Ceftazidime powder for solution for injection 1000 mg vial No. 1

Ceftazidime powder for solution for injection 1000 mg vial No. 1

Composition

active ingredient: ceftazidime;

1 vial contains ceftazidime pentahydrate equivalent to ceftazidime 1000 mg;

excipient: sodium carbonate anhydrous.

Dosage form

Powder for solution for injection.

Main physicochemical properties: white to pale yellow powder.

Pharmacotherapeutic group: Antibacterial for systemic use. Third generation cephalosporins. ATX code: J01D D02.

Pharmacological properties

Pharmacodynamics

Mechanism of action

Ceftazidime inhibits bacterial cell wall synthesis by interacting with penicillin-binding proteins (PBPs). This leads to disruption of cell wall (peptidoglycan) biosynthesis, which leads to lysis and death of bacterial cells.

PK/PD ratio

For cephalosporins, the most important pharmacokinetic-pharmacodynamic (PK-PD) index that correlates with in vivo efficacy is the percentage of the dosing interval over which the unbound concentration remains above the minimum inhibitory concentration (MIC) of ceftazidime for the individual target species (i.e., %T > MIC).

Mechanism of resistance

Bacterial resistance to ceftazidime may be due to one or more of the following mechanisms:

Checkpoints

Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST):

S - sensitive, I - moderately sensitive, R - resistant.

Microbiological susceptibility

The prevalence of acquired resistance to individual species may vary geographically and over time, therefore it is advisable to obtain local information on the resistance of microorganisms, especially when treating severe infections. As necessary, specialist advice should be sought when the local prevalence of resistance is such that the benefit of the agent in at least some types of infections is questionable.

Pharmacokinetics

Absorption

In patients, mean peak concentrations of 18 and 37 mg/L are rapidly achieved after intramuscular injection of ceftazidime 500 mg and 1 g, respectively. Mean serum concentrations of 18 and 37 mg/L are reached 5 minutes after intravenous bolus administration of 500 mg, 1 g or 2 g.
46, 87 and 170 mg/l respectively. The kinetics of ceftazidime are linear within a single dose range of 0.5–2 g after intravenous or intramuscular administration.

Distribution

Plasma protein binding is approximately 10%. Ceftazidime concentrations exceeding the minimum inhibitory concentration (MIC) for most common pathogens are achieved in tissues and media such as bone, heart, bile, sputum, intraocular, synovial, pleural and peritoneal fluids. Ceftazidime readily crosses the placenta and is excreted in breast milk. The drug does not cross the intact blood-brain barrier; in the absence of inflammation, the concentration of the drug in the central nervous system is low. However, in inflammation of the meninges, the concentration of ceftazidime in the central nervous system is 4–20 mg/l and higher, which corresponds to the level of its therapeutic concentration.

Biotransformation

Ceftazidime is not metabolized in the body.

Breeding

2 hours. Ceftazidime is excreted unchanged in the active form 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.

Special patient groups

Kidney failure

In patients with impaired renal function, the elimination of ceftazidime is reduced, therefore the dose should be reduced (see section "Method of administration and dosage").

Liver failure

The presence of mild to moderate hepatic dysfunction did not affect the pharmacokinetics of ceftazidime in patients administered 2 g intravenously every 8 hours for 5 days, provided that renal function was not impaired (see section 4.2).

Elderly patients

The decrease in clearance observed in elderly patients was mainly due to age-related decrease in renal clearance of ceftazidime. The mean half-life in elderly patients (aged 80 years and older) is 3.5-4 hours after both single and long-term administration (for 7 days) of 2 g twice daily intravenously (bolus).

Children

The elimination half-life of ceftazidime increases in premature and full-term neonates from 4.5 to 7.5 hours after a dose of 25–30 mg/kg. However, in patients older than 2 months, the elimination half-life is within the adult range.

Use to treat the following infections in adults and children, including newborns:

For the treatment of bacteremia occurring 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, which mainly includes gram-negative aerobes, should be taken into account (see sections “Special instructions for use” and “Pharmacological properties”).

Ceftazidime should be used with other antibacterial agents if it is expected that some of the microorganisms causing the infection are not within the spectrum of activity of ceftazidime.

The drug should be used in accordance with current official recommendations for the prescription of antibacterial agents.

