Klaforan: Instructions for use: Description of the drug: Price on EUROLAB

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Manufacturers: Aventis Pharma (UK)

Active ingredients

Cefotaxime

Disease class

Powder for the preparation of a solution for intravenous and intramuscular administration of Claforan (Claforan)

Instructions for medical use of the drug

Description of pharmacological action

Cefotaxime is bactericidal. It is also resistant to most β-lactamases. The following are usually sensitive to the drug: Aeromonas hydrophila; Bacillus subtilis; Bordetella pertussis; Borrelia burgdorferi; Moraxella (Branhamella) catarrhalis; Citrobacter diversus; Clostridium perfringens; Corynebacterium diphtheriae; Escherichia coli; Enterobacter spp. (sensitivity depends on epidemiological data and the level of resistance in each specific country); Erysipelothrix insidiosa; Eubacterium; Haemophilus penicillinase-forming and non-penicillinase-forming strains, including ampi-R; Klebsiella pneumoniae; Klebsiella oxytoca; Methi-S-Staphylococcus, including penicillinase-forming and non-penicillinase-forming strains; Morganella morganii; Neisseria gonorrhoeae, including penicillinase-forming and non-penicillinase-forming strains; Neisseria meningitidis; Propionibacterium; Proteus mirabilis, vulgaris; Providencia; Streptococcus pneumoniae, Salmonella; Seratia spp. (sensitivity depends on epidemiological data and the level of resistance in each specific country); Shigella, Streptococcus spp.; Veillonella; Yersinia (sensitivity depends on epidemiological data and the level of resistance in each specific country). The following are resistant to the drug: Acinetobacter baumannii, Bacteroides fragilis; Clostridium difficile; Enterococcus; gram-negative anaerobes; Listeria monocytogenes, Methi-R staphylococcus; Pseudomonas aeruginosa, Pseudomonas cepacia; Stenotrophomonas maltophilia.

Indications for use

Treatment of infections caused by microorganisms sensitive to the drug: - respiratory tract infections; - urinary tract infections; - septicemia, bacteremia; - endocarditis; - intra-abdominal infections (including peritonitis); - meningitis (except for listeria) and other infections of the central nervous system; - infections of the skin and soft tissues; - infections of bones and joints; — prevention of infections after surgical operations on the gastrointestinal tract, urological and obstetric-gynecological operations.

Release form

powder for preparing a solution for intravenous and intramuscular administration 1 g; bottle (bottle) with solvent in ampoules, box (box) 1; powder for preparing a solution for intravenous and intramuscular administration 1 g; bottle (bottle) with solvent in ampoules, box (box) 1; powder for preparing a solution for intravenous and intramuscular administration 1 g; bottle (bottle), box (box) 1; powder for preparing a solution for intravenous and intramuscular administration 1 g; bottle (bottle), tray 162, transport box 110; Composition Powder for preparing a solution for intravenous and intramuscular administration 1 fl. cefotaxime 1 g (corresponds to 1.048 g of cefotaxime sodium salt) in vials (complete with solvent in ampoules); 1 bottle in a box.

Pharmacodynamics

Pharmacokinetics

In adults, 5 minutes after a single intravenous injection of 1 g of cefotaxime, the concentration in the blood plasma is 100 mcg/ml. After intramuscular administration of cefotaxime at the same dose, the maximum concentration in the blood plasma is detected after 0.5 hours and ranges from 20 to 30 mcg/ml. T1/2 of the drug is 1 hour with intravenous administration and 1–1.5 hours with intramuscular administration. Binding to plasma proteins (mainly albumin) averages 25–40%. About 90% of the administered dose is excreted in the urine: 50% unchanged and about 20% as a metabolite of desacetylcefotaxime. In the elderly (over 80 years old), T1/2 of cefotaxime increases to 2.5 hours. In adults with impaired renal function, the volume of distribution does not change, and T1/2 does not exceed 2.5 hours, even in the last stages of renal failure. In children, newborns and premature infants, cefotaxime plasma levels and volume of distribution are similar to those in adults receiving the same mg/kg dose of the drug. T1/2 of cefotaxime ranges from 0.75 to 1.5 hours. In newborns and prematurely born children, the plasma level of cefotaxime and the volume of distribution are similar to those in children. The average T1/2 of cefotaxime ranges from 1.4 to 6.4 hours.

Use during pregnancy

Cefotaxime penetrates the placental barrier. Studies conducted on animals did not reveal the teratogenic effect of the drug. However, the safety of cefotaxime during pregnancy in humans has not been determined and the drug should not be used during pregnancy. Cefotaxime passes into breast milk, so if it is necessary to prescribe the drug, breastfeeding should be interrupted.

