Klaforan then for the preparation of a solution intravenously intramuscularly vial N1
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Active ingredients
Cefotaxime
Composition
1 fl. Cefotaxime sodium 1.048 g, which corresponds to the content of Cefotaxime 1 g. Excipients: Hyprolosis (Clucel LF) 2.4 mg, mannitol (D-mannitol) 21 mg, Croscarmellose sodium (Premellose) 5.4 mg, microcrystalline cellulose 48.4 mg, colloidal silicon dioxide (aerosil ) 1 mg, magnesium stearate monohydrate 1.8 mg. The composition of the shell: opadry II white 10 mg (polyvinyl alcohol 4 mg, titanium dioxide 2.5 mg, macrogol (polyethylene glycol) 2.02 mg, talc 1.48 mg).
Pharmacological effect
Pharmacokinetics
Indications
Semisynthetic antibiotic group III generation cephalosporins for parenteral use. Bactericidal effect. It has a wide spectrum of action. Resistant to most & # 946.-Lactamase. Klaforan is active against Aeromonas hydrophila, Bacillus subtilis, Bordetella pertussis, Borrelia burgdorferi, Moraxella (Branhamella) catarrhalis, Citrobacter diversus, Clostridium perfringens, Corynebacterium diphtheriae, Escherichia coli, Jesus, ihertera, etherepterium diphtheriae, Chernebacterium diphtheriae, Escherichia coli, chyteridium perfringens; (sensitivity depends on epidemiology data and on the level of resistance in each specific country), Erysipelothrix insidiosa, Eubacterium spp., Haemophilus spp. (including strains producing and not producing penicillinase, including ampicillin-resistant), Klebsiella pneumoniae, Klebsiella oxytoca, methicillin-sensitive strains of Staphylococcus spp. (including strains producing and not producing penicillinase), Morganella morganii, Neisseria gonorrhoeae (including strains that produce and not producing penicillinase), Neisseria meningitidis, Propionibacterium spp., Proteus mirabilis, Proteus vulgaris, a part of the prince, a part of the prince, which is a part of the population that produces and does not produce penicillinase. (including Streptococcus pneumoniae), Salmonella spp., Serratia spp. (sensitivity depends on epidemiology data and on the level of resistance in each specific country), Shigella spp., Veillonella spp., Yersinia spp. (sensitivity depends on epidemiology data and on the level of resistance in each specific country). The drug is resistant to Acinetobacter baumanii, Bacteroides fragilis, Clostridium difficile, Enterococcus spp., Listeria monocytogenes, methicillin-resistant strains of Staphylococcus spp., Pseudomonas aeruginosa, Pseudomonas cepomia, Stenotrophomomcapathus, Stenorophomom, and Stotrophomomph, which is Pseudomonas aeruginosa.
