Medicinal reference book geotar. Ceftazidime-akos - side effects
The drug Ceftazidime-Akos – medicine, related to the so-called cephalosporin antibiotic III generation. I will review the instructions for this medication for readers of “Popular About Health” in detail.
What is the composition and release form of Ceftazidime-Akos??
The pharmaceutical industry produces medicine in a whitish-yellow powder with brown tint, where the active compound is ceftazidime at a dose of 500 milligrams. The auxiliary component in Ceftazidime-Acos is sodium carbonate. The solvent included is water for injection. The medicine is placed in bottles. Sold by prescription. In addition, there is a powder where ceftazidime is presented in a dose of 1 gram and 2 grams.
What is the effect of the drug Ceftazidime-Akos?
The antibiotic belongs to the third generation cephalosporins. The action of Ceftazidime-Acos is bactericidal, that is, it leads pathogenic microorganisms to death due to disruption of the biosynthesis of the pathogen cell wall. The drug is resistant to β-lactamases. The medication is active against the following bacteria: Pseudomonas spp., Klebsiella spp., in addition, Proteus mirabilis and vulgaris, Pasteurella multocida, Escherichia coli, as well as Enterobacter aerogenes and cloacae, Neisseria meningitidis, Staphylococcus aureus, Haemophilus influenzae, Bacteroides spp., Clostridium perfringens, Morganella morganii, Peptococcus spp., Providencia spp., Salmonella spp., Staphylococcus epidermidis, as well as Yersinia enterocolitica.
After administration of the antibiotic into the muscle, the maximum concentration is observed within an hour. Ceftazidime-Akos powder binds to blood proteins by 10 percent. The drug accumulates in the following bodies: bone tissue, bile, cardiac muscle, sputum, synovial, intraocular, peritoneal fluid. The drug is not metabolized. The half-life averages two hours. Approximately 90% is excreted throughout the day by the kidneys.
What are the indications for use of Ceftazidime-Akos powder??
In the indications of Ceftazidime-Akos, its instructions for use included the following permissions:
Antibiotic is effective for severe infections eg meningitis, septicemia, bacteremia, infected burns;
Infection of joints and bones, respiratory tract;
Infections urinary tract;
Gonorrhea;
Infections of the skin, soft tissues;
Infections of the gastrointestinal tract and pelvic organs.
In addition, an antibiotic is prescribed for so-called otorhinolaryngological infections.
What are the contraindications for use of the antibiotic Ceftazidime-Akos??
The contraindications for Ceftazidime-Akos included the following prohibitions: not prescribed for hypersensitivity to the substances of the drug. The drug should be used with caution for colitis, renal failure, with malabsorption syndrome, in addition, in newborns.
Application of Ceftazidime-Akos and dosage
The drug is used parenterally, that is, into the muscle and intravenously, and the dosage of Ceftazidime-Akos is set individually. Usual dose The medication is 1 gram every 8 or 12 hours. For urinary tract infections, 250 mg is prescribed twice a day, and for severe infections, 1 gram is used 2 or 3 times a day.
In old age, the amount of antibiotic should not exceed three grams per day. The average duration of treatment with medication is a week or two, and in case of severe meningitis, the duration of antibiotic therapy is extended (extended) to three weeks.
When dissolved, the powder releases so-called carbon dioxide; after introducing the solvent directly into the bottle, it is necessary to shake the container until a so-called clear solution is formed, and small bubbles of carbon dioxide may be present in it. The color of the finished medicine can range from darkish yellow to light yellowish.
What are Ceftazidime-Acos? side effects ?
The abstract warns of the following side effects of Ceftazidime-Acos: allergic reactions, thrombocytopenia, urticaria, chills, eosinophilia, fever, rash, neutropenia, itching, bronchospasm, angioedema, candidal vaginitis, granulocytopenia, anaphylactic shock, neutropenia, hemorrhages, hemolytic anemia, toxic nephropathy, nausea, vomiting, in addition, cholestasis, diarrhea, and flatulence.
In addition, there is impaired renal function, abdominal pain, glossitis, dysbacteriosis, headache, increased liver transaminases, stomatitis, hyperbilirubinemia, pseudomembranous enterocolitis, dizziness, oropharyngeal candidiasis, in addition, paresthesia, seizures, and nose bleed, encephalopathy, hypercreatininemia, phlebitis.
If there is an overdose of Ceftazidime-Akos…
Symptoms of an overdose of Ceftazidime-Acos: inflammation at the injection site, convulsions, phlebitis, dizziness, hypercreatininemia, hyperbilirubinemia. In this case they appoint symptomatic treatment.
When using the drug, the patient should not drink alcohol, since disulfiram-like manifestations in the form of facial skin flushing, headache, and possibly nausea are not excluded. In addition, when using the medication and even two weeks after the end of treatment, diarrhea caused by the pathogen Clostridium difficile may occur. In this case, treatment is carried out using vancomycin, metronidazole and other medications.
How to replace Ceftazidime-Akos, what are the analogues of the drug?
The drug Ceftazidime, the pharmaceutical drug Ceftidine, in addition, Fortum and some other analogues of Ceftazidime-Acos.
Conclusion
Before using CEFTAZIDIME-AKOS you should consult your doctor. These instructions for use are for informational purposes only. To get more complete information Please refer to the manufacturer's instructions.
Clinical and pharmacological group
06.010 (III generation cephalosporin)
Release form, composition and packaging
The powder for preparing a solution for intramuscular injection is white or white with a yellowish or yellowish-beige tint.
Bottles with a volume of 10 ml (1) - cardboard packs. Bottles with a volume of 10 ml (10) - packs of cardboard. Bottles with a volume of 10 ml (50) - cardboard boxes.
The powder for preparing a solution for intramuscular injection is white or white with a yellowish or yellowish-beige tint.
Bottles with a volume of 10 ml (1) - cardboard packs. Bottles with a volume of 10 ml (10) - packs of cardboard. Bottles with a volume of 10 ml (50) - cardboard boxes.
pharmachologic effect
Antibiotic of the cephalosporin group of the third generation with a broad spectrum of action. It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. Resistant to most β-lactamases.
