Ceftazidime
Ceftazidime: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Ceftazidime
ATX code: J01DD02
Active ingredient: ceftazidime (ceftazidime)
Producer: JSC "Krasfarma" (Russia), MJ Biopharm Pvt. Ltd. (India), Shijiazhuang Pharmaceutical Group Ouyi (China)
Description and photo updated: 2018-26-11
Prices in pharmacies: from 64 rubles.
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Ceftazidime is a cephalosporin antibiotic with a broad spectrum of action.
Release form and composition
- powder for the preparation of a solution for intravenous (i / v) and intramuscular (i / m) administration: crystalline, yellowish or almost white (0.5 g, 1 g or 2 g each in a bottle, in a cardboard box 1 bottle; for hospitals - in a cardboard box 10 or 50 bottles of 0.5 g, or 10, 25 or 50 bottles of 1 g);
- powder for preparation of a solution for intravenous administration: from white to white with a yellow tinge [2 g in a glass bottle of 10 or 20 ml, in a cardboard box 1 bottle; 10 bottles in a cardboard box, for hospitals - 1–50 bottles; in a blister strip packaging 1 bottle of the drug and 1 ampoule of solvent (water for injection) 10 ml each or 2 ampoules of solvent 5 ml each, or 5 vials of the drug and 5 ampoules of solvent 10 ml each or 10 ampoules of solvent 5 ml each, in a cardboard box 1 contour cell packaging];
- powder for preparation of injection solution: crystalline, from white to cream color (0.25 g, 0.5 g, 1 g or 2 g in a glass bottle, in a cardboard box 1 bottle).
The composition of the powder, enclosed in 1 bottle:
- active substance: ceftazidime (in the form of pentahydrate) - 0.25 g, 0.5 g, 1 g or 2 g;
- additional component: sodium carbonate.
Pharmacological properties
Pharmacodynamics
Ceftazidime is a representative of the third generation cephalosporin group; antibacterial agent with a wide range of effects. Shows a bactericidal effect, inhibiting the synthesis of the cell wall of microorganisms, is resistant to most beta-lactamases.
Ceftazidime demonstrates activity against the following microorganisms:
- gram-negative: Klebsiella spp. (including Klebsiella pneumoniae), Pseudomonas aeruginosa, Pseudomonas spp. (including Pseudomonas pseudomallei), Proteus vulgaris, Proteus mirabilis, Proteus rettgeri, Escherichia coli, Morganella morganii, Enterobacter spp., Providencia spp., Salmonella spp., Citrobacter spp., Shigella spp., Serratia spp. enterocolitica, Acinetobacter spp., Neisseria meningitidis, Pasteurella multocida, Neisseria gonorrhoeae, Haemophilus parainfluenzae and Haemophilus influenzae (including ampicillin-resistant strains); among the cephalosporins of the third generation, ceftazidime is characterized by the highest activity in relation to nosocomial infection and Pseudomonas aeruginosa;
- gram-positive: Streptococcus pyogenes (β-hemolytic streptococcus group A), Staphylococcus aureus (strains susceptible to methicillin), Micrococcus spp., Staphylococcus epidermidis (strains susceptible to methicillin), Streptococcus pneumococcus, B Streptococcus spp. … (excluding Streptococcus faecalis), Streptococcus mitis;
- anaerobic bacteria: Peptostreptococcus spp., Clostridium perfringens, Peptococcus spp., Propionibacterium spp., Fusobacterium spp., Bacteroides spp. (the vast majority of Bacteroides fragilis strains are resistant).
Ceftazidime is inactive against the following microorganisms: Chlamydia spp., Clostridium difficile, Campylobacter spp., Listeria monocytogenes, Streptococcus faecalis and many other Enterococci, methicillin-resistant Staphylococcus epidermidis and Staphyus strains.
Pharmacokinetics
After intramuscular injections in doses of 0.5 and 1 g, the maximum concentration (Cmax) of ceftazidime in plasma is recorded after 1 hour and is 17 and 39 mg / l, respectively, with intravenous bolus administration of ceftazidime at a dose of 0.5; 1 and 2 g C max is noted 5 minutes after injection and is 46, 87 and 170 mg / l, respectively. Therapeutic effective plasma concentrations of the drug are maintained for 8-12 hours after intramuscular and intravenous administration.
