burning, tightening at the injection site.

Other: epistaxis, superinfection.

Drug Interaction

Pharmaceutically incompatible with aminoglycosides, heparin, vancomycin. Sodium bicarbonate solution cannot be used as solvent. Loop diuretics, aminoglycosides, vancomycin, clindamycin reduce the clearance of ceftazidime, increasing the risk of nephrotoxicity. Pharmaceutically compatible with the following solutions: at a concentration of 1 to 40 mg / ml - sodium chloride 0.9%, sodium lactate, Hartmann'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 0.18% and dextrose 4%, dextrose 10%, dextran 40: 10% in sodium chloride solution 0.9%, dextran 40: 10% in solution dextrose 5%, dextran 70: 6% in sodium chloride solution 0.9%, dextran 70: 6% in dextrose solution 5%. At a concentration of 0.05 to 0.25 mg / ml ceftazidime is compatible with the solution for intraperitoneal dialysis (lactate). For i / m administration, ceftazidime can be diluted with lidocaine hydrochloride solution 0.5% or 1%. Both components remain active if ceftazidime is added to the following solutions (ceftazidime concentration 4 mg / ml): hydrocortisone (hydrocortisone sodium phosphate) 1 mg / ml in sodium chloride solution 0.9% or dextrose 5% solution, cefuroxime (cefuroxime) mg / ml in sodium chloride solution of 0.9%, cloxacillin (cloxacillin sodium) 4 mg / ml in sodium chloride solution of 0.9%, heparin 10 IU / ml or 50 IU / ml in sodium chloride solution of 0.9%, potassium chloride 10 mEq / l or 40 mEq / l in sodium chloride solution 0.9%. 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.

Overdose

Symptoms: pain, inflammation, phlebitis at the injection site, dizziness, paresthesia, headache, convulsions in patients with renal failure, hypercreatininemia, hyperbilirubinemia, thrombocytosis, thrombocytosis, thrombocytosis,

Treatment: carry out symptomatic therapy, in case of renal failure - peritoneal dialysis or hemodialysis.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

Expiration

2 years.

Active ingredient cos

ceftazidime

Dosage form

dosage form

solution srfflff46 injections dpfrd18

Sintez AKOMP, Russia



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