Ceftazidime is a proprietary name. Ceftazidime, powder for the preparation of a solution for intravenous and intramuscular administration. The dosage of the antibiotic and the method of administration depend on

Ceftazidime is a cephalosporin antibacterial drug.

Release form and composition

Ceftazidime is available in three dosage forms:

  • powder for preparing a solution for intravenous (IV) and intramuscular (IM) administration: from light yellow to white, crystalline (in glass bottles of 0.5 or 1 g, in a cardboard box 1 bottle);
  • : from white with a yellowish tint to white (in bottles of 2 g, in a cardboard box 1 bottle);
  • : crystalline, from cream to white (in glass bottles of 0.25; 0.5; 1 or 2 g, 1 bottle in a cardboard box).

1 bottle of powder for preparing a solution for intravenous and intramuscular administration contains:

  • active substance: ceftazidime pentahydrate, sterile – 0.583 or 1.165 g (corresponding to a ceftazidime content of 0.5 or 1 g);
  • auxiliary component: sterile anhydrous sodium carbonate.

1 bottle of powder for preparing a solution for intravenous administration contains:

  • active substance: ceftazidime pentahydrate – 2.33 g (corresponding to the content of ceftazidime – 2 g);
  • auxiliary component: sodium carbonate – 0.236 g.

1 bottle of powder for preparing an injection solution contains:

  • active substance: ceftazidime – 0.25; 0.5; 1 or 2 g;
  • auxiliary components: sodium carbonate – 0.029 5; 0.059; 0.118 or 0.236 g.

Indications for use

  • pleural empyema, lung abscess, pneumonia, infected bronchiectasis, bronchitis, infections associated with cystic fibrosis (infections respiratory tract);
  • sinusitis, mastoiditis, otitis media (infectious diseases ear, throat, nose);
  • kidney abscess, urethritis, cystitis, prostatitis, pyelitis (kidney infections and urinary tract);
  • skin ulcer, mastitis, wound infections, erysipelas, cellulitis (skin and soft tissue infections);
  • septic arthritis, osteomyelitis (bone and joint infections);
  • enterocolitis, diverticulitis, retroperitoneal abscesses, gallbladder empyema, cholecystitis, cholangitis (infectious diseases of the biliary tract, gallbladder and organs abdominal cavity);
  • gonorrhea;
  • infectious diseases of the pelvic organs;
  • meningitis;
  • severe purulent-septic conditions, peritonitis, septicemia.

Powder for the preparation of a solution for intravenous administration

  • infections of the urinary tract, biliary tract, abdominal cavity and gastrointestinal tract;
  • infections of the skin and soft tissues, joints and bones;
  • infections of the ENT organs, respiratory tract, including lung infections in patients with cystic fibrosis;
  • dialysis-related infections;
  • infected burns, infections due to immunodeficiency, meningitis, peritonitis, bacteremia, septicemia (severe infections, including nosocomial infections);
  • prevention of infectious complications during transurethral resection.

Powder for the preparation of injection solution

  • kidney abscess, bacterial urethritis, cystitis, prostatitis, pyelitis, acute and chronic pyelonephritis;
  • mastoiditis, sinusitis, otitis media;
  • severe purulent-septic conditions;
  • bursitis, osteomyelitis, arthritis;
  • septicemia (sepsis);
  • infections of female genital organs;
  • pleural empyema, lung abscess, pneumonia caused by gram-negative bacteria, infected bronchiectasis, chronic and acute bronchitis;
  • meningitis;
  • inflammation of the pelvic organs;
  • infected burns, erysipelas, phlegmon, trophic ulcers, wound infections, mastitis;
  • empyema of the gallbladder, cholangitis, cholecystitis, diverticulitis, retroperitoneal abscesses, enterocolitis, peritonitis;
  • gonorrhea (especially in cases of hypersensitivity to antibiotics from the penicillin group).

Contraindications

The use of Ceftazidime is contraindicated in case of individual intolerance to the components included in its composition, as well as to drugs of the penicillin and cephalosporin group.

Diseases/conditions for which the powder for preparing a solution for intravenous and intramuscular administration is prescribed with caution:

  • malabsorption syndrome (high probability of decreased prothrombin activity);
  • renal and liver failure;
  • neonatal period;
  • pregnancy;
  • lactation period.

Diseases/conditions for which the powder for preparing a solution for intravenous administration is prescribed with caution:

  • renal failure;
  • pathologies of the gastrointestinal tract (including a history of ulcerative colitis);
  • simultaneous therapy with aminoglycosides and loop diuretics;
  • malabsorption syndrome;
  • history of bleeding;
  • neonatal period;
  • pregnancy;
  • breast-feeding.

The powder for the preparation of an injection solution is used with caution in pregnant women and nursing mothers.

Directions for use and dosage

Powder for the preparation of a solution for intravenous and intramuscular administration

The solution prepared from the powder is injected intravenously, dropwise or in a stream, or intramuscularly into large muscles. The dosage regimen for all forms of Ceftazidime is selected by the doctor individually for each patient, taking into account the location of the infection, the severity of the disease, kidney function, sensitivity of the pathogen, age and weight of the patient.

Usual dosage regimen for adults and children over 12 years of age:

  • complicated urinary tract infections: every 8-12 hours, 500–1000 mg;
  • uncomplicated pneumonia and skin infections: every 8 hours, 500–1000 mg;
  • lung infections caused by pseudomonas, cystic fibrosis: the dose is set based on the calculation - 100–150 mg per 1 kg of body weight, distributed over 3 administrations;
  • neutropenia and severe disease: every 8 or 12 hours, 2000 mg;
  • extremely severe or life-threatening infections: 2000 mg IV every 8 hours.

Duration of treatment – ​​1-2 weeks; in cases of infections caused by pseudomonas (meningitis, cystic fibrosis, pneumonia) it can be extended to 3 weeks.

The dosage regimen for impaired renal function (including patients on dialysis) is established depending on creatinine clearance (CC). Initial dose – 1000 mg; supporting depending on CC (ml per 1 min) are:

  • CC 31–50: every 12 hours 1000 mg;
  • QC< 5: каждые 48 ч по 500 мг;
  • patients on hemodialysis: after each hemodialysis session, 1000 mg;
  • patients on peritoneal dialysis: every 24 hours, 500 mg.

In patients undergoing hemodialysis and peritoneal dialysis, it is important to monitor serum drug levels. It should not be > 40 mg per liter.

The half-life of ceftazidime during hemodialysis is 3-5 hours.

The appropriate dose of the drug is repeated after each dialysis period.

In cases of peritoneal dialysis, it is allowed to include the drug in the dialysis fluid at a dose of 125–250 mg per 2 liters of fluid.

Maximum dose drug for elderly patients – 3000 mg per day.

Usual dosage regimen for children under 12 years of age:

  • children under 2 months: IV infusion 30 mg per 1 kg of body weight 2 times a day;
  • children from 2 months to 12 years: IV infusion 30–50 mg per 1 kg of body weight 3 times a day.

Children with meningitis, cystic fibrosis or reduced immunity are prescribed up to 150 mg of the drug per 1 kg of body weight per day every 12 hours.

The maximum dose for children should not exceed 6000 mg.

The drug at a concentration of 1–40 mg per 1 ml is compatible with most solutions for intravenous administration, but less stability is observed when using sodium bicarbonate solution, and therefore it is not used as a solvent. Ceftazidime powder is contained in vials under reduced pressure. When it dissolves, the release of carbon dioxide and an increase in pressure in the vial are observed, which is why there may be a small amount of carbon dioxide bubbles in the prepared solution.

The volume of solvent used to obtain the required dose of the drug during initial dilution:

  • 500 mg powder: 1.5/5 ml water for injection (IV, IM bolus);
  • 1000 mg powder: 3/10 ml water for injection (IV, IM bolus).

For secondary dilution for intravenous drip administration, add 50–100 ml of Ringer's solution (including lactated), 0.9% sodium chloride solution, dextrose solution (5 or 10%), 5% dextrose solution with 0.9% sodium chloride solution.

When diluting, the bottle with the contents is shaken vigorously until the powder is completely dissolved. Before administering the prepared product, it is important to visually verify that there is no sediment or foreign particles in it.

Powder for the preparation of a solution for intravenous administration

The solution prepared from the powder is administered intravenously by infusion or drip.

The maximum dose is 6000 mg per day. The maximum dose for adult patients with cystic fibrosis is 9000 mg per day.

Adults and children over 12 years of age are prescribed 1000–6000 mg per day, divided into 2-3 doses.

Typically, the drug is used every 8 hours for 1000 mg or every 12 hours for 2000 mg.

In cases of severe disease, especially in immunodeficiency (including neutropenia), 2000 mg of the drug is used every 8 or 12 hours or 3000 mg every 12 hours.

