FORTUM

Active material: Ceftazidime
When ATH: J01DD02
CCF: III generation cephalosporins
ICD-10 codes (testimony): A39, A40, A41, G00, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J37, J42, K65.0, K81.0, K81.1, K83.0, L01, L02, L03, L08.0, M00, N10, N11, N15.1, N30, N34, N41, T79.3, Z29.2
When CSF: 06.02.03
Manufacturer: GlaxoSmithKline s. p. a.. (Italy)

Pharmaceutical form, composition and packaging

Powder for solution for injection from white to light yellow in color.

Excipients: sodium carbonate (anhydrous), carbon dioxide.

Bottles (1) – packs cardboard.

Pharmacological action

Zefalosporinovy antibiotic III generation. It has bactericidal activity, disrupting the synthesis of cell walls of microorganisms. It has a wide spectrum of antimicrobial action (including strains pathogens, resistant to gentamicin and other antibiotics group aminoglikozidov). Resistant to most of the β-lactamases.

In in vitro studies have shown, that ceftazidime active against gram-negative bacteria: Pseudomonas aeruginosa, Pseudomonas spp. (incl. Pseudomonas pseudomallei), Klebsiella spp. (incl. Klebsiella pneumoniae), Proteus is wonderful, Proteus vulgaris, Morganella morganii, Proteus rettgeri, Providencia spp., Escherichia coli, Enterobacter spp., Citrobacter spp., Serratia spp., Salmonella spp., Shigella spp., Yersinia enterocolitica, Pasteurella multocida, Acinetobacter spp., Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae (including strains, resistant to ampicillin), Haemophilus parainfluenzae (including strains, resistant to ampicillin); Gram-positive bacteria: Staphylococcus aureus (strains, sensitive to Methicillin), Staphylococcus epidermidis (strains, sensitive to Methicillin), Micrococcus spp., Streptococcus pyogenes (β-hemolytic Streptococcus Group A), Group B Streptococcus (Streptococcus agalactiae), Streptococcus pneumoniae, Streptococcus, Streptococcus spp. (excluding Streptococcus faecalis); Anaerobic bacteria: Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp., Clostridium perfringers, Fusobacterium spp., Bacteroides spp. (many strains of Bacteroides fragilis is resistant).

Ceftazidime are not active against Methicillin-resistant Staphylococcus, Streptococcus faecalis and many other Enterococcus spp., Listeria monocytogenes, Campylobacter spp., Clostridium difficile.

Pharmacokinetics

Absorption

After the/m injection at doses 500 mg 1 г C_max in the blood plasma is achieved quickly and make up 18 mg/l and 37 mg/l, respectively. Through 5 minutes after the on/in the bolusni drug dose 500 mg, 1 or g 2 , plasma concentrations of ceftazidime constitute 46 mg / l, 87 mg/l and 170 mg/l, respectively.

Distribution

After in/in or/m introduction therapeutic concentrations of the active substance in plasma are maintained for 8-12 no. Plasma protein binding is 10%.

Concentrations of ceftazidime, excess of the IPC for the most common pathogens, It can be achieved in bone, the tissues of the heart, bile, mokrote, synovial fluid, intraocular liquid, in the pleural and peritoneal fluids. Ceftazidime easily penetrates through the placental barrier, excreted in breast milk. In the absence of inflammatory process in meningealnah shells ceftazidime poorly crosses the Geb, drug concentration in cerebrospinal fluid (CSF) low. With meningitis in the CSF achieved therapeutic concentrations of ceftazidime, constituents of 4-20 mg/l and above.

Metabolism

Ceftazidime is not metabolized in the body.

Deduction

T_1/2 about 2 no. Ceftazidime is excreted unchanged in urine by clubockova filtering. About 80-90% dose is excreted in the urine within 24 no. Less 1% the drug is excreted in the bile.

Pharmacokinetics in special clinical situations

In the human kidney speed out of ceftazidime is reduced.

In gemodialise T_1/2 is 3-5 no.

The newborn T_1/2 in 3-4 times, than in adults.

Testimony

— severe infections, including nosocomial (septicemia, bacteraemia, peritonitis, meningitis, infections in patients with low immunity, infected burns);

-respiratory tract infections and infections in cystic fibrosis patients;

- Infections of upper respiratory tract;

- Urinary tract infections;

- Infections of the skin and soft tissues;

- Infections of the digestive tract, biliary tract and abdominal cavity;

- Bone and joint infections;

- Infections, dialysis-related.

Prevention of infectious complications from the operations in the prostate gland (Transurethral resection).

Dosage regimen

Dose set individually, Depending on the severity of the disease, Localization, the type of pathogen and its sensitivity to the drug, the age of the patient and the kidney.

The drug is injected in/in or/m deep in the upper outer quadrant area large gluteus muscle or in the area of the lateral part of the thigh. Solution of ceftazidime can be entered directly into a vein or tube infusion system.

The maximum daily dose is 6 g.

Adults appointed 1-6 g/d in/in or/m. The frequency – 2-3 times / day.

In most cases, impose on 1 g every 8 or h 2 g every 12 no.