The drug is active against gram-negative microorganisms: Haemophilus influenzae, Neisseria spp. (including Neisseria gonorrhoeae), Citrobacter spp., Enterobacter spp., Escherichia coli, Klebsiella spp. (incl. Klebsiella pneumoniae), Pseudomonas aeruginosa, Morganella spp. (including Morganella morganii), Proteus spp. (Proteus mirabilis /including indole-positive/, Proteus vulgaris), Providenсia spp. (including Providenсia rettgeri), Serratia spp.), Acinetobacter spp., Haemophilus parainfluenzae (including strains resistant to ampicillin), Pasteurella multocida, Salmonella spp., Shigella spp., Yersinia enterocolitica; gram-positive bacteria: Micrococcus spp., Streptococcus spp. (including Streptococcus mitis, Streptococcus pneumoniae, Streptococcus pyogenes group A, Streptococcus viridans); strains sensitive to methicillin: Staphylococcus aureus, Staphylococcus epidermidis; anaerobic bacteria: Bacteroides spp. (most strains of Bacteroides fragilis are resistant), Clostridium perfringens, Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp.
The drug Ceftazidime has the most high activity among third generation cephalosporins against Pseudomonas aeruginosa and pathogens of nosocomial infections.
The drug is not active against methicillin-resistant strains of Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus faecalis; and also against Campylobacter spp., Chlamydia spp., Clostridium difficile, Enterococcus spp., Listeria spp. (including Listeria monocytogenes).
Pharmacokinetics
Suction
After intramuscular administration of the drug at a dose of 0.5 g or 1 g, Cmax is achieved after 1 hour and is 17 μg/ml and 39 μg/ml, respectively; after intravenous administration, Cmax is reached at the end of the infusion and is 42 mcg/ml and 69 mcg/ml, respectively.
The concentration of the drug, equal to 4 mcg/ml, is maintained for 6-8 hours, the therapeutic concentration in the blood plasma is maintained for 8-12 hours.
Distribution
After administration, the drug is quickly distributed in the human body and reaches therapeutic concentrations in most tissues (bones, myocardium, gallbladder, skin and soft tissues in concentrations sufficient for treatment infectious diseases) and fluids (including synovial, pericardial and peritoneal fluid, as well as in bile, sputum and urine). Penetrates poorly through the intact blood-brain barrier, but is reached by the drug in cerebrospinal fluid The therapeutic level is sufficient for the treatment of meningitis.
Reversibly binds to plasma proteins (less than 15%), and has a bactericidal effect only in its free form. The degree of protein binding does not depend on concentration.
Vd is 0.21–0.28 l/kg. The drug accumulates in soft tissues, kidneys, lungs, bones, joints, and serous cavities.
Removal
T1/2 with normal renal function is 1.8 hours. Up to 80-90% of the administered dose is excreted unchanged by the kidneys (70% of the administered dose is excreted in the first 4 hours) during the day by glomerular filtration and tubular secretion equally.
Pharmacokinetics in special clinical situations
T1/2 for impaired renal function is 2.2 hours. The drug is not metabolized in the liver, therefore, impaired liver function does not affect the pharmacodynamics of the drug.
CEFTAZIDIME-ACOS: DOSAGE
The drug Ceftazidime-AKOS is used only IV (stream or drip) or IM. 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 kidney function.
For complicated urinary tract infections, 0.5–1 g is prescribed IM or IV every 8–12 hours.
For uncomplicated pneumonia and skin infections - 0.5-1 g intramuscularly or intravenously every 8 hours.
For 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).
For infections of bones and joints - 2 g intravenously every 12 hours.
For extremely severe or life-threatening infections - 2 g intravenously every 8 hours.
The half-life of the drug during hemodialysis is 3-5 hours. The appropriate dose of the drug should be repeated after each period of hemodialysis.
For peritoneal dialysis, the drug Ceftazidime-AKOS can be included in the dialysis fluid at a dose of 125 mg to 250 mg per 2 liters of dialysis fluid.
For children under 1 month of age, the drug is prescribed as an intravenous infusion at a dose of 30 mg/kg/day, the frequency of administration is 2 times.
Children aged 2 months to 12 years – in the form of an intravenous infusion of 30-50 mg/kg/day, frequency of administration – 3 times.
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. Maximum daily dose for children - 6 years
Rules for preparing solutions
When the powder dissolves, carbon dioxide is released. After introducing the solvent, the bottle must be shaken to obtain a clear solution. In the received ready solution small bubbles of carbon dioxide may be present.
The resulting solution can range in color from light yellow to dark yellow. If all recommended rules for diluting the drug are followed, then its effectiveness does not depend on the shade.
Primary breeding
Secondary dilution
For intravenous drip administration, the Ceftazidime-AKOS 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% sodium chloride solution, Ringer's solution, 5% or 10% glucose solution ( dextrose), 5% glucose solution (dextrose) with 0.9% sodium chloride solution.
For secondary dilution, only freshly prepared solution should be used.
Creatinine clearance
Dose
>50 ml/min (>0.83 ml/sec)
1 g every 12 hours
1 g every 24 hours
500 mg every 24 hours
500 mg every 48 hours
500 mg every 24 hours
Amount of drug
IM injection
IV jet injection
250 mg
1 ml water for injection
2.5 ml water for injection
500 mg
1.5 ml water for injection
5 ml water for injection
1 g or 2 g
3 ml water for injection
10 ml water for injection
Overdose
Symptoms: dizziness, paresthesia, headache, seizures, abnormal results laboratory tests.
Treatment: provide symptomatic and supportive therapy. In case of severe overdose, hemodialysis may be used.
Drug interactions
Synergism noted antibacterial action when used simultaneously with aminoglycosides, vancomycin, rifampicin.
Loop diuretics, aminoglycosides, vancomycin, clindamycin reduce the clearance of ceftazidime, resulting in an increased risk of nephrotoxicity.
Pharmaceutical interactions
The drug is pharmaceutically incompatible with aminoglycosates, heparin, and vancomycin.
Do not use sodium bicarbonate solution as a solvent.
