Fortum powder for injection vial 1g N1
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Active ingredients
Ceftazidime
Release form
Powder
Composition
Active ingredient: Ceftazidime (Ceftazidimum) Active ingredient concentration (mg): 1 g
Pharmacological effect
Cephalosporin antibiotic III generation. It has a bactericidal effect, disrupting the synthesis of the cell wall of microorganisms. It has a broad spectrum of antimicrobial action (including strains of pathogens resistant to gentamicin and other aminoglycoside antibiotics). Resistant to most β-lactamase. In vitro studies have shown that ceftazidime is active against gram-negative bacteria: Pseudomonas aeruginosa, Pseudomonas spp. (including Pseudomonas pseudomallei), Klebsiella spp. (including Klebsiella pneumoniae), Proteus mirabilis, Proteus vulgaris, Morganella morganii, Proteus rettgeri, Providencia spp., Escherichia coli, Enterobacter spp., Citrobacter spp., Serratia spp., Salmonella spp., Shigella spp. enterocolitica, Pasteurella multocida, Acinetobacter spp., Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae (including ampicillin-resistant strains); Gram-positive bacteria: Staphylococcus aureus (strains sensitive to methicillin), Staphylococcus apychidus (an example of a replica), which is an object that is attached to a systmus. mitis, Streptococcus spp. (excluding Streptococcus faecalis); anaerobic bacteria: Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp., Clostridium perfringers, Fusobacterium spp., Bacteroides spp. (Many strains of Bacteroides fragilis are resistant). Ceftazidime is not active against methicillin-resistant staphylococci, Streptococcus faecalis and many other Enterococcus spp., Listeria monocytogenes, Campylobacter spp., Clostridium difficile.
Pharmacokinetics
Absorption After i / m administration of the drug in doses of 500 mg and 1 g of Cmax in the blood plasma are reached quickly and amount to 18 mg / l and 37 mg / l, respectively. 5 min after i / v bolus administration of the drug at a dose of 500 mg, 1 g or 2 g plasma concentrations of ceftazidime are 46 mg / l, 87 mg / l and 170 mg / l, respectively. DistributionAfter i / v or v / m therapeutic plasma concentrations of the active substance are maintained for 8-12 hours. Plasma protein binding is 10%. Ceftazidime concentrations exceeding BMD for most common pathogens can be achieved in bone tissue, heart tissue, bile, sputum, synovial fluid, intraocular well liquids, in pleural and peritoneal fluids. Ceftazidime easily penetrates the placental barrier, excreted in breast milk. In the absence of inflammation in the meningeal membranes, ceftazidime does not penetrate well through the BBB, the concentration of the drug in the cerebrospinal fluid (CSF) is low. Meningitis in CSF achieves therapeutic concentrations of ceftazidime, which are 4–20 mg / l and more. Metabolism Ceftazidime is not metabolized in the body. Excretion of T1 / 2 is about 2 h.Ceftazidime is excreted unchanged in the urine by glomerular filtration. Approximately 80-90% of the dose is excreted in the urine within 24 hours. Less than 1% of the drug is excreted in the bile. Pharmacokinetics in special clinical situations In renal dysfunction, ceftazidime excretion rate decreases. In hemodialysis, T1 / 2 is 3-5 hours. 2 to 3-4 times more than adults.
Indications
- severe infections, including nosocomial (septicemia, bacteremia, peritonitis, meningitis, infections in patients with reduced immunity, burns); - respiratory infections and infections in patients with cystic fibrosis; - LOR-organs infections; - urinary tract infections; - skin infections and soft tissues; - infections of the gastrointestinal tract, biliary tract and abdominal cavity; - infections of bones and joints; - infections associated with dialysis. Prevention of infectious complications during operations on the prostate gland (transurethral resection).
Contraindications
- hypersensitivity to ceftazidime and other components of the drug; - hypersensitivity to other cephalosporin antibiotics, penicillins.
Precautionary measures
With care prescribed for renal failure, gastrointestinal diseases (including history and NUC), during pregnancy, during lactation, the newborn, in combination with loop diuretics and aminoglycosides.
Use during pregnancy and lactation
Fortum should be used with caution in the first months of pregnancy. Ceftazidime is excreted in breast milk, so care must be taken when prescribing the drug to the mother during the breastfeeding period. There is no evidence of the embryotoxic or teratogenic effect of ceftazidime.
