Active substanceBenzylpenicillinBenzylpenicillin
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  • Dosage form: & nbsp

    powder for solution for intravenous and intramuscular administration

    Composition:

    1 bottle contains benzylpenicillin (benzylpenicillin sodium) (in terms of the active substance) - 0.6 g (1,000,000 units).

    Description:

    White or almost white fine crystalline 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. Inhibits 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), Corynebacte- rium diphtheriae, Bacillus anthracis, Actinomyces spp. Gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, as well as in relation to Treponema sppIt is inactive with respect to the majority of 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 maximum concentration in blood plasma with intramuscular injection is achieved in 20-30 minutes. The half-life of the drug 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. With inflammation of the meningeal membranes, permeability through the blood-brain barrier increases. 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; infection of the ENT organs and infection of the eyeball.

    Contraindications:

    Hypersensitivity (including to others (beta-lactam antibiotics), epilepsy (for endolumbic administration).

    Carefully:

    Renal 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 during lactation, the question of stopping breastfeeding (penetrates into breast milk in low concentrations) should be solved. Action category for the fetus by FDA - AT.

    Dosing and Administration:

    The drug is intended for intramuscular, intravenous, subcutaneous, endolumbic and intratracheal administration.

    In case of moderate disease (lower respiratory tract infections, urine and bile ducts, soft tissue infections, etc.), 4-6mln ED / 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.

    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 to 500000 units / kg. Multiplicity of administration - 4-6 times a day, intravenously - 1-2 times a day in combination with intramuscular injections.

    Endolumbally administered with purulent diseases of the brain and spinal cord and meninges.

    Depending on the disease and the severity of its course: adults - 5-10 thousand units, children - 2-5 thousand units once a day for 2-3 days intravenously, then prescribed intramuscularly.

    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 slowly, for 3-5 minutes.

    For intravenous drip 2-5 million ED are diluted with 100-200 ml of a 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 use a 5-10% solution of dextrose (100-300 ml, depending on the dose and age).

    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% solution of novocaine.

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

    Subcutaneously the drug is used to cut infiltrates in a concentration of 100-200 thousand units per ml of 0.25-0.5% solution of novocaine.

    Preparation of the drug solution for endolumbal application: diluted in sterile water for injection or in 0.9 % solution of sodium chloride at a rate of 1 thousand units / ml.

    Before injection (depending on intracranial pressure), 5-10 ml of cerebrospinal fluid is extracted and added to the antibiotic solution in equal proportions. Enter slowly (1 ml / min), usually 1 time per day for 2-3 days, then go to intravenous or intramuscular injection.

    When suppuration processes in the lungs, a drug solution intratrahealno (after careful anesthesia of throat, larynx and trachea). Usually 100 thousand units are used in 10 ml of 0.9 % solution of sodium chloride.

    In case of eye diseases (acute conjunctivitis, corneal ulcers, gonoblenaire, etc.), appoint eye drops, containing 20-100 thousand units in 1 ml of a 0.9% solution of sodium chloride or distilled water. Enter 1-2 drops 6-8 times a day.

    For ear drops or drops in the nose apply solutions containing 10-100 thousand units / ml.Duration of treatment with the drug, depending on the form and severity of the course of the disease - from 7-10 days to 2 months or more (for example, with sepsis, septic endocarditis).

    Side effects:

    Hypersensitivity reactions: skin rash, itching, fever, chills, arthralgia, swelling, urticaria, exudative erythema multiforme exfoliative dermatitis, quincke angioedema, anaphylactic shock.

    On the part of the respiratory system: bronchospasm.

    From the central and peripheral nervous system: dizziness, headache, tinnitus. Endolumbal administration may cause neurotoxicosis (nausea, vomiting, symptoms of meningealism, convulsions).

    From the digestive tract: nausea, stomatitis, glossitis, diarrhea, pseudomembranous colitis, impaired liver function.

    From the genitourinary system: interstitial nephritis.

    From the cardiovascular system: fluctuations in blood pressure, impaired myocardial pumping function.

    From the side of the blood and lymphatic system: eosinophilia, positive results of Coombs test, hemolytic anemia, leukopenia, thrombocytopenia, agronolocytosis.

    Other: weakened patients, newborns, elderly people with long-term treatment may experience superinfection caused by drug-resistant microflora (yeast-like fungi, gram-negative microorganisms). In patients who undergo treatment for syphilis, the Jarish-Gerxheimer reaction may reappear to bacteriolysis.

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

    Overdose:

    Symptoms: convulsions, impaired consciousness.

    Treatment: withdrawal of the drug, symptomatic therapy (includes hemodialysis, peritoneal dialysis, special attention should be given to the water-electrolyte balance).

    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,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, when combined, increases the risk of allergic reactions (skin rashes).

    Special instructions:

    Drug solutions for all routes of administration are prepared ex tempore.

    If after 2-3 days (maximum 5 days) after the start of the drug, the effect is not observed, you should proceed to use other antibiotics or combination therapy.

    Weakened patients, newborns, elderly people with long-term treatmentand possibly the development of superinfection caused by drug-resistant microflora (yeast-like fungi, gram-negative microorganisms).

    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 to exciteleu. If resistance occurs, continue treatment with another antibiotic.

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

    Not affects the ability to manage transport means and work with other complex mechanisms

    Form release / dosage:
    Powder for solution for intravenous and intramuscular injection 1000000 units.
    Packaging:
    By 1000000 units of active substance into glass bottles with a capacity of 10 ml, hermetically sealed with rubber stoppers, crimped with aluminum caps or aluminum combined caps.
    1 bottle with the drug and instruction for use is placed in a pack of cardboard.
    For 10, 25, 50 vials of the drug with an equal number of instructions
    tions on the use of the drug are placed in a group package - in a box of cardboard with partitions.
    Storage conditions:

    In a dry place, at a temperature not exceeding 20 ° ะก.

    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:LS-001481
    Date of registration:28.10.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.01.2017
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