Contraindications for use

- hypersensitivity to cephalosporins; For forms containing lidocaine: - hypersensitivity to lidocaine or other amide-type local anesthetic; — intracardiac blockade without an established pacemaker; - severe heart failure; - intravenous administration; - children under 2.5 years of age (i.m. administration).

Side effects

Anaphylactic reactions: angioedema, bronchospasm, weakness, rarely - anaphylactic shock. Skin reactions: rash, redness, urticaria. As with other cephalosporins, complications such as erythema multiforme, Stevens-Johnson syndrome, and toxic skin necrolysis are very rarely possible. Gastrointestinal reactions: nausea, vomiting, abdominal pain, diarrhea may occur. As with the prescription of other broad-spectrum antibiotics, diarrhea can be a symptom of enterocolitis, which in some cases is accompanied by the appearance of blood in the stool. A special form of enterocolitis is pseudomembranous colitis (see “Special Instructions”). Liver reactions: increased liver enzymes (ALT, AST, LDH, GGT, alkaline phosphatase) and/or bilirubin. Reactions from peripheral blood: neutropenia, rarely - agranulocytosis, eosinophilia, thrombocytopenia, in isolated cases - hemolytic anemia. Reactions from the kidneys: deterioration of renal function (increased creatinine levels), especially when combined with aminoglycosides, very rarely cases of interstitial nephritis have been reported. Reactions from the central nervous system: encephalopathy (in case of large doses), especially in patients with renal failure. Reactions from the cardiovascular system: in isolated cases - arrhythmias, following bolus administration through a central venous catheter (see "Dosage and Administration"). Other: fever, inflammation at the injection site, superinfection. When treating borreliosis: Jarisch-Herxheimer reaction (during the first days of treatment), skin rash, itching, fever, leukopenia, increased levels of liver enzymes, difficulty breathing and discomfort in the joints. In addition to the above, the rate of administration of the drug should be monitored (See “Dosage and Administration”), as well as renal function should be monitored in all cases of combined use of cefotaxime with aminoglycosides. In patients requiring sodium restriction, the sodium content of cefotaxime sodium salt (48.2 mg/g) should be taken into account. During the course of treatment (more than 10 days), the leukocyte count should be monitored and, in case of neutropenia, treatment should be discontinued.

Directions for use and doses

IM, IV (as a slow injection or infusion). Dosage in adults with normal renal function: For uncomplicated gonorrhea, the single dose is 0.5–1 g and is administered intramuscularly once. For uncomplicated infections of moderate severity, cefotaxime is administered in a single dose of 1–2 g intramuscularly or intravenously, after 8–12 hours, so the daily dose ranges from 2 to 6 g. For severe infections, a single dose is 2 g and is administered intravenously after 6–8 hours, so the daily dose ranges from 6 to 8 g. In cases where the infection is caused by insufficiently sensitive strains, an antibiotic sensitivity test is the only means of confirming the effectiveness of cefotaxime. Dosage in adults with impaired renal function: In cases where the creatinine level is less than 10 ml/min, half the single dose is used. The administration interval remains unchanged (see above). Accordingly, the daily dose will also be reduced by 2 times. In cases where creatinine Cl cannot be measured, it can be calculated from serum creatinine using the Cockcroft formula for adults. For men: Cl creatinine (ml/min) = Weight (kg) × (140 − age)/72 × creatinine (mg/%) or: Weight (kg) × (140 − age)/0.814 × creatinine (mmol/l ) For women: Cl creatinine (ml/min) = 0.85 × value for men For patients on hemodialysis: 1–2 g per day, depending on the severity of the infection. On the day of dialysis, cefotaxime is administered after the end of dialysis. In prematurely born children (up to 1 week of life), the daily dose of the drug is 50–100 mg/kg and is administered intravenously at intervals of 12 hours. In prematurely born children (1–4 weeks of life), the daily dose of the drug is 75–150 mg/kg kg and is administered intravenously at intervals of 8 hours. In children weighing up to 50 kg, the daily dose of the drug is 50–100 mg/kg and is administered intravenously or intramuscularly at intervals of 6–8 hours. Note: the daily dose is never should not exceed 2 g. In case of severe infections, for example meningitis, the daily dose may be doubled. IM administration with 1% lidocaine is strictly contraindicated in children under 2.5 years of age. Children weighing 50 kg or more are prescribed the drug in the same dose as adults. To prevent the development of infections before surgery, 1 g is usually administered intramuscularly or intravenously at the onset of anesthesia, with repeated administration 6–12 hours after surgery. When performing a cesarean section, at the time of applying clamps to the umbilical vein, 1 g of the drug is injected intravenously, then after 6–12 hours, 1 g of cefotaxime is re-introduced intramuscularly or intravenously. Method and duration of use: for intramuscular injection, dissolve cefotaxime with sterile water for injection in an amount of 4 ml for 1 g and 10 ml for 2 g. For intravenous infusion, 1 or 2 g of the drug is dissolved in 40–100 ml of sterile water for injections or infusion solution. Injection of the solution should be carried out slowly over 3–5 minutes, due to the possible development of life-threatening arrhythmias when cefotaxime is administered through a central venous catheter. For intramuscular administration, the contents of the cefotaxime vial can be dissolved in water for injection or in a 1% lidocaine solution. When using lidocaine, intravenous administration of the drug is strictly contraindicated (see “Special Instructions”). The duration of treatment is determined individually. Note: it is necessary to ensure aseptic conditions when diluting the contents of the bottle and preparing the solution (especially if the diluted cefotaxime is not administered immediately).