The dose of the drug for the treatment of urinary tract infections and mild infections is 500–100 mg every 12 hours; infectious complications in cystic fibrosis caused by Pseudomonas aeruginosa - 100–150 mg per 1 kg of body weight per day, divided into 3 administrations; at surgical interventions ah on the prostate gland - 1000 mg during induction of anesthesia and after removal of the catheter.

For children from 2 months to 12 years, the dose is determined based on the calculation of 30–100 mg per 1 kg of body weight per day, distributed over 2-3 administrations. For children with meningitis, cystic fibrosis, and immunodeficiency, up to 150 mg of the drug per 1 kg of body weight per day is used, divided into 3 administrations (up to 6000 mg per day).

Newborns and children from 28 days to 2 months are prescribed 25–60 mg per 1 kg of body weight per day, divided into 2 administrations.

Since ceftazidime is eliminated through the kidneys, the dose is reduced for patients with impaired renal function. Initial dose – 1000 mg; The maintenance dose is selected taking into account the rate of glomerular filtration.

Dosage regimen for renal failure, depending on CC (ml per 1 min) and creatinine concentration in blood plasma (µmol per 1 l):

  • CC > 50, creatinine concentration< 150: применяют стандартные дозы;
  • CC 50–31, creatinine concentration 200–350: 1000 mg every 12 hours;
  • CC 30–16, creatinine concentration 150–200: 1000 mg every 24 hours;
  • CC 15–6, creatinine concentration 350–500: every 24 hours 500 mg;
  • QC< 5, концентрация креатинина >500: every 48 hours 500 mg.

The recommended single dose for severe infections can be increased by 50%, or the frequency of administration of the solution can be increased. In such cases, it is important to monitor the concentration of ceftazidime in the blood plasma (it should not be > 40 mg per 1 l).

The drug can be prescribed to children with impaired renal function, and the QC is calculated in accordance with the ideal weight or body surface area.

The half-life of the drug during hemodialysis is 3–5 hours. After each session, maintenance doses of the drug are administered according to the scheme described above.

For peritoneal dialysis, 500 mg of the drug is prescribed every 24 hours.

Recommended dose for patients suffering from renal failure staying on continuous hemodialysis in the intensive care unit using an arteriovenous shunt, and for patients on high-speed hemofiltration is 1000 mg every day in one or more administrations.

In cases of hemofiltration at low rates, the same doses of the drug are used as in cases of impaired renal function.

Doses of Ceftazidime for patients undergoing hemofiltration using a veno-venous shunt, depending on CC (ml per 1 min) and ultrafiltration rate (ml per 1 min):

  • CC 0, ultrafiltration rate 5/16.7/33.3/50: every 12 hours 250/250/500/500 mg;
  • CC 5, ultrafiltration rate 5/16.7/33.3/50: every 12 hours 250/250/500/500 mg;
  • CC 10, ultrafiltration rate 5/16.7/33.3/50: every 12 hours 250/500/500/750 mg;
  • CC 15, ultrafiltration rate 5/16.7/33.3/50: every 12 hours 250/500/500/750 mg;
  • CC 20, ultrafiltration rate 5/16.7/33.3/50: every 12 hours, 500/500/500/750 mg.

Dose of the drug for patients on continuous hemodialysis using a veno-venous shunt, depending on CC (ml per 1 min), dialysis rate and ultrafiltration:

  • CC 0: dialysis rate 1 liter per 1 hour, ultrafiltration rate 0.5/1/2 liters per 1 hour - 500/500/500 mg every 12 hours; dialysis rate 2 liters per 1 hour, ultrafiltration rate 0.5/1/2 liters per 1 hour - 500/500/750 mg every 12 hours;
  • CC 5: dialysis rate 1 liter per 1 hour, ultrafiltration rate 0.5/1/2 liters per 1 hour - 500/500/750 mg every 12 hours; dialysis rate 2 liters per 1 hour, ultrafiltration rate 0.5/1/2 liters per 1 hour - 500/500/750 mg every 12 hours;
  • CC 10: dialysis rate 1 liter per 1 hour, ultrafiltration rate 0.5/1/2 liters per 1 hour - 500/500/750 mg every 12 hours; dialysis rate 2 liters per 1 hour, ultrafiltration rate 0.5/1/2 liters per 1 hour - 500/750/1000 mg every 12 hours;
  • KK 15: dialysis rate 1 liter per 1 hour, ultrafiltration rate 0.5/1/2 liters per 1 hour - 500/750/750 mg every 12 hours; dialysis rate 2 liters per 1 hour, ultrafiltration rate 0.5/1/2 liters per 1 hour - 750/750/1000 mg every 12 hours;
  • KK 20: dialysis rate 1 liter per 1 hour, ultrafiltration rate 0.5/1/2 liters per 1 hour - 750/750/1000 mg every 12 hours; dialysis rate 2 liters per 1 hour, ultrafiltration rate 0.5/1/2 liters per 1 hour - 750/750/1000 mg every 12 hours.

Duration of therapy is 1-2 weeks. The course of treatment can be extended to 3 weeks in cases of infections caused by Pseuchmonas aeruginosa (meningitis, infectious complications of cystic fibrosis, pneumonia). Therapy with the drug, like other antibacterial agents, is continued for at least 48-72 hours after the temperature has normalized and the symptoms of acute inflammation have decreased.

The solution with the drug may contain small bubbles of carbon dioxide, which does not affect its effectiveness. Sodium bicarbonate solution is not used as a solvent.

The volume of solvent used to obtain the required dose of the drug

  • 2000 mg of powder: 10 ml of solvent (injected intravenously);
  • 2000 mg powder: 50 ml solvent (administered via intravenous infusion).

Before intravenous bolus administration, 10 ml of solvent is added to the contents of the bottle. For intravenous drip administration, the resulting product is additionally diluted in 50–100 ml of solvent. Water for injection or compatible infusion solutions are used as a solvent, namely:

  • drug concentration 1–40 mg in 1 ml: 5% dextrose solution and 0.45/0.9% sodium chloride solution, Hartmann's solution, metronidazole solution 5 mg in 1 ml, 5% dextrose solution and 0.225% sodium chloride solution, 0 .9% sodium chloride solution, dextrose solution (5 or 10%), 4% dextrose solution and 0.18% sodium chloride solution, 10% solution of Dextran 40 in 5% dextrose solution or 0.9% sodium chloride solution, 6% a solution of Dextran 70 in a 5% dextrose solution or 0.9% sodium chloride solution;
  • drug concentration 0.05–0.25 mg per 1 ml: lactate (solution for intraperitoneal dialysis);
  • drug concentration 4 mg per 1 ml: potassium chloride 10/40 mEq per 1 liter in 0.9% sodium chloride solution, heparin 10/50 international units per 1 ml in 0.9% sodium chloride solution, cloxacillin 4 mg per 1 ml in 0.9% sodium chloride solution, cefuroxime 3 mg per 1 ml in 0.9% sodium chloride solution, hydrocortisone 1 mg per 1 ml in 5% dextrose solution or 0.9% sodium chloride solution.

It is important to use only freshly prepared solution. It should be borne in mind that slight yellowing of the solution does not affect its effectiveness.

Powder for the preparation of injection solution

The solution prepared from the powder is administered parenterally: IM into large muscles or IV stream/drip, every 8-12 hours, 500–2000 mg. In most cases, it is effective to administer 1000 mg every 8 hours or 2000 mg every 12 hours. In case of reduced immunity, including neutropenia and severe pathology, 2000 mg is prescribed every 8 or 12 hours.

Dosage regimen for adults and adolescents:

  • complicated urinary tract infections: 500–1000 mg IV or IM every 8–12 hours;
  • uncomplicated skin infections and pneumonia: 500–1000 mg IV or IM every 8 hours;
  • cystic fibrosis, lung infections caused by pseudomonas: 100–150 mg per 1 kg of body weight per day, divided into 3 administrations;
  • infections of bones and joints: 2000 mg intravenously every 12 hours;
  • life-threatening or extremely severe infections: 2000 mg IV every 8 hours.

Adult patients with impaired renal function, including patients on dialysis, after administration of an initial loading dose of 1000 mg, may require a dose reduction depending on the QC (ml per 1 min), namely:

  • QC > 50: usual dose for adults and adolescents;
  • CC 35–50: every 12 hours 1000 mg;
  • CC 16–30: every 24 hours 1000 mg;
  • QC 6–15: every 24 hours 500 mg;
  • QC< 5: каждые 48 ч по 500 мг;
  • patients on hemodialysis: after each session, 1000 mg;
  • patients on peritoneal dialysis: every 24 hours, 500 mg.

The figures presented are indicative only. In such cases, monitoring serum drug levels is recommended; it should not exceed 40 mg per 1 liter.

During hemodialysis, the half-life of Ceftazidime is 3-5 hours. The appropriate dose of the drug is repeated after each dialysis period.

In cases of peritoneal dialysis, 125–250 mg of the drug can be included in 2 liters of dialysis fluid.