At severe disease, especially in patients with reduced immunity, including patients with neutropenia, appoint 2 g every 8 or h 12 or h 3 g every 12 no.

At urinary tract infections and infections of the lung flow We recommend that you enter on the 500 mg or 1 g every 12 no.

To treatment of infectious complications in cystic fibrosis, caused by Pseudomonas, appoint 100-150 mg / kg / day 3 admission.

At operations on the prostate gland Fortum appointed dose 1 g during induction of anesthesia and administered a second dose when you remove a catheter.

Elderly patients, especially over 80 years, Fortum is recommended in a dose of not more 3 g / day.

Children over 2 Months the drug is prescribed in a dose 30-100 mg / kg / day; multiplicity of introduction – 2-3 times / day.

Children with low immunity, with cystic fibrosis or meningitis to appoint 150 mg / kg / day (maximally 6 g / day) in 3 admission.

Newborns and infants up to the age of 2 Months the drug is prescribed in a dose 25-60 mg / kg / day 2 admission.

Patients with renal insufficiency dose reduction is required, tk. ceftazidime displayed kidneys in an unmodified form.

The initial dose is 1 g. Supporting dose picked depending on the speed of glomeruliarna filtering.

Supporting dose of ceftazidime in renal failure are shown in table.

Patients with severe infections You can increase the dose to 50% or increase the frequency of drug administration. In this case, you should monitor the level of ceftazidime in the serum, serum concentrations of ceftazidime not exceed 40 mg / l.

To children QC is calculated in accordance with the ideal weight or body surface area.

Hemodialysis

After each hemodialysis session introducing maintenance doses of ceftazidime in accordance with the above table.

Pyeritonyealinyi dialysis

The drug is injected in a dose 500 mg every 24 no.

For patients with renal insufficiency, located in ITD on continuous hemodialysis using low-flow-arterio-venous shunt, and for patients, located on the high-speed Hemofiltration, The recommended dose is 1 g / day every day (in 1 or several introductions).

Patient, located on Hemofiltration with low speed, the drug is prescribed in doses, recommended if any of the kidneys.

The recommended doses for patients, located on Hemofiltration using Weno-venous shunt, are presented in Table.

*Supporting dose is prescribed every 12 no.

Dose of ceftazidime for patients, located on a continuous hemodialysis at a speed 1 l/h using Weno-venous shunt, are presented in Table.

*Supporting dose is prescribed every 12 no

Dose of ceftazidime for patients, located on a continuous hemodialysis at a speed 2 l/h using Weno-venous shunt, are presented in Table.

*Supporting dose is prescribed every 12 no

Terms of solution for injection

LETI is compatible with most of the solutions for the on/in the introduction.

Fortum is in powder form in vials under low pressure. By dissolving powder stands out carbon dioxide, and pressure in the vial is increased. In the finished solution may attend small bubbles of carbon dioxide, This can be ignored.

*Add solution is carried out in 2 admission.

Depending on the concentration, types of solvents and storage conditions, the resulting solution Anne can have color from light-yellow to dark yellow. Rules are breeding drug, his effectiveness does not depend on the shade.

Ceftazidime in concentration from 1 to 40 mg/ml is compatible with the following solutions: 0.9% rr sodium chloride; r-r Hartman; 5% r-r dextrose; 0.225% r-r sodium chloride and 5% r-r dextrose; 0.45% r-r sodium chloride and 5% r-r dextrose; 0.9% r-r sodium chloride and 5% r-r dextrose; 0.18% r-r sodium chloride and 4% r-r dextrose; 10% r-r dextrose; dextran 40 Injectable 10% in 0.9% r-re of sodium chloride; dextran 40 Injectable 10% in 5% r-re dextrose; dextran 70 Injectable 6% in 0.9% sodium chloride solution; dextran 70 Injectable 6% in 5% r-re dextrose.

When the concentration of 0.05 to 0.25 mg/ml ceftazidime is compatible with intraperitoneal′nogo solution for dialysis (lactate).

For the/m of ceftazidime can be divorced 0.5% or 1% lidocaine hydrochloride.

If the ceftazidime in concentration 4 mg/ml mix with the following solutions, both components remain active: gidrokortizon (hydrocortisone sodium phosphate) 1 mg/ml 0.9% r-re sodium chloride or 5% r-re dextrose; cloxacillin (cloxacillin sodium) 4 mg/ml 0.9% r-re of sodium chloride; Heparin 10 IU/ml or 50 IU/ml 0.9% r-re of sodium chloride; potassium chloride 10 mèkv/l or 40 mèkv/l 0.9% r-re of sodium chloride.

When mixing a solution of ceftazidime (500 mg 1.5 ml water d/and) and metronidazole (500 mg / 100ml) both components remain active.

Solution preparation for v/m or/in the bolusni

1. The needle of the syringe into the vial to enter through the rubber stopper and add the recommended amount of solvent through it.

2. Remove the needle of the syringe and shake the bottle, to make a transparent solution.

3. Turn the bottle. When fully inserted into the syringe piston needle puncture rubber stopper of the vial and push it into the vial so, so she was completely in solution. Dial the entire solution in the syringe. Solution in the syringe may contain small bubbles of carbon dioxide.