Overdose

There is a risk of developing reversible encephalopathy when using high doses of β-lactam antibiotics, including cefotaxime. There is no specific antidote.

Interactions with other drugs

Probenecid delays excretion and increases plasma concentrations of cephalosporins. As with other cephalosporins, cefotaxime may potentiate the nephrotoxic effect of drugs that have nephrotoxic effects. During therapy with cephalosporins, a positive Coombs test may occur. It is recommended to use glucose oxidase methods for determining blood sugar levels, due to the development of false-positive results when using nonspecific reagents. Compatibility instructions: cefotaxime should not be mixed with other antibiotics, either in the same syringe or in the same infusion solution. This also applies to aminoglycosides. For infusions, the following solutions can be used (cefotaxime concentration 1 g/250 ml): water for injection, 0.9% sodium chloride solution, 5% dextrose, Ringer's solution, sodium lactate, as well as: Hemaccel, Yonosteril, Macrodex 6%, Reomacrodex 12%, Tutofusin V.

Precautions for use

Anaphylactic reactions: - the prescription of cephalosporins requires the collection of an allergic history (allergic diathesis, hypersensitivity reactions to β-lactam antibiotics); - if the patient develops a hypersensitivity reaction, treatment should be discontinued; - the use of cefotaxime is strictly contraindicated in patients with a history of an immediate hypersensitivity reaction to cephalosporins. If there is any doubt, the presence of a doctor during the first administration of the drug is mandatory due to a possible anaphylactic reaction; — cross-allergy between cephalosporins and penicillins is known, which occurs in 5–10% of cases. In persons with a history of allergy to penicillins, the drug is used with extreme caution. Pseudomembranous colitis In the first weeks of treatment, pseudomembranous colitis may occur, manifested by severe, prolonged diarrhea. The diagnosis is confirmed by colonoscopy and/or histological examination. This complication is regarded as very serious: the administration of Claforan is immediately stopped and adequate therapy is prescribed, including oral vancomycin or metronidazole. When using lidocaine as a solvent, it is necessary to take into account the information presented in the “Contraindications” section. Shelf life of solutions after dilution For intramuscular injection: sterile cefotaxime powder after dilution in water or 0.5 or 1% solution of lidocaine hydrochloride is chemically stable for 8 hours (at room temperature not higher than +25 °C) or for 24 hours (at a temperature of 2–8 °C, protected from light). For injection or infusion when dissolved with water for injection: within 12 hours (at room temperature not exceeding +25 °C) or within 24 hours (at a temperature of 2–8 °C, protected from light). A pale yellow tint of the solution does not mean a decrease in the activity of the antibiotic. For infusion in infusion solutions: sterile cefotaxime powder is chemically stable for 8 hours after dilution in Hemaccel, Yonosteril or Tutofusin solution, and for 6 hours after dilution in 10% glucose solution, Macrodex or Reomacrodex.

Storage conditions

List B.: In a place protected from light, at a temperature not exceeding 25 °C

Best before date

24 months

ATX classification:

J Antimicrobials for systemic use

J01 Antimicrobials for systemic use

J01D Other beta-lactam antibiotics

J01DA Cephalosporins

J01DA10 Cefotaxime

Claforan®

The drug is administered intramuscularly or intravenously (as a slow injection or infusion).

Adults with normal kidney function

for
uncomplicated gonorrhea,
Claforan® is prescribed intramuscularly at a dose of 0.5-1 g once.

For uncomplicated moderate infections

Klaforan® is administered intramuscularly or intravenously in a single dose of 1-2 g with an interval of 8-12 hours; The daily dose is 2-6 g.

For severe infections

Klaforan® is administered intravenously in a single dose of 2 g, the interval between administrations is 6-8 hours; daily dose - 6-8 g.

In cases where the infection is caused by insufficiently sensitive strains, an antibiotic sensitivity test is the only means of confirming the effectiveness of Claforan.

Adults with impaired renal function (creatinine clearance 10 ml/min or less)

the single dose is reduced by 2 times, the interval between administrations is not changed, while the daily dose is also reduced by 2 times.