Dosage regimen for children:

  • age up to 1 month: IV infusion of 30 mg per 1 kg of body weight 2 times a day;
  • age from 2 months to 12 years: intravenous infusion of 30–50 mg per 1 kg of body weight 3 times a day.

For children with meningitis, cystic fibrosis, and reduced immunity, up to 150 mg per 1 kg of body weight is administered every 12 hours.

The maximum dose for children is no more than 6000 mg per day.

The volume of solvent to obtain the required dose of the drug during initial dilution:

  • 250 mg of powder: for intramuscular administration – 1.5 ml of water for injection, 1% solution of lidocaine hydrochloride (without epinephrine); for intravenous administration – 5 ml of water for injection;
  • 500 mg of powder: for intramuscular administration – 1.5 ml of water for injection; for intravenous administration – 5 ml of water for injection;
  • 1000 mg of powder: for intramuscular administration – 3 ml of water for injection; for intravenous administration – 10 ml of water for injection;
  • 2000 mg of powder: for intramuscular administration – 3 ml of water for injection; for intravenous administration – 10 ml of water for injection.

For secondary dilution for intravenous drip administration, the solution obtained as described above is additionally diluted in 50–100 ml of 5% sodium bicarbonate solution, 5% dextrose (glucose) solution with 0.9% sodium chloride solution, 5 or 10% dextrose solution (glucose), Ringer's solution, lactated Ringer's solution, 0.9% sodium chloride solution.

When diluting, the bottle with the contents is shaken vigorously until the powder is completely dissolved.

Before administration, visually check the solution for unchanged color and the absence of foreign particles or sediment. The color of the solution can vary from amber to light yellow, depending on the chosen solvent and volume.

Use only freshly prepared solution.

Side effects

Powder for the preparation of a solution for intravenous and intramuscular administration

  • local reactions: phlebitis (with intravenous administration); compaction, burning, pain at the injection site (with intramuscular injection);
  • central and peripheral nervous system: fluttering tremor, encephalopathy, seizures, paresthesia, dizziness, headache;
  • genitourinary system: candidal vaginitis;
  • urinary system: toxic nephropathy, renal dysfunction;
  • digestive system: oropharyngeal candidiasis, cholestasis, colitis, abdominal pain, diarrhea, vomiting, nausea;
  • hematopoietic organs: hemorrhage, hemolytic anemia, lymphocytosis, thrombocytopenia, neutropenia, leukopenia;
  • allergic reactions: anaphylactic shock, exudative erythema multiforme, itchy skin, urticaria, eosinophilia, bronchospasm, angioedema, Lyell's syndrome, including Stevens-Johnson syndrome), fever;
  • laboratory parameters: increased prothrombin time, hyperbilirubinemia, increased activity of alkaline phosphatase and liver transaminases, false positive reaction urine for glucose, hypercreatininemia, increased urea concentration.

Powder for the preparation of a solution for intravenous administration

  • local reactions: thrombophlebitis, phlebitis;
  • allergic reactions: urticaria, Lyell's syndrome, decreased blood pressure, maculopapular rash, anaphylactic shock, exudative erythema multiforme, including Stevens-Johnson syndrome, bronchospasm, angioedema, itching, fever;
  • gastrointestinal tract: pseudomembranous colitis, oropharyngeal candidiasis, abdominal pain, vomiting, diarrhea, nausea;
  • genitourinary system: acute renal failure, renal dysfunction, interstitial nephritis, candidal vaginitis;
  • pancreas and hepatobiliary system: jaundice;
  • central nervous system: unpleasant taste in the mouth, paresthesia, dizziness, headache; in case of renal failure, more often than in other cases, the development of tremor, encephalopathy, myoclonus, coma (neurological disorders) is noted;
  • laboratory parameters: transient increase in the concentration of urea, creatinine and/or nitrogen in the blood, increased activity of liver enzymes (alkaline phosphatase, gamma-glutamyl transpeptidase, alanine aminotransferase lactate dehydrogenase, aspartate aminotransferase), thrombocytosis, false-positive direct Coombs test, eosinophilia;
  • hematopoietic organs: hemolytic anemia, lymphocytosis, thrombocytopenia, agranulocytosis, neutropenia, leukopenia.

Powder for the preparation of injection solution

  • less often/rarely: hypothrombinemia, pseudomembranous colitis;
  • rarely: phlebitis or thrombophlebitis, seizures, renal dysfunction, autoimmune hemolytic anemia, erythema multiforme or Steven-Johnson syndrome, allergic reactions, especially anaphylaxis;
  • more/less often: genital and anal itching, vaginitis, paresthesia, dizziness, headaches, cholestatic jaundice, transient hepatitis, transient increase in the activity of liver transaminases and alkaline phosphatase, vaginal candidiasis, reactions from the gastrointestinal tract, candidal stomatitis, candidiasis of the cavity mouth

special instructions

In the presence of a history of allergic reactions to penicillins, cross-hypersensitivity to cephalosporins was noted.

By suppressing intestinal flora, the drug may interfere with the synthesis of vitamin K, which may result in a decrease in the level of vitamin K-dependent blood clotting factors and, in rare cases, bleeding and hypothrombinemia. The rapid elimination of hypothrombinemia is facilitated by taking vitamin K. Most often, bleeding develops in elderly and debilitated patients, with impaired liver function and malnutrition.

During therapy, ethanol should not be consumed, as effects similar to those of disulfiram may develop.

In cases of concomitant use of ceftazidime in high dose with nephrotoxic drugs (aminoglycosides and diuretics), it is necessary to monitor renal function.

Long-term treatment with ceftazidime may increase the growth of non-susceptible microorganisms (for example, candida or enterococci), which may require discontinuation of the drug or appropriate therapy. During the treatment period, constant assessment of the patient's condition is required.

Some initially sensitive strains of Enterobacter and Serratiamarcescens may develop resistance when treated with the drug, and therefore, when treating infections caused by these pathogens, sensitivity tests to antibacterial agents are periodically carried out.

Patients during therapy should be careful when driving. Vehicle and conducting potentially hazardous activities.

Drug interactions

The drug is pharmaceutically incompatible with vancomycin and aminoglycosides.

When used in combination with clindamycin, vancomycin, aminoglycosides, loop diuretics, the risk of developing nephritis increases toxic effect.

The effect of the drug is reduced by bacteriostatic antibacterial agents, including chloramphenicol.

In cases of mixing a solution of ceftazidime (500 mg in 1.5 ml of water for injection) and metronidazole (500 mg in 100 ml), the activity of both components is maintained.

Analogs

Analogues of Ceftazidime are Cefzid, Fortum, Fortazim, Tizim, Orzid, Vicef, Vockhard, Bestum.

Terms and conditions of storage

Store at a temperature not exceeding 25 °C, away from children.

Shelf life – 2 years.

Conditions for dispensing from pharmacies

Dispensed by prescription.

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Catad_pgroup Antibiotics cephalosporins

Vicef - instructions for use

INSTRUCTIONS
By medical use drug

Registration number: P No. 000653/01

Trade name of the drug: Vicef ®

International generic name(INN): ceftazidime

Chemical name: ]-1-[[(2-amino-4-thiazolyl) [(1-carboxy-1-methylethoxy)amino]acetyl] amino]-2-carboxy-8-oxo-5-thia-1-azabicyclooct-2 -en-3-yl]methyl]pyridinium hydroxide.

Dosage form: powder for the preparation of solution for intravenous and intramuscular injection.

Compound: one bottle contains 0.5 g of ceftazidime and 0.05 g of sodium carbonate, 1 g of ceftazidime and 0.1 g of sodium carbonate or 2 g of ceftazidime and 0.2 g of sodium carbonate.

Description: White to cream colored powder.

Pharmacotherapeutic group: antibiotic, cephalosporin.
ATX Code J01DA11

Pharmacological properties
Pharmacodynamics
Ceftazidime is an antibacterial drug from the group of third generation cephalosporins, has wide range and acts bactericidal, disrupting the final stages of bacterial cell wall synthesis due to irreversible binding to transpeptidases (penicillin-binding proteins); resistant to most beta-lactamases. Effective on many strains resistant to ampicillin and other cephalosporins.
Active against gram-negative microorganisms: Pseudomonas spp. (including 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), Pasteurella multocida, Neisseria meningitidis, Haemophilus influenzae(including strains resistant to ampicillin); gram-positive microorganisms: Staphylococcus aureus(penicillinase-producing and non-penicillinase-producing strains sensitive to methicillin), Steptococcus pyogenes(group A beta-hemolytic streptococcus), Streptococcus agalactiae(group B), Streptococcus pneumoniae; anaerobic bacteria: Bacteroides spp.(most strains Bacteroides fragilis resistant).
Active in research in vitro against most strains: Acinetobacter spp., Haemophilus parainfluenzae, Morganella morganii, Neisseria gonorrhoeae, Providencia spp., Providencia rettgeri, Salmonella spp., Shigella spp., Staphylococcus epidermidis, Yersinia enterocolitica, Clostridium perfringens, excluding Clostridium difficile, Peptococcus spp., Peptostreptococcus spp.
Ceftazidime is inactive against methicillin-resistant Staphylococcus spp., Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Campylobacter spp. And Clostridium difficile.