The active substance of the drug binds to plasma proteins by 10-15%. Only the free fraction of ceftazidime has a bactericidal effect. Plasma concentration of ceftazidime does not determine the degree of protein binding.
After intravenous administration of the agent, it is rapidly distributed in most tissues and body fluids. In therapeutic concentrations, the drug is detected in pleural, peritoneal, pericardial, synovial and intraocular fluids, as well as in sputum, bile and urine. Ceftazidime concentrations in excess of the minimum inhibitory concentration (MIC) for most drug-sensitive pathogens can be found in the myocardium, bone tissue, bones, gallbladder, and soft tissues. The active substance easily crosses the placenta and is excreted in breast milk. In the absence of inflammation in the meningeal membranes, the antibiotic poorly penetrates the blood-brain barrier. Against the background of meningitis, the concentration of the substance in the cerebrospinal fluid reaches a therapeutic level of 4–20 mg / l or more.
Ceftazidime is not biotransformed in the liver. With normal renal function, the half-life (T ½) of the drug reaches approximately 2 hours, with functional impairment of the kidneys - 2.2 hours. The kidneys are excreted unchanged through glomerular filtration and tubular secretion up to 80–90% of the administered dose within 24 hours (70% - in the first 4 hours). Up to 1% of the substance is excreted with bile. In newborns, T ½ ceftazidime exceeds that in adults by 3-4 times.
Indications for use
According to the instructions, Ceftazidime is recommended for use in adults and children for the treatment of the following infectious and inflammatory lesions excited by microorganisms sensitive to it:
- purulent-septic conditions in severe form;
- sepsis (septicemia);
- meningitis;
- bronchitis in acute and chronic forms, pneumonia, excited by gram-negative bacteria, infected bronchiectasis, pleural empyema, lung abscess, lung infections in patients with cystic fibrosis;
- sinusitis, otitis media, mastoiditis;
- osteomyelitis, arthritis, bursitis;
- bacterial urethritis, acute and chronic pyelonephritis, cystitis, pyelitis, prostatitis, kidney abscess;
- enterocolitis, peritonitis, retroperitoneal abscesses, cholecystitis, diverticulitis, cholangitis, empyema of the gallbladder;
- wound infections, mastitis, trophic ulcers, erysipelas, phlegmon, infected burns;
- infectious diseases of the female genital organs (endometritis);
- inflammation of the pelvic organs;
- gonorrhea (especially with increased sensitivity to antibiotics of the penicillin group);
- infections caused by dialysis.
Also, Ceftazidime is used to prevent complications caused by operations on the prostate gland (transurethral resection).
Contraindications
Ceftazidime is contraindicated in the presence of hypersensitivity to any of its constituents, as well as to other antibiotics from the group of penicillins and cephalosporins.
The antibacterial agent should be used with caution in the following diseases / conditions:
- neonatal period;
- a history of bleeding;
- severe renal dysfunction;
- diseases of the gastrointestinal tract (including data in the anamnesis, ulcerative colitis);
- malabsorption syndrome (due to the increased risk of decreased prothrombin activity, especially in the presence of severe renal and / or liver failure);
- combination with aminoglycosides and loop diuretics.
Instructions for the use of Ceftazidime: method and dosage
Ceftazidime is for parenteral use only. The solution prepared from the drug is injected intravenously (jet / drip) or intramuscularly (into large muscles) at a dose of 0.5–2 g every 8–12 hours. The dose of the drug is prescribed individually, taking into account the sensitivity of the pathogen, localization and severity course of infection, kidney function, body weight and age of the patient. For most infectious diseases, a dose of 1 g every 8 hours or 2 g every 12 hours is most effective.
Recommended dosage regimen of Ceftazidime for adults and adolescents over 12 years old:
- skin infections, uncomplicated pneumonia: 0.5–1 g IM or IV every 8 hours;
- complicated infections of the urinary tract: 0.5–1 g IM or IV every 8/12 hours;
- joint and bone infections: 2 g IV every 12 hours;
- lung infections caused by Pseudomonas spp., cystic fibrosis: 0.1–0.15 g / kg per day, divided into 3 injections (using a dose of up to 9 g in patients of this group did not lead to the development of complications);
- neutropenia and severe disease (especially in immunocompromised patients): 2 g every 8 hours or 3 g every 12 hours;
- infections of an extremely severe or life-threatening nature: 2 g IV every 8 hours;
- surgery on the prostate gland: 1 g IV during induction of anesthesia, the second dose is used after removal of the catheter.
