Fortum powder for injection 1000mg bottle №1

Mechanism of action

III generation cephalosporin antibiotic for parenteral use. Bactericidal effect. Violates the synthesis of the cell wall of microorganisms. It has a wide spectrum of action. Resistant to most beta-lactamase.
In vitro studies have shown that ceftazidime active against gram-negative bacteria: Pseudomonas aeruginosa, Pseudomonas spp. (including Pseudomonas pseudomallei), Klebsiella spp. (including Klebsiella pneumoniae), Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia spp., Escherichia coli, Enterobacter spp., Citrobacter spp., Serratia spp., Salmonella spp., Shigella spp., Shigellapp. enterocolitica, Pasteurella multocida, Acinetobacter spp., Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae (including ampicillin-resistant strains, resistant strains). Gram-positive bacteria: Staphylococcus aureus (strains sensitive to methicillin), Staphylococcus epidermidis (strains sensitive to methicillin), Micrococcus spp., Streptococcus pyogenes (b-hemolytic Streptococcus group A), Streptococcus group B (Streptococcus agalactiae), Streptococcus pneumoniae, Streptococcus mitis, Streptococcus spp. (excluding Streptococcus faecalis); anaerobic bacteria: Peptococcus spp., Peptostreptococcus spp., Streptococcus spp., Propionibacterium spp., Clostridium perfringers, Fusobacterium spp., Bacteroides spp. (many strains of Bacteroides fragilis are resistant).
In vitro ceftazidime not active against methicillin-resistant staphylococci, Streptococcus faecalis and many other Enterococci, Listeria monocytogenes, Campylobacter spp. and Clostridium difficile.

Indications and usage

Treatment of monoinfections or mixed infections caused by microorganisms sensitive to the drug:
- severe infections (septicemia, bacteremia, peritonitis, meningitis, infections in immunocompromised patients; infections in patients in intensive care units, such as infected burns);
- respiratory infections, including infections of the lungs and cystic fibrosis;
- infections of the ear, nose and throat;
- urinary tract infections;
- infections of the skin and soft tissues;
- infections of the digestive tract, biliary tract and abdominal cavity;
- infections of bones and joints;
- infections of the pelvic organs;
- infections associated with hemodialysis and peritoneal dialysis, as well as with continuous ambulatory peritoneal dialysis;
- prevention of infectious complications during operations on the prostate gland (transurethral resection).
Fortum can be used without combination with other antibacterial agents as a first choice drug until microorganism sensitivity data are obtained.
Fortum can be used in combination with aminoglycosides and most other antibiotics that are resistant to beta-lactamase.
Fortum can be used in combination with other antibiotics for anaerobic infections if the presence of Bacteroides fragilis is suspected.

The drug is used only parenterally. Dose set individually, depending on the severity of the disease, the type of pathogen, age, body weight, kidney function.
The drug is administered in / in or deep in / m in the upper outer quadrant of the gluteus maximus muscle or in the region of the lateral part of the thigh. The ceftazidime solution can be injected directly into the vein or into the tube of the infusion system.
For adults appoint 1-6 g / day in / in or in / m. The multiplicity of the introduction - 2-3 times / day.
At urinary tract infections appoint 0.5-1 g every 12 hours
For most infections, an effective dose of 1 g every 8 hours or 2 g every 12 hours.
At severe disease, especially in patients with reduced immunity, including patients with neutropenia, should be administered 2 g every 8 or 12 hours, or 3 g every 12 hours.
Patients with cystic fibrosis and at pseudomonas lung infections, prescribed Fortum in a dose of 100-150 mg / kg / day; the frequency of administration is 3 times / day.
For prevention of infectious complications during operations on the prostate gland administer the drug in a dose of 1 g before the induction of anesthesia. The second dose is administered when the catheter is removed.
Children older than 2 months the drug is prescribed in a dose of 30-100 mg / kg / day; the frequency of administration is 2-3 times / day.
Children with reduced immunity with cystic fibrosis or meningitis appoint up to 150 mg / kg / day (maximum 6 g / day); the multiplicity of injections - 3 times / day.
Newborns and babies under 2 months the drug is prescribed in a dose of 25-60 mg / kg / day; the multiplicity of injections - 2 times / day.
Elderly patients, taking into account the reduced clearance of ceftazidime in case of acute diseases, it is recommended to prescribe Fortum in a dose of not more than 3 g / day, especially for patients over 80 years old.
Dosing regimen for patients with impaired renal function set depending on the values ​​of QC. The initial dose is 1 g. Recommended maintenance doses:

Patients with severe infections can increase the single dose by 50% or increase the frequency of drug administration.In this case, the level of ceftazidime in the serum should be monitored, while the concentration of ceftazidime should not exceed 40 mg / l.
For children creatinine clearance is calculated according to the ideal mass or surface area of ​​the body.
Hemodialysis. After each hemodialysis session, maintenance doses of ceftazidime are administered in accordance with the table above.
Peritoneal dialysis. In addition to iv administration, ceftazidime can be included in the dialysis solution (usually 125-250 mg per 2 liters of dialysis solution).
For patients with renal insufficiency who are on continuous hemodialysis using an arterio-venous shunt, and for patients who are on hemofiltration at a high rate in the intensive care unit, the recommended doses are: 1 g / day daily (in 1 or more administrations).
For patients who are on hemofiltration low speed, prescribed in doses recommended for impaired renal function.
Terms of preparation of the solution for injection
Fortum is compatible with most intravenous injection solutions. However, ceftazidime is less stable in sodium bicarbonate solution, so it is not recommended to use it as a solvent. Fortum should not be mixed with aminoglycosides in one syringe or in one system.
When Vancomycin was added to the ceftazidime solution, a precipitate was observed. It is therefore recommended to flush the infusion system between injections of these two drugs.
Fortum in powder form is in vials under reduced pressure. When the powder is dissolved, carbon dioxide is released, and the pressure in the vial rises. Small bubbles of carbon dioxide may be present in the resulting ready-made solution of the drug, you can not pay attention to this.

* Addition is carried out in 2 administrations.
Depending on the concentration, type of solvent and storage conditions, the resulting solution Fortum may have a color from light yellow or dark yellow. If all the recommended rules for dilution of the drug, then its effectiveness does not depend on the shade.
Ceftazidime at a concentration of from 1 to 40 mg / ml is compatible with the following solutions: 0.9% sodium chloride solution; M / 6 solution of sodium lactate; Hartman's solution (complex solution of sodium lactate); 5% dextrose solution; 0.225% sodium chloride solution and 5% dextrose solution; 0.45% sodium chloride solution and 5% dextrose solution; 0.9% solution of sodium chloride and 5% dextrose solution; 0.18% solution of sodium chloride and 4% dextrose solution; 10% dextrose solution; dextran 40: 10% in a 0.9% solution of sodium chloride; dextran 40: 10% in 5% dextrose solution; dextran 70: 6% in 0.9% sodium chloride solution; Dextran 70: 6% in 5% dextrose solution.
At concentrations from 0.05 to 0.25% mg / ml, ceftazidime is compatible with the solution for intraperitoneal dialysis (lactate).
For intramuscular administration, ceftazidime can be diluted with 0.5% or 1% Lidocaine hydrochloride solution.
Both components remain active if ceftazidime is added to the following solutions (ceftazidime concentration 4 mg / ml): Hydrocortisone (hydrocortisone sodium phosphate) 1 mg / ml in 0.9% sodium chloride solution or 5% dextrose solution; cefuroxime (cefuroxime sodium) 3 mg / ml in 0.9% sodium chloride solution; Cloxacillin (cloxacillin sodium) 4 mg / ml in 0.9% sodium chloride solution; Heparin 10 IU / ml or 50 IU / ml in 0.9% sodium chloride solution; potassium chloride 10 mEq / l or 40 mEq / l in a 0.9% solution of sodium chloride.
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.
Preparation of solution for intramuscular or intravenous bolus administration
1. Insert the syringe needle into the vial cap and add the recommended amount of solvent.
2. Remove the syringe needle and shake the vial to form a clear solution.
3. Invert the vial. With the syringe piston fully inserted, insert the needle into the cap of the bottle so that the needle is completely in solution. To collect all the solution in the syringe (the needle must be in solution). The solution in the syringe may contain small bubbles of carbon dioxide.
Preparation of solution for intravenous infusion (bottles of 1 g and 2 g)
1. Insert the syringe needle into the vial cap and add 10 ml of solvent.
2. Remove the syringe needle and shake the vial to form a clear solution.
3. Insert a gas needle into the vial cap to reduce internal pressure.
4. Without removing the needle to release the gas, add the remaining amount of solvent to the vial.Remove both needles from the bottle cap (gas needle and syringe needle); shake the vial and set it for infusion.
To ensure sterility, it is important not to insert a needle into the vial to release the gas until the powder is dissolved.