Pharmacokinetics
Following intravenous (IV) bolus administration of 0.5 g and 1 g of ceftazidime, mean maximum serum concentrations were 42 mg/L and 90 mg/L, respectively. Following intramuscular (IM) administration of 0.5 g or 1 g, maximum serum concentrations averaging 17 mg/mL and 39 mg/L, respectively, are achieved 1 hour after administration. Therapeutically significant concentrations in blood plasma persist for 8-12 hours.
After intravenous or intramuscular administration, ceftazidime is rapidly distributed in the human body. Antibiotic concentrations exceeding the MIC for sensitive microorganisms are achieved in most tissues and fluids, including synovial, intraocular, pericardial and peritoneal fluids, bile, sputum, urine, bone tissue, myocardium, gallbladder, skin and soft fabrics; diffusion of the drug increases during inflammatory processes. It penetrates poorly through unchanged membranes of the brain. With meningitis, permeability through the blood-brain barrier increases, and therapeutic concentrations of 4-20 mg/l or higher are achieved in the cerebrospinal fluid. Passes through the placenta; passes into breast milk in low concentrations. Reversibly binds to plasma proteins (less than 10%). The degree of binding does not depend on the concentration of the antibiotic. Ceftazidime does not displace bilirubin from complexes with plasma proteins. The volume of distribution is 0.21 - 0.28 l/kg.
It is excreted by the kidneys (90% of the administered dose unchanged within 24 hours) by glomerular filtration and tubular secretion. In adults with normal renal function, the half-life from serum is 1.9 hours. In newborns, especially premature infants, the half-life of ceftazidime from serum can be 3-4 times higher than that in adults. The half-life from tissues is longer than from blood serum.
In patients with impaired renal function, the half-life increases, which requires adjustment of doses and administration regimens (if creatinine clearance is less than 50 ml/min).
Less than 1% of the drug is excreted in the bile. The drug is not metabolized in the liver, liver dysfunction does not affect the pharmacokinetics of the drug. The dose in such patients remains normal.

Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to ceftazidime:

  • central infections nervous system(bacterial meningitis and brain abscess);
  • infections of the ENT organs (otitis media, malignant inflammation of the external ear, mastoiditis, sinusitis, etc.);
  • lower respiratory tract infections (bronchitis, infected bronchiectasis, pneumonia, lung abscess, pleural empyema, lung infections in patients with cystic fibrosis);
  • infections of the abdominal organs and biliary tract (cholangitis, cholecystitis, empyema of the gallbladder, retroperitoneal abscesses, peritonitis, diverticulitis);
  • gastrointestinal tract infections (enterocolitis);
  • skin and soft tissue infections, wound and burn infections;
  • infections of bones and joints (osteomyelitis, septic arthritis);
  • kidney and urinary tract infections (pyelonephritis, pyelitis, kidney abscess, prostatitis, cystitis, urethritis, kidney infections in patients with urolithiasis);
  • infectious and inflammatory diseases of the pelvic organs in women (endometritis, pelvioperitonitis, salpingitis, parametritis, pelvic cellulitis);
  • sepsis;
  • dialysis-related infections;
  • prevention of infectious complications during prostate surgery.

Contraindications
Hypersensitivity to ceftazidime, other cephalosporins and penicillins.

Carefully
when there is a history of colitis; malabsorption syndrome (increased risk of decreased prothrombin activity); neonatal period, renal failure, in combination with loop diuretics and aminoglycosides.

Use during pregnancy and during breastfeeding
There is no data confirming the embryotoxic or teratogenic effect of ceftazidime, however, during pregnancy (first trimester) it is used only according to strict indications, with confidence that the potential benefit of use for the mother outweighs the possible risk to the fetus.
Ceftazidime passes into breast milk in small concentrations, so if it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.

Directions for use and doses
Vicef ® is administered parenterally - intravenously and intramuscularly.
U adults and children over 12 years old The usual single dose of Vicef ® is 1 g every 8-12 hours or 2 g every 12 hours.
The following doses, frequency and route of administration are also recommended, which are determined by the location and severity of the disease:

  • for uncomplicated urinary tract infections - 0.25 g every 12 hours IV or IM;
  • for complicated urinary tract infections - 0.5 g every 8 or 12 hours IV or IM;
  • for uncomplicated pneumonia, infections of the skin and soft tissues, infections of the ENT organs - 0.5-1 g every 8 hours IV or IM;
  • with severe intra-abdominal or gynecological infections- 2 g every 8 hours IV;
  • for infections of bones and joints - 2 g every 12 hours IV;
  • for bacterial meningitis - 2 g every 8 hours IV;
  • for severe, life-threatening infections and febrile neutropenia - 2 g every 8 hours IV, or 3 g every 12 hours IV (maximum daily dose - 6 g);
  • for severe pulmonary infection caused by Pseudomonas aeruginosa, in patients with cystic fibrosis and normal renal function - 30-50 mg/kg every 8 hours IV.

For antibiotic prophylaxis postoperative complications during operations on the prostate gland, 1 g of Vicef ® is administered intravenously 30 minutes before surgery; when removing urinary catheter It is recommended to re-introduce 1 g of Vicefa ®.
Children over 1 month. and up to 12 years usually administered at 30-50 mg/kg every 8 hours. For the treatment of bacterial meningitis, as well as the treatment of infections in children with immunodeficiency or cystic fibrosis, the daily dose is 150 mg/kg (but not higher than 6 g per day), which is divided into 3 administrations.
Newborns (children up to 1 month) prescribed 30 mg/kg every 12 hours IV.
In patients with impaired renal function, dose adjustment and administration regimens are required based on creatinine clearance. Treatment begins with the introduction of 1 g of Vicef ® as the first loading dose. Subsequently, the maintenance mode is calculated as presented in the table:

For patients with severe infections due to chronic renal failure, the single doses indicated in the table (see above) can be increased by 50%, or the intervals between doses can be reduced. Subsequently, correction of the dosage regimen is carried out based on data on the sensitivity of the isolated microorganisms, the severity of the patient’s condition and data from therapeutic monitoring of ceftazidime concentrations in the blood serum (the residual concentration should not exceed 40 mg/l).
For hemodialysis: loading dose - 1 g, then 1 g after each hemodialysis procedure. For continuous hemodialysis using an arteriovenous shunt and for high-speed hemofiltration - 1 g/day daily (for one or more injections). When performing hemofiltration at a low rate, Vicef ® is prescribed in doses recommended for impaired renal function (see table above).
For peritoneal dialysis, 1 g is initially administered (loading dose), then 0.5 g is prescribed every 24 hours. In addition to IV or IM administration, it is possible to administer Vicef ® as part of a dialysis solution at the rate of 0.25 g of Vicef ® per 2 liters of dialysis solution.
Administration of Vicef should be continued for another 2 days after the symptoms of infection disappear. In cases of severe and complicated infections, long courses of treatment may be required.
Vicef ® is administered intravenously (stream, drip) and intramuscularly.
The dissolution of Vicef ® is accompanied by a slight exothermic reaction, during which carbon dioxide is released and positive pressure is created in the vial. Carbon dioxide bubbles may be present in the finished solution, which does not affect the effectiveness of the drug. Slight yellowing of the solution also does not affect the effectiveness.
Intramuscular administration
For intramuscular administration, sterile Vicefa ® powder is dissolved in sterile water for injection or 0.5-1% solution of lidocaine hydrochloride (in the absence of indications of intolerance local anesthetics amide type).
The following minimum amounts of solvent are added directly to the bottle of dry antibiotic powder:

The resulting solution, the approximate concentration of ceftazidime in which is 260 mg/ml, is injected deeply intramuscularly into areas of the body with a pronounced muscle layer (upper outer quadrant of the buttock or lateral thigh). An aspiration test is recommended to avoid unwanted injection of solution into the blood vessel.
Intravenous administration
For intravenous jet administration, Vicef ® is dissolved in sterile water for injection. The following amounts of solvent are added directly to the bottle with dry antibiotic powder: The resulting solution, the approximate concentration of ceftazidime in which is 90 mg/ml, is administered intravenously slowly over 3-5 minutes; it is possible to administer through a special node or injection port of the system for intravenous infusions if the patient receives fluids compatible with Vicef ® parenterally.
For IV drip administration, Vicef ® is dissolved as for IV jet administration (see above). The resulting solution is added to a vial containing 50-100 ml of compatible infusion medium. Administered through an intravenous infusion system over at least 30 minutes. Vicef ® is compatible with 5% dextrose solution, 0.9% sodium chloride solution, 10% dextrose solution, aqueous solution, containing 0.225% sodium chloride and 5% dextrose; an aqueous solution containing 0.45% sodium chloride and 5% dextrose; an aqueous solution containing 0.9% sodium chloride and 5% dextrose; Ringer's solution; lactated Ringer's solution; 1/6 M sodium lactate solution; 10% invert sugar solution; “Normozol-M” solution with 5% glucose.