Children under the age of 2 months are prescribed intravenous infusion in a daily dose of 0.03 g / kg, divided into 2 injections, for children from 2 months to 12 years old - in a daily dose of 0.03-0.05 g / kg, divided for 3 introductions. If children have cystic fibrosis, meningitis or reduced immunity, ceftazidime is administered in a dose of up to 0.15 g / kg per day every 12 hours, the maximum permissible daily dose is 6 g.
After the introduction of an initial dose of 1 g, adult patients with functional impairment of the kidneys (including patients undergoing dialysis) may need the following dose reduction of ceftazidime, taking into account creatinine clearance (CC):
- CC <5 ml / min (0.08 ml / sec) - every 48 hours, 0.5 g;
- CC 6-15 ml / min (0.1-0.25 ml / sec) - every 24 hours, 0.5 g;
- CC 16-30 ml / min (0.27-0.5 ml / sec) - every 24 hours, 1 g;
- CC 31-50 ml / min (0.52-0.83 ml / sec) - every 12 hours, 1 g;
- CC> 50 ml / min (0.83 ml / sec) are the usual recommended doses for adults and adolescents after 12 years.
Patients who are shown to carry out hemodialysis, after each session, are recommended to inject the drug in a dose of 1 g. When carrying out peritoneal dialysis, appoint 0.5 g every 24 hours. These figures are approximate. In patients of this risk group, the concentration of the agent in the serum should be monitored, avoiding values above 40 mg / l. During a hemodialysis session, T ½ of ceftazidime is 3-5 hours. The appropriate dose should be repeated after each dialysis period.
When performing peritoneal dialysis, the antibacterial agent can be included in the dialysis fluid: per 2 liters of dialysis fluid - 0.125-0.25 g of ceftazidime. In elderly patients, the maximum daily dose is 3 g. Patients with renal insufficiency who are prescribed continuous hemodialysis using an arteriovenous shunt or high-speed hemofiltration in the intensive care unit, the drug is recommended to be administered daily at 1 g per day. If a patient is indicated for hemofiltration at a low rate, Ceftazidime is used in the same doses as for impaired renal function.
The duration of ceftazidime therapy is on average 7-14 days. In the treatment of meningitis, pneumonia, infectious complications against the background of cystic fibrosis, the course can reach 21 days.
To prepare an i / m or i / v solution, the drug contained in the vial is diluted in the following volumes of solvent (primary dilution):
- dose 0.25 g: for i / m administration - 1% lidocaine hydrochloride solution (without epinephrine), water for injection (d / i) 1.5 ml; for intravenous administration - water d / and 5 ml;
- dose 0.5 g: for intramuscular injection - water d / and 1.5 ml; for intravenous administration - water d / and 5 ml;
- dose of 1 g or 2 g: for i / m administration - water d / and 3 ml; for intravenous administration - water d / and 10 ml.
To carry out intravenous drip infusion, the ceftazidime solution prepared by the above method must be further diluted in one of the following solvents for intravenous administration, taken in a volume of 50-100 ml: Ringer's solution, glucose (dextrose) solution 5% or 10%, sodium chloride solution 0.9%, glucose (dextrose) solution 5% with sodium chloride solution 0.9%, lactated Ringer's solution, sodium bicarbonate solution 5%.
When diluting, the vial with the drug must be shaken vigorously until its contents are completely dissolved. Only a freshly prepared solution must be introduced!
Before starting the injection, you need to make sure that there is no sediment or foreign particles in the resulting solution. The color of the latter depends on its volume and solvent and can be from pale yellow to amber. In the prepared solution, the presence of small bubbles of carbon dioxide is allowed (does not affect the efficiency).
