Fortum 2g 1 piece powder for solution for injection

Pharmacological properties of the drug Fortum™

Pharmacodynamics . Ceftazidime is a bactericidal cephalosporin antibiotic, the mechanism of action of which is due to disruption of the synthesis of the bacterial cell wall. It has high activity against a wide range of gram-positive and gram-negative bacteria, including strains resistant to gentamicin and other aminoglycoside antibiotics. Very resistant to the action of most β-lactamases produced by both gram-positive and gram-negative microorganisms. in vitro activity and is active within a narrow minimum inhibitory concentration (MIC) range against most infectious agents. In vitro studies have shown that when the drug is used in combination with aminoglycoside antibiotics, an additive effect is noted, and in experiments with some strains, synergistic phenomena were also recorded. In vitro studies have shown that ceftazidime is active against the following microorganisms:

• gram-negative: Pseudomonas aeruginosa, Pseudomonas spp . (including Pseudomonas pseudomallei ), Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae), Proteus mirabilis, Proteus vulgaris, Morganella morganii (Proteus morganii), Proteus rettgeri, Providencia spp., Enterobacter spp., Citrobacter spp., Serratia spp., Salmonella spp., Shigella spp., Yersinia enterocolitica, Pasteurella multocida, Acinetobacter spp., Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae (including ampicillin-resistant strains);
• gram-positive: Staphylococcus aureus (strains sensitive to methicillin) , Staphylococcus epidermidis (strains sensitive to methicillin), Micrococcus spp., Streptococcus pyogenes (β-hemolytic streptococci of group A), Streptococcus group B ( Streptococcus agalactiae ), Streptococcus pneumoniae, Streptococcus m itis , Streptococcus spp. (excluding Streptococcus faecalis );
• anaerobic: Peptococcus spp ., Peptostreptococcus spp., Streptococcus spp., Propionibacterium spp., Clostridium perfringens, Fusobacterium spp., Bacteroides spp. (many strains of Bacteroides fragilis are resistant).

Ceftazidime is inactive in vitro against methicillin-resistant staphylococci, Streptococcus faecalis and many other enterococci, Listeria monocytogenes, Campylobacter spp. and Clostridium difficile . Pharmacokinetics . In patients after intramuscular injection at a dose of 500 mg and 1 g, the average maximum concentration of 18 and 37 mg/l, respectively, is quickly achieved. 5 minutes after an intravenous bolus injection of 500 mg, 1 or 2 g in the blood plasma, an average concentration of 46, 87 or 170 mg/l is achieved, respectively. The therapeutically effective concentration remains in the blood plasma even 8–12 hours after IV and IM administration. Plasma protein binding is about 10%. Concentrations of ceftazidime exceeding the MIC for most common pathogens are achieved in tissues and media such as bone, heart, bile, sputum, intraocular, synovial, pleural and peritoneal fluids. Ceftazidime quickly crosses the placenta and is excreted into breast milk. The drug penetrates poorly through the intact BBB; the concentration of the drug in the central nervous system in the absence of inflammation is insignificant. However, with inflammation of the meninges, the concentration of ceftazidime in the central nervous system is ≥4–20 mg/l, which corresponds to the level of its therapeutic concentration. Ceftazidime is not metabolized in the body. After parenteral administration, a high and stable concentration of ceftazidime in the blood plasma is achieved. The half-life is about 2 hours. The drug is excreted unchanged in its active form by the kidneys by glomerular filtration; about 80–90% of the dose is excreted in the urine within 24 hours. In patients with impaired renal function, the elimination of ceftazidime is reduced, so the dose of the drug should be reduced. Less than 1% of the drug is excreted in the bile, which significantly limits the amount of drug that enters the intestine.

Indications for use of the drug Fortum™

ceftazidime is intended for the treatment of mono- and mixed infections caused by susceptible microorganisms.