Contraindication

Hypersensitivity to ceftazidime or to any of the other ingredients of the drug.

Hypersensitivity to cephalosporin antibiotics.

History of severe hypersensitivity (e.g. anaphylactic reactions) to other beta-lactam antibiotics (penicillins, monobactams and carbapenems).

Interaction with other medicinal products and other types of interactions

Interaction studies have only been conducted with probenecid and furosemide.

Concomitant use of high doses of the drug with nephrotoxic drugs may adversely affect renal function (see section "Special warnings and precautions for use").

Chloramphenicol is an antagonist of ceftazidime and other cephalosporins in vitro. The clinical significance of this phenomenon is unknown, however, if concomitant use of the drug with chloramphenicol is considered, the possibility of antagonism should be considered.

Like other antibiotics, ceftazidime may affect the intestinal flora, leading to reduced reabsorption of estrogens and reduced efficacy of combined oral contraceptives.

Ceftazidime does not affect the results of glycosuria determination by enzymatic methods, however, a slight effect on the analysis results may be observed when using copper reduction methods (Benedict, Fehling, "Clinitest").

Ceftazidime does not affect the alkaline picrate method of creatinine determination.

Application features

Hypersensitivity reactions

As with other beta-lactam antibiotics, severe and sometimes fatal hypersensitivity reactions have been reported. If severe hypersensitivity reactions occur, ceftazidime treatment should be discontinued immediately and appropriate emergency measures should be initiated.

Before initiating treatment, the patient should be evaluated for a history of severe hypersensitivity reactions to ceftazidime, cephalosporin antibiotics, or other beta-lactam antibiotics. The drug should be administered with caution to patients who have had non-severe hypersensitivity reactions to other beta-lactam antibiotics.

Activity spectrum

Ceftazidime has a limited spectrum of antibacterial activity. It is not an acceptable drug for monotherapy for some types of infections, except in cases where the causative agent of the disease is identified and known to be susceptible to this drug or there is a high probability that the causative agent will be susceptible to treatment with ceftazidime. This is especially important when considering the treatment of patients with bacteremia, bacterial meningitis, skin and soft tissue infections, and bone and joint infections. In addition, ceftazidime is susceptible to hydrolysis by some extended-spectrum beta-lactamases (ESBLs). Therefore, when choosing ceftazidime for treatment, information on the distribution of microorganisms producing extended-spectrum beta-lactamases should be taken into account.

Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. It is therefore important to consider this diagnosis in patients who develop diarrhoea during or after antibiotic treatment (see section 4.8). Ceftazidime should be discontinued and specific treatment for Clostridium difficile should be considered. Medicinal products that slow intestinal motility should not be administered.

Kidney function

Concomitant treatment with high doses of cephalosporins and nephrotoxic drugs such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function. Ceftazidime is excreted by the kidneys, so the dose should be reduced according to the degree of renal impairment. In patients with impaired renal function, careful clinical monitoring of the safety and efficacy of the drug is recommended. Cases of neurological complications have been reported when the dose was not reduced accordingly (see sections “Method of administration and dosage” and “Adverse reactions”).

Overgrowth of non-susceptible microorganisms

As with other broad-spectrum antibiotics, prolonged treatment with ceftazidime may result in overgrowth of non-susceptible organisms (e.g. Enterococci, fungi); in this case, discontinuation of treatment or other appropriate measures may be necessary. It is very important to monitor the patient's condition continuously.

Impact on laboratory parameters

Ceftazidime does not affect the results of enzymatic methods for determining glucosuria, but may slightly affect the results when using methods based on copper reduction (Benedict, Fehling, "Clinitest"): false-positive results may be obtained.

Ceftazidime does not affect the result of the alkaline picrate creatinine test.

Approximately 5% of patients receiving ceftazidime have had a positive Coombs test. This phenomenon may interfere with blood cross-compatibility testing.

Sodium content

The medicinal product contains sodium (1 vial of 1 g of ceftazidime - 52 mg (2.3 mmol) of sodium), which should be taken into account when treating patients on a controlled sodium diet.

Use during pregnancy or breastfeeding

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, embryonal/fetal development, parturition or postnatal development. Ceftazidime should be used during pregnancy only if the potential benefit justifies the potential risk.

