Active substanceBenzylpenicillinBenzylpenicillin
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  • Dosage form: & nbsp

    Powder for solution for injection

    Composition:Benzylpenicillin sodium in terms of active substance - 500,000 units, 1,000,000 units.
    Description:

    White powder with a weak characteristic odor.

    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: Staphylococcus spp. (non-treating penicillinase), Streptococcus spp. (including Streptococcus pneumoniae), Corynebacterium diphtheriae, Bacil­lus anthracis, Actinomyces spp. Gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, as well as with respect to the class Spirochaetes, including Treponema spp. Not active against most Gram-negative bacteria, Rickettsia spp., protozoa.

    Penicillinase-forming strains of microorganisms are resistant to the action of the drug.

    Pharmacokinetics:

    The time to reach the maximum concentration (TCmax) with intramuscular injection - 20-30 minutes. Connection with plasma proteins - 60%. Penetrates into organs, tissues and biological fluids, except for cerebrospinal fluid, eye and prostate gland tissue, when inflammation of meningeal membranes penetrates the blood-brain barrier (GEB). It is excreted by the kidneys unchanged. Half-life (T1 / 2) is 30-60 minutes, with renal insufficiency - 4-10 hours or more.

    Indications:

    Infectious-inflammatory diseases caused by susceptible pathogens:

    - respiratory organs: community acquired pneumonia, pleural empyema, bronchitis;

    - ENT-organs;

    - urogenital system: pyelonephritis, pyelitis, cystitis, urethritis, cervicitis;

    - bile ducts: cholangitis, cholecystitis;

    - skin and soft tissues: rye, impetigo, secondarily infected dermatoses, wound infection;

    - eye diseases: gonoblenorea, corneal ulcer;

    - sepsis, septic endocarditis (acute and subacute),

    - peritonitis;

    - gonorrhea, syphilis;

    - meningitis;

    - osteomyelitis;

    - diphtheria; scarlet fever; actinomycosis; anthrax.

    Contraindications:

    Hypersensitivity, including to other penicillins, cephalosporins.

    Carefully:Allergic diseases (bronchial asthma, pollinosis), kidney failure.
    Pregnancy and lactation:

    Use during pregnancy is possible if the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Intravenous, intramuscular, subcutaneous.

    Intravenous and intramuscular: with moderate infections of the upper and lower respiratory tract, urinary and bile ducts, soft tissue infections, etc. - 2.5-5 million units per day for 4 injections. 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 1 year - 50000 units / kg; if necessary - 200000-300000 units / kg, according to "vital" indications - increase - up to 500000 units / kg. Multiplicity of administration - 4-6 times a day, intravenously 1-2 times a day in combination with intramuscular injections.

    Subcutaneously for chipping infiltrates in a concentration of 100,000-200,000 units per ml of 0.25-0.5% procaine solution.

    In case of eye diseases: eye drops in the concentration of 20000-100000 units in 1 ml of a 0.9% solution of sodium chloride or distilled water, 1-2 drops 6-8 times a day. Duration of treatment with the drug, depending on the form and severity of the course of the disease - 7-10 days.

    Method of preparation of solutions

    Solution of the drug for intramuscular injection are prepared immediately before administration, adding to the contents of the vial 1-3 ml of water for injection or 0.9% solution of sodium chloride or 0.5% of the solution of procaine.

    When diluting benzylpenicillin in a procaine solution, cloudiness of the solution may occur due to the formation of crystals benzylpenicillin procaine, which is not an obstacle for intramuscular and subcutaneous administration of the drug.

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

    For intravenous drip 2-5 million ED are diluted with 100-200 ml of 0.9% sodium chloride solution 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.

    Solution for topical application in ophthalmology should be prepared ex tempore: Dissolve the contents of the vial in a 0.9% solution of sodium chloride or distilled water: 500,000 units in 5-25 ml, 1000000 units in 10-50 ml, respectively.

    Side effects:

    Allergic reactions: hyperthermia, urticaria, skin rash, rash on the mucous membranes, arthralgia, eosinophilia, angioedema, interstitial nephritis, bronchospasm; rarely anaphylactic shock. At the beginning of the course of treatment (especially in the treatment of congenital syphilis) is rare - fever, chills, increased sweating, exacerbation of the disease, the reaction of Yarisch-Gerxheimer.

    From the cardiovascular system: reduction of myocardial ejection fraction, arrhythmia, cardiac arrest, chronic heart failure (because hypernatremia may occur when large doses are administered).

    Local reactions: pain and tightness at the site of intramuscular injection.

    Other: with prolonged use: dysbacteriosis, development of superinfection.

    Overdose:

    Symptoms: convulsions, impaired consciousness.

    Treatment: withdrawal of the drug, symptomatic therapy.

    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 - 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, 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 for the long-term treatment with benzylpenicillin, if necessary, antifungal drugs. 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.

    Effect on the ability to drive transp. cf. and fur:Information on the effect of the drug on the ability to drive vehicles and other mechanisms are absent. However, given the possible side effect of the cardiovascular system, care should be taken when doing this kind of activity.
    Form release / dosage:Powder for solution for injection 500000 units, 1000000 units.
    Packaging:

    Powder for the preparation of solution for injection 500000 units, 1000000 units in bottles with a capacity of 10 ml.

    1 bottle together with instructions for use are placed in a pack.

    10 bottles together with the instruction for use are placed in a box of cardboard box.

    For hospital: 50 vials and 5 instructions for use are placed in a box of cardboard box.

    Storage conditions:

    List B.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:P N003271 / 01
    Date of registration:12.04.2004 / 10.06.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:KRASFARMA, JSC KRASFARMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.01.2017
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