Cefat® (Cefat®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCefamandolCefamandol
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    powdersolution w / m in / in 
    PREBAND PFC, LLC     Russia
  • Cefat®
    powdersolution for injections 
    SYNTHESIS, OJSC     Russia
    • Dosage form: & nbspPowder for solution for injection
    Composition:Active substance: cefamandola naphate (in terms of cefamandol) - 0.5 g or 1.0 g
    Excipient: sodium carbonate 25-37.5 mg or 50-75 mg
    Description:White or white with a yellowish tinge powder, odorless.
    Pharmacotherapeutic group:Antibiotic-cephalosporin
    ATX: & nbsp

    J.01.D.C.03   Cefamandol

    Pharmacodynamics:
    Cephalosporin antibiotic II generation for parenteral use. It acts bactericidal (it breaks the synthesis of the cell wall of microorganisms). Has a wide range of activities.
    Highly active against Gram-positive microorganisms - Staphylococcus aureus (including strains that produce and do not produce penicillinase), Staphylococcus epidermidis, Streptococcus spp. (including beta-hemolytic strains, Streptococcus pneumoniae);
    Gram-negative microorganisms - Echerichia coli, Klebsiella spp., Enterobacter spp., Hemophilus influenzae, Providencia rettgeri, Morganella morganii, Proteus mirabilis et vulgaris;
    anaerobic microorganisms - Gram-positive and Gram-negative cocci (including Peptococcus, Peptostreptococcus), Gram-positive rods (including Clostridium spp.), Gram-negative rods (including Fusobacterium spp., Bacteroides spp.).
    Resistant to the action of beta-lactamases. Not active against various species of Pseudomonas, most strains of Enterococcus spp. (incl.Enterococcus faecalis), Enterobacter cloacae spp., Bacteroides fragilis, Staphylococcus spp. (methicillin-resistant strains) and Listeria monocytogenes, Serratia spp.
    Has a disulfiram-like action.
    Pharmacokinetics:
    After an / m introduction of 0.5 or 1 g of TCmax -30-120 min, the value of Cmax is 13 and 25 μg / ml, respectively. After intravenous administration of 1, 2 or 3 g, after 10 minutes Cmax is 139, 240 and 533 μg / ml and remains at the therapeutic level for 6 hours. Therapeutic concentration is achieved in pleural and joint fluids, bile and bones.
    Do not cumulate. T1 / 2 after IV, 30-35 minutes, after IM for 60 minutes.
    It is excreted by the kidneys in the unchanged form (in 8 hours 65-85% is output and provides high concentrations of the drug in the urine). After an / m introduction of 0.5 and 1 g, the urine content is 254 and 1357 μg / ml, respectively; when i / in the introduction of 1 and 2 g - 750 and 1380 mcg / ml, respectively. With CRF excretion slows down. In patients on hemodialysis, T1 / 2 increases to 6 hours.
    Indications:Infectious-inflammatory diseases caused by drug-susceptible pathogens, incl. abdominal and gynecological infections, sepsis, meningitis, endocarditis, urinary tract infections, respiratory tract, bones and joints, skin and soft tissues. Prevention of postoperative infectious complications.
    Contraindications:
    Hypersensitivity (including to cephalosporins, penicillins, carbapenems).
    Carefully:
    Renal failure, pseudomembranous colitis (in the anamnesis), pregnancy, lactation, early childhood (up to 6 months).
    Dosing and Administration:
    The drug is administered intramuscularly or intravenously.
    For intramuscular injection, the preparation (0.5 g or 1.0 g) is dissolved in 3 ml of water for injection or in 3 ml of a 0.9% solution of sodium chloride.
    For intravenous fluid administration, the drug is dissolved for 1 g of the drug in 10 ml of water for injection or in 10 ml of a 0.9% solution of sodium chloride.
    For intravenous drip introduction, the drug dissolved as described above is mixed with 10% dextrose solution or 0.9% sodium chloride solution.
    Adults appoint 500 mg-1 g every 4-8 hours, with urinary tract infections -500 mg (in severe cases - 1 g) every 8 hours, with life-threatening infections - up to 2 g every 4 hours (12 g per day ). Children - 50-100 mg / kg (with severe infections - up to 150 mg / kg) per day with intervals between administrations of 4-8 hours. For infections caused by beta-hemolytic streptococcus, treatment should be continued for at least 10 days. Patients on hemodialysis are administered 1 g every 12 h intravenously or intramuscularly (if intramuscular injection is used, then after the completion of hemodialysis, 1 / 3-1 / 2 doses are additionally administered).For the prevention of postoperative infectious complications for 30-60 minutes before the intervention, adults are given - 1-2 g, children - 50-100 mg / kg, followed by the same doses for 24-48 hours.
    For patients with impaired renal function, the dosing regimen is set taking into account the values ​​of creatinine clearance.
    After the initial dose of 1-2 g (depending on the severity of the infection), the following maintenance doses are prescribed:

    Clearance

    creatinine (ml / min)

    Severe infections

    Moderately severe infections

    50-80

    2g every 4 hours

    1.5 g every 6 hours or 2 g every 8 hours

    25-50

    1.5 g every 4 hours or 2 g every 6 hours

    1,5 g every 8 hours

    10-25

    1 g every 6 hours or 1.25 g every 8 hours

    1 g every 8 hours

    2-10

    670 mg every 8 hours or 1 g every 12 hours

    500 mg every 8 hours or 750 mg every 12 hours

    Less than 2

    500 mg every 8 hours or 750 mg every 12 hours

    500 mg every 12 hours

    Side effects:
    Allergic reactions: urticaria, chills or fever, rash, itching, rarely - bronchospasm, eosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, anaphylactic shock.
    From the side of the digestive system: nausea, vomiting,diarrhea or constipation, dysbiosis, impaired liver function (increased activity of "liver" transaminases, alkaline phosphatase, hyperbilirubinemia, cholestatic jaundice, hepatitis), rarely - stomatitis, glossitis, pseudomembranous enterocolitis.
    From the hematopoiesis: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, hypocoagulation.
    On the part of the urinary system: azotemia, increased urea in the blood, hypercreatininaemia, impaired renal function.
    From the nervous system: headache, dizziness.
    Local reactions: phlebitis, pain along the vein, soreness and infiltration at the site of the / m introduction.
    Other: superinfection.
    Overdose:Symptoms: seizures (especially in patients with CRF). Treatment: symptomatic therapy, including diazepam and short-acting barbiturates, in severe cases - hemodialysis.
    Interaction:
    Nephrotoxicity increases aminoglycosides, "loop" diuretics, drugs that reduce tubular secretion.
    Not compatible with ethanol (inhibits acetaldehyde).
    Antibacterial activity increases aminoglycosides, but with simultaneous use of drugs should not be mixed in one syringe (not pharmaceutically compatible).
    Special instructions:
    Patients who had a history of allergic reactions to penicillins, may have increased sensitivity to cephalosporin antibiotics.
    During treatment with cefamandol, a false positive Coombs reaction and a false positive urine reaction to glucose and proteinuria are possible.
    In elderly and debilitated patients with vitamin K deficiency, there is an increased risk of developing hypoprothrombinemia with or without bleeding (in these cases, vitamin K administration is indicated).
    During treatment should refrain from taking ethanol - possible effects similar to the action of disulfiram (red face, stomach and stomach spasm, nausea, vomiting, headache, lowering blood pressure, tachycardia, dyspnea).
    When appointing during lactation, it is necessary to cancel breastfeeding.
    Freshly prepared solution is suitable for use for 24 hours when stored at room temperature, and for 96 hours - when stored in a refrigerator.
    Form release / dosage:
    Powder for solution for injection for 0.5 g and 1.0 g.
    Packaging:
    Powder for the preparation of solution for injection of 0.5 g and 1.0 g of substance in bottles with a capacity of 10 or 20 ml.
    For 1, 5 or 10 vials with instructions for use are placed in a pack of cardboard.
    50 bottles are placed in a carton box with 1-5 instructions for use for delivery to hospitals.
    Storage conditions:
    List B. In dry, protected from light, out of reach of children, at a temperature of 15 to 25 ° C.
    The freshly prepared solution should not be stored for more than 24 hours at room temperature or for 96 hours in a refrigerator (at a temperature of + 5 ° C).
    Shelf life:
    2 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N001515 / 01-2002
    Date of registration:10.06.2008
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.10.2015
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