In cases where CK cannot be measured, it can be calculated from serum creatinine using the Cockcroft formula for adults.

For men:

body weight (kg) x (140-age) CC (ml/min) = ————————————-, 72 x serum creatinine (mg/dl) or body weight (kg) x (140 -age) CC (ml/min) = ——————————————-; 0.814 x serum creatinine (µmol/l)

For women:

CC (ml/min) = 0.85 x indicator for men.

For patients on hemodialysis

, prescribe 1-2 g/day depending on the severity of the infection. On the day of dialysis, Claforan® is administered after the end of the procedure.

In prematurely born children (up to 1 week of life)

The daily dose of Klaforan is 50-100 mg/kg IV, divided into 2 injections with an interval of 12 hours. In
prematurely born children (1-4 weeks of life),
the daily dose of Klaforan is 75-150 mg/kg IV, divided into 3 injections with an interval of 8 hours.

In children weighing up to 50 kg

The daily dose of Klaforan is 50-100 mg/kg, administered intravenously or intramuscularly at intervals of 6-8 hours. The daily dose should never exceed 2 g. For
severe infections, incl.
meningitis , the daily dose may be doubled.

Children weighing 50 kg or more

the drug is prescribed in the same dose as for adults.

IM administration of the drug with 1% lidocaine solution is strictly contraindicated in children under 2.5 years of age

To prevent the development of postoperative infections

before surgery, during induction anesthesia, the drug is administered intramuscularly or intravenously at a dose of 1 g with repeated administration 6-12 hours after surgery.

When performing a caesarean section

at the moment of applying clamps to the umbilical vein, Claforan® is administered intravenously at a dose of 1 g, then after 6-12 hours, 1 g of Claforan is re-introduced intramuscularly or intravenously.

The duration of treatment is determined individually.

Rules for preparing solutions for injections

To prepare a solution for intramuscular administration

The powder should be dissolved with sterile water for injection in an amount of 4 ml for 1 g and 10 ml for 2 g. A 1% solution of lidocaine can be used as a solvent for intramuscular administration. When using lidocaine as a solvent, intravenous administration of Claforan is strictly contraindicated.

To prepare a solution for intravenous administration

1 g or 2 g of powder is dissolved in 40-100 ml of sterile water for injection or infusion solution. The injection is carried out slowly over 3-5 minutes, due to the possible development of life-threatening arrhythmias when cefotaxime is administered through a central venous catheter. For infusions, the following solutions can be used (cefotaxime concentration 1 g/250 ml): water for injection, 0.9% sodium chloride solution, 5% dextrose (glucose) solution, Ringer's solution, sodium lactate solution, as well as solutions of hemaccel, ionosteril, macrodex 6%, reomacrodex 12%, Tutofusin V.

It is necessary to ensure aseptic conditions when dissolving dry substance for injection and preparing solutions for injection, especially if the diluted drug is not administered immediately.

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Pharmacodynamics

Semisynthetic antibiotic of the third generation cephalosporin group for parenteral use. Cefotaxime is bactericidal. It is also resistant to most b-lactamases.

The following are usually sensitive to the drug: Aeromonas hydrophila; Bacillus subtilis; Bordetella pertussis; Borrelia burgdorferi; Moraxella (Branhamella) catarrhalis; Citrobacter diversus; Clostridium perfringens; Corynebacterium diphtheriae; Escherichia coli; Enterobacter spp. (sensitivity depends on epidemiological data and the level of resistance in each specific country); Erysipelothrix insidiosa; Eubacterium spp.; Haemophilus spp., including penicillinase-forming and ampicillin-resistant; Klebsiella pneumoniae; Klebsiella oxytoca; methicillin-sensitive Staphylococcus spp., including penicillinase-forming strains; Morganella morganii; Neisseria gonorrhoeae, including penicillinase-producing strains; Neisseria meningitidis; Propionibacterium spp.; Proteus mirabilis; Proteus vulgaris; Providencia spp.; Streptococcus spp.; Salmonella spp.; Serratia spp. (sensitivity depends on epidemiological data and the level of resistance in each country); Shigella spp., Streptococcus spp.; Veillonella spp.; Yersinia spp. (sensitivity depends on epidemiological data and the level of resistance in each country).

The following are resistant to the drug: Acinetobacter baumannii, Bacteroides fragilis; Clostridium difficile; Enterococcus spp.; gram-negative anaerobes; Listeria monocytogenes; Staphylococcus spp., methicillin-resistant; Pseudomonas aeruginosa; Pseudomonas cepacia; Stenotrophomonas maltophilia.