Pharmaceutically compatible with the following solutions: at concentrations from 1 to 40 mg/ml - sodium chloride 0.9%, sodium lactate, Hartmann's solution, dextrose 5%, sodium chloride 0.225% and dextrose 5%, sodium chloride 0.45% and dextrose 5%, sodium chloride 0.9% and dextrose 5%, sodium chloride 0.18% and dextrose 4%, dextrose 10%, dextran 40 (10%) in a solution of sodium chloride 0.9%, dextran 40 (10%) in a solution of dextrose 5%, dextran 70 (6 %) in a solution of sodium chloride 0.9%, dextran 70 (6%) in a solution of dextrose 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 lidocaine hydrochloride 0.5% or 1%. Both components remain active when ceftazidime is added to the following solutions (ceftazidime concentration 4 mg/ml): hydrocortisone, (hydrocortisone sodium phosphate) 1 mg/ml in sodium chloride solution 0.9% or dextrose solution 5%, 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 in sodium chloride solution 0.9%, potassium chloride 10 meq/l or 40 meq/l in solution sodium chloride 0.9%. When mixing a solution of ceftazidime (500 mg in 1.5 ml of water for injection) and metronidazole (500 mg/100 ml), both components retain their activity.
Pregnancy and lactation
During pregnancy and lactation, the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child.
CEFTAZIDIME-ACOS: SIDE EFFECTS
Allergic reactions: urticaria, chills or fever, rash, itching; rarely - bronchospasm, eosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, anaphylactic shock.
From the outside digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, dysbiosis, liver dysfunction (increased activity of liver transaminases, alkaline phosphatase, hypercreatininemia); rarely – stomatitis, glossitis, pseudomembranous enterocolitis.
From the hematopoietic system: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, hypocoagulation.
From the urinary system: impaired renal function (azotemia, increased urea content in the blood), oliguria, anuria.
From the outside nervous system: headache, dizziness.
Local reactions: with intravenous administration - phlebitis, pain along the vein; with intramuscular injection - pain and infiltration.
Other: nosebleeds, candidiasis, superinfection.
Storage conditions and periods
List B. The drug should be stored in a dry place, protected from light, at a temperature not exceeding 25°C. Shelf life - 2 years.
Freshly prepared injection solution is suitable for use within 18 hours when stored at a temperature not exceeding 25°C. When stored in the refrigerator at temperatures from 2° to 8°C, the shelf life of the solution is 120 hours.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Indications
Sepsis (septicemia);
Severe purulent-septic conditions;
Infections of bones and joints (incl. septic arthritis, osteomyelitis, bacterial bursitis);
Respiratory tract infections (including acute and Chronical bronchitis, infected bronchiectasis, pneumonia caused by gram-negative bacteria, lung abscess, pleural empyema);
Urinary tract infections (including acute and chronic pyelonephritis, pyelitis, prostatitis, cystitis, urethritis /bacterial only/, kidney abscess);
Skin and soft tissue infections (mastitis, wound infections, skin ulcers, cellulitis, erysipelas, infected burns);
Gastrointestinal infections abdominal cavity And biliary tract(peritonitis, enterocolitis, retroperitoneal abscesses, diverticulitis, cholecystitis, cholangitis, gallbladder empyema);
Infections of the female genital organs;
Infections of the pelvic organs;
Meningitis;
Ear, nose and throat infections ( otitis media, sinusitis, mastoiditis);
Gonorrhea (especially with hypersensitivity to antibacterial drugs from the penicillin group).
Contraindications
Hypersensitivity to cephalosporins and penicillins;
Pregnancy;
Lactation (breastfeeding).
special instructions
The drug should be prescribed with caution if there is a history of bleeding, a history of gastrointestinal diseases (especially nonspecific ulcerative colitis).
In patients with a history of hypersensitivity reaction to penicillins, incomplete cross-reaction of hypersensitivity to cephalosporins was observed (3-7%). Although many patients with penicillin allergy manifesting as rash have used cephalosporins without undesirable consequences, it is recommended to exercise caution when prescribing Ceftazidime-AKOS to this category of patients.
Cephalosporins may interfere with vitamin K synthesis by inhibiting intestinal flora, which can cause a decrease in the levels of vitamin K-dependent blood clotting factors, and in in rare cases lead to hypoprothrombinemia and bleeding. Administration of vitamin K eliminates hypoprothrombinemia. In severely ill, 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 caused by Clostridium difficile toxin during or after use of cephalosporins. In mild cases, discontinuation of the drug is sufficient; in more severe cases, it is recommended to restore the water-salt and protein balance; if necessary, metronidazole, bacitracin, and vancomycin should be prescribed orally.
Use in pediatrics
The drug should be prescribed with caution to newborns under 1 month of age.
Use for renal impairment
If renal function is impaired, dose adjustment is necessary.
After an initial loading dose of 1 g, adult patients with renal impairment (including patients undergoing dialysis) may require a dose reduction as follows:
These figures are indicative. In such patients, it is recommended to monitor serum drug levels, which should not exceed 40 mg/l.
Creatinine clearance
Dose
>50 ml/min (>0.83 ml/sec)
Usual Dose for Adults and Adolescents
35-50 ml/min (0.52–0.83 ml/sec)
1 g every 12 hours
16-30 ml/min (0.27–0.5 ml/sec)
1 g every 24 hours
6–15 ml/min (0.1–0.25 ml/sec)
500 mg every 24 hours
500 mg every 48 hours
Patients on hemodialysis
1 g after each hemodialysis session
Patients on peritoneal dialysis
500 mg every 24 hours
Use for liver dysfunction
The drug should be prescribed with caution in patients with impaired liver function.
Registration numbers
powder for preparation. d/i.m. injection solution. 2 g: fl. 1, 10 or 50 pcs. R No. 002274/02-2003 (2022-04-08 – 2022-04-13) powder for preparation. d/i.m. injection solution. 1 g: fl. 1, 10 or 50 pcs. R No. 002274/02-2003 (2022-04-08 – 2022-04-13) powder for preparation. d/i.m. injection solution. 500 mg: fl. 1, 10 or 50 pcs. R No. 002274/02-2003 (2022-04-08 – 2022-04-13)
Antibacterial agents
Code in 1C
Name
Powder for solution for injection 0.5 g, 1.0 g and 2.0 g
Residue storage unit
Pharmacotherapeutic group
Antibiotic, cephalosporin
Tradename
Ceftazidime-AKOS
International nonproprietary name
Ceftazidime
Dosage form
Powder for solution for injection
Compound
Each vial contains 0.5 g, 1.0 g and 2.0 g of ceftazidime sodium carbonate pentahydrate (in terms of ceftazidime).