• Severe infections: – sepsis, bacteremia, peritonitis, meningitis; – infections in patients with reduced immunity; – in intensive care unit patients, for example with infected burns.
• Respiratory tract infections, including lung infections in patients with cystic fibrosis.
• Infections of ENT organs.
• Urinary tract infections.
• Skin and soft tissue infections.
• Infections of the gastrointestinal tract, biliary tract and abdominal cavity.
• Bone and joint infections.
• Infections associated with hemo- and peritoneal dialysis or continuous ambulatory peritoneal dialysis.
• For prophylactic purposes during surgical interventions on the prostate gland (transurethral resection).

Fortum 2g n1 powder for solution for injection

Latin name

Fortum

Release form

Powder for preparation of injections.

Compound

1 fl. contains ceftazidime (in the form of pentahydrate) 250, 500, 1000 and 2000 mg,

excipients: sodium carbonate (anhydrous); carbon dioxide

Package

There is 1 bottle in a cardboard pack.

pharmachologic effect

Fortum has a broad spectrum antibacterial and bactericidal effect.

Indications

Severe infections, including nosocomial infections (septicemia, bacteremia, peritonitis, meningitis, infections in patients with reduced immunity, infected burns); respiratory tract infections and infections in patients with cystic fibrosis; ENT infections; urinary tract infections; skin and soft tissue infections; infections of the gastrointestinal tract, biliary tract and abdominal cavity; bone and joint infections; infections associated with dialysis; prevention of infectious complications during prostate surgery (transurethral resection).

Contraindications

Hypersensitivity to ceftazidime or any other component of Fortum and to other cephalosporin antibiotics, penicillins.

Directions for use and doses

IV or IM deep into the upper outer quadrant of the gluteus maximus muscle or lateral thigh. Ceftazidime solution can be injected directly into a vein or into an infusion line. The dose of the drug is set individually depending on the severity of the disease, localization, type of pathogen and its sensitivity to the drug, as well as on the patient’s age and kidney function. The maximum daily dose is 6 g.

Use during pregnancy and breastfeeding

Carefully.

Side effects

Local reactions:

phlebitis or thrombophlebitis with intravenous administration of Fortum; pain, burning, compaction at the injection site during intramuscular injection.

Hypersensitivity reactions:

maculopapular rash, urticaria, fever, itching, angioedema, bronchospasm, decreased blood pressure, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From the gastrointestinal tract:

diarrhea, nausea, vomiting, abdominal pain; oropharyngeal candidiasis, colitis. As with other cephalosporins, colitis can be caused by Clostridium difficile and manifest as pseudomembranous colitis.

From the genitourinary system:

candidal vaginitis, renal dysfunction.

From the hepatobiliary system and pancreas:

very rarely - jaundice.

From the side of the central nervous system:

headache, dizziness, paresthesia, disturbance of taste. Patients with renal failure are more likely than others to experience neurological disorders, including tremor, myoclonus, convulsions, encephalopathy, and coma.

From the laboratory parameters:

eosinophilia, false-positive direct Coombs reaction, thrombocytosis, increased activity of liver enzymes - ALT, AST, LDH, gamma-glutamyl transpeptidase and alkaline phosphatase. Sometimes there is a transient increase in the level of urea, urea nitrogen and/or creatinine in the blood.

From the hematopoietic organs:

leukopenia, neutropenia, agranulocytosis, thrombocytopenia, lymphocytosis, hemolytic anemia.

