Active substancePolymyxin BPolymyxin B
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  • Dosage form: & nbspPowder for solution for injection
    Composition:

    Composition per 1 bottle of Polymyxin B sulfate

    in terms of the sum of polymyxins B1, B2, B3, B1-I - 25 mg; 50 mg.

    Description:White or almost white powder, odorless or almost odorless.
    Pharmacotherapeutic group:Antibiotic-polypeptide is cyclic
    ATX: & nbsp

    J.01.X.B.02   Polymyxin B

    Pharmacodynamics:

    Antibiotic, produced by spore-forming bacteria Bacillus polymixa. Each mg of purified polymyxin B is equivalent to 10,000 units of polymyxin B. It has a bactericidal effect associated with a violation of the integrity of the membrane of the microbial cell. Absorbed on membrane phospholipids, increases its permeability, causes bacterial lysis.

    It is active against most Gram-negative bacteria, incl. Pseudomonas aeruginosa, Salmonella spp., Shigella spp., Escherichia coli, Klebsiella spp., Bordetella pertussis, Haemophilus influenzae, Enterobacter spp. Moderately sensitive Fusobacterium spp. and Bacteroides spp.. He acts on coccal aerobic {Staphylococcus spp., Streptococcus spp. (incl. Streptococcus pneumoniae), Neisseria gonorrhoeae, Neisseria meningitidis) and anaerobic microorganisms, Corynebacterium diphtheriae, on most strains Proteus spp., Mycobacterium tuberculosis and mushrooms. Stability develops slowly, but is cross-linked with colistin and polymyxin E.

    Pharmacokinetics:

    With intramuscular injection, maximum plasma concentrations of 2-7 mg / ml are achieved after 1-2 hours; when administered intravenously at a dose of 2-4 mg / kg, the maximum concentration in the blood plasma is 2-8 mg / ml. Connection with plasma proteins - 50%. Poorly penetrates through tissue barriers, does not penetrate through blood-brain barrier. In small amounts, it penetrates the placenta and into breast milk. It is not metabolized. It is excreted by the kidneys in unchanged form (60% within 3-4 days) and through the intestine. Half-life is 3-4 hours, with severe renal failure - 2-3 days. When re-introduced cumulates.

    Indications:

    Severe infections caused by susceptible to polymyxin B in Gram-negative microorganisms with multiple resistance to other antibiotics: sepsis, meningitis (injected intrathecally), pneumonia, generalized wound infection.

    Contraindications:

    Hypersensitivity to polymyxin, myasthenia gravis.

    Carefully:

    Chronic renal failure.

    Pregnancy and lactation:The drug Sabvixin is contraindicated in pregnancy. For the period of application of the drug during lactation, breastfeeding should be discontinued.
    Dosing and Administration:

    Intravenous, intramuscular, intrathecal.

    Intravenous administration: for adults and children (over 1 year old) with normal renal function, the daily dose is 1.5-2.5 mg / kg (taking into account that 1 mg of purified polymyxin B is equivalent to 10,000 units of polymyxin B) in 2 administrations at intervals of 12 hours.

    The maximum daily dose should not exceed 2.5 mg / kg.

    In children younger than 1 year with normal kidney function, if necessary, the daily dose can be increased to 4 mg / kg, which is divided into 2 injections and administered at an interval of 12 hours.

    To prepare a solution for intravenous administration to adults, 50 mg of the drug is dissolved in 300-500 ml of 5% dextrose solution and injected at a rate of 60-80 cap / min. In children, the dose of the drug, intended for intravenous administration, is dissolved in 30-100 ml of a 5-10% solution of dextrose.

    Intramuscular injection (only with the impossibility of intravenous administration): for adults and children (over 1 year old) with normal renal function, a daily dose of 2.5-3 mg / kg in 3-4 injections every 6-8 hours. In children up to 1 year old with normal renal function, if necessary, the daily dose can be increased to 4 mg / kg, which is divided into 4 injections and administered at an interval of 6 hours.

    To prepare a solution for intramuscular injection, 25 mg is dissolved in 1 ml, 50 mg in 2 ml of 1% solution of procaine, water for injection or 0.9% solution of sodium chloride.

    Intrathecal administration (is a therapy of choice for meningitis caused by Pseudomonas aeruginosa): adults and children (over 2 years) - 5 mg once a day for 3-4 days, then every other day for 2 weeks after receiving a negative result of bacteriological inoculation and normalization of glucose concentration in the cerebrospinal fluid; children under 2 years - 2 mg once a day for 3-4 days or 2.5 mg once every 2 days. Then in a dose of 2.5 mg every other day for 2 weeks after receiving a negative result of bacteriological inoculation and normalization of glucose concentration in the cerebrospinal fluid.

    Before the introduction, the preparation 25 mg is dissolved in 5 ml, 50 mg in 10 ml of 0.9% sodium chloride solution (concentration of the prepared solution 5 mg / ml).