ATX code
Pharmacological properties
The drug Ceftazidime is an antibacterial drug from the group of third-generation cephalosporins, has a broad spectrum and is bactericidal, disrupts the synthesis of the cell wall of microorganisms, and is resistant to the action of most beta-lactamases. The drug is active against gram-negative microorganisms: Haemophilus influenzae, Neisseria gonorrhoeae and other Neisseria spp. and most members of the family Enterobacteriaceae (Citrobacter spp., Enterobacter spp., Escherichia coli, Klebsiella pneumoniae and other Klebsiella spp., Morganella morganii and other Morganella spp., Proteus mirabilis (including indole-positive), Proteus vulgaris and other Proteus spp ., Providenсia rettgeri and other Providenсia spp. and Serratia spp.), Acinetobacter spp., Haemophilus parainfluenzae (including strains resistant to ampicillin), Pasteurella multocida. Salmonella spp., Shigella spp. and Yersinia enterocolitica. The drug Ceftazidime has the highest activity among third generation cephalosporins against Pseudomonas aeruginosa and nosocomial infections. The drug is active against gram-positive bacteria: Micrococcus spp., Streptococcus aureus, Streptococcus mitis, Streptococcus pneumoniae, Streptococcus pyogenes group A, Streptococcus viridans and other Streptococcus spp. (excluding Streptococcus faecalis); strains sensitive to methicillin: Staphylococcus aureus, Staphylococcus epidermidis. The drug Ceftazidime is active against anaerobic bacteria: Bacteroides spp. (most strains of Bacteroides fragilis are resistant), Clostridium perfringens, Peptococcus spp., Peplostreptococcus spp. and Propionobacterium spp. The drug is not active against methicillin-resistant strains of Campilobacter spp., Chlamydia spp., Clostridium difficile, Enterococcus spp., Listeria monocytogenes and other Lisleria spp., Staphylococcus aureus and Staphylococcus epidermidis; Streptococcus faecalis.
Pharmacokinetics
After administration, the drug is rapidly distributed in the human body and reaches therapeutic concentrations in most tissues and fluids, including synovial, pericardial and peritoneal fluid, as well as in bile, sputum and urine. Distribution also occurs in the bones, myocardium, gall bladder, skin and soft tissues in concentrations sufficient to treat infectious diseases, especially in inflammatory processes that enhance the diffusion of the drug. It penetrates poorly through the intact blood-brain barrier, but the therapeutic level achieved by the drug in the cerebrospinal fluid is sufficient for the treatment of meningitis. Reversibly binds to plasma proteins (less than 15%), and has a bactericidal effect only in its free form. The degree of protein binding does not depend on concentration. Maximum concentration at intramuscular injection 0.5 g or 1 g after an hour, respectively, is 17 mcg/ml and 39 mcg/ml, with intravenous administration, respectively, 42 mcg/ml and 69 mcg/ml. The time to reach maximum concentration with intramuscular administration is 1 hour, with intravenous administration - by the end of the infusion. The concentration of the drug, equal to 4 mcg/ml, is maintained for 6-8 hours. The therapeutic concentration in the blood plasma is maintained for 8-12 hours. The half-life with normal renal function is 1.8 hours; if impaired - 2.2 hours. The drug is not metabolized in the liver, impaired liver function does not affect the pharmacodynamics and pharmacokinetics of the drug. The dose in such patients remains normal. Up to 80-90% is excreted unchanged by the kidneys (70% of the administered dose is excreted in the first 4 hours) during the day by glomerular filtration and tubular secretion to an equal extent. If renal function is impaired, a dose reduction is recommended. The volume of distribution is 0.21-0.28 l/kg. The drug accumulates in soft tissues, kidneys, lungs, bones and joints, and serous cavities.
Indications for use
The drug Ceftazidime is prescribed to adults and children for the treatment of the following infectious diseases caused by microorganisms sensitive to the drug: severe infections: meningitis; sepsis (septicemia); severe purulent-septic conditions; infections of bones and joints: septic arthritis, osteomyelitis, bacterial bursitis; respiratory tract infections: acute and chronic bronchitis, infected bronchiectasis, pneumonia caused by gram-negative bacteria, lung abscess, pleural empyema; urinary tract infections: acute and chronic pyelonephritis, pyelitis, prostatitis, cystitis, urethritis (bacterial only), kidney abscess; infections of the skin and soft tissues: mastitis, wound infections, skin ulcers, cellulitis, erysipelas, infected burns; infections of the gastrointestinal tract, abdominal cavity and biliary tract: peritonitis, enterocolitis, retroperitoneal abscesses, diverticulitis, pelvic inflammation, cholecystitis, cholangitis, gallbladder empyema; infections of female genital organs; infections of the ear, nose and throat: otitis media, sinusitis, mastoiditis, etc.; gonorrhea (especially with hypersensitivity to antibacterial drugs from the penicillin group);
Contraindications
Hypersensitivity to cephalosporins and penicillins. Pregnancy and lactation.
Use during pregnancy
Contraindicated.