Side effect
Allergic reactions: in 2% or less - maculopapular rash, itching, fever; very rarely - angioedema, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
From the outside digestive system : in 2% or less - diarrhea, nausea, vomiting, abdominal pain, colitis, cholestasis; very rarely - jaundice, pseudomembranous colitis associated with Clostridium difficile.
From the nervous system: in 1% or less - dizziness, headache; paresthesia; very rarely - convulsive seizures. Cases have been reported neurological complications such as tremor, myoclonus, convulsions, encephalopathy and coma in patients with renal failure for whom the dose of ceftazidime has not been appropriately reduced.
From the hematopoietic organs: in 2% or less - eosinophilia, thrombocytosis; very rarely - transient leukopenia, neutropenia, thrombocytopenia, lymphocytosis, hemolytic anemia and agranulocytosis.
From the urinary system: very rarely - interstitial nephritis, renal dysfunction, renal failure.
From the laboratory parameters: in 2% or less - transient increase in the activity of “liver” transaminases (AST, ALT), alkaline phosphatase, LDH, false-positive direct Coombs reaction without hemolysis; less than 1% - transient hypercreatininemia, increased levels of urea and/or plasma creatinine.
Local reactions : in 2% or less - pain and/or inflammation at the site of intravenous injection; with intramuscular injection - pain and hardness at the injection site.
Others: less than 1% - fever, oral candidiasis and candidal vaginitis.

Overdose
Overdose of ceftazidime has been observed in patients with renal failure.
Symptoms: increased convulsive activity, “fluttering” tremor, encephalopathy, neuromuscular irritability, coma.
Treatment: symptomatic and supportive therapy. In case of severe overdose, the concentration of the drug in the blood can be reduced using hemodialysis.

Interaction with other drugs
When Vicef ® is administered simultaneously with aminoglycosides, synergistic and additive effects are observed.
In solution, it is pharmaceutically incompatible with aminoglycosides (significant mutual inactivation: when used simultaneously) and vancomycin (forms a precipitate depending on the concentration). When used simultaneously, do not mix them in the same syringe or infusion medium; with intramuscular injection, inject into different parts of the body; at intravenous administration It is recommended to administer separately, following a certain sequence with a time interval between injections (infusions), or to use separate IV catheters.
Do not use sodium bicarbonate solution as a solvent.
When cephalosporins are used concomitantly with loop diuretics and aminoglycosides, the risk of nephrotoxicity increases.
Chloramphenicol and beta-lactam antibiotics, incl. ceftazidime act antagonistically, so their simultaneous use should be avoided.
Ceftazidime 4 mg/ml solution prepared using 5% dextrose or 0.9% sodium chloride solution is compatible with cefuroxime sodium 3 mg/ml solution; heparin solution 10 IU/ml and 50 IU/ml, potassium chloride solution 10 mEq/l and 40 mEq/l.
When mixing a solution of Vicefa ® at a concentration of 20 mg/ml and metronidazole 5 mg/ml, both components retain their activity.
At concentrations of 0.05 to 0.25 mg/ml, ceftazidime is compatible with peritoneal dialysis solution (lactate).

special instructions
When administered intramuscularly to patients with intolerance to amide-type local anesthetics, 0.5% or 1% lidocaine solution should not be used as a solvent.
If diarrhea occurs during treatment with Vicef ®, one should be wary due to the possible development of pseudomembranous colitis. If a diagnosis of antibiotic-associated diarrhea or pseudomembranous colitis is established, the administration of Vicef ® should be stopped immediately and appropriate treatment should be prescribed.
As with the use of other antibiotics, the use of Vicef ® can lead to the colonization of insensitive microflora and the development of superinfection.
When determining glucose in urine using the Benedict or Fehling method, as well as using Clinitest ®, false positive results can rarely be observed.

Influence on the performance of potentially hazardous activities requiring special attention and speed of reactions
There have been no studies on the effect of ceftazidime on the performance of potentially hazardous activities that require special attention and speed of reactions.
Given the possible development of dizziness, when using ceftazidime, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form
Powder for the preparation of a solution for intravenous and intramuscular administration of 0.5 g, 1 g and 2 g.
0.5 g and 1.0 g active substance in glass bottles with a capacity of 10 ml;
2.0 g of active substance in glass bottles with a capacity of 20 ml.
Solvent - “Water for injection” in glass ampoules of 5 ml.
1 bottle with the drug and instructions for use is placed in a cardboard pack.
1 bottle with the drug and 1 ampoule with the solvent are packaged in a blister pack. One blister pack and instructions for use are placed in a cardboard box.
5 bottles of the drug are packaged in blister packs. One blister pack and instructions for use are placed in a cardboard box.
5 bottles of the drug, complete with 5 ampoules of solvent, are packaged in blister packs. One blister pack with the drug, one blister pack with a solvent and instructions for use are placed in a cardboard pack.

Storage conditions
List B. In a dry place, protected from light, out of reach of children, at a temperature not exceeding 25°C.
A freshly prepared solution of the drug is suitable for use for 18 hours at a temperature not exceeding 25°C.

Best before date
3 years. Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies
By doctor's prescription.

Manufacturer/address for filing complaints
ABOLmed LLC, Russia.
Legal address:
Manufacturer's address:
630071, Novosibirsk region, Novosibirsk, Leninsky district, st. Dukach, 4.

III generation cephalosporin

Active substance

Ceftazidime (as pentahydrate) (ceftazidime)

Release form, composition and packaging

Powder for the preparation of a solution for intravenous and intramuscular administration crystalline, almost white or yellowish.

Excipients: sodium carbonate.

Glass bottles (1) - cardboard packs.

pharmachologic effect

Ceftazidime is an antibacterial drug from the group of third generation cephalosporins. It has a wide spectrum and has a bactericidal effect, disrupting the synthesis of the cell wall of microorganisms. Resistant to most beta-lactamases.

A drug active against gram-negative microorganisms: Haemophillus influenzae, Neisseriaspp. 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., Proteusmirabilis (including indole positive), Proteus vulgaris and other Proteus spp ., Providensia rettgeri and other Providensia spp. and Serratia spp., Salmonella spp., Shigella spp. and Yersinia enterocolitica), Acinetobacter spp., Haemophillus parainfluenzae (including strains resistant to ), Pasteurella multocida, Pseudomonas spp., (including .ch. Pseudomonas aeruginosa).

A drug active against gram-positive bacteria: Micrococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes group A, Streptococcus viridans and other Streptococcus spp. (excluding Streptococcus faecalis); strains sensitive to methicillin: Staphylococcus aureus, Staphylococcus epidermidis.

Ceftazidime active against anaerobic bacteria: Bacteroides spp. (most strains of Bacterioides fragilis are resistant), Clostridium perfingens, Peptococcus spp., Peptostreptococcus spp. and Propionobacterium spp.

A drug not active regarding methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis; Streptococcus faecalis, Campylobacter spp., Chlamydia spp., Clostridium difficile, Enterococcus spp., Listeria monocytogenes and other Listeria spp.

Pharmacokinetics

Suction

After intramuscular administration in doses of 0.5 g and 1 g, Cmax in blood plasma is 17 mg/l and 39 mg/l, respectively, Tmax is 1 hour. Cmax after intravenous bolus administration in doses of 0.5, 1 and 2 g is 42 mg/l, 69 mg/l and 170 mg/l, respectively. Therapeutic serum concentrations persist for 8-12 hours after IV and IM administration.

Distribution

Plasma protein binding is less than 15%. Concentrations of ceftazidime exceeding the minimum inhibitory concentration for most common pathogens can be achieved in bone tissue, heart tissue, bile, sputum, synovial, intraocular, pleural and peritoneal fluids. Easily penetrates the placental barrier and is excreted in breast milk. With absence inflammatory process poorly penetrates the BBB. With meningitis, the concentration in the cerebrospinal fluid reaches a therapeutic level (4-20 mg/l and above).

Removal

T 1/2 – 1.9 hours, in newborns - 3-4 times longer; for hemodialysis - 3-5 hours.

Not metabolized in the liver. Excreted by the kidneys (80-90% unchanged through glomerular filtration), within 24 hours; with bile - less than 1%.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

- meningitis;

- peritonitis;

- sepsis (septicemia);

- severe purulent-septic conditions;

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

- infections of the lower respiratory tract (acute and Chronical bronchitis, infected bronchiectasis, pneumonia, lung abscess, pleural empyema);

- urinary tract infections (acute and chronic pyelonephritis, pyelitis, prostatitis, cystitis, urethritis, kidney abscess);

- infections of the skin and soft tissues (mastitis, wound infections, cellulitis, erysipelas, infected burns);

- infections of the gastrointestinal tract, abdominal cavity and biliary tract(enterocolitis, retroperitoneal abscesses, diverticulitis, cholecystitis, cholangitis, gallbladder empyema);

- infections of the female genital organs (endometritis);

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

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

Contraindications

increased sensitivity to other cephalosporins and penicillins.

