Active substanceBenzylpenicillinBenzylpenicillin
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  • Dosage form: & nbsp

    Powder for solution for injection and placesapplication

    Composition:

    Active substance: Benzylpenicillin sodium (benzylpenicillin sodium salt) - 500,000 units and 1,000,000 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: Staphylococcus spp. (non-treating penicillinase), Streptococcus spp. (incl. Streptococcus pneumoniae), Corynebacterium spp. (incl. Corynebacterium diphtheriae), Bacillus anthracis, Actinomyces spp. Gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, as well as in relation to Treponema spp., class Spirochaetes. He is active against most gram-negative bacteria (incl. Pseudomonas aeruginosa), Rickettsia spp., viruses, protozoa. The action of the drug is stable Staphylococcus spp., producing penicillinase.

    Pharmacokinetics:

    The time required to achieve the maximum concentration in blood plasma with intramuscular injection is 20-30 minutes. Connection with plasma proteins - 60%. Penetrates into organs, tissues and biological fluids, except for CSF, eye and prostate gland tissue, inflammation of meningeal membranes penetrates through blood-brain barrier. It is excreted by the kidneys unchanged. Half-life 30-60 minutes, with renal insufficiency - 4-10 hours or more.

    Indications:

    Bacterial infections caused by penicillin-sensitive pathogens: community-acquired pneumonia, pleural empyema, bronchitis; sepsis, septic endocarditis (acute and subacute), peritonitis; meningitis; osteomyelitis; infection of the genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis, cervicitis), bile ducts (cholangitis, cholecystitis); wound infection, skin and soft tissue infections: erysipelas, impetigo, secondarily infected dermatoses; diphtheria; scarlet fever; anthrax; actinomycosis; infection of the ENT organs, eye diseases (acute conjunctivitis,ulcer of the cornea, etc.); gonorrhea, syphilis.

    Contraindications:

    Hypersensitivity, including to other penicillins, cephalosporins.

    Carefully:

    Pregnancy, allergic diseases (bronchial asthma, pollinosis), kidney failure.

    Pregnancy and lactation:

    The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

    If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Benzylpenicillin sodium salt is administered intramuscularly, intravenously, subcutaneously, topically.

    Intravenous and intramuscular: with moderate disease (upper and lower respiratory tract infections, urinary and biliary tract infections, soft tissue infection, etc.) - 4-6 million units / day for 4 injections. In severe infections (sepsis, septic endocarditis, meningitis, etc.) - 10-20 million ED / day; with gas gangrene - up to 40-60 million units / day.

    The daily dose for children under the age of 1 year - 50-100 thousand units / kg, over the year A - 50 thousand units / kg; if necessary - 200-300 thousand units / kg, according to "vital" indications - an increase to 500 thousand units / kg.Multiplicity of administration: intramuscularly - 4-6 times a day, intravenously 1-2 times a day in combination with intramuscular injections.

    Subcutaneously for the cutting of infiltrates in a concentration of 100-200 thousand units per ml of 0.25-0.5% solution of procaine.

    In the cavity (abdominal, pleural, etc.) solution of benzylpenicillin sodium salt to adults is administered at a concentration of 10-20 thousand units in 1 ml, children - 2-5 thousand units in 1 ml. As the solvent is used water for injections, or 0,9 % solution of sodium chloride. Duration of treatment is 5-7 days with the subsequent transition to intramuscular injection.

    With eye diseases appoint eye drops, containing 20-100 thousand units in 1 ml of a sterile 0.9% solution of sodium chloride or distilled water. Enter 1-2 drops 6-8 times a day. The solution is used freshly prepared.

    For the ear drops or drops in the nose apply solutions containing 10-100 thousand units in 1 ml sterile, 0.9% sodium chloride solution or distilled water. Enter 1-2 drops 6-8 times a day.

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

    The solutions are used immediately after preparation, not allowing the addition of other drugs to them.

    For intramuscular injection to the contents of the bottle add 1-3 ml of water for injection, 0.9% solution of sodium chloride or 0.5% solution of procaine (novocaine). The resulting solution is injected deep into the muscle.

    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 (1-2 million units) is dissolved in 5-10 ml of sterile water for injection or 0.9 % solution of sodium, chloride and injected t slowly, within 3-5 minutes.

    For intravenous drip 2-5 million ED are diluted in 100-200 ml of 0.9 % solution of sodium chloride or 5-10% solution of dextrose 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).

    For subcutaneous administration the contents of the vial are diluted in 0.25-0.5 % solution of procaine: 500 thousand units in 2.5-5 ml, 1 million units in 5-10 ml, respectively.

    For intracavitary administration the contents of the vial are diluted in 0.9% solution of sodium chloride or in water for injections: adults - 500 thousand.ED in 25-50 ml, 1 million units in 50-100 ml respectively; children - 500 thousand units in 100-250 ml, 1 million units in 200-500 ml respectively.

    Eye drops should be prepared ex tempore: the contents of the bottle are diluted in 0.9% solution of sodium chloride or distilled water: 500 thousand units in 5-25 ml, 1 million units in 10-50 ml, respectively.

    Ear drops and drops in the nose: the contents of the bottle are diluted in 0.9% solution of sodium chloride or distilled water: 500 thousand units in 5-50 ml, 1 million units in 10-100 ml, respectively.

    Side effects:

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

    From the cardiovascular system: disturbance of pumping function of the myocardium, arrhythmias, cardiac arrest, chronic heart failure (because with the introduction of large doses hypernatremia may occur).

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

    With prolonged use: dysbiosis, development of superinfection.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    It manifests itself as a toxic effect on the central nervous system (convulsions, headache, myalgia, arthralgia).

    Treatment is symptomatic.

    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 parahaminobenzoic acid is formed.

    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:Drug solutions are prepared immediately before administration.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 in the long-term treatment with benzylpenicillin and, 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:

    During the administration of the drug, care should be taken when controlling vehicles, mechanisms and other potentially hazardous activities, requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:

    Powder for solution for injection and topical application 500000 units, 1000000 units.

    Packaging:

    For 500000 units and 1000000 units of active substance in bottles with a capacity of 10 ml or 20 ml, hermetically sealed with stoppers rubber, crimped caps aluminum or caps combined aluminum with plasticcovers.

    1, 5, 10 bottles together with the instruction for use are placed in a pack of cardboard.

    50 bottles are placed in a box of cardboard, with an equal number of instructions for use for delivery to hospitals.

    Storage conditions:

    In a dry place at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000410
    Date of registration:04.05.2010 / 11.04.2012
    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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