Directions for use and doses
The drug Ceftazidime is used only parenterally. 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 kidney function. Usual dose for adults and adolescents: for complicated urinary tract infections, intramuscularly or intravenously, 500 mg - 1 g every 8-12 hours; for uncomplicated pneumonia and skin infections, intramuscular or intravenous, 500 mg - 1 g every 8 hours; for cystic fibrosis, infections lungs caused by Pseudomonas spp., from 100 to 150 mg/kg/day, frequency of administration - 3 times a day (use of a dose of up to 9 g/day in such patients did not cause complications); for infections of bones and joints, intravenously 2 g every 12 hours; for very severe or life-threatening infections, 2 g IV every 8 hours. After an initial loading dose of 1 g, adults with renal impairment (including patients undergoing dialysis) may require a dose reduction as follows:
| CREATININE CLEARANCE | DOSE |
|---|---|
| > 50 ml/min (0.83 ml/sec) | See Usual Dose for Adults and Adolescents. |
| 35 - 50 ml/min (0.52 - 0.83 ml/sec) | 1 g every 12 hours |
| 16 - 30 ml/min (0.27 - 0.50 ml/sec) | 1 g every 24 hours |
| 6 - 15 ml/min (0.10 - 0.25 ml/sec) | 500 mg every 24 hours |
| 500 mg every 48 hours | |
| Patients undergoing hemodialysis | 1 g after each session hemodialysis |
| Patients undergoing peritoneal dialysis | 500 mg every 24 hours |
These figures are indicative. In such patients, it is recommended to monitor serum drug levels, which should not exceed 40 mg/l. The half-life of the drug during hemodialysis is 3-5 hours. The appropriate dose of the drug should be repeated after each dialysis period. For peritoneal dialysis, the drug Ceftazidime can be included in the dialysis fluid at a dose of 125 mg to 250 mg per 2 liters of dialysis fluid. Usual dose for children: Children under 1 month of age - intravenous infusion 30 mg/kg per day (a frequency of 2 administrations). Children from 2 months to 12 years - intravenous infusion of 30-50 mg/kg per day (a frequency of 3 administrations). A dose of up to 150 mg/kg/day every 12 hours is prescribed to children with reduced immunity, cystic fibrosis, meningitis. The maximum daily dose for children should not exceed 6 g. PREPARATION OF SOLUTIONS When the powder is dissolved, carbon dioxide is released. After introducing the solvent, the bottle must be shaken to obtain a clear solution. The resulting finished solution of the drug may contain small bubbles of carbon dioxide. The resulting solution can range in color from light yellow to dark yellow. If all recommended rules for diluting the drug are followed, then its effectiveness does not depend on the shade.
1. "PRIMARY BREEDING".
|
250 mg | 1 ml of water for injection for intramuscular administration. |
2.5 ml of water for injection for intravenous administration. |
|---|---|---|
|
500 mg |
1.5 ml of water for injection for intramuscular administration. |
5 ml of water for injection for intravenous administration. |
|
1.0 g; 2.0 g |
3 ml of water for injection for intramuscular administration. |
10 ml of water for injection for intravenous administration. |
2. "SECONDARY BREEDING" For intravenous Drip administration The solution of the drug Ceftazidime obtained as described above is additionally diluted in 50-100 ml of one of the following solvents intended for intravenous administration:- 0.9% sodium solution chloride, - solution Ringer's, - 5%, 10% glucose (dextrose) solution, - 5% glucose (dextrose) solution with 0.9% sodium chloride solution, - 5% sodium bicarbonate solution. Use only freshly prepared solution!
Side effect
Allergic reactions: urticaria, 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 (increased activity<печеночных>transaminases, alkaline phosphatase, hypercreatininemia), rarely - stomatitis, glossitis, pseudomembranous enterocolitis. From the hematopoietic organs: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, hypocoagulation. From the urinary system: impaired renal function (azotemia, increased urea content in the blood), oliguria, anuria. From the nervous system: headache, dizziness. Local reactions: phlebitis, pain along the vein, pain and infiltration at the site of intramuscular injection. Other: nosebleeds, candidiasis, superinfection.
Overdose
Symptoms of overdose: Administration of inappropriately high doses of the drug Ceftazidime can cause dizziness, paresthesia, headache, seizures, and abnormal laboratory test results. Treatment of overdose: Since there is no specific antidote, treatment of overdose of cephalosporin antibiotics is symptomatic and supportive. In case of severe overdose, when conservative therapy is unsuccessful, the concentration of the drug in the blood can be reduced using hemodialysis.
Use with other drugs
Pharmaceutically incompatible with aminoglycosides, heparin, vancomycin. Do not use sodium bicarbonate solution as a solvent. Loop diuretics, aminoglycosides, vancomycin, clindamycin reduce the clearance of ceftazidime, resulting in an increased risk of nephrotoxicity. Pharmaceutically compatible with the following solutions: at concentrations from 1 to 40 mg/ml - sodium chloride 0.9%, sodium lactate, Hartmann's solution, dextrose 5%, sodium chloride 0.225% and dextrose 5%, sodium chloride 0.45% and dextrose 5%, sodium chloride 0.9% and dextrose 5%, sodium chloride 0.18% and dextrose 4%, dextrose 10%, dextran 40:10% in sodium chloride solution 0.9%, dextran 40:10% in solution dextrose 5%, dextran 70:6% in a solution of sodium chloride 0.9%, dextran 70:6% in a solution of dextrose 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 lidocaine hydrochloride 0.5% or 1%. Both components remain active when ceftazidime is added to the following solutions (ceftazidime concentration 4 mg/ml): hydrocortisone (hydrocortisone sodium phosphate) 1 mg/ml in sodium chloride 0.9% solution or dextrose solution 5%, 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%, potassium chloride 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.
special instructions
In the presence of the following diseases or conditions, it is necessary to carefully weigh the balance of benefit and risk for the patient: - pregnancy and breastfeeding; - newborns and children up to 1 month; - history of bleeding; - history of gastrointestinal diseases, especially ulcerative colitis. In patients with a history of penicillin allergy, cross-hypersensitivity to cephalosporins was observed in 3-7% of patients. Although cephalosporins have been used without adverse effects in many patients with penicillin allergy manifesting as rash, caution is advised when prescribing ceftazidime. All cephalosporins may interfere with vitamin K synthesis by suppressing intestinal flora, which may cause decreased levels of vitamin K-dependent clotting factors and, in rare cases, lead to hypothrombinemia and bleeding. Administration of vitamin K quickly eliminates hypothrombinemia. In severely ill, 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 caused by Clostridium difficile toxin during or after use of cephalosporins. In mild cases, discontinuation of the drug is sufficient; in more severe cases, it is recommended to restore the water-salt and protein balance; if the above measures do not help, metronidazole, bacitracin, and vancomycin are prescribed.
