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Klaforan - instructions for use, analogs, reviews and release forms (powder for the preparation of antibiotic solution for injections in ampoules 1 gram) medications for the treatment of angina, sinusitis and other infections in adults, children and pregnancy. Composition

Klaforan - instructions for use, analogs, reviews and release forms (powder for the preparation of antibiotic solution for injections in ampoules 1 gram) medications for the treatment of angina, sinusitis and other infections in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Claforan. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Klaforan antibiotic in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Claforan in the presence of existing structural analogues.Use for the treatment of angina, sinusitis, bronchitis and other infectious diseases in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

 

Claforan - Semisynthetic antibiotic group of 3 generation cephalosporins for parenteral use.

 

It is bactericidal. Has a wide range of action. Resistant to the action of most beta-lactamases.

 

Klaforan 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 epidemiology data and on the level of resistance in each country), Erysipelothrix insidiosa, Eubacterium spp., Haemophilus spp. (Including strains producing and not producing penicillinase, including ampicillin-resistant), Klebsiella pneumoniae (Klebsiella), Klebsiella oxytoca, methicillin-sensitive strains of Staphylococcus spp. (Staphylococcus aureus) (including strains producing and not producing penicillinase), Morganella morganii, Neisseria gonorrhoeae (including strains producing and not producing penicillinase), Neisseria meningitidis, Propionibacterium spp., Proteus mirabilis (proteus), Proteus vulgaris, Providencia spp., Streptococcus spp. (streptococcus) (including Streptococcus pneumoniae), Salmonella spp. (Salmonella), Serratia spp. (sensitivity depends on epidemiology data and on the level of resistance in each country), Shigella spp. (shigella), Veillonella spp., Yersinia spp.(sensitivity depends on epidemiology data and on the level of resistance in each country).

 

Acinetobacter baumanii, Bacteroides fragilis, Clostridium difficile, Enterococcus spp., Listeria monocytogenes (listeria), methicillin-resistant strains of Staphylococcus spp., Pseudomonas aeruginosa, Pseudomonas cepacia, Stenotrophomonas maltophilia, gram-negative anaerobes are resistant to the drug.

 

Composition

 

Cefotaxime sodium + excipients.

 

Indications

 

Treatment of infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

  • respiratory tract infections;
  • urinary tract infections;
  • septicemia;
  • bacteremia;
  • endocarditis;
  • intra-abdominal infections (including peritonitis);
  • infections of the central nervous system (including meningitis, with the exception of listeriosis);
  • infections of the skin and soft tissues;
  • infection of bones and joints.

 

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

 

Forms of release

 

Powder for the preparation of solution for intravenous and intramuscular injection (injections in ampoules for injection).

 

Other dosage forms, be it tablets or capsules, at the time of publication of the drug in the Directory did not exist.

 

Instructions for use and dosage

 

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

 

Adults with normal kidney function with uncomplicated gonorrhea Claforan is given / m in a dose of 0.5-1 g once.

 

In uncomplicated infections of moderate severity, Claforan is given in / m or IV in a single dose of 1-2 g at intervals of 8-12 hours; The daily dose is 2-6 g.

 

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

 

In cases where the infection is caused by insufficiently sensitive strains, the antibiotic sensitivity test is the only way to confirm Claforan's effectiveness.

 

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, is divided into 3 injections with an interval of 8 hours.

 

In children with a body weight of up to 50 kg, the daily dose of Claforan is 50-100 mg / kg, administered intravenously or in / m at intervals of 6-8 hours. The daily dose should never exceed 2 g. In severe infections, h.meningitis, it is possible to increase the daily dose by 2 times.

 

Children with a body weight of 50 kg or more are prescribed the drug at the same dose as adults.

 

In / m injection with a 1% solution of Lidocaine is strictly contraindicated in children under the age of 2.5 years.

 

In order to prevent the development of postoperative infections before the operation during an initial anesthesia, the drug is given in / m or IV in a dose of 1 g with repeated administration 6-12 hours after the operation.

 

When performing cesarean section at the time of application of the clamps on the umbilical vein, Claforan IV is administered at a dose of 1 g, then 1 g of Claforan IM or IV is re-introduced after 6-12 hours.

 

The duration of treatment is determined individually.

 

Rules for the preparation of solutions for injection (equilibration of the drug)

 

To prepare the solution for the / m introduction, 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. As a solvent for the / m introduction, 1% lidocaine solution can be used. When using lidocaine as a solvent, iv 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 for 3-5 minutes, in view of 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 (concentration of cefotaxime: 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 hemaccele, yonosterol, 6%, reomacrodex 12%, tutofusin B.

 

It is necessary to ensure aseptic conditions when dissolving dry matter for injections and preparing injectable solutions, especially if the diluted drug is not injected immediately.