Side effects
- hematopoietic organs: neutropenia, leukopenia, thrombocytopenia, hypocoagulation, hemolytic anemia, lymphocytosis, agranulocytosis, increased prothrombin time;
- nervous system: unpleasant taste in the mouth, dizziness, headache, paresthesia; mainly in patients with renal failure - myoclonus, tremor, seizures, encephalopathy, coma;
- genitourinary system: candidal vaginitis, increased blood urea, azotemia, hypercreatininemia, anuria, oliguria, toxic nephropathy, interstitial nephritis, acute renal failure;
- digestive system: vomiting, nausea, constipation / diarrhea, abdominal pain, flatulence, dysbiosis, liver dysfunction (hyperbilirubinemia, transient increase in the activity of hepatic transaminases and alkaline phosphatase); rarely - glossitis, stomatitis, cholestatic jaundice, oropharyngeal candidiasis, cholestasis, pseudomembranous colitis;
- local reactions: with intravenous administration - soreness along the vein, thrombophlebitis or phlebitis; with intramuscular injection - pain and infiltration at the injection site;
- allergic reactions: itching, rash, hives, fever / chills; rarely - eosinophilia, bronchospasm, decreased blood pressure, toxic epidermal necrolysis (Lyell's syndrome), angioedema, erythema multiforme (including Stevens-Johnson syndrome), anaphylactic shock;
- others: nosebleeds, superinfection.
Overdose
Symptoms of an overdose of Ceftazidime may include: dizziness, headache, paresthesia, abnormal laboratory test results (hyperbilirubinemia, hypercreatininemia, leukopenia, thrombocytosis, eosinophilia, thrombocytopenia, prolongation of prothrombin time), encephalopathy, seizures.
In this condition, symptomatic and supportive treatment is carried out, the specific antidote is unknown. In the case of unsuccessful conservative therapy in severe overdose, the level of the drug in the blood can be reduced during hemodialysis.
special instructions
In the presence of a history of allergic reactions to penicillins, cross-hypersensitivity to cephalosporins was observed.
Ceftazidime can block the synthesis of vitamin K as a result of suppression of the intestinal flora, which in turn can lead to a decrease in the concentration of blood clotting factors dependent on this vitamin, and in some cases, provoke the appearance of hypothrombinemia and bleeding. Taking vitamin K in an appropriate dose relieves hypothrombinemia. In persons with malnutrition, debilitated and elderly patients, and in patients with impaired liver function, the risk of bleeding is aggravated.
In some patients, during drug therapy or after its completion, the appearance of pseudomembranous colitis may be observed. With the development of this complication in mild cases, it is enough to stop using the drug, and in severe cases, it is required to restore the protein and water-salt balance, the appointment of metronidazole, vancomycin or bacitracin.
During the course, the use of ethanol is contraindicated due to the possible appearance of effects similar to the action of disulfiram (flushing of the face, vomiting, abdominal cramps, nausea, headache, tachycardia, decreased blood pressure, shortness of breath).
Ceftazidime at concentrations of 1-40 mg / ml is compatible with the following solutions: sodium lactate solution, sodium chloride solution 0.9%, Hartman's solution, dextrose solutions 5% and 10%, sodium chloride solution 0.225% and dextrose 5%, sodium chloride solution 0.9% or 0.45% and dextrose 5%, Dextran 40 10% or Dextran 70 6% solution in 0.9% sodium chloride solution or 5% dextrose solution, 0.18% sodium chloride solution and 4% dextrose, metronidazole solution 5 mg / ml.
At concentrations of 0.05–0.25 mg / ml, ceftazidime is compatible with a solution for intraperitoneal dialysis (lactate). For intramuscular injections, Ceftazidime can be diluted with a solution of lidocaine hydrochloride 0.5% or 1%.
If ceftazidime at a concentration of 4 mg / ml is added to the following solutions, activity will be observed in both components: cefuroxime sodium 3 mg / ml in a solution of sodium chloride 0.9%, hydrocortisone sodium phosphate 1 mg / ml in a solution of sodium chloride 0.9% or dextrose 5%, cloxacillin sodium 4 mg / ml in sodium chloride 0.9%, potassium chloride 10 or 40 milliequivalents (meq) / l in sodium chloride 0.9%, heparin 10 or 50 International units (IU) / ml in a solution of sodium chloride 0.9%.