Breast-feeding

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 breast-feeding.

Fertility

No data available.

Ability to influence reaction speed when driving vehicles or other mechanisms

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 (see section "Adverse reactions").

Method of administration and doses

Adults and children weighing ≥ 40 kg

1 In adult patients with normal renal function, administration of 9 g per day did not cause adverse reactions.

* If associated or suspected to be associated with infections listed in the Indications section.

Children weighing < 40 kg

Infants and children > 2 months of age with a body weight < 40 kg

Infants and children ≤ 2 months of age

Children

The safety and efficacy of the drug by continuous intravenous infusion in infants and children ≤ 2 months of age have not been established.

Elderly patients

Given the reduced clearance of ceftazidime, the daily dose should not exceed 3 g in elderly patients, especially in patients over 80 years of age.

Liver failure

No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. Clinical studies have not been conducted in patients with severe hepatic impairment (see section 5.2). Close clinical monitoring of safety and efficacy is recommended.

Kidney failure

Ceftazidime is excreted unchanged by the kidneys. Therefore, the dose should be reduced in patients with impaired renal function (see section "Special instructions").

The initial loading dose should be 1 g. The maintenance dose should be based on creatinine clearance.

Recommended maintenance doses of ceftazidime in renal failure: intermittent administration

Adults and children weighing ≥ 40 kg

For patients with severe infections, the single dose may be increased by 50% or the frequency of administration may be increased accordingly.

In children, creatinine clearance should be adjusted for body surface area or body weight.

Children weighing < 40 kg

Careful clinical monitoring of the safety and efficacy of the medicinal product is recommended.

Recommended maintenance doses of ceftazidime in renal failure: continuous infusion

Adults and children weighing ≥ 40 kg

A loading dose of 2 g is administered followed by a continuous infusion of 1 to 3 g every 24 hours

Dose selection should be done with caution. Close clinical monitoring of safety and efficacy is recommended.

Children weighing < 40 kg

The safety and efficacy of continuous intravenous infusion in children weighing < 40 kg with renal impairment have not been established. Close clinical monitoring of safety and efficacy is recommended.

If children with impaired renal function need to be administered the drug by continuous intravenous infusion, creatinine clearance should be adjusted according to the child's body surface area or body weight.

Hemodialysis

The serum elimination half-life of ceftazidime during hemodialysis is 3 to
5 hours.

After each hemodialysis session, a maintenance dose of ceftazidime should be administered as recommended in the tables below.

Peritoneal dialysis

Ceftazidime can be used in routine peritoneal dialysis and in long-term ambulatory peritoneal dialysis.

In addition to intravenous administration, ceftazidime can be included in the dialysis fluid (usually 125 to 250 mg per 2 liters of dialysis solution).

For patients with renal insufficiency undergoing long-term arteriovenous hemodialysis or high-flux hemofiltration in intensive care units, the recommended dose is 1 g per day in a single dose or in divided doses. For low-flux hemofiltration, doses should be used as for impaired renal function.

For patients undergoing venovenous hemofiltration and venovenous hemodialysis, dosage recommendations are provided in the tables below.

Ceftazidime dosing recommendations for patients undergoing long-term venovenous hemofiltration

Ceftazidime dosing recommendations for patients undergoing long-term venovenous hemodialysis

Introduction

The dose depends on the severity of the disease, sensitivity, location and type of infection, as well as the patient's age and renal function.

The drug should be administered by intravenous injection or infusion or by deep intramuscular injection. The recommended sites for intramuscular administration are the upper outer quadrant of the gluteus maximus muscle or the lateral part of the thigh.

Ceftazidime solutions can be administered directly into a vein or into an intravenous infusion system if the patient is receiving fluids parenterally.

The standard recommended methods are intravenous intermittent administration or intravenous continuous infusion.

Intramuscular administration should only be used when the intravenous route is not possible or less suitable for the patient.

Preparation of solution for injection

Ceftazidime is compatible with most commonly used intravenous solutions. However, sodium bicarbonate for injection should not be used as a diluent (see section "Incompatibilities").

All sizes of vials are manufactured under reduced pressure. As the drug dissolves, carbon dioxide is released and the pressure in the vial increases. Small bubbles of carbon dioxide in the dissolved drug can be ignored.