special instructions

If an allergic reaction to ceftazidime develops, the drug should be discontinued immediately; in severe cases, the use of adrenaline, hydrocortisone, antihistamines and other emergency measures may be required. When taking high-dose cephalosporins concomitantly with nephrotoxic drugs such as aminoglycosides and diuretics (furosemide), it is necessary to monitor renal function. Since ceftazidime is excreted via the kidneys, in patients with renal impairment the dose should be reduced according to the degree of renal impairment. Long-term use of broad-spectrum antibiotics, incl. and ceftazidime may lead to an increase in the growth of non-susceptible microorganisms (eg Candida, Enterococci), which may require discontinuation of treatment or appropriate therapy. During treatment, it is necessary to constantly assess the patient's condition. When treated with ceftazidime, some initially susceptible strains of Enterobacter and Serratia may develop resistance, so antibiotic susceptibility testing should be performed periodically when treating infections caused by these microorganisms. Ceftazidime does not affect the results of determining glucose in urine using enzymatic methods, but may have a slight effect on the results of methods based on copper reduction (Benedict, Fehling, Clinitest). Ceftazidime does not affect the quantitative determination of creatinine by the alkaline picrine method (Jaffe method).

Interaction

Concomitant administration of high doses of ceftazidime and nephrotoxic drugs may have an adverse effect on renal function.

Loop diuretics, aminoglycosides, vancomycin, and clindamycin reduce the clearance of ceftazidime, resulting in an increased risk of nephrotoxicity.

Bacteriostatic antibiotics (including chloramphenicol) reduce the effect of beta-lactam antibiotics.

Overdose

Symptoms:

neurological disorders (including encephalopathy, seizures, coma).

Treatment:

carrying out symptomatic and supportive therapy. Serum concentrations of ceftazidime may be reduced during hemodialysis or peritoneal dialysis.

Storage conditions

Store in a place protected from light, at a temperature not exceeding 20°C.

Best before date

3 years.

Use of the drug Fortum™

The dose depends on the severity of the disease, sensitivity, location and type of infection, as well as the age and renal function of the patient. It is recommended to conduct a skin tolerance test before using the drug. Adults In most cases, the daily dose is 1-6 g 2-3 times a day by intravenous or intramuscular injection. Urinary tract and less severe infections: 500 mg–1 g every 12 hours. Most infections: 1 g every 8 hours or 2 g every 12 hours. Very severe infections, especially in immunocompromised patients, including those with neutropenia: 2 g every 8 or 12 hours or 3 g every 12 hours. Cystic fibrosis as a complication of Pseudomonas aeruginosa lung infection: from 100 to 150 mg/kg/day in 3 divided doses. Therapy with the drug should be continued for another 2 days after the symptoms of the infection have subsided, but for severe infections, treatment may be longer. Doses up to 9 g/day in adults with normal renal function did not cause any complications. For prophylactic purposes during surgical interventions on the prostate gland, 1 g should be administered during induction of anesthesia, the second dose is administered at the time of removal of the catheter from the urethra. Newborns (0–2 months): 25–60 mg/kg/day as 2 injections. In neonates, the plasma half-life of ceftazidime may be 3–4 times longer than in adults. Children over 2 months of age and up to one year: 30–100 mg/kg/day in 2–3 doses. For children with immunodeficiency, cystic fibrosis or meningitis, it is recommended to administer doses up to 150 mg/kg/day (maximum 6 g/day) in 3 divided doses. Elderly patients. Given the reduced clearance of ceftazidime, in elderly patients with acute infections the daily dose should not exceed 3 g (especially for patients over 80 years of age). The duration of therapy is determined individually. Dosing for renal impairment. Ceftazidime is excreted unchanged in the urine. Therefore, in patients with impaired renal function, the dose should be reduced. The initial dose is 1 g. The determination of the maintenance dose should be based on the glomerular filtration rate. Recommended maintenance doses of ceftazidime for renal failure