Contraindications
The drug is administered in / m or / in (in the form of a slow injection or infusion). Adults with normal renal function with uncomplicated gonorrhea, Claforan is prescribed i / m at a dose of 0.5-1 g once. With 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. In severe infections, Claforan is administered intravenously in a single dose of 2 g, the interval between injections is 6-8 hours. daily dose - 6-8 g. In cases where the infection is caused by insufficiently sensitive strains, the antibiotic susceptibility test is the only means of confirming the effectiveness of Claforan.For adults with impaired renal function (CC 10 ml / min or less), a single dose is reduced by 2 times, the interval between injections is not changed, while the daily dose is also reduced by 2 times. In cases where QC cannot be measured, it can be calculated from the level of serum creatinine using the Cockroft formula for adults. For men: body weight (kg) x (140-age) QC (ml / min) = ----------------------------- --------, 72 x serum creatinine (mg / dL) or body weight (kg) x (140-age) QC (ml / min) = ------------- ------------------------------. 0.814 x serum creatinine (mcmol / 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, Klaforan 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 administrations with an interval of 12 hours. 150 mg / kg IV, divided into 3 administrations with an interval of 8 hours. In children weighing up to 50 kg, the daily dose of Claforan is 50-100 mg / kg, administered in / in or in an interval of 6-8 hours. The daily dose should never exceed 2 g. In severe infections, incl. meningitis, it is possible to increase the daily dose by 2 times. For children weighing 50 kg or more, the drug is prescribed in the same dose as adults. V / m drug administration with 1% lidocaine solution is strictly contraindicated in children under 2.5 years of age. In order to prevent the development of postoperative infections before surgery during induction anesthesia, the drug is administered intramuscularly or intravenously in a dose of 1 g with repeated administration 6-12 hours after surgery. When performing a caesarean section, at the moment of application of the clamps on the umbilical vein, Klaforan is injected at a dose of 1 g, then, after 6-12 hours, 1 g of Klaforan is injected w / v or v. The duration of treatment is set individually. Rules for the preparation of solutions for injection To prepare a solution for i / m administration, dissolve the powder with sterile water for injection in an amount of 4 ml for 1 g and 10 ml for 2 g. 1% lidocaine solution can be used as a solvent for i / m administration . When using lidocaine as a solvent in / in the introduction of Claforan is strictly contraindicated. To prepare a solution for intravenous injection, 1 g or 2 g of powder is dissolved in 40-100 ml of sterile water for injection or an infusion solution.The injection is carried out slowly over 3-5 minutes, due to the possible development of life-threatening arrhythmias, with the introduction of Cefotaxime through the 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 solution (glucose), Ringer's solution, sodium lactate solution, as well as hemaccel solution, ionosteryl, macrodex 6%, reomacrodex 12%, tutofuzin V. It is necessary to ensure aseptic conditions when dissolving dry matter for injection and preparing solutions for injection, especially if the diluted drug is not administered immediately.
Use during pregnancy and lactation
Before prescribing Claforan, an allergic history should be collected, especially with regard to indications of allergic diathesis, hypersensitivity reactions to beta-lactam antibiotics. Known cross-allergy between penicillins and cephalosporins, 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 immediate hypersensitivity reactions to cephalosporins. In case of any doubt, the presence of a doctor at the first injection of the drug is mandatory because of a possible anaphylactic reaction. In the event of hypersensitivity reactions, the drug is canceled. In the first weeks of treatment, pseudomembranous colitis may occur, resulting in severe, prolonged diarrhea. The diagnosis is confirmed by colonoscopy and / or histological examination. This complication is regarded as very serious. Klaforan is immediately discontinued and adequate therapy is prescribed (including oral administration of 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 danger of nephrotoxic action). Patients who need to limit sodium intake should take into account the sodium content of cefotaxime sodium salt (48.2 mg / g).During the treatment period, a Coombs false positive test may occur. During the period of treatment, the use of glucose-oxidase methods for determining the level of glucose in the blood is recommended, due to the development of false-positive results when using non-specific reagents. The rate of administration of the drug should be controlled. Control of laboratory parameters With the duration of drug treatment over 10 days, it is necessary to monitor the picture of peripheral blood. If neutropenia develops, treatment should be discontinued.
Side effects
With simultaneous use with Claforan, probenecid delays excretion and increases plasma concentrations of cefotaxime. With the simultaneous use of Claforan can potentiate the nephrotoxic effect of drugs that have a nephrotoxic effect. Pharmaceutical interaction Clarafan's solution is incompatible with solutions of other antibiotics (including aminoglycosides) in the same syringe or infusion solution.
special instructions
With simultaneous use with Claforan, probenecid delays excretion and increases plasma concentrations of cefotaxime. With the simultaneous use of Claforan can potentiate the nephrotoxic effect of drugs that have a nephrotoxic effect. Pharmaceutical interaction Clarafan's solution is incompatible with solutions of other antibiotics (including aminoglycosides) in the same syringe or infusion solution.