When a solution of ceftazidime (500 mg in 1.5 ml of water d / i) and metronidazole (500 mg / 100 ml) are combined, both components retain their activity.
Influence on the ability to drive vehicles and complex mechanisms
Patients operating complex mechanisms and equipment while using Ceftazidime should be careful when performing these works (including driving a car).
Application during pregnancy and lactation
Adequate and strictly controlled studies on the safety of using the drug in pregnant women have not yet been conducted. According to animal studies, no adverse effects of the drug on the fetus were found. Taking into account that Ceftazidime crosses the placenta, its appointment during pregnancy is allowed only if absolutely necessary, after a careful assessment of the ratio of the expected benefits of therapy to the mother and the potential risk to fetal health.
Since the drug passes into breast milk, it is recommended to stop breastfeeding when administered during lactation.
Pediatric use
If it is necessary to administer Ceftazidime to children under 1 month of age, it is necessary to carefully balance the benefits and risks of therapy.
With impaired renal function
Ceftazidime should be used with caution in patients with renal insufficiency - a dose reduction is recommended depending on the CC value.
For violations of liver function
Liver dysfunctions do not affect the pharmacokinetic parameters of the drug, as a result of which a dose change is not required.
Use in the elderly
Elderly patients are not recommended to use Ceftazidime in a daily dose exceeding 3 g (especially for patients over 80 years old), during the period of treatment, renal function should be monitored.
Drug interactions
- aminoglycosides, chloramphenicol, vancomycin - these drugs are incompatible with ceftazidime; if necessary, a combination with aminoglycosides should be administered to different areas of the body; if vancomycin and ceftazidime are administered through one tube, in the interval between their use, it is required to flush the systems for intravenous administration;
- chloramphenicol and other bacteriostatic antibiotics - the effect of ceftazidime is weakened;
- vancomycin, aminoglycosides, loop diuretics, clindamycin - the clearance of ceftazidime decreases, as a result of which the threat of nephrotoxic action is aggravated (monitoring of renal function is necessary);
- sodium bicarbonate solution - it is forbidden to use it as a solvent due to the formation of carbon dioxide;
- combined oral hormonal contraceptives - the reabsorption of estrogen and the effectiveness of these contraceptives decrease.
Analogs
Analogues of Ceftazidime are: Vicef, Tizim, Fortum, Ceftazidim Kabi, Ceftazidim-Jodas, Bestum, Ceftazidim-Vial, Orzid, Cefzid, Ceftazidim-AKOS, Fortazim, Ceftazidim Sandoz, Ceftidin.
Terms and conditions of storage
Keep out of reach of children, protected from light and moisture at a temperature not exceeding 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Ceftazidime
The few reviews of Ceftazidime are rather mixed. Some patients characterize the drug as a serious and strong antibacterial agent, which completely suited them and demonstrated high efficiency in the treatment of an infectious disease. Others believe that the drug did not help them get rid of the disease, and at the same time caused a number of pronounced adverse reactions. In this case, the absence of a positive result during treatment may be associated with insensitivity to the action of this antibiotic of the causative agent of the disease, since the latter cannot always be accurately determined without conducting special studies. Some patients advise to use 1% Lidocaine solution as a solvent to reduce the pain of intramuscular injections of the drug, which provides an analgesic effect.
Price for Ceftazidime in pharmacies
The approximate price for Ceftazidime is 75–85 rubles per bottle containing powder for preparing a solution for intravenous and intramuscular administration in a dosage of 1 g.
Ceftazidime: prices in online pharmacies
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Drug name Price Pharmacy |
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Ceftazidime 0.5 g powder for preparation of solution for intravenous and intramuscular administration 1 pc. RUB 64 Buy |
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Ceftazidime 1 g powder for preparation of a solution for intravenous and intramuscular administration 1 pc. 77 RUB Buy |
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Ceftazidime powder for prig solution for intravenous and intramuscular injection. 1g 84 rbl. Buy |
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Ceftazidime 1 g powder for preparation of a solution for intravenous and intramuscular administration 1 pc. 84 rbl. Buy |
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Ceftazidime 1 g powder for preparation of a solution for intravenous and intramuscular administration 1 pc. RUB 86 Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