Release form
Release form
Powder for the preparation of a solution for intravenous and intramuscular administration 0.5 g, 1 g, 2 g.
0.5 g, 1 g each active substance in bottles with a capacity of 10 ml or 20 ml, 2 g of active substance in bottles with a capacity of 20 ml, hermetically sealed with rubber stoppers, crimped aluminum caps or combined aluminum caps with plastic caps.
1, 5 or 10 bottles with instructions for use are placed in a cardboard pack.
50 bottles with an equal number of instructions for use are placed in a cardboard box for delivery to hospitals.
1 bottle with the drug, 1 or 2 ampoules with solvent (5 ml of water for injection) are placed in a blister pack made of polyvinyl chloride film. 1 blister pack with instructions for use and an ampoule scarifier is placed in a cardboard pack.
1 bottle with the drug, 1 or 2 ampoules with solvent, instructions for use and an ampoule scarifier are placed in a pack or cardboard box.
5 bottles with the drug are placed in a blister pack made of polyvinyl chloride film.
1 blister pack with the drug, 1 or 2 blister packs (5 ampoules of solvent each), instructions for use, an ampoule scarifier are placed in a cardboard pack.
When using ampoules with a crowbar ring or with a cut and a point, do not insert an ampoule scarifier.
Storage conditions
List B. In a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children.
Best before date
2 years. Do not use the drug after the expiration date indicated on the package!
Dosage form: Powder for preparing a solution for intravenous and intramuscular administration. Compound:Active substance:
Ceftazidime pentahydrate 0.5 g 1 g 2 g
(in terms of ceftazidime)
Excipients:
Sodium carbonate 0.05 g 0.1 g 0.2 g
Description: White or white with a yellowish or yellowish-brown tint powder. Pharmacotherapeutic group:Antibiotic cephalosporin. ATX:J.01.D.D.02 Ceftazidime
Pharmacodynamics:III generation cephalosporin antibiotic for parenteral use. Acts bactericidal (disturbs the synthesis of the cell wall of microorganisms). Has a wide spectrum of action. Resistant to most beta-lactamases. Effective on many strains resistant to ampicillin and other cephalosporins. Active against gram-negative microorganisms: Pseudomonas spp., incl. 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, meningitidis, Haemophilus influenzae (including strains resistant to ampicillin);gram-positive microorganisms: Staphylococcus aureus (penicillinase-producing and non-penicillinase-producing strains sensitive to methicillin), Streptococcus pyogenes (group A beta-hemolytic streptococcus), Streptococcus agalactiae (group B), Streptococcus pneumoniae; anaerobic microorganisms: Bacteroides spp. (many strains of Bacteroides fragilis are resistant).
Inactive against methicillin-resistant Staphylococcus spp., Streptococcus faecalis, Enterococcus spp., Listeria monocytogenes, Campylobacter spp. and Clostridium difficile. Active in vitro against most strains the following organisms (clinical significance this activity is unknown): Clostridium perfringens excluding Clostridium difficile, Acinetobacter spp., Haemophilus parainfluenzae, Morganella morganii, Neisseria gonorrhoeae, Peptococcus spp., Peptostreptococcus spp., Providencia spp., Providencia rettgeri, Salmonella spp.; Shigella spp., Staphylococcus epidermidis, Yersinia enterocolitica.
Pharmacokinetics:The maximum concentration (Cmax) after intramuscular administration in doses of 0.5 and 1 g is 17 and 39 mg/l, respectively, the time required to achieve the maximum concentration (TCmax) is 1 hour. Cmax after intravenous bolus administration in doses of 0.5, 1 and 2 g - 42, 69 and 170 mg/l, respectively. Therapeutically effective serum concentrations persist 8-12 hours after intravenous and intramuscular administration. Communication with plasma proteins is less than 10%. Concentrations of ceftazidime exceeding the minimum inhibitory concentrations for most common pathogenic microorganisms, can be achieved in bone tissue, heart tissue, bile, sputum, synovial fluid, intraocular, pleural and peritoneal fluids. Easily penetrates the placental barrier and is excreted breast milk. With absence inflammatory process V meningeal membranes poorly penetrates the blood-brain barrier, the concentration of the drug in the cerebrospinal fluid (CSF) is low. With meningitis, therapeutic concentrations of ceftazidime in the cerebrospinal fluid are 4 - 20 mg/l and higher. not metabolized in the body. The half-life is about 2 hours, in newborns it is 3-4 times longer than in adults. excreted unchanged by the kidneys by glomerular filtration. Approximately 80-90% of the dose is excreted by the kidneys within 24 hours. Less than 1% of the drug is excreted in the bile. If renal function is impaired, the rate of elimination of ceftazidime is reduced. With hemodialysis, the half-life is 3-5 hours. Indications:The drug is prescribed to adults and children for the treatment of the following infectious diseases caused by microorganisms sensitive to the drug:
severe infections including nosocomial (septicemia, bacteremia, peritonitis, meningitis, infections in patients with reduced immunity, infected burns); bone and joint infections: septic arthritis, osteomyelitis, bacterial bursitis;
respiratory tract infections: acute and chronic bronchitis, infected bronchiectasis, pneumonia caused by gram-negative bacteria, lung abscess, pleural empyema, lung infections in patients with cystic fibrosis;
urinary tract infections : acute and chronic pyelonephritis, pyelitis, prostatitis, cystitis, urethritis (bacterial only), kidney abscess;
skin and soft tissue infections: mastitis, wound infections, skin ulcers, cellulitis, erysipelas; infections gastrointestinal tract, abdominal cavity and biliary tract: enterocolitis, retroperitoneal abscesses, diverticulitis, pelvic inflammation, cholecystitis, cholangitis, gallbladder empyema;
infections of female genital organs;
ear, nose and throat infections: otitis media, sinusitis, mastoiditis, etc.;
gonorrhea (especially with hypersensitivity to antibacterial drugs from the penicillin group).
