Claforan®
Anaphylactic reactions
The prescription of cephalosporins requires the collection of an allergic history (allergic diathesis, hypersensitivity reactions to beta-lactam antibiotics).
If the patient develops a hypersensitivity reaction, treatment should be discontinued. The use of cefotaxime is contraindicated in patients with a history of 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.
Anaphylactic reactions that occur in this situation can be serious or even fatal.
In patients with a history of allergy to penicillins, the drug is used with extreme caution. Should be carefully monitored
the patient’s condition upon first administration of the drug due to a possible anaphylactic reaction.
If the first symptoms and signs of anaphylactic shock develop, you should immediately stop administering the drug. The patient should remain in a supine position with legs elevated. Slow intravenous administration of 0.1 mg (1 ml) of epinephrine (adrenaline) solution is indicated under control of pulse and blood pressure, as well as intravenous administration of plasma expanders, human albumin or balanced electrolyte solutions; subsequently - intravenous administration of glucocorticosteroids (for example, 250-1000 mg of hydrocortisone), once or, if necessary, repeatedly.
Supportive therapeutic measures should be carried out: artificial ventilation, oxygen inhalation, administration of antihistamines.
Diseases caused by Clostridium difficile (eg, pseudomembranous colitis)
Diarrhea, especially severe and/or prolonged, developing during treatment or in the first weeks after the end of treatment with various antibiotics, especially broad-spectrum antibiotics, may be a symptom of a disease caused by Clostridium difficile, the most severe form of which is pseudomembranous colitis. The diagnosis of this rare but possibly fatal disease is confirmed endoscopically and/or histologically. The most important method for confirming the diagnosis of pseudomembranous colitis is the detection of Clostridium difficile toxins in the stool. If a diagnosis of pseudomembranous colitis is suspected, cefotaxime should be discontinued immediately and appropriate specific antibiotic therapy (eg, oral vancomycin or metronidazole) should be started immediately. Drugs that inhibit intestinal motility are contraindicated.
Encephalopathy
When using beta-lactam antibiotics, including cefotaxime, there is an increased risk of developing encephalopathy (which may manifest as seizures, confusion, impaired consciousness, movement disorders), especially in cases of overdose or renal failure.
Use of lidocaine as a solvent
When using lidocaine as a solvent, it is necessary to take into account the information presented in the “Contraindications” section.
Injection rate
The rate of administration of the drug should be monitored (See section “Method of administration and dosage”).
Kidney failure
In case of renal failure, the dose should be adjusted depending on creatinine clearance (See section "Dosage and Administration").
Caution should be exercised when using cefotaxime and aminoglycosides simultaneously. Renal function should be monitored in all cases of combined use of cefotaxime with aminoglycosides, other nephrotoxic drugs, in elderly patients or with renal impairment.
Sodium content
In patients requiring sodium restriction, the sodium content of cefotaxime sodium salt (48.2 mg/g) should be taken into account.
Hematopoietic disorders
During treatment with cefotaxime, leukopenia, neutropenia and, more rarely, bone marrow hematopoietic failure, pancytopenia and agranulocytosis may develop.
If the course of treatment lasts more than 10 days, the number of blood cells should be monitored. If these blood parameters deviate from the norm, the drug should be discontinued.
Laboratory tests
During therapy with cephalosporins, a positive Coombs test may occur.
It is recommended to use glucose oxidase methods for determining the concentration of glucose in the blood, due to the development of false positive results when using nonspecific reagents.
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.
h.
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
h.
peritonitis); - central nervous system infections (incl.
h.
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.
h.
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.