 

Side effect

  • angioedema;
  • bronchospasm;
  • rash;
  • redness of the skin;
  • hives;
  • anaphylactic shock;
  • erythema multiforme;
  • Stevens-Johnson syndrome;
  • toxic epidermal necrolysis (Lyell's syndrome);
  • nausea, vomiting;
  • stomach ache;
  • diarrhea (diarrhea can be a symptom of enterocolitis, which in a number of cases is accompanied by the appearance of blood in the stool.) Pseudomembranous colitis is a special form of enterocolitis;
  • impairment of kidney function (increase in creatinine), especially when combined with aminoglycosides;
  • interstitial nephritis;
  • neutropenia, agranulocytosis, eosinophilia, thrombocytopenia, hemolytic anemia;
  • encephalopathy (when the drug is administered in high doses), especially in patients with renal insufficiency;
  • arrhythmia (with bolus injection through the central venous catheter);
  • weakness;
  • fever;
  • superinfection;
  • inflammation at the injection site;
  • Yaris-Gerxheimer's reaction (during the first days of treatment);
  • skin rash;
  • itching;
  • fever;
  • shortness of breath and discomfort in the joints.

 

Contraindications

  • hypersensitivity to cephalosporins.

 

When using lidocaine as a solvent, the following contraindications should be considered (with intramuscular administration of Claforan):

  • intracardiac blockades without an established pacemaker;
  • severe heart failure;
  • intravenous administration;
  • children under 2.5 years of age (for intramuscular injection);
  • hypersensitivity to lidocaine or other local anesthetic of the amide type.

 

Application in pregnancy and lactation

 

The safety of Claforan during pregnancy in humans has not been studied. Cefotaxime penetrates the placental barrier, so the drug should not be prescribed during pregnancy.

 

Cefotaxime penetrates into breast milk, so if Claphoran is needed during lactation, breastfeeding should be stopped.

 

In experimental studies on animals, the teratogenic effect of the drug was not revealed.

 

Use in children

 

Contraindicated in children under the age of 2.5 years (with intramuscular use).

 

It is possible to use the drug in children according to the indications and in the age dosage indicated above.

 

special instructions

 

Before the appointment of Claforan it is necessary to collect an allergic anamnesis, especially with regard to indications for allergic diathesis, reactions of hypersensitivity to beta-lactam antibiotics. There is a cross-allergy between penicillins and cephalosporins, which occurs in 5-10% of cases. In patients who have a history of indicating 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 sensitivity reaction to cephalosporins. In case of any doubt, the presence of a physician at the first administration of the drug is necessary because of a possible anaphylactic reaction.

 

When reactions of hypersensitivity occur, the drug is canceled.

 

In the first weeks of treatment, there may be a pseudomembranous colitis, 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 withdrawn and appropriate therapy is prescribed (including the use of Vancomycin or Metronidazole inside).

 

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

 

Patients who require a reduction in sodium intake should take into account the sodium content of cefotaxime sodium salt (48.2 mg / g).

 

During the treatment period, a false positive test of Coombs may occur.

 

During the treatment period it is recommended to use glucose oxidase methods for determining blood glucose level, in view of the development of false positive results with the use of nonspecific reagents.

 

It is necessary to control the rate of drug administration.

 

The use of ethanol (alcohol) during treatment Claphorane is not allowed in view of the possible summation of the hepatotoxic effect and impaired liver function.

 

Storage conditions of prepared antibiotic solutions

 

Solution for intramuscular injection, prepared using water for injection or 0.5% or 1% solution of lidocaine hydrochloride, is chemically stable for 8 hours (at room temperature not higher than 25 degrees Celsius) or for 24 hours (when stored in a protected from light place at a temperature of 2 to 8 degrees).

 

Solution for injection or infusion, prepared using water for injection, is chemically stable for 12 hours (at room temperature not higher than 25 degrees Celsius) or for 24 hours (when stored in a dark place at a temperature of 2 to 8 degrees ). The pale yellow shade of the solution does not mean a decrease in the activity of the antibiotic.

 

Solution for infusion, prepared on the basis of infusion solutions, is chemically stable for 8 hours after dilution in a solution of hemaccel, yonostearil or tutofusine and for 6 hours after dilution in a 10% solution of dextrose (glucose), macrodex or reomacrodex.

 

Control of laboratory indicators

 

With a duration of treatment with the drug for more than 10 days, it is necessary to monitor the picture of peripheral blood. In the case of neutropenia, treatment should be discontinued.

 

Drug Interactions

 

With simultaneous application with Claforan, probenecid retards 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

 

Claforane solution is incompatible with solutions of other antibiotics (including aminoglycosides) in a single syringe or infusion solution.

 

Analogues of the drug Klaforan

 

Structural analogs for the active substance:

  • Intrataxime;
  • Kefotex;
  • Clafhorn;
  • Clafotaxime;
  • Liphoran;
  • Oritax;
  • Ortaxime;
  • Resibelact;
  • Spirozin;
  • Taltsef;
  • Tarcephoxime;
  • Tirotax;
  • Cetax;
  • Cefabol;
  • Cefanthral;
  • Cefosin;
  • Cefotaxime;
  • Cefotaxime sodium;
  • Cefotaxime sodium salt.

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