Active substanceBenzylpenicillinBenzylpenicillin
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  • Dosage form: & nbsp

    powder for solution for intravenous and intramuscular administration

    Composition:
    Active substance: Benzylpenicillin sodium salt 1000000 units.
    Description:

    White or almost white fine crystalline powder.

    Pharmacotherapeutic group:Antibiotic - penicillin biosynthetic
    ATX: & nbsp

    S.01.A.A.14   Benzylpenicillin

    Pharmacodynamics:

    Bactericidal antibiotic from the group of biosynthetic ("natural") penicillins. Suppresses the synthesis of the cell wall of microorganisms. It is active against gram-positive pathogens: staphylococci (non-prone penicillinase), streptococci, pneumococci, corynebacterium diphtheria, anaerobic spore-forming rods, anthrax rods, Actinomyces spp. Gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, as well as in relation to Treponema spp., spirochete. Inactive with most gram-negative bacteria, rickettsia, viruses, protozoa. Penicillinase-forming strains of microorganisms are resistant to the action of the drug. Destroyed in an acidic environment.

    Pharmacokinetics:The time to reach the maximum concentration (TCmax) with the / m introduction is 20-30 min. The half-life (T1 / 2) is 30-60 minutes, with renal failure 4-10 hours or more. Connection with plasma proteins - 60%. Penetrates into organs, tissues and biological fluids, except for CSF, eye and prostate tissues during inflammation of meningeal membranes penetrates the blood-brain barrier. Passes through the placenta and penetrates into breast milk. It is excreted by the kidneys unchanged.
    Indications:

    Bacterial infections caused by susceptible pathogens: croup and focal pneumonia, empyema of the pleura, bronchitis; sepsis, septic endocarditis (acute and subacute), peritonitis; meningitis; osteomyelitis; infection of the genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, blenorrhea, syphilis, cervicitis), bile ducts (cholangitis, cholecystitis); wound infection, skin and soft tissue infections: erysipelas, impetigo,secondarily infected dermatoses; diphtheria; scarlet fever; anthrax; actinomycosis; ENT diseases, eye diseases.

    Contraindications:

    Hypersensitivity, including to other beta-lactam antibiotics; epilepsy (for endolumbal administration).

    Carefully:

    Pregnancy, lactation, kidney failure.

    Dosing and Administration:

    Benzylpenicillin sodium salt is injected in / m, iv. With intravenous and intramuscular injection, single doses for moderate to severe infections of the upper and lower divisions of the respiratory tract, urinary and bile ducts, infections of soft tissues, etc. are - 250,000 - 500,000 units 4 times a day. In severe infections (sepsis, septic endocarditis, meningitis, etc.) - 10-20 million units per day; with gas gangrene - up to 40-60 million units per day.

    The daily dose for children under the age of 1 year is 50000-100000 units / kg, over 50000 U / kg over 1 year, 200000-300000 U / kg if necessary, and for "vital" indications - an increase to 500000 U / kg. Multiplicity of administration - 4-6 times a day, intravenously 1-2 times a day in combination with intramuscular injections.

    The drug solution for intramuscular injection is prepared immediately before administration, adding to the contents of the vial 1-3 ml of water for injection or a solution of sodium chloride isotonic 0.9% or 0.5% solution of novocaine.

    For intravenous administration, a single dose (1-2 million units) is dissolved in 5-10 ml of sterile water for injection or 0.9% solution NaCl and injected slowly, within 3-5 minutes.

    For intravenous drip injection of 2-5 million units, dilute 100-200 ml of a 0.9% solution NaCl or 5-10% dextrose solution and injected at a rate of 60-80 cap / min. When drip introduction to children as a solvent used 5-10% solution of dextrose (30-100 ml, depending on the dose and age). The solutions are used immediately after preparation, not allowing the addition of other drugs to them.

    The duration of treatment with benzylpenicillin, depending on the form and severity of the course of the disease - 7-10 days.

    Side effects:

    Allergic reactions: hyperthermia, urticaria, skin rash, rash on the mucous membranes, arthralgia, eosinophilia, angioedema, interstitial nephritis, bronchospasm; rarely anaphylactic shock.

    From the cardiovascular system: edema, an increase in the volume of circulating blood, it is possible to reduce the pump function of the myocardium.

    Neurotoxic reactions: nausea, vomiting, increased reflex excitability, meningeal symptoms, convulsions, coma.

    Overdose:

    Cases of overdose are not described.

    Interaction:

    Bactericidal antibiotics (including cephalosporins, vancomycin, rifampicin, aminoglycosides) have a synergistic effect; bacteriostatic (including macrolides, chloramphenicol, lincosamides, tetracyclines) -antagonistic. Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the prothrombin index); reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which produces paraaminobenzoic acid, ethinyl estradiol - the risk of bleeding "breakthrough". Diuretics, allopurinol, tubular secretion blockers, phenylbutazone, non-steroidal anti-inflammatory drugs, reducing tubular secretion, increase the concentration of benzylpenicillin. Allopurinol increases the risk of allergic reactions (skin rashes).

    Special instructions:

    Solutions of the drug for intravenous and / or injections are prepared ex tempore.

    If after 2-3 days (maximum 5 days) after the start of the drug, no effect is observed, you should switch to using other antibiotics or combination therapy. In connection with the possibility of developing fungal lesions, it is advisable to prescribe vitamin B and vitamin C for long-term treatment with benzylpenicillin, and, if necessary, nystatin and levorin. It should be noted that the use of insufficient doses of the drug or too early cessation of treatment often leads to the emergence of resistant strains of pathogens.

    Form release / dosage:
    Powder for the preparation of solution for intramuscular and intravenous administration 1000000 units.
    Packaging:
    A bottle with a preparation together with the instruction for use is placed in a pack of cardboard.
    10 bottles of the drug, along with instructions for use, are placed in a cardboard pack.
    50 bottles of the drug along with instructions for use are placed in a box of cardboard (for hospitals).
    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:LSR-002213/07
    Date of registration:15.08.2007 / 17.10.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:VIAL, LLC VIAL, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspMapichem AGMapichem AG
    Information update date: & nbsp17.10.2013
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