Active substanceBenzylpenicillinBenzylpenicillin
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  • Dosage form: & nbsp

    Powder for suspension for intramuscular administration

    Composition:

    Active substance - benzylpenicillin procaine (benzylpenicillin novocaine salt) - 600,000 units.

    Description:White 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., gonococci, meningococci and spirochaetes. Not active against most gram-negative bacteria, rickettsia, viruses, protozoa. To the action of the drug, penicillinase-forming strains of microorganisms are resistant. Destroyed in an acidic environment. Procaine salt of benzylpenicillin in comparison with potassium and sodium salts is characterized by a longer duration of action.

    Pharmacokinetics:

    Time to reach the maximum concentration with intramuscular injection - 20-30 minutes. Half-life 30-60 minutes, with renal insufficiency - 4-10 hours or more. Connection with plasma proteins - 60%. Penetrates into organs, tissues and biological fluids, except for CSF, eye and prostate tissues. Inflammation of meningeal membranes penetrates the blood-brain barrier. 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 to the penicillin group, an allergy to procaine.

    Carefully:Bronchial asthma, hay fever and other allergic diseases, reduction of blood coagulation, pregnancy, lactation, renal failure.
    Dosing and Administration:

    Intramuscularly. Intravenous and endolyubalic administration is prohibited!

    The average therapeutic dose for adults: one-time - 300,000 units, daily - 600,000 units. The highest daily intake for adults is 1200000 units. Children under the age of 1 year are appointed to 50000-100000 units / kg / day, over 1 year - 50,000 units / kg / day. Multiplicity of administration 1-2 times a day.

    Duration of treatment, depending on the form and severity of the disease, lasts from 7-10 days to 2 months or more (septic endocarditis, sepsis).

    Solutions are prepared ex tempore, adding to the contents of the bottle 3 ml of water for injection or a solution of sodium chloride for injection 0.9%.The contents of the vial are vigorously shaken, the resulting suspension is quickly injected into the syringe and injected deep into the muscle.

    Side effects:

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

    Locally: soreness and compaction at the injection site.

    When entering the vascular bed: noise in the ears, impaired vision, fear, dizziness, short-term loss of consciousness.

    With the introduction of very large doses may be observed neurotoxic phenomena: nausea, vomiting, increased reflex excitability, symptoms of meningeism, convulsions, coma.

    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 of which forms para-aminobenzoic 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:

    If after 2-3 days (maximum 5 days) after the start of the drug the effect is not observed, you should go to the use of 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.

    You should not allow intravenous and endolumbral administration (maybe the development of the Ouenier syndrome - the development of feelings of depression, anxiety, paresthesia and visual impairment).

    In the treatment of sexually transmitted diseases, if there is a suspicion of syphilis, microscopic and serological tests are necessary before starting therapy and then for 4 months.

    If any allergic reaction occurs, immediate cessation of treatment is required.
    Form release / dosage:Powder for the preparation of suspension for intramuscular injection of 600,000 units.
    Packaging:

    Powder for the preparation of suspension for intramuscular injection of 600,000 units in vials with a capacity of 10 ml.

    1, 5 or 10 bottles with instructions for use are placed in a pack of cardboard.
    Storage conditions:

    List B. In a dry place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:5 years.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000631 / 01
    Date of registration:26.10.2007
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.01.2017
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