Contraindications:Hypersensitivity to ceftazidime and other components of the drug; hypersensitivity to other cephalosporin antibiotics and penicillins. Carefully:Renal failure, neonatal period, history of colitis, malabsorption syndrome (increased risk of decreased prothrombin activity, especially in persons with severe renal and/or liver failure), simultaneous administration with loop diuretics and aminoglycosides. Pregnancy and lactation:During pregnancy, it is used only if the expected benefit to the mother outweighs the potential risk to the fetus. When using the drug during lactation, breastfeeding should be discontinued. Directions for use and dosage:Ceftazidime is used parenterally only. The dose of the drug is set individually, taking into account the severity of the disease, location, type of pathogen and its sensitivity to the drug, the patient’s age and kidney function. The drug is administered intravenously or deeply intramuscularly into the area of the upper outer quadrant of the gluteus maximus muscle or into the area of the lateral thigh. Ceftazidime solution can be injected directly into a vein or into an infusion line.
Usual dose for adults and children over 12 years of age is 1 g intramuscularly or intravenously every 8-12 hours.
For uncomplicated urinary tract infections, 250 mg intramuscularly or intravenously every 12 hours;
For complicated urinary tract infections, 500 mg-1 g intramuscularly or intravenously every 8-12 hours;
For uncomplicated pneumonia, infections of the skin and soft tissues, intramuscularly or intravenously, 500 mg - 1 g every 8 hours;
For cystic fibrosis, respiratory tract infections caused by
Pseudomonas spp. from 100 to 150 mg/kg/day, frequency of administration - 3 times a day (use of a dose of up to 9 g/day in such patients did not cause complications);For infections of bones and joints, 2 g intravenously every 12 hours;
- for severe infections, including nosocomial infections, 2 g intravenously every 8 hours;
- for extremely severe or life-threatening infections, 2 g intravenously every 8 hours. For elderly patients, the maximum daily dose should not exceed 3 g.
Patients with renal failure require a dose reduction, since it is excreted unchanged by the kidneys.
The initial dose is 1 g. The maintenance dose is selected depending on the rate of glomerular filtration.
Maintenance doses of ceftazidime for renal failure are presented in the table.
| CREATININE CLEARANCE | DOSE |
| > 50 ml/min (0.83 ml/sec) | See Usual Dose for Adults and Children over 12 Years of Age. |
| 35-50 ml/min (0.52 - 0.83 ml/sec) | 1 g every 12 hours |
| 16-30 ml/min (0.27 - 0.50 ml/sec) | 1 g every 24 hours |
| 6-15 ml/min (0.10 - 0.25 ml/sec) | 500 mg every 24 hours |
| < 5 мл/мин (0,08 мл/сек) | 500 mg every 48 hours |
| Patients undergoing hemodialysis | 1 g after each hemodialysis session |
| Patients undergoing peritoneal dialysis | 500 mg every 24 hours |
Patients with severe infections you can increase the maintenance dose by 50% or increase the frequency of drug administration. In this case, the level of ceftazidime in the blood serum should be monitored; the serum concentration of ceftazidime should not exceed 40 mg/l.
For children Creatinine clearance is calculated according to ideal body weight or body surface area.
The half-life 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 the drug can be included in the dialysis solution at a dose of 125 mg to 250 mg per 2 liters of dialysis solution. In patients with renal failure undergoing continuous hemodialysis using an arteriovenous shunt and in patients undergoing hemofiltration high speed in the department intensive care, recommended doses are 1 g per day daily (for one or more administrations).
In patients undergoing low-rate hemofiltration, doses recommended for renal impairment are prescribed.
Usual dose for children:
Children under 2 months of age Prescribe 25 - 60 mg/kg per day (in 2 administrations).
Children from 2 months to 12 years Prescribe 30 - 100 mg/kg per day (in 2 - 3 administrations), for children with reduced immunity, cystic fibrosis and meningitis - 150 mg/kg per day (in 3 administrations).
The maximum daily dose for children is 6 g.
Duration of treatment
The duration of treatment with ceftazidime is 7-14 days. For infections caused
Pseudomonas aeruginosa (pneumonia, cystic fibrosis, meningitis) the course of treatment can be extended to 21 days.Preparation of solutions
1. "PRIMARY "BREEDING
| DOSAGE | VOLUME OF SOLVENT FOR INTRAMUSCULAR ADMINISTRATION | VOLUME OF SOLVENT FOR INTRAVENOUS ADMINISTRATION |
| 500 mg | 1.5 ml water for injection or 0.5% or 1% lidocaine hydrochloride solution | 5 ml water for injection |
| 1.0 g; 2.0 g | 3 ml water for injection or 0.5% or 1% lidocaine hydrochloride solution | 10 ml water for injection |
2. "SECONDARY "BREEDING
For intravenous DROP administration obtained as described above
the drug solution is additionally diluted in 50 - 100 ml of one of the following solvents intended for intravenous administration:- 0.9% sodium chloride solution,
- Ringer's solution,
- 5%, 10% glucose solution (dextrose),
- 5% glucose (dextrose) solution with 0.9% sodium chloride solution.
When the powder dissolves, carbon dioxide is released. After introducing the solvent, the bottle must be shaken to obtain a clear solution. The resulting finished solution of the drug may contain small bubbles of carbon dioxide.
The resulting solution can range in color from light yellow to dark yellow. If all recommended rules for diluting the drug are followed, then its effectiveness does not depend on the shade.
Use only freshly prepared solution!
Side effects:Allergic reactions: urticaria, chills or fever, rash, itching, bronchospasm, multiforme exudative erythema(including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), angioedema, anaphylactic shock.
From the nervous system: headache, dizziness, paresthesia, seizures, encephalopathy, fluttering tremor.
From the outside genitourinary system: candidal vaginitis.
From the urinary system: renal dysfunction, toxic nephropathy.
From the digestive system: nausea, vomiting, diarrhea, abdominal pain, colitis, cholestasis, oropharyngeal candidiasis, flatulence, dysbacteriosis, stomatitis, glossitis, pseudomembranous colitis.
From the hematopoietic organs: eosinophilia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, lymphocytosis, granulocytopenia, hemolytic anemia, hemorrhages.
Laboratory indicators: hypercreatininemia, increased urea concentration, false-positive urine reaction to glucose, increased activity of “liver” transaminases and alkaline phosphatase, hyperbilirubinemia, false-positive directCoombs reaction, increase in prothrombin time.