    In patients with impaired renal function, the dose of the drug decreases and increases the interval between administrations in accordance with the creatinine clearance:

    Creatinine clearance, ml / min

    % of the dose with normal kidney function

    Interval between administrations, hour

    20-50

    75-100

    12

    5-20

    50

    12

    Less than 5

    15

    12

    Solutions of the drug Sabvixin, prepared with water for injection, 0.9% sodium chloride solution, 5% dextrose solution, 0.5-1% procaine solution, can be stored for 12 hours at room temperature (25 ° C) or for 4 days in the refrigerator (from 2 to 8 ° C).

    Side effects:

    From the nervous system: dizziness, ataxia, impaired consciousness, drowsiness, paresthesia, neuromuscular blockade.

    From the urinary system: albuminuria, cylindruria, azotemia, proteinuria, renal tubular necrosis.

    From the respiratory system: paralysis of the respiratory musculature, apnea.

    From the digestive system: pain in the epigastric region, nausea, decreased appetite, pseudomembranous colitis.

    From the side of the organ of vision: impaired vision.

    Allergic reactions: skin rash, itching, eosinophilia.

    General reactions and reactions at the site of administration: phlebitis, periphlebitis, thrombophlebitis, soreness in the site of the IM injection.

    Other: superinfection, candidiasis, with intrathecal administration - meningeal symptoms (facial flushing, headache, fever, stiff neck, increase in the number of cells and protein in the cerebrospinal fluid).

    Overdose:Symptoms: paralysis of the respiratory muscles, neurotoxicity, nephrotoxicity. Treatment: supportive and symptomatic therapy.
    Interaction:

    Simultaneous use with nondepolarizing muscle relaxants (the threat of developing paralysis of the respiratory muscles) and other neurotoxic drugs is not recommended.

    With simultaneous use, a synergistic effect is observed with chloramphenicol, carbenicillin, tetracycline, sulfonamides and trimethoprim with respect to Pseudomonas aeruginosa, Proteus spp., Serratia spp.; with ampicillin - for most gram-negative bacteria.

    When combined with aminoglycosides (kanamycin, streptomycin, neomycin, gentamycin), the risk of oto- and nephrotoxicity, as well as neuromuscular blockade, increases. Increases the nephrotoxicity of amphotericin B. Pharmaceutically incompatible with the sodium salt of ampicillin, chloramphenicol, antibiotics of the cephalosporin group. tetracycline, amino acid solutions, heparin; they should not be mixed in one syringe or infusion medium.

    Special instructions:

    In infections caused by gram-negative microorganisms (Enterobacter, Pseudomonas aeruginosa , etc.), are prescribed only if the pathogen is resistant to other less toxic antimicrobial agents. With prolonged treatment, it is necessary to monitor kidney function once in 2 days. Parenteral use only in a hospital. Intramuscular injections are painful, therefore, for the preparation of a solution for intravenous administration, it is recommended to use a local anesthetic (0.5-1 % solution of procaine).

    Pseudomembranous colitis caused by Clostridium difficile, can appear both on the background of long-term use, and 2-3 weeks after cessation of treatment: manifested by diarrhea, leukocytosis, fever, abdominal pains (sometimes accompanied by discharge with mucous masses of blood and mucus). If these phenomena occur in mild cases, it is sufficient to cancel the treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin or metronidazole. Do not use drugs that inhibit the intestinal motility.

    Manifestations of side effects of polymyxin B may be a violation of kidney function (nephrotoxicity) and the nervous system (neurotoxicity),the risk of which is higher in patients with chronic renal failure and / or with simultaneous use with other drugs with neurotoxic and / or nephrotoxic properties.

    Polymyxin B should be used with caution in chronic renal disease insufficiency. It should avoid the use of the drug Sabvixin with other neuro- and nephrotoxic drugs.

    Effect on the ability to drive transp. cf. and fur:

    During drug treatment, care should be taken when carrying out potentially dangerous activities requiring increased concentration and speed of psychomotor reactions (vehicle management, working with moving mechanisms, dispatcher, operator).

    Form release / dosage:

    Powder for solution for injection 25 mg, 50 mg.

    Packaging:

    25 mg, 50 mg active ingredient in 10 ml vials of colorless transparent glass, hermetically sealed with rubber stoppers, crimped with aluminum caps or combined.

    1 bottle with instructions for use in a pack of cardboard.

    10 bottles with instructions for use in a cardboard box.

    For hospitals:

    - 50 bottles with an equal number of instructions for use in a cardboard box;

    - from 1 to 50 bottles with an equal number of instructions for use in a cardboard box.

    Complete with a solvent.

    Water for injection 5 ml in a glass ampoule.

    1 vial and ampule 1 in blisters (KYAU) of the polyvinylchloride film with instructions for use in paper cartons.

    5 bottles and 5 ampoules in separate KNU with instructions for use in a pack of cardboard. In the pack put a knife to open the ampoules or a scarifier ampoule. When using ampoules with notches, rings or break points, the ampoule opener opener or ampoule scarifier is allowed not to be inserted.

    Storage conditions:

    In the 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:LP-004368
    Date of registration:07.07.2017
    Expiration Date:07.07.2022
    The owner of the registration certificate:KRASFARMA, JSC KRASFARMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp18.09.2017
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