Preparation of the solution for the on/in infusions (bottles, containing 1 or g 2 g product)

1. Insert the needle of the syringe into the vial through the rubber stopper and add through it 10 mL of solvent.

2. Remove the needle of the syringe and shake the bottle, to make a transparent solution.

3. Insert the needle for gas bottle cover, to reduce internal pressure in the vial.

4. Not removing the needle for gas, Add in a bottle remaining solvent. Remove the lid of the bottle both needles (gas needle and syringe needle); shake the bottle and set it for infusion.

To ensure sterility, it is important not to introduce into the vial the needle for gas until, until the powder has dissolved.

Side effect

From the digestive system: diarrhea, nausea, vomiting, stomach ache, candidiasis of the oral cavity and pharynx, tranzithornoe increase in ALT, IS, LDH, GGT and ALP; rarely – jaundice.

Like other cephalosporins, colitis can be caused by Clostridium difficile and manifest as pseudomembranous colitis.

From the hematopoietic system: eozinofilija, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, thrombocytosis, Lymphocytosis, gemoliticheskaya anemia.

From the central and peripheral nervous system: headache, dizziness, paresthesia, dysgeusia; more often in patients with renal insufficiency – neurological disorders, include tremor, miokloniû, convulsions, encephalopathy, whom.

From the urinary system: tranzithornoe raising urea, urea nitrogen and creatinine in the blood and/or, impairment of renal function.

Allergic reactions: maculo-papular rash, hives, fever, itch, angioedema, bronchospasm, decrease in blood pressure, mnogoformnaya Erythema ekssoudatus ( incl. Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

Local reactions: flebit or throm with on/in the introduction; pain, burning, seal in the injection with the/m introduction.

Other: kandidozny vaginitis, false-positive direct Coombs' test.

Contraindications

-hypersensitivity to sirtazidimu and other components of the drug;

-hypersensitivity to other zefalosporinovm antibiotics, penicillins.

FROM caution designate of renal failure, diseases of the digestive tract (incl. in history and at NSU), Pregnancy, lactation, newborn, in combination with “loop” dioretikami and aminoglikozidami.

Pregnancy and lactation

LETI should be used with caution in the first months of pregnancy.

Ceftazidime is the breast milk, Therefore, you must use caution when prescribing the drug to the mother during breastfeeding.

No data received, embriotoksicescoe or teratogenic effects zeftazidima.

Cautions

In developing allergic reactions to medication should be the immediate repeal of ceftazidime. With the development of hypersensitivity reactions can be shown to epinephrine (epinephrine), hydrocortisone, antihistamines and other emergency events.

While receiving the high dose cephalosporin with nefrotoksičeskimi drugs, such as aminoglycosides and diuretics (furosemid), You need to monitor renal function. However, no data, that ceftazidime in therapeutic doses violates kidney function.

Since ceftazidime displayed kidneys, in patients with renal insufficiency dose should be reduced according to the degree of kidney function.

Prolonged use of broad spectrum antibiotics, incl. and Anne, It may lead to increased growth of microorganisms insensitive (eg, Candida, Enterococcus spp.), This may require discontinuation of treatment or appropriate therapy. When treating the patient's condition should be constantly evaluated.

When treating Fortumom some originally sensitive strains of Enterobacter spp. and Serratia spp. may develop resistance. So if you want to, When treating infections, caused by these microorganisms, should periodically conduct a study on the sensitivity to antibiotics.

Ceftazidime no effect on results of enzymatic methods for the determination of glucose in the urine, but can a small impact on benchmark results with copper recovery (Benedict, 'S, Clinical laboratory).

Ceftazidime no effect on results of creatinine alkaline pikratnym method.

Overdose

Symptoms: neurological disorders (incl. encephalopathy, convulsions, coma).

Treatment: the holding of symptomatic and supportive therapy. Concentrations of ceftazidime in the serum can be reduced by dialysis or peritoneal dialysis.

Drug Interactions

The simultaneous introduction of ceftazidime in high doses and nefrotoksicskih drugs can have adverse effects on kidney function.

“Loop” Diuretic, aminoglikozidy, vancomycin, clindamycin reduce clearance of ceftazidime, as a result, increases the risk of nefrotoksicski action.

Bacteriostatic antibiotics (incl. chloramphenicol) reduce the action of beta-lactam antibiotics.

Pharmaceutical interaction

LETI is compatible with most of the solutions for the on/in the introduction.

However, ceftazidime is less stable in solution of sodium bicarbonate, Therefore, it is not recommended to use as a solvent.

Fortum farmatsevticeski incompatible with aminoglikozidami, geparinom, vancomycin, chloramphenicol. Chloramphenicol acts as an antagonist of ceftazidime and other cephalosporin.

When added to a solution of vancomycin ceftazidime observed precipitation, Therefore, we recommend that you rinse the infuzionnuu system between wvedeniami these two drugs.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in the dark and out of reach of children at a temperature of no higher than 25° c. Shelf life - 3 year.

After breeding mortar store can Anne 24 hours at room temperature (above 25 ° C) or 7 days in a refrigerator.