WITH caution should be used for severe renal dysfunction, in the neonatal period, with a history of bleeding, a history of ulcerative colitis, malabsorption syndrome (increased risk of decreased prothrombin activity, especially in persons with severe renal and/or liver failure).

Dosage

Administer intramuscularly (should be injected into large muscles) or intravenously (stream or drip). The dose of the drug is set individually, taking into account the severity of the disease, the location of the infection and the sensitivity of the pathogen, age and body weight, and renal function.

Adults and children over 12 years old

Complicated urinary tract infections- 500 mg - 1 g every 8-12 hours.

Uncomplicated pneumonia and skin infections- 500 mg - 1 g every 8 hours.

Cystic fibrosis, lung infections caused by Pseudomonas spp. - from 100 to 150 mg/kg/day, frequency of administration - 3 times/day (use of a dose of up to 9 g/day in such patients did not cause complications).

Bone and joint infections - IV 2 g every 12 hours.

Neutropenia and severe disease- 2 g every 8 or 12 hours.

For extremely severe or life-threatening infections- IV 2 g every 8 hours.

After an initial dose of 1 g adults with impaired renal function (including patients undergoing dialysis) Dose reduction may be necessary as follows:

These figures are indicative. In such patients, it is recommended to monitor serum drug levels, which should not exceed 40 mg/l.

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

At peritoneal dialysis Ceftazidime can be included in the dialysis fluid at a dose of 125 mg to 250 mg per 2 liters of dialysis fluid. For elderly patients, the maximum daily dose is 3 g.

Children under 12 years of age

Children under 2 months of age– intravenous infusion 30 mg/kg/day (multiplicity of administration 2 times/day).

Children aged 2 months to 12 years– IV infusion 30-50 mg/kg/day (infusion rate 3 times/day).

For children with reduced immunity, cystic fibrosis, meningitis the drug is prescribed at a dose of up to 150 mg/kg/day every 12 hours.

The maximum daily dose for children should not exceed 6 g.

Rules for the preparation of solutions for parenteral administration

1. Primary breeding

2. Secondary dilution

For intravenous drip administration The drug solution obtained in the above described manner is additionally diluted in 50-100 ml of one of the following solvents intended for intravenous administration: 0.9% solution, Ringer's solution, lactated Ringer's solution, 5% glucose (dextrose) solution, 5% glucose (dextrose) solution with sodium chloride solution 0.9%, glucose solution (dextrose) 10%.

During dilution, bottles with the drug must be shaken vigorously until their contents are completely dissolved.

Before introducing the solution, you should visually ensure that there are no foreign particles or sediment and that the color is unchanged. medicinal product for parenteral administration. The color of solutions can vary from light yellow to amber, depending on the solvent and volume, which does not affect the effectiveness. The resulting finished solution may contain small bubbles of carbon dioxide, which does not affect the effectiveness of the drug.

Only freshly prepared solution can be used.

Side effects

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

From the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, dysbacteriosis, liver dysfunction (transient increase in the activity of liver transaminases, alkaline phosphatase, hyperbilirubinemia), rarely - stomatitis, glossitis, pseudomembranous enterocolitis, cholestasis.

From the hematopoietic organs: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, hypocoagulation, increased prothrombin time.

From the urinary system: impaired renal function (azotemia, hypercreatininemia, increased urea levels in the blood), oliguria, anuria, toxic nephropathy.

From the central nervous system and peripheral nervous system: headache, dizziness, paresthesia, seizures, encephalopathy, “fluttering” tremor.

Local reactions: phlebitis, pain along the vein, pain and infiltration at the site of intramuscular injection.

Others: nosebleeds, candidiasis, superinfection.

Overdose

Symptoms: dizziness, paresthesia, headache, seizures, abnormal laboratory test results.

Treatment: carrying out symptomatic and supportive therapy. There is no specific antidote. In case of severe overdose, when conservative therapy is unsuccessful, the concentration of the drug in the blood can be reduced using hemodialysis.

Drug interactions

"Loop" diuretics, aminoglycosides, vancomycin, clindamycin reduce the clearance of ceftazidime, as a result of which the risk of nephrotoxicity increases.

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

Pharmaceutical interactions

Pharmaceutically incompatible with aminoglycosides, heparin, vancomycin.

The solution must not be used as a solvent.

special instructions

In patients with a history of allergic reactions to penicillins, cross-hypersensitivity to cephalosporins has been noted.

Ceftazidime may interfere with the synthesis of vitamin K due to suppression of intestinal flora, which may cause a decrease in the levels of vitamin K-dependent clotting factors, and in rare cases lead to hypothrombinemia and bleeding. Administration of vitamin K quickly eliminates hypothrombinemia.

In elderly and debilitated patients, in patients with impaired liver function and in people with poor nutrition, the risk of bleeding is highest.

Some patients may develop pseudomembranous colitis during or after use of ceftazidime. In mild cases, discontinuation of the drug is sufficient, and in more severe cases, restoration of water-salt and protein balance is recommended; metronidazole, bacitracin or vancomycin are prescribed.

A positive Coombs test and a false positive urine test for glucose are possible.

During treatment, you should not consume ethanol - effects similar to those of disulfiram are possible (facial hyperemia, spasms in the abdomen and stomach area, nausea, vomiting, headache, decreased blood pressure, tachycardia, shortness of breath).

Pharmaceutically compatible with the following solutions: at concentrations from 1 to 40 mg/ml – sodium chloride solution 0.9%; sodium lactate solution; ; dextrose solution 5%; solution of sodium chloride 0.225% and dextrose 5%; solution of sodium chloride 0.45% and dextrose 5%; solution of sodium chloride 0.9% and dextrose 5%; solution of sodium chloride 0.18% and dextrose 4%; dextrose solution 10%; dextran with molecular weight 40 thousand Da 10% in a solution of sodium chloride 0.9% or in a solution of dextrose 5%; dextran with a molecular weight of about 70 thousand Da 6% in sodium chloride solution 0.9 % or in a dextrose solution 5%.

At concentrations of 0.05 to 0.25 mg/ml, ceftazidime is compatible with intraperitoneal dialysis solution (lactate).

For intramuscular administration, ceftazidime can be diluted with a solution of 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 0.9% sodium chloride solution or 5% dextrose solution; cefuroxime (cefuroxime sodium) 3 mg/ml in sodium chloride solution 0.9%; cloxacillin (cloxacillin sodium) 4 mg/ml in sodium chloride solution 0.9%; heparin 10 IU/ml or 50 IU/ml in sodium chloride solution 0.9%; 10 meq/l or 40 meq/l in 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 retain their activity.

Pregnancy and lactation

Given that ceftazidime, like most other cephalosporins, crosses the placenta, ceftazidime should be prescribed to pregnant women only in cases of vital need, with careful assessment of the consequences of treatment in terms of possible risk to the fetus and benefit to the mother.

If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

For impaired renal function

Use with caution in cases of severe renal impairment.

For liver dysfunction

Not metabolized in the liver.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

List B. The drug should be stored out of the reach of children, in a dry, dark place at a temperature not exceeding 25° C. Shelf life - 2 years.

One bottle of injection solution includes 500 or 1000 mg ceftazidime .

Release form

The release form of the drug Ceftazidime is a powder used for the preparation of intravenous (IV) and intramuscular (IM) injections. One factory package can contain 10 or 50 bottles.

pharmachologic effect

Bactericidal.

Pharmacodynamics and pharmacokinetics

Ceftazidime belongs to the group cephalosporins III generation, in which it is the most active antibacterial drug against pathogens nosocomial infections And Pseudomonas aeruginosa . Also, due to its wide spectrum of action, it is used for therapy severe infections , When pathogen the disease has not yet been identified, it is recommended for use in nosocomial infections. Ceftazidime exhibits bactericidal activity due to disruption of the synthesis processes of membrane cellular components, which leads to an imbalance in the stability of the membranes themselves and ultimately to death bacterial cell . Ceftazidime is resistant to most beta-lactamases .

The following bacterial strains are sensitive to Ceftazidime: neiserius , hemophilus influenzae, citrobacteria , Escherichia coli, enterobacteria , Klebsiella , Proteus , Morganella , providences, acinetobacter , serratius, salmonella , hemophilus parainfluenza, shigella , Yersinia, staphylococci (including Staphylococcus aureus ), micrococci, streptococci , propion bacteria, bacteroids, group A hemolytic streptococcus, peptococci, clostridium , peptostreptococci .

Resistance to the effects of ceftazidime is demonstrated by: bacteroides fragilis, Staphylococcus epidermalis , Staphylococcus aureus (methicillin-resistant), streptococcus fecalis, chlamydia , campylobacter, clostridium diphysile, listeria, enterococci .

