Active substanceCeftizoximeCeftizoxime
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  • Cefoxime J
    powdersolution w / m in / in 
    JODAS EKSPOIM, LLC     Russia
  • Dosage form: & nbspPowder for the preparation of solution for intramuscular and intravenous administration.
    Composition:Active substance: ceftizoxime sodium in terms of anhydrous ceftizoxime - 1000 mg
    Description:White or slightly yellow crystalline powder.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.D.07   Ceftizoxime

    Pharmacodynamics:
    Cephalosporin antibiotic III generation for parenteral administration. It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. Resistant to a broad spectrum beta-lactamases (cephalosporinase and penicillinases), including beta-lactamase I, II, III and IV and type of Richmond TEM type produced by both gram-positive and gram-negative aerobes and anaerobes.
    Has a wide spectrum of action, which includes various aerobic and anaerobic Gram-positive and Gram-negative microorganisms.
    Gram-positive aerobes:

    Staphylococcus aureus (including strains that form and do not form penicillinase). Methicillin-resistant staphylococci resistant to cephalosporins, including ceftizoxime.

    Staphylococcus epidermidis (including strains that form and do not form penicillinase)

    Streptococcus agalactiae

    Streptococcus pneumoniae

    Streptococcus pyogenes

    Ceftithoxime is usually inactive for most strains Enterococcus faecalis (formerly S. faecalis).

    Gram-negative aerobes:

    Acinetobacter spp.

    Enterobacter spp.

    Escherichia coli

    Haemophilus influenzae (including ampicillin-resistant strains)

    Klebsiella pneumoniae

    Morganella morganii (before Proteus morganii)

    Neisseria gonorrhoeae

    Proteus mirabilis

    Proteus vulgaris

    Providencia rettgeri (before Proteus rettgeri)

    Pseudomonas aeruginosa

    Serratia marcescens

    Anaerobes

    Bacteroides spp.

    Peptococcus spp.

    Peptostreptococcus spp.

    Ceftizoxime is usually active in relation to the following microorganisms in vitro, but the clinical significance of this data is unknown.

    Gram-positive aerobes:

    Corynebacterium diphtheriae

    Gram-negative aerobes:

    Aeromonas hydrophila

    Citrobacter spp.

    Moraxella spp.

    Neisseria meningitidis

    Pasteurella multocida

    Providencia stuartii

    Salmonella spp.

    Shigella spp.

    Yersinia enterocolitica

    Anaerobes

    Actinomyces spp.

    Bifidobacterium spp.

    Clostridium spp. (most strains Clostridium difficile resistant)

    Eubacterium spp.

    Fusobacterium spp.

    Propionibacterium spp.

    Veillonella spp.

    Pharmacokinetics:
    The maximum concentration (Cmax) after intramuscular injection (in / m) at doses of 0.5 and 1 g is 13.7 and 39 μg / ml, respectively. Time to reach the maximum concentration (Tcah) -1h. Stax after intravenous administration (iv) in doses of 2 and 3 g - 110.9 and 174 mcg / ml, respectively, TCam - 10 min. The half-life (T1 / 2) after IM and IV is 1.7 hours. The connection with blood proteins is 30%. Two hours after intravenous administration in urine, a concentration of more than 6 mg / ml is achieved. Therapeutic concentrations are achieved in various fluids and body tissues: bile, pleural, peritoneal, ascitic and other fluids, bones, gall bladder, heart, prostate gland, uterus; accumulates in saliva, bile and cerebrospinal fluid. In small amounts penetrates into breast milk.
    It is excreted by the kidneys in an unchanged form, creating high concentrations in the urine.

    Indications:
    Bacterial infections caused by susceptible to ceftizoxime strains of microorganisms:
    -infection of the lower respiratory tract;
    -urinary tract infections;
    -gonorrhea;
    Infectious-inflammatory diseases of the pelvic organs;
    -in-abdominal infections (excluding infections caused by enterococci);
    -septicemia;
    -infection of the skin and subcutaneous tissues (excluding infections caused by enterococci);
    -infection of bones and joints (excluding infections caused by enterococci);
    -meningitis.
    Cefthysoxime is effective in the treatment of severe infections, incl. in weakened patients, patients with reduced immunity, neutropenia, mixed aerobic-anaerobic infections resistant to other cephalosporins and aminoglycosides.
    Contraindications:Hypersensitivity (including to other beta-lactam antibiotics), breast age (up to 6 months).
    Carefully:Renal failure, pseudomembranous colitis associated with the use of antibacterial drugs, pregnancy, lactation.
    Dosing and Administration:
    In / m, in / in struyno (for 3-5 minutes) or drip. The IV route is preferred in patients with bacterial septicemia, parenchymal abscess limited (in particular, intra-abdominal abscess), peritonitis, or other severe or life-threatening infections. The dose of the drug, the way of doing it should be determined depending on the patient's condition, the severity of the infection and the sensitivity of the microorganism.
    Usually the dose of the drug in adults is 1-2 g every 8-12 hours.
    In uncomplicated urinary tract infections - 500 mg every 12 hours IV or / m. In the treatment of infections caused by P. aeruginosa, the dose should be increased, since many strains P. aeruginosa are moderately sensitive to ceftizoxime. In the event that the response to treatment does not occur within the next time, it is necessary to start another therapy.
    For infections of other localizations, 1 g every 8-12 h IV or IM.
    Heavy or refractory infections - 1 g every 8 h or 2 g every 8-12 h iv or in / m.If it is necessary to administer 2 g / m dose should be divided and introduced separately into different large muscles.
    Infectious-inflammatory diseases of the pelvic organs - 2 g every 8 hours in / in. In the event that the agent is suspected C. trachomatis, it is necessary to additionally introduce antibiotics effective against C. trachomatis, because the ceftizoxime is inactive in relation to this pathogen.
    Life-threatening infections - 3-4 g every 8 hours in / in. There is an experience of administering doses up to 2 g every 4 h.
    For treatment of uncomplicated gonorrhea -1 g IM once.
    With normal kidney function, doses of 2 to 12 g IV may be given daily, with bacterial septicemia IV, doses of 6-12 g are usually administered for several days, after which the dose is gradually reduced in accordance with the clinical response and laboratory parameters .
    Children older than 6 months - 50 mg / kg / day every 6-8 hours. If necessary, the dose may be increased to a total daily dose of 200 mg / kg, but should not exceed the maximum recommended dose in adults for the treatment of severe infections.
    If the excretory function of the kidneys is disturbed, correction of the dosing regimen is required depending on the values ​​of creatinine clearance (CK).After an initial dose of 500 mg or 1 g IV or IM, a dose reduction should be made according to the data in the table:

    CK ml / min

    Less severe infections

    Life-threatening infections

    50-79

    500 mg every 8 hours

    750 mg-1.5 g every 8 hours

    5-49

    250-500 mg every 12 hours

    500 mg-1 g every 12 hours

    0-4

    500 mg

    500 mg-1 g every 48 hours

    (patients on hemodialysis)

    every 48 hours

    or 250 every 24 hours

    or 500 mg every 24 hours

    Patients on hemodialysis do not need an additional dose, but the drug should be administered (according to the table above) at the end of the hemodialysis session.

    To prepare a solution for intravenous injections, the contents of the vial (1 g) are dissolved in 3 ml of sterile water for injection.

    To prepare a solution for IV injections, the contents of the vial (1 g) are dissolved with 10 ml of sterile water for injection. The prepared solution can be injected directly into the vein, or through the cannula for the introduction of parenteral fluids. For intravenous administration, the previously reconstituted solution is then diluted in 50-100 ml of 0.9% sodium chloride solution, 5% or 10% dextrose (glucose) solution, 5% dextrose solution and 0.9%, 0.45% or 0.2% sodium chloride solution, in Ringer's and Ringer's lactate solution, 5% sodium bicarbonate solution.


    Side effects:

    The most frequent (more than 1%, but less than 5%): Allergic reactions: rash, itching, fever.

    From the hepatobiliary system: transient increase in alanine aminotransferase activity (ALT), aspartate aminotransferase (ACT) and alkaline phosphatase (APF).

    On the part of the organs of hematopoiesis: transient eosinophilia, thrombocytosis, false-positive Coombs test.

    Reactions at the site of administration: burning, inflammation of the subcutaneous tissue, phlebitis (with / in the introduction), pain, tightness, tenderness in pressure, paresthesia.

    Less frequent (less than 1%):

    Allergic reactions: numbness and anaphylaxis.

    From the hepatobiliary system: increased bilirubin in the blood. From the genitourinary system: transient increase in blood urea nitrogen and creatinine; vaginitis.

    From the hematopoiesis: anemia (including hemolytic), leukopenia, neutropenia, thrombocytopenia.

    From the digestive system: diarrhea, nausea, vomiting, pseudomembranous colitis.

    Overdose:There have been no cases of overdose to date.
    Interaction:When used simultaneously with other cephalosporins and aminoglycosides, the risk of nephrotoxicity increases.Pharmaceutically incompatible with other medicines (only solvents listed in the section "Dosing and Administration" should be used to reconstitute the drug).
    Special instructions:
    Patients with penicillin allergy may have a cross-sensitivity to cephalosporin antibiotics.
    If a severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be deleted, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.
    Like other cephalosporins ceftizoxime is inactive against Chlamydia trachomatis, therefore, in case of treatment of infectious-inflammatory diseases of the pelvic organs, when one of the pathogens is suspected of Chlamydia trachomatis, it is necessary to add antibiotics active against this pathogen.
    During the treatment period, it is necessary to periodically monitor the function of the kidneys.
    Before starting treatment with ceftizoxime, a laboratory test should be performed to establish the type of pathogen and its sensitivity; treatment with ceftizoxime may be initiated before the results of these studies are obtained,However, in the future should be adjusted in accordance with the results. In case of severe infections ceftizoxime can be used in combination with aminoglycosides.
    After dilution, the drug can be stored at room temperature for 7 hours, in the refrigerator - 48 hours. The reconstituted solution can acquire a yellowish color, which does not affect its activity.

    Effect on the ability to drive transp. cf. and fur:Studies on the effect of the drug on the ability to drive vehicles and work with mechanisms have not been conducted.
    Form release / dosage:Powder for solution for intramuscular and intravenous administration 1.0 g.
    Packaging:By 1.0 g of powder in a vial of transparent glass, sealed with a stopper of chlorobutyl rubber, crimped with an aluminum ring, and a plastic cap. 1 bottle with instructions for use in a pack of cardboard.
    Storage conditions:
    In dry, dark place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.

    Shelf life:
    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006699/10
    Date of registration:15.06.2010
    The owner of the registration certificate:JODAS EKSPOIM, LLC JODAS EKSPOIM, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspJodas Expoim, Open CompanyJodas Expoim, Open Company
    Information update date: & nbsp10.11.2015
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