For patients with severe infections, the single dose can be increased by 50% or the frequency of administration increased accordingly. In such patients, it is recommended to monitor the plasma level of ceftazidime, which should not exceed 40 mg/l. In children, creatinine clearance should be adjusted in relation to surface area or body weight. Hemodialysis The half-life of ceftazidime from blood plasma during hemodialysis is 3–5 hours. After each hemodialysis session, a maintenance dose of ceftazidime recommended in the table above should be administered. Peritoneal dialysis Ceftazidime can be used in routine peritoneal dialysis and in long-term ambulatory peritoneal dialysis. In addition to IV use, ceftazidime can be included in the dialysis fluid (usually from 125 to 250 mg per 2 liters of dialysis fluid). For patients with renal failure undergoing long-term arteriovenous hemodialysis or high-flow hemofiltration in intensive care units, the recommended dose is 1 g/day as a single dose or in divided doses. For hemofiltration at a low rate, the same doses should be used as for impaired renal function. For patients undergoing venovenous hemofiltration or venovenous hemodialysis, dosing recommendations are given in the tables. Ceftazidime dosing recommendations for patients undergoing long-term venovenous hemofiltration

*Maintenance dose should be administered every 12 hours.

Dosing recommendations for ceftazidime in patients undergoing long-term venovenous hemodialysis

*Maintenance dose should be administered every 12 hours.

Administration Fortum is administered intravenously or by deep intramuscular injection. IM injection is recommended to be carried out in the upper outer quadrant of the gluteus maximus muscle or the lateral surface of the thigh. Ceftazidime solutions can be administered directly into a vein or into an intravenous infusion system if the patient is undergoing parenteral therapy. Fortum is compatible with the most commonly used solutions for intravenous administration. The dry substance in the bottles is under reduced pressure. As the drug dissolves, carbon dioxide is released and the pressure in the bottle increases. Small bubbles of carbon dioxide in the dissolved drug do not affect its use.

*Dissolution should be carried out in 2 stages (see text).

Fortum is compatible with most solutions used for parenteral administration. However, sodium bicarbonate injection should not be used as a solvent (see INTERACTIONS). 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 at a concentration of 1–40 mg/ml is compatible with the following solutions: 0.9% sodium chloride solution; 6M sodium lactate solution; Hartman solution; 5% glucose solution; 0.225% sodium chloride solution in 5% glucose solution; 0.45% sodium chloride solution in 5% glucose solution; 0.9% sodium chloride solution in 5% glucose solution; 0.18% sodium chloride solution in 4% glucose solution; 10% glucose solution; 10% solution of dextran-40 in 0.9% solution of sodium chloride; 10% solution of dextran-40 in 5% solution of glucose; 6% dextran-70 solution in 0.9% sodium chloride solution; 6% dextran-70 solution in 5% glucose solution. Ceftazidime at a concentration of 0.05–0.25 mg/ml is compatible with intraperitoneal dialysis fluid (lactate). Ceftazidime for intramuscular administration can be dissolved in 0.5 or 1% lidocaine solution. The effectiveness of both drugs is maintained when mixing ceftazidime at a dose of 4 mg/ml with the following substances: hydrocortisone (hydrocortisone sodium phosphate) 1 mg/ml in 0.9% sodium chloride solution or 0.5% glucose 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 or 50 IU/ml in 0.9% sodium chloride solution; potassium chloride 10 or 40 meq/l in 0.9% sodium chloride solution. The contents of the bottle - 500 mg, dissolved in 1.5 ml of water for injection, can be added to a solution of metronidazole (500 mg in 100 ml), while both drugs retain their activity. Preparation of solutions for intramuscular or intravenous bolus injection Inject the syringe needle through the bottle cap and inject the recommended volume of solvent. Remove the syringe needle and shake the bottle several times to dissolve the dry substance and obtain a clear solution. Turn the bottle over. With the syringe plunger fully inserted, insert the needle into the bottle. Draw the entire solution into the syringe, while the needle should be in the solution at all times. Small bubbles of carbon dioxide can be neglected. Preparation of solutions for intravenous infusion (1 g and 2 g bottles) Inject the syringe needle through the bottle cap and inject 10 ml of solvent. Remove the syringe needle and shake the bottle several times to dissolve the dry substance and obtain a clear solution. Insert an air needle through the cap into the bottle to increase pressure. Without removing the air needle, add another 40 ml of solvent. Remove the air needle, shake the bottle and set up the infusion system as usual. Note. To ensure the sterility of the drug, it is very important not to insert the air needle through the cap of the vial until the drug has dissolved.

