Cephanorm (Cefanorm)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceTsefpyromTsefpyrom
Similar drugsTo uncover
  • Isodep®
    powder w / m in / in 
       
  • Cephanorm
    powdersolution w / m in / in 
    Simpex Pharma Pvt Ltd.     India
  • Tsefpyroma sulfate and sodium carbonate
       
    • Dosage form: & nbspPowder for the preparation of solution for intravenous and intramuscular injection.
    Composition:
    Each vial contains:
    For vials of 500 mg: a sterile mixture of ceftpirom sulfate and sodium carbonate 699 mg, which corresponds to cefpirom 500 mg in terms of cefpyroma sulfate 595 mg and sodium carbonate 104 mg.
    For vials of 1000 mg: a sterile mixture of cefproma sulfate and sodium carbonate, 1398 mg, which corresponds to cefpirom 1000 mg in terms of cefpyroma sulfate 1190 mg and sodium carbonate 208 mg.
    Description:
    Powder from white to white with a yellowish or kremovatym color shade.

    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.E.02   Tsefpyrom

    Pharmacodynamics:
    Antibiotic from the group of cephalosporins of IV generation. It acts bactericidal, disrupting the synthesis of the cell wall of the microorganism. Has a wide spectrum of action against gram-positive and gram-negative bacteria (including Pseudomonas aeruginosa), including strains resistant to aminoglycosides and / or cephalosporin antibiotics of the third generation.Highly resistant to the action of most beta-lactamases, within the bacterial cell, the molecular target is penicillin-binding proteins.
    It is active against: Acinetobacter spp., Citrobacter diversus, Citrobacter freundii, Clostridium perfringens, Enterobacter spp., Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Hafhia alvei, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, Morganella morganii, Neisseria spp. ., Peptostreptococcus spp., Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas aeruginosa, Salmonella spp., Shigella spp., Serratia spp., Streptococcus spp., Staphylococcus spp.
    Pharmacokinetics:Tsefpyrom is administered only parenterally. Penetrates into wound exudate, spinal fluid, female genital organs, prostate, kidneys, bronchial secretion, sputum and bronchial mucosa, peritoneal fluid, gallbladder tissue.
    It penetrates through the placental barrier, weakly into the breast milk. In therapeutic concentrations it is found in the blood and in most tissues and liquids for 12 hours after the administration. The kinetics of ceftpiri concentrations in the blood after intravenous and intramuscular injection is linear and depends on the dose administered. After repeated intravenous or intramuscular injection at an interval of 12 hours for 3-5 days, there was no cumulation of the drug and a change in the main pharmacokinetic parameters.
    Connection with plasma proteins - 10%. The half-life (T1 / 2) of cefpirom -1.8-2.2 parts of T1 / 2 cephviroma and its total clearance are dose independent.The volume of distribution is 12-21 liters.
    In children, pronounced changes in the ketics of ceftirom are not observed.
    In the elderly, there may be changes in pharmacokinetics, the severity of which is related to the degree of impaired renal function. Correction of ceftpirium doses is necessary for creatinine clearance (CK) below 50 ml / min.
    It is not metabolized in the body, excreted by the kidneys (80-90%) and with bile.
    Indications:
    Infectious-inflammatory diseases caused by sensitive bacteria:

    sepsis / bacteremia;

    complicated urinary system infections (including pyelonephritis, pyelitis, urethritis, cystitis);

    respiratory tract infections (including pneumonia, lung abscess, pleural empyema);

    skin and soft tissue infections, wound infections;

    infection in patients with neutropenia.
    Contraindications:Hypersensitivity (including to other beta-lactam antibiotics), pregnancy, children under 12 years of age
    Carefully:Diseases of the gastrointestinal tract (including in the history: ulcerative colitis, regional enteritis or antibiotic-associated colitis), severe renal failure.
    Pregnancy and lactation:Studies in animals have not shown any adverse effects on the developing fetus.If you need to use the drug during lactation should stop breastfeeding.
    Dosing and Administration:
    Intravenous (jet or drip for 30 minutes) or intramuscularly.
    For intramuscular injection, the contents of the 500 mg or 1000 mg cephanorm are dissolved in 5 ml of water for injection.
    Intravenous (jet or drip for 30 minutes) or intramuscularly.
    For intramuscular injection, the contents of the 500 mg or 1000 mg cephanorm are dissolved in 5 ml of water for injection.
    For intravenous fluid administration, the contents of a 500 mg or 1000 mg cephanorm bottle are dissolved in 10 ml of 0.9% NaCl solution, Ringer's solution, 5% dextrose solutions, 5% fructose solution.
    For intravenous drip, 500 mg and 1000 mg of the drug are dissolved in 100 ml of 0.9% NaCl solution, Ringer's solution, 5% dextrose solutions, 5% fructose solution.
    The daily dose is administered 2 times, with an interval of 12 hours.
    With infections of the urinary system, skin or soft tissues, the daily dose is 2 g (in severe cases, the dose may be increased to 4 g); with respiratory infections - 2-4 g; at a sepsis and infections against a background of a neutropenia - 4.
    The duration of treatment depends on the severity and characteristics of the course of the infection process,sensitivity of microflora and is determined individually by the attending physician, usually is 5-10 days.
    If the renal function is impaired, dose adjustment is performed depending on the QC. The first dose (initial) is 1 - 2 g, in the future, at a dose of 5-20 ml / min, 0.5-1 g is administered once a day; with KK 20-50 ml / min - 0.5-1 g 2 times a day. In patients on hemodialysis, the daily dose is 0.5-1 g; after each procedure of hemodialysis, add 0.25-0.5 g.
    Side effects:

    Local reactions: phlebitis, pain along the vein, soreness and infiltration at the site of intramuscular injection.

    Allergic reactions: urticaria, chills or fever, rash, itchy skin, rarely - bronchospasm, eosinophilia, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), angioedema, extremely rarely anaphylactic shock.

    From the nervous system: headache, dizziness, encephalopathy.

    From the urinary system: disturbance of kidney function, oliguria, interstitial nephritis.

    From the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, dysbiosis, impaired liver function, rarely - candidal stomatitis and / or glossitis, pseudomembranous enterocolitis.

    From the hematopoiesis: Hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia.

    From the cardiovascular system: potentially life-threatening arrhythmias after a rapid bolus injection into the central vein.

    Laboratory indicators: azotemia, increased urea concentration in the blood, increased activity of "liver" transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, Coombs positive reaction, hypocoagulation.

    Other: Superinfection (in particular, candidal vaginitis).

    Overdose:
    Symptoms: seizures of encephalopathy (in the case of the administration of large doses, especially in patients with renal insufficiency), tremor, increased neuromuscular excitability.
    Treatment: symptomatic, hemodialysis.
    Interaction:
    Tsefpyre is pharmaceutically incompatible with other antibiotics, with a solution of sodium bicarbonate, with heparin and most other antimicrobial medicines.
    When administered concomitantly with bactericidal antibiotics cephpie shows synergism, with bacteriostatic (macrolides, chloramphenicol, tetracyclines) - antagonism.
    Non-steroidal anti-inflammatory drugs, diuretics, aminoglycosides, polymyxin B, other drugs that block tubular secretion inhibit the excretion of cephalosporins, increase their concentration in serum, extend T1 / 2, increase the risk of developing nephrotoxic reactions and bleeding.
    Tsefpyrom increases the effect of indirect anticoagulants.
    Special instructions:
    At the first introduction, the presence of a doctor is mandatory (the possibility of developing an anaphylactic reaction). In the case of developing anaphylactic reactions, urgent therapy is performed (epinephrine, dopamine, electrolyte balance correction, oxygen therapy, antihistamines, glucocorticosteroids).
    Against the background of the introduction of ceftirom, it is necessary to take into account the possibility of developing pseudomembranous colitis, in case of its development, immediately stop the administration of the drug, prescribe the appropriate treatment (incl. vancomycin (inside) or metronidazole).
    When combined severe renal and hepatic insufficiency should regularly determine the concentration of the drug in the plasma (dose adjustment is performed depending on the CK).
    With long-term treatment, regular monitoring of peripheral blood (control of the number of leukocytes every 10 days), indicators of the functional state of the liver and kidneys is necessary.
    With mixed aerobic-anaerobic infection before the identification of pathogens, it is advisable to add drugs that work against anaerobes.
    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular administration of 1 g and 500 mg.
    Packaging:
    For 500 mg of cefpiroma in a colorless glass bottle with a volume of 10 or 20 ml;
    For 1000 mg of cefpyroma in a colorless glass bottle in volume of 20 or 30 ml, closed with a rubber stopper, crimped with an aluminum cap and plastic lid.
    1, 5 or 10 vials per pack of cardboard along with instructions for use.
    Storage conditions:
    List B. In a dry, the dark place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.
    Shelf life:
    2 years.
    Do not use the drug after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-007627/09
    Date of registration:29.09.2009
    The owner of the registration certificate: Simpex Pharma Pvt Ltd. Simpex Pharma Pvt Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspKORAL-MED, CJSCKORAL-MED, CJSC
    Information update date: & nbsp07.11.2015
    Illustrated instructions
      Instructions
      Up