In adults:

5 minutes after a single intravenous injection of 1 g of cefotaxime, the plasma concentration is 100 mcg/ml. After intravenous administration of cefotaxime at the same dose, the maximum plasma concentration is detected after 0.5 hours and ranges from 20 to 30 mcg/ml.

The half-life of the drug is 1 hour with intravenous administration and 1-1.5 hours with intramuscular administration. Binding to plasma proteins (mainly albumin) averages 25-40%.

About 90% of the administered dose is excreted in the urine: 50% unchanged and about 20% as a metabolite of desacetylcefotaxime.

In the elderly:

The half-life of cefotaxime increases to 2.5 hours in patients over 80 years of age.

In adults with impaired kidney function:

the volume of distribution does not change, and the half-life does not exceed 2.5 hours, even in the last stages of renal failure.

In children, newborns and premature newborns:

In children, cefotaxime plasma levels and volume of distribution are similar to those in adults receiving the same dose of the drug in mg/kg. The half-life of cefotaxime ranges from 0.75 to 1.5 hours.

In neonates and preterm neonates, cefotaxime plasma levels and volume of distribution are similar to those in children. The average half-life of cefotaxime ranges from 1.4 to 6.4 hours.

Cefotaxime is intended for the treatment of infections caused by microorganisms sensitive to the drug.

respiratory tract infections;
urinary tract infections;
septicemia, bacteremia;
endocarditis;
intra-abdominal infections (including peritonitis);
meningitis (except listeria) and other central nervous system infections;
skin and soft tissue infections;
infections of bones and joints.

Prevention of infections after surgical operations on the gastrointestinal tract, urological and obstetric-gynecological operations.

hypersensitivity to cephalosporins;
for forms containing lidocaine: hypersensitivity to lidocaine or other amide-type local anesthetic;
intracardiac blockade without an established pacemaker;
severe heart failure;
intravenous administration;
children under 2.5 years of age.

Anaphylactic reactions:

the prescription of cephalosporins requires the collection of an allergic history (allergic diathesis, hypersensitivity reactions to b-lactam antibiotics);
if the patient develops a hypersensitivity reaction, treatment should be discontinued;
the use of cefotaxime is strictly contraindicated in patients with a history of an immediate hypersensitivity reaction to cephalosporins.

If there is any doubt, the presence of a doctor during the first administration of the drug is mandatory due to a possible anaphylactic reaction.

Cross-allergy between cephalosporins and penicillins is known, which occurs in 5-10% of cases. In persons with a history of allergy to penicillins, the drug is used with extreme caution.

Pseudomembranous colitis.

In the first weeks of treatment, pseudomembranous colitis may occur, manifested by severe, prolonged diarrhea. The diagnosis is confirmed by colonoscopy or histological examination. This complication is regarded as very serious: the administration of Claforan is immediately stopped and adequate therapy is prescribed, including oral vancomycin or metronidazole.

Lidocaine-containing samples:

(see Contraindications)

Pregnancy and breastfeeding.

Cefotaxime passes into breast milk, so if it is necessary to prescribe the drug to the mother, breastfeeding should be interrupted.

Cefotaxime is administered intramuscularly or intravenously (as a slow injection or infusion).

Dosage in adults with normal renal function:

For uncomplicated gonorrhea, a single dose is 0.5-1 g and is administered intramuscularly once.
For uncomplicated infections of moderate severity, cefotaxime is administered in a single dose of 1-2 g IM or IV every 8-12 hours, so the daily dose ranges from 2 to 6 g.
For severe infections, a single dose is 2 g and is administered intravenously after 6-8 hours, so the daily dose ranges from 6 to 8 g.

In cases where the infection is caused by insufficiently sensitive strains, an antibiotic susceptibility test is the only means of confirming the effectiveness of cefotaxime.

In cases where the creatinine level is less than 10 ml/min, half a single dose is used. The interval between administrations remains unchanged (see above). Accordingly, the daily dose will also be halved.

In cases where creatinine clearance cannot be measured, it can be calculated from the serum creatinine level using the Cockcroft formula for adults:

For men:

ClCr (ml/min) = Weight (kg) x (140 – age)/72 x creatinine (mg%).

ClCr (ml/min) = Weight (kg) x (140 – age)/0.814 x creatinine (mmol/l).

For women:

ClCr (ml/min) = 0.85 x value in men.

For patients on hemodialysis:

1-2 g per day, depending on the severity of the infection. On the day of dialysis, cefotaxime is administered after the end of dialysis.

In prematurely born newborns (up to 1 week of life)

The daily dose of the drug is 50-100 mg/kg and is administered intravenously at intervals of 12 hours.

In prematurely born newborns (1-4 weeks of life)

The daily dose of the drug is 75-150 mg/kg and is administered intravenously at intervals of 8 hours.