Fortum instructions for use

pharmachologic effect

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. In vitro studies have shown that ceftazidime is 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., Yersinia enterocolitica, Pasteurella multocida, Acinetobacter spp., Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae (including ampicillin-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 is not active against methicillin-resistant staphylococci, Streptococcus faecalis and many other Enterococci, Listeria monocytogenes, Campylobacter spp. and Clostridium difficile.

Indications

Treatment of monoinfections or mixed infections caused by microorganisms sensitive to the drug: - severe infections (septicemia, bacteremia, peritonitis, meningitis, infections in patients with reduced immunity; infections in patients in intensive care units, such as infected burns); – respiratory tract infections, including lung infections and cystic fibrosis; – ear, nose and throat infections; - urinary tract infections; – infections of the skin and soft tissues; – infections of the gastrointestinal 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 prostate surgery (transurethral resection). Fortum can be used without combination with other antibacterial agents as a first-choice drug until data on the sensitivity of microorganisms is obtained. Fortum can be used in combination with aminoglycosides and most other beta-lactamase-resistant antibiotics. Fortum may be used in combination with other antibiotics for anaerobic infections if the presence of Bacteroides fragilis is suspected.

Dosage regimen

The drug is used only parenterally. The dose is set individually, depending on the severity of the disease, the type of pathogen, age, body weight, and kidney function. The drug is administered IV or deep IM in the area of ​​the upper outer quadrant of the gluteus maximus muscle or in the area of ​​the lateral thigh. Ceftazidime solution can be injected directly into a vein or into an infusion line. For adults

Prescribe 1-6 g/day IV or IM.
Frequency of administration: 2-3 times/day. For urinary tract infections, 0.5-1 g is prescribed every 12 hours. For most infections, a dose of 1 g every 8 hours or 2 g every 12 hours is effective. In severe cases of the disease, especially in patients with reduced immunity, including patients with neutropenia, it should be prescribed 2 g every 8 or 12 hours or 3 g every 12 hours. Patients with cystic fibrosis and lung infections caused by pseudomonas are prescribed Fortum at a dose of 100-150 mg/kg/day; frequency of administration - 3 times/day. To prevent infectious complications during prostate surgery, the drug is administered at a dose of 1 g before induction of anesthesia. The second dose is administered when the catheter is removed. For children over 2 months of age,
the drug is prescribed at a dose of 30-100 mg/kg/day;
frequency of administration - 2-3 times/day. Children with reduced immunity, with cystic fibrosis or meningitis are prescribed up to 150 mg/kg/day (maximum 6 g/day); frequency of injections - 3 times/day. For newborns and infants under 2 months of age,
the drug is prescribed at a dose of 25-60 mg/kg/day;
frequency of injections - 2 times/day. For elderly patients
, taking into account the reduced clearance of ceftazidime in acute diseases, it is recommended to prescribe Fortum at a dose of no more than 3 g/day, especially for patients over 80 years of age.
The dosage regimen for patients with impaired renal function
is established depending on the CC values. The initial dose is 1 g. Recommended maintenance doses:

For patients with severe infections, the single dose can be increased by 50% or the frequency of administration of the drug can be increased. In this case, the level of ceftazidime in the blood serum should be monitored; the concentration of ceftazidime should not exceed 40 mg/l. For children,
creatinine clearance is calculated according to ideal weight or body surface area.
Hemodialysis.
After each hemodialysis session, maintenance doses of ceftazidime are administered in accordance with the table above.
Peritoneal dialysis.
In addition to intravenous administration, ceftazidime can be included in the dialysis solution (usually 125-250 mg per 2 liters of dialysis solution).
For patients with renal failure on continuous hemodialysis using an arteriovenous shunt, and for patients on high-flow hemofiltration in the intensive care unit, the recommended dose is: 1 g/day daily (in 1 or more administrations). For patients undergoing low-rate hemofiltration, it is prescribed in doses recommended for impaired renal function. Rules for preparing injection solution
Fortum is compatible with most solutions for intravenous administration. However, ceftazidime is less stable in sodium bicarbonate solution and is therefore not recommended for use as a solvent. Fortum should not be mixed with aminoglycosides in the same syringe or system. When vancomycin was added to a ceftazidime solution, precipitation was observed. Therefore, it is recommended to flush the infusion system between administrations of these two drugs. Fortum in powder form is stored in bottles under reduced pressure. When the powder dissolves, carbon dioxide is released, and the pressure in the bottle increases. The resulting finished solution of the drug may contain small bubbles of carbon dioxide; this can be ignored.

*Addition is carried out in 2 injections. Depending on the concentration, type of solvent and storage conditions, the resulting Fortum solution can have a color ranging 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. Ceftazidime at concentrations from 1 to 40 mg/ml is compatible with the following solutions: 0.9% sodium chloride solution; M/6 sodium lactate solution; Hartmann's solution (complex sodium lactate solution); 5% dextrose solution; 0.225% sodium chloride solution and 5% dextrose solution; 0.45% sodium chloride solution and 5% dextrose solution; 0.9% sodium chloride solution and 5% dextrose solution; 0.18% sodium chloride solution and 4% dextrose solution; 10% dextrose solution; dextran 40: 10% in 0.9% sodium chloride solution; 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 of 0.05 to 0.25% mg/ml, ceftazidime is compatible with intraperitoneal dialysis solution (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 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. Preparation of a solution for IM or IV bolus administration
1. Insert the syringe needle into the cap of the bottle and add the recommended amount of solvent.
2. Remove the syringe needle and shake the bottle to obtain a clear solution. 3. Turn the bottle over. With the syringe plunger fully inserted, insert the needle into the cap of the bottle so that the needle is completely in the solution. Draw up the entire solution into the syringe (the needle must be in the 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 cap of the bottle and add 10 ml of solvent. 2. Remove the syringe needle and shake the bottle to obtain a clear solution. 3. Insert the gas release needle into the cap of the bottle to reduce the internal pressure. 4. Without removing the needle to release the gas, add the remaining amount of solvent to the bottle. Remove both needles from the bottle cap (gas outlet needle and syringe needle); shake the bottle and set it for infusion. To ensure sterility, it is important not to insert a needle into the vial to release gas until the powder has dissolved.

Side effect

From the digestive system: diarrhea, nausea, vomiting, abdominal pain, transient increase in the activity of transaminases, LDH, GGT and alkaline phosphatase; rarely - stomatitis, colitis (including pseudomembranous). From the hematopoietic system: eosinophilia; very rarely - leukopenia, neutropenia, agranulocytosis, thrombocytopenia, lymphocytosis. From the central nervous system and peripheral nervous system: headaches, dizziness, paresthesia, disturbance of taste; in patients with renal failure, if the dose is incorrectly selected, tremor, convulsions, encephalopathy. Other: positive Coombs test without hemolysis, transient increase in serum creatinine level. Effects due to biological action: superinfection (candidiasis, including the vaginal mucosa). Allergic reactions: rash, urticaria, fever, itching, 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 intravenous administration, pain at the site of intramuscular injection.

Contraindications

– hypersensitivity to ceftazidime, cephalosporins.