After intramuscular injection of Ceftiazidime in doses of 500 and 1000 mg, the Cmax of the drug is 17 and 39 mg/l, respectively, TCmax is observed after 60 minutes. After intravenous administration of the same doses, Cmax is 42 and 69 mg/l, respectively.

Effective therapeutically serum concentrations of Ceftiazidime after parenteral administration persist for 8-12 hours. Contacts plasma proteins less than 10% of the drug.

Ceftazidime concentrations are above minimal inhibitory levels, relative to most pathogenic , sensitive to this medicine, are observed in bone tissue , bile , heart tissue , sputum , intraocular, synovial, peritoneal and pleural fluids.

Penetrates easily placental barrier and is found in the milk of nursing mothers. In the absence of inflammation, it does not pass through the BBB well.

IN cerebrospinal fluid Ceftazidime concentration at reaches therapeutic levels and is equal to 4-20 mg/l or even more. T1/2 in adults is 1.9 hours, in newborns it is 3-4 times longer, when carried out it is 3-5 hours. Not subject to hepatic metabolism.

Within a day, through glomerular filtration, it is excreted kidneys , and 80-90% unchanged, with bile less than 1% is excreted.

Indications for use

The drug Ceftazidime is prescribed for severe infectious and inflammatory diseases , provoked by microorganisms sensitive to it:

  • pelvic organ infections;
  • cholangitis ;
  • peritonitis;
  • empyema of the gallbladder;
  • sepsis ;
  • infections of soft tissues, skin, joints and bones;
  • lung abscess ;
  • pneumonia ;
  • pleural empyema;
  • kidneys ;
  • infected burns and wounds.

Ceftazidime is also used for therapy infectious-inflammatory pathologies of a severe nature in patients with reduced and infectious processes that arose during the peritoneal dialysis And hemodialysis .

Contraindications

Hypersensitivity the patient has a history of ceftazidime or other cephalosporins.

Prescribe with caution when:

  • gastrointestinal diseases;
  • renal failure ;
  • parallel therapy using loop diuretics And aminoglycosides ;
  • , as well as the newborns themselves.

Side effects

  • paresthesia ;
  • headache;
  • seizures;
  • "fluttering";

Genitourinary system:

  • renal dysfunction;
  • nephropathy toxic in nature;

Blood-forming organs:

  • leukopenia;
  • hemolytic anemia;
  • neutropenia;
  • hemorrhages ;
  • thrombocytopenia.
  • nausea;
  • vomit;
  • cholestasis ;
  • oropharyngeal ;
  • stomach ache.

Local appearances:

  • phlebitis (when administered intravenously);
  • burning , soreness , seal at the injection site (with intramuscular injections).

Allergic reactions:

  • eosinophilia ;
  • skin itching;
  • Lyell's syndrome;
  • bronchospasm ;
  • Stevens-Johnson syndrome;

Laboratory indicators:

  • increase in quantity urea ;
  • hypercreatininemia ;
  • false positive reactions (direct Coombs and urine tests for glucose);
  • increased activity of liver enzymes;
  • hyperbilirubinemia ;
  • increase prothrombin time .

Ceftazidime, instructions for use

Adults are prescribed Ceftazidime 1000 mg every 8-12 hours; as an alternative treatment regimen, 2000 mg is used with a break of 12 hours. In case of severe infections, especially reduced immunity (including patients neutropenia ), prescribed 2000 mg every 8 hours.

During infectious processes urinary tract The dose of ceftazidime is 250 mg twice daily.

Treatment cystic fibrosis , patients with respiratory system infections , provoked pseudomonas , recommend 30-50 mg/kg ceftazidime every 8 hours.

During surgery on prostate gland , administered for the purpose of prophylaxis before 1000 mg of the drug, with duplicate administration after removal of the catheter.

Elderly patients should not exceed daily dose Ceftazidime 3000 mg.

At reduced immunity in children, and cystic fibrosis a dose of 150 mg/kg per day is prescribed, divided into 3 administrations, with a maximum daily dose of 6000 mg.

At the age of up to 2 months (newborns), ceftazidime can be prescribed at a daily dose of 30 mg/kg divided into 2 administrations (with extreme caution).

At kidney pathologies begin Ceftazidime therapy with a dose of 1000 mg, with a maintenance dose prescribed depending on the rate of drug elimination: for CC ( cryatenine clearance ) 50-31 ml/min, 1000 mg twice a day, with CC 30-16 ml/min, 1000 mg once a day, with CC 15-6 ml/min, 500-1000 mg once every 24 hours, with CC less than 5 ml/min, 500-1000 mg every two days.

For patients with severe infections, the single dose of Ceftazidime can be doubled, with monitoring of the drug concentration in the blood, which should not exceed 40 mg/l.

During the procedure, maintenance doses of Ceftazidime are prescribed, taking into account QC, with injections after the process hemodialysis . At peritoneal dialysis In addition to intravenous administration, it is possible to include the drug in the dialysis solution (125-250 mg of Ceftazidime is added to 2 liters of solution). The recommended dose of the drug for patients with continuous hemodialysis with the use of an arteriovenous shunt, as well as patients undergoing high-speed hemofiltration , is 1000 mg per 24 hours. When conducting low-speed hemofiltration use doses of ceftazidime recommended for kidney pathologies.

To prepare an intramuscular solution, dissolve Ceftazidime powder in 1-3 ml of solvent, to prepare an intravenous solution, use 2.5-10 ml of solvent, and to prepare an infusion solution, use 50 ml of solvent. Small bubbles in the resulting solution are carbon dioxide and do not affect the effectiveness of Ceftazidime (gas removal may be required), as well as yellowing of the solution itself. Only use freshly prepared solution.

Overdose

In case of an overdose of Ceftazidime, there may be dizziness , pain and phlebitis at the injection site, inflammation, headache, paresthesia , convulsions in patients with kidney pathologies, hypercreatininemia , thrombocytosis, hyperbilirubinemia, thrombocytopenia, leukopenia, eosinophilia , prolongation of prothrombin time.

Therapy is symptomatic with the use, in case of kidney failure, hemodialysis or peritoneal dialysis .

Interaction

Ceftazidime is incompatible with aminoglycosides , due to significant mutual inactivation (in case of parallel administration, injections should be made into different parts of the body).

The semisynthetic antibiotic ceftazidime ® is a representative of the third generation of injectable cephalosporins. It has a pronounced bactericidal effect and a wide spectrum of antimicrobial activity.

Ceftazidime ® inhibits the synthesis of peptidoglycan in the bacterial wall, reducing its resistance to the osmotic pressure gradient. Also, it is capable of activating enzymatic autolysis, leading to the death of the pathogen.

Ceftazidime ® is a cephalosporin for parenteral administration, that is, it does not have a tablet form. The drug is used only intravenously (stream or drip) or intramuscularly.

The dosage of the antibiotic and the method of administration depend on:

  • severity of the patient's condition,
  • presence of underlying diseases,
  • creatinine clearance level,
  • age and localization of the inflammatory process.

Pharmacological group

The drug belongs to the third generation cephalosporins.

Composition of ceftazidime ®

Ceftazidime pentahydrate 2.33 g. Additionally, sodium carbonate - 0.236 g.

Features of making an injection solution and how can the powder be diluted?

When administered intramuscularly at a dose of five hundred milligrams, the volume of the solvent is 1.5 milliliters of water for injection. Also, lidocaine hydrochloride (0.5 or 1% solution) can be used for intramuscular injections. For one or two grams of antibiotic, three milliliters of solvent are needed.

For intravenous administration, 5 and 10 milliliters of water for injection are taken for 500 and 1000 mg of ceftazidime ®.

If an intravenous drip infusion of the drug is prescribed, the resulting solution must be diluted in 0.9% saline.

Intravenously, the drug is administered slowly, about five minutes. The infusion lasts up to an hour.

The bottle with the drug must be shaken during the dilution process in order to ensure complete dissolution of the product. Before administering the resulting medicine, you must make sure that there are no foreign suspensions or particles in the liquid. The color of the solution can range from light to dark yellowish (amber). Since carbon dioxide will be released during the dilution of the powder, the presence of bubbles (carbon dioxide) in the liquid is normal.

Ceftazidime ® dosages for adults and children

Babies up to 2 months are prescribed from 25 to 50 milligrams per kg of body weight. The dose is divided into two injections.

From 2 months prescribed from 50 to one hundred mg/kg in two administrations.

For adults and children over 12 years of age, the standard dose is one to 2 grams two or three times a day. In severe cases of the disease and the presence of complications, the dose can be up to 6 grams per day (2 g 3 times a day or 3 g every 12 hours).

For moderate forms of the disease, as a rule, the administration of 1 gram of ceftazidime every 8 hours or 2 g twice a day is indicated.