In children weighing up to 50 kg

The daily dose of the drug is 50-100 mg/kg and is administered intravenously or intramuscularly at intervals of 6-8 hours.

Note:

the daily dose should never exceed 2 g.

In case of severe infections, e.g. for meningitis, it is possible to increase the daily dose by 2 times.

IM administration with 1% lidocaine is strictly contraindicated in children under 2.5 years of age.

Children weighing 50 kg or more

the drug is prescribed in the same dose as for adults.

To prevent infections before surgery, 1 g is usually administered intramuscularly or intravenously with the onset of anesthesia, then 6-12 hours after surgery.

When performing a cesarean section, at the time of applying clamps to the umbilical vein, 1 g is injected intravenously, then after 6-12 hours, 1 g is re-introduced intramuscularly or intravenously.

For intramuscular injection, dissolve cefotaxime with sterile water for injection in an amount of 4 ml for 1 g, and 10 ml for 2 g. For intravenous infusion, 1 g or 2 g of the drug is dissolved in 40-100 ml of sterile water for injection or infusion solution. The injection of the solution should be carried out slowly over 3-5 minutes due to the possible development of life-threatening arrhythmias when cefotaxime is administered through a central venous catheter.

For intramuscular administration, cefotaxime can be dissolved in water for injection or in a 1% lidocaine solution. When using lidocaine, intravenous administration of the drug is strictly contraindicated.

The duration of the course of treatment is determined individually.

Probenecid delays excretion and increases plasma concentrations of cephalosporins.

As with other cephalosporins, cefotaxime may potentiate the nephrotoxic effect of drugs that have nephrotoxic effects.

During therapy with cephalosporins, a positive Coombs test may occur.

It is recommended to use glucose oxidase methods for determining blood sugar levels due to the development of false positive results when using nonspecific reagents.

Anaphylactic reactions: angioedema, bronchospasm, weakness, rarely anaphylactic shock.
Skin reactions: rash, redness, urticaria. As with other cephalosporins, complications such as erythema multiforme, Stevens-Johnson syndrome, and toxic skin necrosis are very rarely possible.
Gastrointestinal reactions: nausea, vomiting, abdominal pain, diarrhea may occur. As with the prescription of other broad-spectrum antibiotics, diarrhea can be a symptom of enterocolitis, which in some cases is accompanied by the appearance of blood in the stool. A special form of enterocolitis is pseudomembranous colitis (see Warning).
Liver reactions: increased liver enzymes (ALT, AST, LDH, g-GT, alkaline phosphatase) or bilirubin.
Reactions from peripheral blood: neutropenia, rarely agranulocytosis, eosinophilia, thrombocytopenia, isolated cases of hemolytic anemia.
Reactions from the kidneys: deterioration of renal function (increased creatinine levels), especially when combined with aminoglycosides, very rarely cases of interstitial nephritis have been reported.
Reactions from the central nervous system: encephalopathy (in case of large doses, especially in patients with renal failure.
Reactions from the cardiovascular system: in isolated cases of arrhythmia, following bolus administration through a central venous catheter (see Method and duration of use).
Other: fever, inflammation at the injection site, superinfection.

There is a risk of developing reversible encephalopathy when using high doses of b-lactam antibiotics, including cefotaxime. There is no specific antidote.

Cefotaxime should not be mixed with other antibiotics, either in the same syringe or in the same infusion solution. This also applies to aminoglycosides.

For infusions, the following solutions can be used (cefotaxime concentration 1 g/250 ml): water for injection, 0.9% sodium chloride solution, 5% glucose, Ringer's solution, sodium lactate solution, as well as commercial solutions: Hemaccel, Yonosteril, Macrodex 6%, Reomacrodex 12%, Tutofusin V.

Vials containing 1 g of cefotaxime.

Content

Characteristics of claforan (1g bottle)

Composition: 1 g bottle of Cefotaxime sodium 1.

048

Powder for the preparation of a solution for intravenous and intramuscular administration, white or yellowish-white, crystalline.

Pharmacological Action: Semisynthetic antibiotic of the third generation cephalosporin group for parenteral use.

Acts bactericidal.

Has a wide spectrum of action.

Resistant to the action of most β-lactamases.

Klaforan® is active against Aeromonas hydrophila, Bacillus subtilis, Bordetella pertussis, Borrelia burgdorferi, Moraxella (Branhamella) catarrhalis, Citrobacter diversus, Clostridium perfringens, Corynebacterium diphtheriae, Escherichia coli, Enterobacter spp.

(sensitivity depends on epidemiological data and the level of resistance in each specific country), Erysipelothrix insidiosa, Eubacterium spp.

, Haemophilus spp.

(including penicillinase-producing and non-penicillinase-producing strains, including ampicillin-resistant strains), Klebsiella pneumoniae, Klebsiella oxytoca, methicillin-sensitive strains of Staphylococcus spp.