Pregnancy and lactation

Fortum should be used with caution in the first trimester of pregnancy. Ceftazidime is excreted into breast milk in low concentrations, so caution must be exercised when prescribing the drug during breastfeeding. Experimental studies have not provided data confirming the possibility of embryopathic or teratogenic effects of ceftazidime.

special instructions

Before starting therapy with Fortum, it is necessary to establish that the patient has not experienced hypersensitivity reactions to ceftazidime, antibiotics from the group of cephalosporins and penicillin, or to other drugs. Fortum should be prescribed with extreme caution to patients who have a history of allergic reactions to antibiotics from the penicillin group or other antibiotics resistant to beta-lactamases. If an allergic reaction to ceftazidime develops, the drug should be discontinued immediately. If hypersensitivity reactions develop, the use of adrenaline, hydrocortisone, antihistamines and other emergency measures may be indicated. Long-term use of broad-spectrum antibiotics, incl. and Fortum may lead to an increase in the growth of non-susceptible microorganisms (eg Candida, Enterococcus), which may require discontinuation of treatment or appropriate therapy. During treatment, it is necessary to constantly assess the patient's condition. As with the use of other broad-spectrum antibiotics from the penicillin or cephalosporin group, resistance may develop in some sensitive Enterobacter strains when treated with Fortum. Therefore, if necessary, when treating infections caused by Enterobacter, sensitivity testing of microorganisms should be periodically carried out. In case of renal failure, the dose of Fortum is reduced in accordance with the degree of renal dysfunction. With incorrect selection of doses, isolated cases of neurological disorders have been reported. Ceftazidime does not affect the results of enzymatic methods for determining glucose in urine, but may to a small extent affect the results of tests with copper reduction (Benidicta, Fehling, Clinitest). Ceftazidime does not affect the results of creatinine determination in the alkaline picrate test. Use in pediatrics Use the drug with caution in newborns

.

Overdose

Symptoms: neurological disorders (including encephalopathy, seizures, coma). Treatment: Ceftazidime serum concentrations can be reduced by dialysis or peritoneal dialysis.

Drug interactions

In vitro, chloramphenicol acts as an antagonist to 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, the possible antagonistic effect should be taken into account. High-dose cephalosporin antibiotics should be administered with caution to patients receiving nephrotoxic drugs (eg, aminoglycoside antibiotics or potent diuretics such as furosemide) as such combinations may have adverse effects on renal function. Experience with the clinical use of ceftazidime has shown that this effect is unlikely if the recommended dosage regimen is followed.

Storage conditions and periods

The drug should be stored in a place protected from light at a temperature not exceeding 25°C. When accidentally stored at a temperature not exceeding 30°C for 2 months, no qualitative changes in the drug were observed. Keep out of the reach of children. Shelf life – 3 years. Do not use the drug after the expiration date indicated on the package. Freshly prepared Fortum solutions can be stored at a temperature not exceeding 25°C for 18 hours or for 7 days at a temperature of 4°C (in the refrigerator). Conditions for dispensing from pharmacies The drug is dispensed with a prescription.

Side effects of the drug Fortum™

Side effects were classified by organs and systems and by the frequency of their occurrence: very often (1/10); often (1/100–1/10); uncommon (1/1000–1/100); rare (1/10,000–1/1000); very rare (1/10,000). Infections and infestations Uncommon : candidiasis (including vaginitis and aphthous stomatitis). Blood and lymphatic systems Often - eosinophilia and thrombocytosis; uncommon - leukopenia, neutropenia and thrombocytopenia; very rarely - lymphocytosis, hemolytic anemia and agranulocytosis. Immune system Very rarely - anaphylaxis (including bronchospasm and/or hypotension). CNS Uncommon : dizziness, headache; very rarely - paresthesia. Cases of neurological complications such as tremor, myoclonus, convulsions, encephalopathy and coma have been reported in patients with renal failure for whom the dose of ceftazidime was not appropriately reduced. Vascular disorders Often - phlebitis or thrombophlebitis at the site of drug administration. Gastrointestinal disorders Often - diarrhea; uncommon - nausea, vomiting, abdominal pain, colitis; very rarely - taste disturbance. As with other cephalosporins, colitis may manifest as pseudomembranous colitis associated with Clostridium difficile. From the urinary system Very rarely - interstitial nephritis, acute renal failure. Reactions from the hepatobiliary system Often - a transient increase in the level of liver enzymes (ALAT, AST, LDH, gamma-glutamine transferase, alkaline phosphatase); very rarely - jaundice. Skin and subcutaneous tissue disorders Common : maculopapular rash or urticaria; infrequently - itching; very rarely - angioedema, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. General reactions and disorders at the injection site Often - pain and/or inflammation at the site of intravenous injection; infrequently - fever. Laboratory indicators Often - positive Coombs test; infrequently - as with the use of some other cephalosporins, a transient increase in the level of urea, urea nitrogen and/or creatinine in the blood plasma was sometimes noted. A positive Coombs test is observed in approximately 5% of patients, which may affect the accuracy of the blood typing result.