Dosage and administration
The dose is set individually, depending on the severity of the disease, localization, the type of pathogen and its sensitivity to the drug, the patient's age and kidney function. The drug is injected or deep v / m into the upper outer quadrant of the gluteus maximus or the lateral part thighs The solution of ceftazidime can be injected directly into a vein or into the tube of the infusion system. The maximum daily dose is 6 g. The adults are prescribed 1-6 g / day i / v or m.The frequency of administration is 2-3 times / day. In most cases, 1 g is administered every 8 hours or 2 g at intervals of 12 hours. In severe cases, especially in patients with reduced immunity, including patients with neutropenia, 2 g are prescribed. every 8 hours or 12 hours, or 3 g every 12 hours. For urinary tract infections and lung infections, it is recommended to inject 500 mg or 1 g every 12 hours. For the treatment of infectious complications of cystic fibrosis caused by Pseudomonas, 100-150 are prescribed. mg / kg / day in 3 doses. During operations on the prostate gland, Fortum mean at a dose of 1 g during induction anesthesia and the second dose is administered when the catheter is removed. For elderly patients, especially over 80 years old, Fortum is recommended to be given at a dose of not more than 3 g / day. / kg / day; the multiplicity of the introduction is 2-3 times / day. Children with reduced immunity, with cystic fibrosis or meningitis are prescribed up to 150 mg / kg / day (maximum 6 g / day) in 3 doses. The newborn and infants under 2 months are prescribed in the dose 25-60 mg / kg / day in 2 doses. Patients with renal insufficiency require dose reduction, since ceftazidime is excreted by the kidneys in unchanged form. The initial dose is 1 g. The maintenance dose is selected depending on the speed of glomerular filtration.
Side effects
on the side of the digestive system: diarrhea, nausea, vomiting, abdominal pain, candidiasis of the oral cavity and pharynx, transient increase in the activity of ALT, AST, LDG, GGT and ALP; very rarely - jaundice. As with the use of other cephalosporins, colitis can be caused by Clostridium difficile and manifest as pseudomembranous colitis. On the hemopoietic system: eosinophilia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, thrombocytosis, lymphocytograft, and cytocytosis, and cytocytosis, the cytotoxicant, the cytotoxicant, and the cytotoxicant, the cytophalosporins, agranulocytosis, thrombocytopenia, thrombocytosis, and lymphocytotherapy, are used. peripheral nervous system: headache, dizziness, paresthesia, impaired taste sensations; more often in patients with renal insufficiency - neurological disorders, including tremor, myoclonus, seizures, encephalopathy, to whom. On the urinary system: transient increase in urea, urea nitrogen and / or creatinine in the blood, renal dysfunction. rash, urticaria, fever, pruritus, angioedema, bronchospasm, decrease in blood pressure, exudative erythema multiforme (includingStevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome). Local reactions: phlebitis or thrombophlebitis with a / in the introduction; pain, burning, tightness at the injection site with the / m injection. Others: candidal vaginitis, Coombs' false positive direct reaction.
Overdose
Symptoms: neurological disorders (including encephalopathy, convulsions, coma). Treatment: conducting symptomatic and supportive therapy. Ceftazidime serum concentrations may be reduced by hemodialysis or peritoneal dialysis.
Interaction with other drugs
Simultaneous administration of ceftazidime in high doses and nephrotoxic drugs may have an adverse effect on kidney function. Loop diuretics, aminoglycosides, vancomycin, clindamycin reduce the clearance of ceftazidime, as a result of which the risk of nephrotoxic action increases. - lactam antibiotics. Pharmaceutical interaction Forta is compatible with most solutions for intravenous administration. However, ceftazidime is less stable in bicar solution sodium Onat, so it is not recommended as rastvoritelya.Fortum pharmaceutically incompatible with aminoglycosides, heparin, vancomycin, chloramphenicol. Chloramphenicol acts as an antagonist of ceftazidime and other cephalosporins. When vancomycin is added to a solution of ceftazidime, a precipitate is noted, therefore, it is recommended to flush the infusion system between injections of these two drugs.
special instructions
If an allergic reaction to ceftazidime develops, the drug should be immediately discontinued. With the development of hypersensitivity reactions, the use of adrenaline (epinephrine), hydrocortisone, antihistamines and other emergency measures can be shown. If you take cephalosporins in high doses with nephrotoxic drugs such as aminoglycosides and diuretics (furosemide), kidney function must be monitored. However, there is no evidence that ceftazidime in therapeutic doses impairs renal function. Since ceftazidime is excreted by the kidneys, in patients with renal insufficiency, the dose should be reduced in accordance with the degree of impaired renal function. Long-term use of broad-spectrum antibiotics, includingand Fortum, can lead to an increase in the growth of insensitive microorganisms (for example, Candida, Enterococcus spp.), which may require discontinuation of treatment or appropriate therapy. During treatment, it is necessary to constantly evaluate the patient's condition. During treatment with Fortum, in some initially sensitive strains of Enterobacter spp. and Serratia spp. resistance may develop. Therefore, if necessary, in the treatment of infections caused by these microorganisms, it is necessary to periodically conduct a study on sensitivity to antibiotics. Ceftazidime does not affect the results of enzymatic methods for determining glucose in the urine, but may slightly affect the results of tests with copper recovery (Benedict, Fehlinga , Klinitest). Ceftazidime does not affect the results of creatinine determination using the alkali-picrate method.