From the digestive system: diarrhea, nausea, vomiting, abdominal pain, transient increase in the activity of transaminases, LDH, GGT and ALP; rarely - stomatitis, colitis (including pseudomembranous).
From the hemopoietic system: eosinophilia; very rarely - leukopenia, neutropenia, agranulocytosis, thrombocytopenia, lymphocytosis.
From the side of the central nervous system and peripheral nervous system: headaches, dizziness, paresthesias, a violation of taste sensations; in patients with renal insufficiency with improper dose selection - tremor, convulsions, encephalopathy.
Other: positive Coombs reaction without hemolysis, transient increase in serum creatinine level.
Effects due to biological effects: superinfection (candidiasis, including the vaginal mucosa).
Allergic reactions: rash, urticaria, fever, pruritus, eosinophilia; very rarely - bronchospasm, decreased blood pressure, angioedema; in some cases, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Local reactions: phlebitis or thrombophlebitis with a / in the introduction, pain in the place of the / m injection.

- Hypersensitivity to ceftazidime, cephalosporins.

Fortum should be used with caution in the first trimester of pregnancy.
Ceftazidime is excreted in breast milk in low concentrations, so care must be taken when prescribing the drug during breastfeeding.
AT experimental studies no data confirming the possibility of the embryopathic or teratogenic effect of ceftazidime have been obtained.

Before starting treatment with Fortum, it is necessary to establish that the patient did not have hypersensitivity reactions to ceftazidime, antibiotics from the cephalosporins group and penicillin or to other drugs. Fortum should be prescribed with extreme caution to patients who had a history of allergic reactions to antibiotics from the penicillin group or other antibiotics that are resistant to beta-lactamase.
If an allergic reaction to ceftazidime develops, the drug should be immediately discontinued. With the development of hypersensitivity reactions can be shown the use of adrenaline, hydrocortisone, antihistamine drugs and other emergency measures.
Prolonged use of broad-spectrum antibiotics, incl. and Fortum, can lead to an increase in the growth of insensitive microorganisms (for example, Candida, Enterococcus), which may require discontinuation of treatment or appropriate therapy. During treatment, it is necessary to constantly assess the condition of the patient.
As with the use of other broad-spectrum antibiotics from the group of penicillins or cephalosporins, resistance may occur in some sensitive strains of Enterobacter with Fortum. Therefore, if necessary, in the treatment of infections caused by Enterobacter, should periodically conduct a study on the sensitivity of microorganisms.
In renal insufficiency, doses of Fortum are reduced in accordance with the degree of renal dysfunction. With the wrong dose selection, there were isolated cases of neurological disorders.
Ceftazidime does not affect the results of enzymatic methods for the determination of glucose in the urine, but may have a slight effect on the results of tests with the recovery of copper (Benidict, Fehlinga, Klinitest).
Ceftazidime does not affect the results of the determination of creatinine in the test with alkaline picrate.
Use in pediatrics
With caution should use the drug in newborns.

Symptoms: neurological disorders (including encephalopathy, convulsions, coma).
Treatment: serum ceftazidime concentration can be reduced by dialysis or peritoneal dialysis.

In vitro, chloramphenicol acts as an antagonist of ceftazidime and other cephalosporins. The clinical significance of this phenomenon has not been established, but in the case of simultaneous use of ceftazidime and chloramphenicol, a possible antagonistic effect should be taken into account.
High-dose cephalosporin antibiotics should be used with caution in patients receiving nephrotoxic drugs (for example, aminoglycoside antibiotics or potent diuretics, such as furosemide), since such combinations can have an adverse effect on kidney function. Experience with the clinical use of ceftazidime has shown that if the recommended dosing regimen is observed, this action is unlikely.

The drug should be stored in a dark place at a temperature no higher than 25 ° C.