(including penicillinase-producing and non-penicillinase-producing strains), Morganella morganii, Neisseria gonorrhoeae (including penicillinase-producing and non-penicillinase-producing strains), Neisseria meningitidis, Propionibacterium spp.

, Proteus mirabilis, Proteus vulgaris, Providencia spp.

, Streptococcus spp.

(incl.

Streptococcus pneumoniae), Salmonella spp.

, Serratia spp.

(sensitivity depends on epidemiological data and the level of resistance in each specific country), Shigella spp.

, Veillonella spp.

, Yersinia spp.

(sensitivity depends on epidemiological data and the level of resistance in each specific country).

Acinetobacter baumanii, Bacteroides fragilis, Clostridium difficile, Enterococcus spp are resistant to the drug.

, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus spp.

, Pseudomonas aeruginosa, Pseudomonas cepacia, Stenotrophomonas maltophilia, gram-negative anaerobes.

Indications for Use: Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - respiratory tract infections; - genitourinary tract infections; - septicemia; - bacteremia; - endocarditis; - intra-abdominal infections (including

peritonitis); - central nervous system infections (incl.

meningitis, with the exception of listeria); - infections of the skin and soft tissues; - infections of bones and joints.

Prevention of infectious complications after surgical operations on the gastrointestinal tract, urological and obstetric-gynecological operations.

Method of Administration: The drug is administered intramuscularly or intravenously (as a slow injection or infusion).

For adults with normal renal function and uncomplicated gonorrhea, Claforan® is prescribed IM at a dose of 0.

5-1 g once.

For uncomplicated infections of moderate severity, Claforan® is administered intramuscularly or intravenously in a single dose of 1-2 g with an interval of 8-12 hours; The daily dose is 2-6 g.

For severe infections, Claforan® is administered intravenously in a single dose of 2 g, the interval between administrations is 6-8 hours; daily dose - 6-8 g.

In cases where the infection is caused by insufficiently sensitive strains, an antibiotic sensitivity test is the only means of confirming the effectiveness of Claforan.

For adults with impaired renal function (creatinine clearance 10 ml/min or less), the single dose is reduced by 2 times, the interval between doses is not changed, and the daily dose is also reduced by 2 times.

In cases where CK cannot be measured, it can be calculated from serum creatinine using the Cockcroft formula for adults.

For men: body weight (kg) x (140-age) CC (ml/min) = ————————————-.72 x serum creatinine (mg/dl) or body weight (kg) x (140-age) CC (ml/min) = ——————————————-;0.

814 x serum creatinine (µmol/l) For women: CC (ml/min) = 0.

85 x indicator for men.

Patients on hemodialysis are prescribed 1-2 g/day depending on the severity of the infection.

On the day of dialysis, Claforan® is administered after the end of the procedure.

In prematurely born children (up to 1 week of life), the daily dose of Claforan is 50-100 mg/kg IV, divided into 2 injections with an interval of 12 hours.

In prematurely born children (1-4 weeks of life), the daily dose of Claforan is 75-150 mg/kg IV, divided into 3 injections with an interval of 8 hours.

In children weighing up to 50 kg, the daily dose of Claforan is 50-100 mg/kg, administered intravenously or intramuscularly at intervals of 6-8 hours.

The daily dose should never exceed 2 g.

For severe infections, incl.

meningitis, it is possible to increase the daily dose by 2 times.

Children weighing 50 kg or more are prescribed the drug in the same dose as adults.

IM administration of the drug with 1% lidocaine solution is strictly contraindicated in children under 2 years of age.

5 years.

In order to prevent the development of postoperative infections before surgery during induction of anesthesia, the drug is administered intramuscularly or intravenously at a dose of 1 g with repeated administration 6-12 hours after surgery.

When performing a cesarean section, at the time of applying clamps to the umbilical vein, Claforan® is administered intravenously at a dose of 1 g, then after 6-12 hours, 1 g of Claforan is re-administered intramuscularly or intravenously.

The duration of treatment is determined individually.

Rules for preparing solutions for injection To prepare a solution for intramuscular administration, dissolve the powder with sterile water for injection in an amount of 4 ml for 1 g and 10 ml for 2 g.

A 1% lidocaine solution can be used as a solvent for intramuscular administration.

When using lidocaine as a solvent, intravenous administration of Claforan is strictly contraindicated.

To prepare a solution for intravenous administration, 1 g or 2 g of powder is dissolved in 40-100 ml of sterile water for injection or infusion solution.

The injection is carried out slowly over 3-5 minutes, due to the possible development of life-threatening arrhythmias when cefotaxime is administered through a central venous catheter.