Special instructions for the use of Fortum™

Before starting treatment, the patient should exclude a history of hypersensitivity reactions to the administration of ceftazidime or other cephalosporin antibiotics or penicillins. Ceftazidime should be prescribed with extreme caution to patients who have a history of an allergic reaction to penicillins or other β-lactam antibiotics. If an allergic reaction to ceftazidime occurs, discontinue use of the drug immediately. If severe hypersensitivity reactions occur, the use of epinephrine, hydrocortisone, antihistamines and other emergency medications may be necessary. Concomitant use of high doses of cephalosporins and nephrotoxic drugs (aminoglycosides or potent diuretics (furosemide)) may adversely affect renal function. Experience with the clinical use of ceftazidime has shown that this phenomenon is unlikely if the recommended doses are observed. There is no evidence of an adverse effect of ceftazidime, used in usual therapeutic doses, on renal function. Ceftazidime is excreted by the kidneys, so the dose should be reduced according to the degree of renal impairment. Cases of neurological complications have been reported if the dose was not appropriately reduced. As with the use of other broad-spectrum antibiotics, prolonged treatment with Fortum may lead to an excessive increase in the number of insensitive microorganisms (for example, Candida, Enterococci ); in this case, it may be necessary to discontinue treatment or apply appropriate measures. It is very important to constantly monitor the patient's condition. As with other cephalosporins and broad-spectrum antibiotics, some previously susceptible strains of Enterobacter spp . and Serratia spp. may become resistant during treatment with ceftazidime. To monitor the development of microflora resistance during treatment, microflora should be periodically tested for sensitivity to antibiotics. During pregnancy and breastfeeding. Experimental evidence of embryotoxic and teratogenic effects of ceftazidime has not been identified, but, like other drugs, it should be prescribed with caution to women in the first trimester of pregnancy and infants. Ceftazidime passes into breast milk in small amounts and should therefore be administered with caution during breastfeeding. Children . It is used in children from the first days of life. The effect on the ability to drive vehicles and other machinery has not been described .

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Fortum, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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Drug interactions Fortum™

Combination therapy of high-dose cephalosporins with nephrotoxic drugs may adversely affect renal function. Chloramphenicol in vitro to ceftazidime and other cephalosporins. The clinical significance of this phenomenon is unknown, however, if concomitant use of Fortum with chloramphenicol is proposed, the possibility of antagonism should be considered. Like other antibiotics, Fortum can affect the intestinal microflora, which leads to a decrease in estrogen reabsorption and a decrease in the effectiveness of combined oral contraceptives. Ceftazidime does not affect the results of determining glucose in urine by enzymatic methods and has a slight effect on the results of the study when using methods based on copper reduction (Benedict, Felling, Clinitest). Ceftazidime does not affect the alkaline picrate method for determining creatinine. Incompatibility Fortum is less stable in sodium bicarbonate solution for injection than in other solutions for intravenous administration, therefore it is not recommended for use as a solvent. Ceftazidime and aminoglycosides should not be mixed in the same infusion set or syringe. When adding vancomycin solution to ceftazidime, sediment may form, so it is recommended to flush infusion systems and IV catheters between use of these drugs.