Lorazidime

powder for solution for injection in vials No. 1

Instructions Normative documents

Composition

1 vial contains ceftazidime for injection in terms of ceftazidime 1000 mg.

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Dosage form

Powder for solution for injection.

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Pharmacological group

Antibacterial medications for systemic use. Cephalosporins of III generation. ATC code J01D D02.

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Pharmacological properties

Pharmacological.

Ceftazidime is a bactericidal cephalosporinium antibiotic whose mechanism of action is associated with impaired synthesis of the walls of the bacterial cell.

Acquired resistance to the antibiotic varies in different regions and may change over time, and for individual strains may differ significantly. It is advisable to use local (local) data on sensitivity to the antibiotic, especially in the treatment of severe infections.

sensitive microorganisms

Gram-positive aerobes Streptococcus pyogenes, Streptococcus agalactiae.

Gram-negative aerobes Citrobacter koseri, Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Neisseria meningitidis, Proteus mirabilis, Proteus spp., Providencia spp.

Strains with possible acquired resistance

Acinetobacter baumannii, Burkholderia cepacia, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella pneumoniae, Klebsiella spp., Pseudomonas aeruginosa, Serratia spp., Morganella morganii.

Gram-positive aerobic Staphylococcus aureus, Staphylococcus pneumoniae.

Gram-positive anaerobes: Clostridium perfringens, Peptococcus spp., Peptostreptococcus spp.,

Gram-negative anaerobes: Fusobacterium spp.

insensitive microorganisms

Gram-positive aerobic Enterococcus spp., Including E. faecalis and E. faecium, Listeria spp.

Gram-positive anaerobes: Clostridium difficile.

Gram-negative anaerobes: Bacteroides spp., Including B. fragilis.

Others: Chlamydia spp., Mycoplasma spp., Legionella spp.

Pharmacokinetics.
In patients after injection of 500 mg and 1 g, the maximum concentrations of 18 and 37 mg / l, respectively, are quickly reached. After 5 minutes after intravenous bolus administration, 500 mg, 1 g or 2 g in serum concentrations on average are achieved 46, 87 or 170 mg / l, respectively. Therapeutically effective concentrations remain in the serum even 8 to 12:00 after intravenous and intramuscular administration. Plasma protein binding is approximately 10%. Ceftazidime concentration, which exceeds the MIC for most common pathogens, is achieved in tissues and media such as bones, heart, bile, sputum, intraocular, synovial, pleural, and peritoneal fluids. Ceftazidime quickly passes through the placenta and into breast milk. The drug does not penetrate through the intact blood-brain barrier, in the absence of inflammation, the concentration in the central nervous system is small. However, with inflammation of the meninges, the concentration of ceftazidime in the CNS is 4–20 mg / l and higher, which corresponds to the level of its therapeutic concentration.

Ceftazidime is not metabolized in the body. After parenteral administration, a high and persistent serum ceftazidime concentration is achieved. The half-life is approximately 2:00. The drug is excreted unchanged, in active form with urine by glomerular filtration; approximately 80–90% of the dose is excreted in the urine within 24 hours. In patients with impaired renal function, ceftazidime elimination is reduced, so the dose should be reduced. Less than 1% is excreted in the bile, which significantly limits the amount of the drug that enters the intestine.

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Indications

Treatment of the following infections in adults and children, including newborns:

– hospital-acquired pneumonia
– respiratory bacterial infections in cystic fibrosis;
– bacterial meningitis
– chronic otitis media;
– malignant otitis externa;
– complicated urinary tract infections;
– complicated skin and soft tissue infections;
– complicated abdominal infections;
– infections of bones and joints;
– peritonitis associated with dialysis in patients on continuous ambulatory peritoneal dialysis.
Treatment of bacteremia that occurs in patients as a result of any of the above infections.
Ceftazidime can be used to treat patients with neutropenia and fever resulting from a bacterial infection.
Ceftazidime can be used to prevent infectious complications during operations on the prostate gland (transurethral resection).

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SIDE EFFECTS

Local: phlebitis or thrombophlebitis with a / in the introduction; pain and / or inflammation after i / m injection. Hypersensitivity: maculopapular rash or sprinkling, fever, itching, very rarely – angioedema and anaphylaxis (including bronchospasm and / or hypotension). Possible cases of polymorphic erythema, Stevens-Johnson syndrome and toxic epidermal necrolysis. Gastrointestinal: diarrhea, nausea, vomiting, abdominal pain, constipation, rarely – candidal stomatitis, pseudomembranous colitis. Urogenital: vaginal candidiasis, vaginitis, renal failure. Liver, biliary tract and pancreas: very rarely – jaundice. Central nervous system: headache, dizziness, hearing loss, paresthesia, and taste disturbance. Cases of neurological complications such as tremor, myoclonia, convulsions, encephalopathy and coma have been reported in patients with renal insufficiency for whom the ceftazidime dose has not been reduced accordingly. Changes in laboratory parameters (minuschi): eosinophilia, very rarely – hemolytic anemia, thrombocytosis and increased levels of one or more liver enzymes (ALT, AST, LDH, GGT, alkaline phosphatase), transient increase in blood urea, blood urea nitrogen and / or creatinine in serum. Very rarely, leukopenia, neutropenia, agranulocytosis, thrombocytopenia and lymphocytosis have been reported. Approximately 5% of patients had a positive Coombs reaction, which may affect blood group determination.

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