When treating uncomplicated urinary tract infections or lesions of the skin and gastrointestinal tract, 0.5 - 1 g is administered every 12 hours.

In case of localization of the infectious-inflammatory process in bone tissue, it is necessary to administer 2 g twice a day.

For cystic fibrosis complicated by Pseudomonas aeruginosa infection, administration of 100-150 mg/kg per day, divided into three times, is indicated.

For meningitis, up to 150 mg/kg/day is also administered three times.

For the treatment of nosocomial infections, it is necessary to prescribe two grams three times a day.

It is important to remember that injections of the drug must be continued for at least 48 hours after relief. acute symptoms and stabilization of the condition.

When performing surgical interventions on the prostate, for prophylactic purposes, to prevent septic complications, 1 g of antibiotic is administered before and 1 g after surgery.

For elderly patients, it is prohibited to exceed the daily dose of 3000 milligrams.

Adjustment of the prescribed dosage in patients with renal impairment should be carried out in accordance with creatinine clearance.

The standard course duration is from seven to 14 days. At nosocomial pneumonia, meningitis and cystic fibrosis, the course of therapy can be extended to 21 days.

Adjustment of the prescribed dose in patients with renal failure

As a starting dose, patients with renal impairment are prescribed 1000 milligrams once. Further, dose reduction or increase in intervals between administrations is carried out in accordance with creatinine clearance.

If the clearance is more than fifty milliliters per minute, the usual doses are prescribed, no correction is required.

If the clearance is below 50 but above 31 milliliters per minute, the patient is administered 1000 milligrams of ceftazidime ® every twelve hours.

If it decreases below thirty, but more than sixteen ml/min, leave the dose, but extend the intervals between injections (one gram once every twenty-four hours).

If creatinine clearance is between six and 15 ml/minute, administer 500 milligrams of antibiotic every 24 hours.

If it decreases below five ml/min, it is necessary to prescribe five hundred milligrams every forty-eight hours (one dose every two days).

If the patient is on hemodialysis, administration of a gram of antibiotic after the end of the session is indicated.

With peritoneal dialysis, it is necessary to administer five hundred milligrams of the drug once every 24 hours.

Spectrum of antimicrobial activity of ceftazidime

It is resistant to the action of most bacterial lactamases. Of all the antibiotics in the class, ceftazidime ® is most effective against Pseudomonas aeruginosa and strains that cause nosocomial infections.

The spectrum of action of the antibiotic covers: Haemophilus influenzae, Neisseria, Citrobacter, Enterobacteriaceae, Escherichia coli, Proteus, Klebsiella, streptococci and staphylococci, propionobacteria, Salmonella, Serration, Shigella, Peptococcus, etc.

The following are resistant to its action:

  • enterococcus;
  • listeria;
  • campylobacter;
  • chlamylia;
  • Staphylococcus epidermidis;
  • strains Staphylococcus aureus resistant to methicillin;
  • fecal streptococcus;
  • bacterioides fragilis;
  • clostridia.

Pharmacokinetics and pharmacodynamics of the drug

The antibiotic easily and quickly penetrates organs and tissues. Maximum plasma concentrations are reached twenty minutes after intravenous administration and within an hour after intramuscular administration. Capable of creating therapeutic concentrations in bone and cardiac tissues, sputum, bile, synovial, pleural and peritoneal fluids, tissues and fluids of the eye. It penetrates the blood-brain barrier only during meningitis. Found in small quantities in breast milk, it is able to cross the placental barrier.

Bactericidal concentrations in the body are maintained for eight to 12 hours after administration.

It does not undergo biotransformation and is not metabolized in the liver tissue; up to ninety percent of the drug is excreted unchanged by the kidneys. Up to 1% of the drug is excreted with bile. In newborns and patients with renal failure, excretion of the antibiotic is slowed down several times.

When is ceftazidime ® prescribed?

The antibiotic is highly effective in the treatment of nosocomial infections, including septicemia, bacteremia, peritonitis, infected burn wounds and complicated infections in immunocompromised patients.

It is used in the treatment of complicated and uncomplicated inflammation of the urinary tract. Active in, including severe cases and the presence of purulent complications.

Contraindications to the use of ceftazidime ®

The antibiotic is not used to treat patients with intolerance to beta-lactam drugs.

The following should be prescribed with caution:

  • pregnant women, especially in the first trimester;
  • newborns;
  • patients with severe renal impairment and liver failure;
  • with malabsorption syndrome;
  • for colitis associated with a history of antibiotic use (especially beta-lactams).

The drug can be used during pregnancy, however, if it is necessary to prescribe it to breastfeeding women, it is recommended to stop breastfeeding.

During treatment with ceftazidime, it is strictly forbidden to drink alcohol, since the antibiotic is incompatible with alcohol.

Interaction of ceftazidime ® with other drugs

Antibacterial drugs with a bacteriostatic mechanism of action reduce the effectiveness of ceftazidime ® , therefore this combination is contraindicated.

It is pharmaceutically incompatible with vancomycin, aminoglycosides and heparin. Also, combination with aminoglycosides can lead to a pronounced increase in toxic effects on the kidneys.

It is prohibited to use sodium bicarbonate as a solvent, since this leads to a violation of the stability of ceftazidime solutions.

Combination with diuretics increases the risk of toxic kidney damage.

It is not prescribed simultaneously with, since it is a beta-lactam antagonist.

Ceftazidime ® reduces the effectiveness of estrogen-containing oral contraceptives, which is important to consider if these drugs were used to eliminate dysfunctional uterine bleeding. In this case, prescribing an antibiotic increases the risk of rebleeding.

Due to the risk of inhibition of prothrombin activity in patients taking antimicrobial drugs for a long time, depleted and weakened patients, as well as in the presence of severe renal or liver failure, additional use of vitamin K is indicated.

Side effect of antibiotic

Allergic reactions are possible. As a rule, they manifest themselves as urticaria, eosinophilia, and itching of the skin. Less commonly, anaphylactic reactions and angioedema may develop.

A burning sensation, painful infiltration, and redness may appear at the injection site. With intravenous administration, phlebitis is possible.

Sometimes central nervous system disorders develop (headaches, limb tremors, convulsions, and extremely rarely, encephalopathy).

Frequent complications from antimicrobial therapy are gastrointestinal disorders, dysbiosis, candidiasis of the vaginal or oral mucosa. Dyspeptic disorders are also characteristic.

In the peripheral blood picture, a decrease in the level of leukocytes, neutrophils, platelets and lymphocytes may be observed. Rarely - hemolytic anemia.

In a biochemical blood test, increased levels of liver transaminases are possible. A coagulogram may reveal an increase in prothrombin time.

Nephropathy and nosebleeds are extremely rare.

Diarrhea that develops during antibiotic therapy usually stops immediately after discontinuation of the antimicrobial agent. In rare cases, bloody stools may occur, accompanied by cramping abdominal pain and high fever.

The antibiotic may affect the reaction rate and the ability to control transport and complex mechanisms, due to dizziness and weakness.

Symptoms of an overdose of ceftazidime ® may include sensory disturbances, convulsions, phlebitis, headaches, changes in peripheral blood patterns, and rarely, symptoms of renal failure.

Eliminating overdose symptoms

If symptoms of overdose appear, immediate discontinuation of the drug is recommended. Further therapy is carried out symptomatically. When seizures develop, anticonvulsants are prescribed. It is also necessary to monitor water and electrolyte balance indicators. Hemodialysis combined with hemoperfusion can be performed in patients with severe renal impairment. For other patients, such therapy is not indicated, since there is no data on its effectiveness.

Analogs of ceftrazidime ®

  • Amzheceft ® ;
  • Mirocef ® ;
  • Ceftazidime Sandoz ® .
  • Bestum ® ;
  • Biotum ® ;
  • Vicef®;
  • Zatseph ® ;
  • Kefadim ® ;
  • Cefzide ® ;
  • Auroceph ® ;
  • Lorazidim ® ;
  • Orzid ® ;
  • Tazid ® ;
  • Tasicephus;
  • Tizim ® ;
  • Fortadine ® ;
  • Fortazim ® ;
  • Ceftazidime-Acos ® .

There are no analogues of ceftazidime ® in tablets. This is an injectable cephalosporin.
One of the best drugs ceftazidime ® is Fortum ® .

Fortum ® is produced by the pharmaceutical company GlascoSmithKline ®, the country of origin is Great Britain.

The antibiotic is available in the form of a powder for the preparation of a solution for injection, containing 500 and 1000 milligrams of ceftazidime ® in one bottle.

The cost of one 0.5 gram bottle in Russian pharmacies is about 250 rubles.

The release form of 1000 milligrams will cost the buyer 450 rubles (1 bottle).

Cheap analogues of Fortum ® include the Russian Ceftazidime AKOS ®, produced by the Sintez-AKOMP campaign, the cost of 1 bottle. 1000 mg costs 90 rubles. Ceftazidime ® produced by Kraspharma ® costs about 80 rubles.