The following solutions can be used for infusions (cefotaxime concentration 1 g/250 ml): water for injection, 0.

9% sodium chloride solution, 5% dextrose (glucose) solution, Ringer's solution, sodium lactate solution, as well as solutions of hemaccel, ionosteril, macrodex 6%, rheomacrodex 12%, tutofusin B.

It is necessary to ensure aseptic conditions when dissolving dry substance for injection and preparing solutions for injection, especially if the diluted drug is not administered immediately.

Interaction: When used simultaneously with Claforan, probenecid delays excretion and increases plasma concentrations of cefotaxime.

With simultaneous use, Claforan® may potentiate the nephrotoxic effect of drugs that have a nephrotoxic effect.

Pharmaceutical interactions Claforan solution is incompatible with solutions of other antibiotics (including

h aminoglycosides) in one syringe or infusion solution.

Side Effects: Allergic reactions: - angioedema, bronchospasm, rash, redness of the skin, urticaria; - very rarely - anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

From the digestive system: possible - nausea, vomiting, abdominal pain, increased activity of liver enzymes (ALT, AST, LDH, GGT, alkaline phosphatase) and/or bilirubin, diarrhea (diarrhea can be a symptom of enterocolitis, which in some cases is accompanied by the appearance of blood in feces.

A special form of enterocolitis is pseudomembranous colitis).

From the urinary system: - deterioration of kidney function (increased creatinine levels), especially when combined with aminoglycosides; - very rarely - interstitial nephritis.

From the hematopoietic system: - neutropenia; - rarely - agranulocytosis, eosinophilia, thrombocytopenia; - in isolated cases - hemolytic anemia.

From the side of the central nervous system: encephalopathy (when administered in high doses), especially in patients with renal failure.

From the cardiovascular system: in isolated cases - arrhythmias (with bolus administration through a central venous catheter).

Other: weakness, fever, superinfection.

Local reactions: inflammation at the injection site.

When treating borreliosis: Jarisch-Herxheimer reaction (during the first days of treatment), skin rash, itching, fever, leukopenia, increased levels of liver enzymes, difficulty breathing and discomfort in the joints.

Contraindications: - hypersensitivity to cephalosporins.

When using lidocaine as a solvent, the following contraindications should be taken into account (with intramuscular administration of Claforan): - intracardiac blockades without an established pacemaker; - severe heart failure; - intravenous administration; - children under 2 years of age.

5 years (for intramuscular administration); - hypersensitivity to lidocaine or other amide-type local anesthetic.

Use during pregnancy and breastfeeding The safety of cefotaxime during pregnancy in humans has not been studied.

Cefotaxime crosses the placental barrier, so the drug should not be prescribed during pregnancy.

Cefotaxime passes into breast milk, therefore, if it is necessary to use Claforan during lactation, breastfeeding should be stopped.

Experimental studies on animals did not reveal a teratogenic effect of the drug.

Overdose: Symptoms: when using beta-lactam antibiotics, including cefotaxime, in high doses, there is a risk of developing reversible encephalopathy.

Treatment: if necessary, carry out symptomatic therapy.

There is no specific antidote.

Special Instructions: Before prescribing Claforan, it is necessary to collect an allergic history, especially with regard to indications of allergic diathesis, hypersensitivity reactions to beta-lactam antibiotics.

Cross-allergy between penicillins and cephalosporins is known, which occurs in 5-10% of cases.

In patients with a history of allergic reactions to penicillin, the drug is used with extreme caution.

The use of Claforan is strictly contraindicated in patients with a history of an immediate hypersensitivity reaction to cephalosporins.

If there is any doubt, the presence of a doctor during the first administration of the drug is mandatory due to a possible anaphylactic reaction.

If hypersensitivity reactions occur, the drug is discontinued.

In the first weeks of treatment, pseudomembranous colitis may occur, manifested by severe, prolonged diarrhea.

The diagnosis is confirmed by colonoscopy and/or histological examination.

This complication is regarded as very serious.

Claforan® is immediately discontinued and adequate therapy is prescribed (including the use of oral vancomycin or metronidazole).

With the simultaneous use of Claforan and potentially nephrotoxic drugs (aminoglycoside antibiotics, diuretics), it is necessary to monitor renal function (due to the risk of nephrotoxicity).

In patients who require sodium restriction, the sodium content of cefotaxime sodium salt should be taken into account (48.

2 mg/g).

During treatment, a false-positive Coombs test may occur.

During the treatment period, it is recommended to use glucose oxidase methods for determining blood glucose levels, due to the development of false-positive results when using nonspecific reagents.

The rate of drug administration should be controlled.

Monitoring laboratory parameters During treatment with the drug for more than 10 days, it is necessary to monitor the peripheral blood picture.

If neutropenia develops, treatment should be discontinued.