* Dissolution should be carried out in two stages (see below “Preparation of solution for intravenous infusion”).

The color of the solution varies from light yellow to amber depending on the concentration, solvent and storage conditions. If the recommendations are followed, the effect of the drug does not depend on variations in its color.

Ceftazidime in concentrations from 1 mg/ml to 40 mg/ml is compatible with the following solutions: 0.9% sodium chloride solution; M/6 sodium lactate solution; Hartmann's solution; 5% glucose solution; 0.225% sodium chloride solution and 5% glucose solution; 0.45% sodium chloride solution and 5% glucose solution;
0.9% sodium chloride solution and 5% glucose solution; 0.18% sodium chloride solution and 4% glucose solution; 10% glucose solution; 10% dextran 40 solution and 0.9% sodium chloride solution; 10% dextran 40 solution and 5% glucose solution; 6% dextran 70 solution and 0.9% sodium chloride solution; 6% dextran 70 solution and 5% glucose solution.

Ceftazidime in concentrations from 0.05 mg/ml to 0.25 mg/ml is compatible with intraperitoneal dialysis fluid (lactate).

Ceftazidime for intramuscular administration can be dissolved in 0.5% or 1% lidocaine hydrochloride solution.

Preparation of solution for intramuscular or intravenous bolus injection:

Preparation of solution for intravenous infusion (1 g vials) in two stages.

Note: To ensure sterility of the product, it is very important not to insert the air needle through the cap until the product is dissolved.

The medicine is intended for single use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Children.

Apply to children from the first days of life.

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 (see sections 4.2 and 4.4). Serum ceftazidime concentrations can be reduced by haemodialysis or peritoneal dialysis.

Adverse reactions

The most common adverse reactions are eosinophilia, thrombocytosis, phlebitis or thrombophlebitis with intravenous administration, diarrhea, transient elevation of liver enzymes, maculopapular rash or urticaria, pain and/or inflammation after intramuscular injection, and positive Coombs test.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Adverse reactions were classified by system organ class and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 and < 1/10); uncommon (≥ 1/1,000 and < 1/100); rare (≥ 1/10,000 and < 1/10,000).
< 1/1000); very rare (< 1/10000); frequency unknown (cannot be estimated from the available data).

Infections and infestations

Uncommon: candidiasis (including vaginitis and candidal stomatitis).

Blood and lymphatic system disorders

Often - eosinophilia, thrombocytosis.

Uncommon: neutropenia, leukopenia, thrombocytopenia.

Frequency unknown - agranulocytosis, hemolytic anemia, lymphocytosis.

On the part of the immune system

Frequency unknown - anaphylaxis (including bronchospasm and/or hypotension)
(see section "Features of use").

From the nervous system

Uncommon: headache, dizziness.

Frequency unknown - neurological complications1, paresthesia.

From the vascular side

Often - phlebitis or thrombophlebitis at the site of drug injection.

Gastrointestinal tract

Often - diarrhea.

Uncommon: Antibiotic-associated diarrhea and colitis2 (see section "Special warnings and precautions for use"), abdominal pain, nausea, vomiting.

Frequency unknown - taste disturbance.

Hepatobiliary system

Often, transient elevations of one or more liver enzymes3.

Frequency unknown - jaundice.

Skin and subcutaneous tissue disorders

Often - maculopapular rash or urticaria.

Uncommon: itching.

Frequency unknown - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)4.

From the urinary system

Uncommon: Transient increase in blood urea, blood urea nitrogen and/or serum creatinine.

Very rare: interstitial nephritis, acute renal failure.

General disorders and administration site conditions

Common: pain and/or inflammation at the site of intramuscular injection.

Uncommon: fever.

Laboratory indicators

Often a positive Coombs test5.

Expiration date

3 years (from the date of manufacture of the bulk form).

Storage conditions

Store in original packaging at a temperature not exceeding 25 degrees Celsius.

Keep out of reach of children.

Incompatibility

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 line or syringe. Precipitation has been observed when vancomycin has been added to ceftazidime solutions. Therefore, it is recommended to flush infusion lines and intravenous catheters between the administration of these two drugs.

Packaging

Vial with powder. 1 or 10 vials in a box.

Vacation category

According to the recipe.

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