Powder for solution for injection "Ceftazidime" is used for the indications listed below.
Treatment of the following infections in adults and children, including newborns:
hospital-acquired pneumonia; respiratory tract infections in patients with cystic fibrosis; bacterial meningitis; chronic otitis media; malignant otitis externa; complicated urinary tract infections; complicated skin and soft tissue infections; complicated intra-abdominal infections; bone and joint infections; dialysis-associated peritonitis 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 urinary tract infections during prostate surgery (transurethral resection).
When prescribing ceftazidime, its antibacterial spectrum, directed mainly against gram-negative aerobes, should be taken into account.
Ceftazidime should be used with other antibacterial agents if it is expected that the range of microorganisms causing the infection is not within the spectrum of activity of ceftazidime.
Composition
The active substance is ceftazidime (1 vial contains ceftazidime (as ceftazidime pentahydrate) 1.0 g).
The excipient is sodium carbonate.
Contraindication
Hypersensitivity to ceftazidime or to any of the excipients; Hypersensitivity to cephalosporin antibiotics; History of severe hypersensitivity (e.g. anaphylactic reactions) to other beta-lactam antibiotics (penicillins, monobactams and carbapenems).
Method of application
Ceftazidime should be administered parenterally. The dose depends on the severity of the disease, susceptibility, location and type of infection, as well as the patient's body weight and renal function. A skin test should be performed before use to ensure tolerance.
Adults and children ≥ 40 kg
Intermittent input:
respiratory tract infections in patients with cystic fibrosis - 100-150 mg/kg body weight/day every 8 hours, maximum up to 9 g per day; febrile neutropenia, hospital-acquired pneumonia, bacterial meningitis, bacteremia - 2 g every 8 hours; bone and joint infections, complicated skin and soft tissue infections, complicated intra-abdominal infections, peritonitis (associated with continuous ambulatory peritoneal dialysis) - 1-2 g every 8 hours; complicated urinary tract infections - 1-2 g every 8 hours or 12 hours; prevention of infectious complications during prostate surgery (transurethral resection) - 1 g during induction of anesthesia, and the second dose at the time of catheter removal; chronic otitis media, malignant otitis externa - 1-2 g every 8 hours.
Continuous infusion: febrile neutropenia, hospital-acquired pneumonia, respiratory tract infections in patients with cystic fibrosis, bacterial meningitis, bacteremia, bone and joint infections, complicated skin and soft tissue infections, complicated intra-abdominal infections, peritonitis (associated with continuous ambulatory peritoneal dialysis) - a loading dose of 2 g is administered followed by a continuous infusion of 4 to 6 g every 24 hours.
Children <40 kg (infants and children >2 months and weighing <40 kg)
Intermittent input:
Complicated urinary tract infections, chronic otitis media, malignant external otitis - 100-150 mg/kg body weight / day in 3 doses, maximum 6 g per day; neutropenia in children, respiratory tract infections in patients with cystic fibrosis, bacterial meningitis, bacteremia - 150 mg/kg body weight / day in 3 doses, maximum 6 g per day; bone and joint infections, complicated skin and soft tissue infections, complicated intra-abdominal infections, peritonitis (associated with continuous ambulatory peritoneal dialysis) - 100-150 mg/kg body weight / day in 3 doses, maximum 6 g per day.
Continuous infusion: febrile neutropenia, hospital-acquired pneumonia, respiratory tract infections in patients with cystic fibrosis, bacterial meningitis, bacteremia, bone and joint infections, complicated skin and soft tissue infections, complicated intra-abdominal infections, peritonitis (associated with continuous ambulatory peritoneal dialysis) - a loading dose of 60-100 mg/kg of body weight is administered, followed by a continuous infusion of 100-200 mg/kg of body weight per day, up to a maximum of 6 g per day.
Children <40 kg (infants and children ≤ 2 months)
Intermittent administration: most infections - 25-60 mg/kg body weight/day in 2 divided doses.
Preparation of solution for intravenous infusion in 2 stages
Insert the syringe needle through the vial cap and inject 10 ml of the solvent. Remove the syringe needle and shake the vial until a clear solution is obtained. Do not insert the air needle until the drug is completely dissolved. Insert the air needle through the cap into the vial to relieve the internal pressure in the vial. Add the resulting solution to the infusion system so that the total volume of the solution is at least 50 ml, and use for infusion within 15-30 minutes.
Note: To ensure sterility of the drug, it is very important not to insert the needle through the vial cap until the drug is dissolved.
Application features
Pregnancy
Data on the use of ceftazidime in pregnant women are limited. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic or postnatal development. The drug should be prescribed to pregnant women only if the benefit of its use outweighs the possible risk.
Ceftazidime is excreted in breast milk in small amounts, but at therapeutic doses, no effects on the breastfed infant are expected. Ceftazidime can be used during breastfeeding.
Drivers
No relevant studies have been conducted. However, certain adverse reactions (e.g. dizziness) may occur, which may affect the ability to drive or use machines.
Overdose
Overdose may lead to neurological complications such as encephalopathy, convulsions and coma. Symptoms of overdose may occur in patients with renal insufficiency unless the dose is reduced accordingly.
Plasma concentrations of ceftazidime can be reduced by hemodialysis or peritoneal dialysis.
Treatment: symptomatic.
Side effects
From the side of the circulatory and lymphatic systems: often (≥1/100 and <1/10) - eosinophilia and thrombocytosis.
Vascular disorders: often (≥1/100 and <1/10) - phlebitis or thrombophlebitis at the site of drug administration.
Gastrointestinal: often (≥1/100 and <1/10) - diarrhea.
On the part of the hepatobiliary system: common (≥1/100 and <1/10) - transient increase in the level of one or more liver enzymes (ALT, AST, LDH, GGT, alkaline phosphatase).
Skin and subcutaneous tissue disorders: often (≥1/100 and <1/10) - maculopapular rash or urticaria.
Interaction
Ceftazidime is less stable in sodium bicarbonate solution for injection than in other intravenous solutions. Therefore, it is not recommended as a diluent. Ceftazidime and aminoglycosides should not be mixed in the same infusion set or syringe. When vancomycin solution is added to ceftazidime solution, a precipitate may form, therefore it is recommended to flush infusion sets and intravenous catheters between the use of these drugs.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
The prepared solution can be stored for 24 hours at a temperature below 25 °C.
Shelf life - 2 years.