Local reactions: with intravenous administration phlebitis; with intramuscular injection - pain, burning, compaction at the injection site.
Others:nosebleeds, superinfection.
Overdose:Symptoms: pain, inflammation, phlebitis at the injection site, dizziness, paresthesia, headache, convulsions in patients with renal failure, hypercreatininemia, hyperbilirubinemia, thrombocytosis, thrombocytopenia, eosinophilia, leukopenia, prolongation of prothrombin time.
Treatment: symptomatic, in case of renal failure - peritoneal dialysis or hemodialysis.
Interaction:Pharmaceutically incompatible with heparin.
Pharmaceutically incompatible with aminoglycosides (significant mutual inactivation: when used simultaneously, these drugs should be administered intravenously different areas body) and vancomycin (forms a precipitate depending on the concentration; if necessary, administer two drugs through the same tube, and flush the IV system between uses). Do not use sodium bicarbonate solution as a solvent (carbon dioxide is formed, this may require venting the gas to the outside).
Loop diuretics, aminoglycosides, reduce the clearance of ceftazidime, resulting in an increased risk of nephrotoxicity. Bacteriostatic antibiotics (including) reduce the effect of the drug. Pharmaceutically compatible with the following solutions: at concentrations from up to 40 mg/ml - 0.9%, sodium lactate, Hartmann's solution, 5%, 0.225% and
Broad-spectrum cephalosporin antibiotic of the third generation.Drug: CEFTAZIDIM-AKOS
Active substance: ceftazidime
ATX code: J01DD02
KFG: III generation cephalosporin
Reg. number: P No. 002274/01-2003
Registration date: 04/22/08
Owner reg. cred.: SYNTHEZ JSC (Russia)
DOSAGE FORM, COMPOSITION AND PACKAGING
Excipients: sodium carbonate.
Bottles with a volume of 10 ml (1) - cardboard packs.
Powder for solution for injection white or white with a yellowish or yellowish-beige tint.
Excipients: sodium carbonate.
Bottles with a volume of 20 ml (1) - cardboard packs.
DESCRIPTION OF THE ACTIVE SUBSTANCE.
The scientific information provided is general and cannot be used to make a decision about the possibility of using a particular drug.
PHARMACHOLOGIC EFFECT
Broad-spectrum cephalosporin antibiotic of the third generation. Renders bactericidal effect due to inhibition of bacterial cell wall synthesis. Ceftazidime acetylates membrane-bound transpeptidases, thereby disrupting the cross-linking of peptidoglycans necessary for cell wall strength and rigidity.
Active against aerobic, anaerobic, gram-positive and gram-negative bacteria, incl. Pseudomonas aeruginosa. Ceftazidime is active against strains of pathogens resistant to ampicillin, methicillin, aminoglycosides and many cephalosporins.
Resistant to the action of?-lactamase.
PHARMACOKINETICS
Plasma protein binding is 10-17%. Distributed in tissues and body fluids. Therapeutic concentrations are achieved in the cerebrospinal fluid. Penetrates the placental barrier and is excreted in breast milk. It is excreted in small quantities into bile. The main part (80-90%) is excreted unchanged in the urine.
INDICATIONS
Infectious and inflammatory diseases severe course caused by microorganisms sensitive to ceftazidime, incl. peritonitis, sepsis; cholangitis, empyema of the gallbladder; pelvic organ infections; pneumonia, lung abscess, pleural empyema; pyelonephritis, kidney abscess; infections of bones, joints, skin and soft tissues, infected wounds and burns. Infectious processes caused by hemodialysis and peritoneal dialysis. Severe infectious and inflammatory diseases in patients with reduced immunity.
DOSING REGIME
They are set individually depending on the location and severity of the infection and the sensitivity of the pathogen. Enter intramuscularly or intravenously. Adults - 0.5-2 g every 8 or 12 hours. Children aged 1 month-12 years - 30-50 mg/kg/day, frequency of administration 2-3 times/day; at the age of up to 1 month - 30 mg/kg/day with an interval of 12 hours.
In patients with impaired renal function, the dosage regimen is adjusted taking into account the CC values.
Maximum daily doses: for adults and children - 6 years.
SIDE EFFECT
From the digestive system: nausea, vomiting, diarrhea, transient increase in the activity of liver transaminases, cholestatic jaundice, hepatitis, pseudomembranous colitis.
Allergic reactions: skin rash, itching, eosinophilia; rarely - Quincke's edema.
From the hematopoietic system: at long-term use V high doses Picture changes are possible peripheral blood(leukopenia, neutropenia, thrombocytopenia, hemolytic anemia).
From the blood coagulation system: hypoprothrombinemia.
From the urinary system: interstitial nephritis.
Effects due to chemotherapeutic action: candidiasis.
Local reactions: phlebitis (with intravenous administration), pain at the injection site (with intramuscular administration).
CONTRAINDICATIONS
Hypersensitivity to ceftazidime and other cephalosporins.
PREGNANCY AND LACTATION
Adequate and strictly controlled studies of the safety of ceftazidime during pregnancy have not been conducted.
The use of ceftazidime during pregnancy and lactation is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
Ceftazidime is excreted into breast milk in low concentrations.
IN experimental studies No teratogenic or embryotoxic effects of ceftazidime were detected in animals.
SPECIAL INSTRUCTIONS
Use with caution in patients with severe renal impairment, as well as in newborns.
In patients with hypersensitivity To penicillins, allergic reactions to cephalosporin antibiotics are possible.
During the period of use of ceftazidime, a positive direct Coombs test and a false positive urine test for glucose are possible.
Use with caution simultaneously with loop diuretics and aminoglycosides.
Ceftazidime should not be mixed in the same syringe with aminoglycosides.
DRUG INTERACTIONS
When used simultaneously with drugs that may have a nephrotoxic effect (including aminoglycoside antibiotics), the nephrotoxic effect may be enhanced; with furosemide - the risk of developing nephrotoxicity increases.
In vitro, chloramphenicol acts as an antagonist to ceftazidime and other cephalosporins. Clinical relevance this phenomenon has not been established, but in the case simultaneous use ceftazidime and chloramphenicol should take into account possible antagonistic effects.
