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Dosage form: & nbsp

Powder for suspension for intramuscular administration

Composition:

Composition per one bottle:

600,000 units,

1200000 units

Active substances:



benzathine benzylpenicillin

200,000 units

400,000 units

benzylpenicillin sodium (benzylpenicillin sodium salt) or benzylpenicillin potassium (benzylpenicillin potassium salt)

200,000 units

400,000 units

Benzylpenicillin procaine (benzylpenicillin novocaine salt)

200,000 units

400,000 units

Description:
White or white with a slightly yellowish tint powder, prone to clumping, forming a stable suspension with the addition of water.
Pharmacotherapeutic group:Antibiotic - penicillin biosynthetic
ATX: & nbsp
  • Penicillins sensitive in combination
  • Pharmacodynamics:

    Combined bactericidal preparation of 3 salts of benzylpenicillin: dibenzyl-ethylenediamine, procaine, sodium or potassium, with long-lasting action. Suppresses the synthesis of the cell wall of microorganisms.

    Active with respect to gram-positive microorganisms: Staphylococcus spp. (non-treating penicillinase), Streptococcus spp., in t.ch. Streptococcus pneumoniae, Corynebacterium diphtheriae;

    anaerobic spore-forming sticks: Bacillus anthracis, Clostridium spp., Actinomyces israelii;

    gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, Treponema spp.

    To the action of the drug resistant strains Staphylococcus sppforming a penicillinase.

    Pharmacokinetics:

    After intramuscular injection, it is slowly absorbed with the release of benzylpenicillin from the depot. With a single administration, it remains at an average therapeutic concentration of 6-7 days.The time required to reach the maximum concentration (TCmax) in plasma is 12-24 hours after the injection. On day 14 after the administration of 2.4 million DB, the serum concentration is 0.12 μg / ml; on day 21 after the administration of 1.2 million DB - 0.06 μg / ml (1 DB = 0.6 μg). Penetration in the liquid is high, in the tissue - low. The connection with plasma proteins is 40-60%. Penetrates through the placental barrier, is found in the mother's milk. Metabolized slightly, excreted mainly by the kidneys unchanged.

    Indications:

    Infections (in adults) caused by sensitive microorganisms: syphilis and other diseases caused by pale treponema (yaws), streptococcal infections (excluding infections caused by group B Streptococcus) - acute tonsillitis, scarlet fever, wound infections, erysipelas; rheumatism (prevention).

    Contraindications:

    Hypersensitivity to drugs of the penicillin group, etc. beta-lactam antibiotics, to procaine.

    Carefully:

    Pregnancy, lactation, renal failure, allergic diseases, including bronchial asthma, pollinosis (including in the anamnesis), pseudomembranous colitis.

    Pregnancy and lactation:

    Use in pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

    If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

    Dosing and Administration:
    Enter deeply intramuscularly in the upper outer quadrant of the gluteus muscle at a dose of 300 thousand AD. If necessary, 2 injections are done in different buttocks. Repeated injections are performed on the 4th day after the previous injection.
    In a dose of 600 thousand AD injected 1 time in 6 days.
    In the treatment of primary and secondary syphilis a single dose of the drug is 1.8 million units. The course of treatment consists of 7 injections. The first injection is carried out at a dose of 300 thousand AD, the second injection - after 1 day in a full dose, subsequent injections are carried out 2 times a week.
    In the treatment of secondary recurrent and latent early syphilis for the first injection, a dose of 300 kt is used, for subsequent injections - 1.8 million units. Injections are carried out 2 times a week. The course of treatment - 14 injections.
    To prepare the suspension use sterile water for injection, isotonic sodium chloride solution or 0.25-0.5% solution of novocaine (5-6 ml), prepared ex tempore. The solvent in the vial is injected slowly, at a rate of 5 ml in 20-25 seconds.The vial with the mixture is gently shaken in the direction of its longitudinal axis until a homogeneous suspension (or suspension) is formed. Bubbles are allowed on the surface of the suspension near the walls of the flask.
    kona. The suspension is injected immediately deep into the upper outer quadrant of the buttock. Rubbing the buttocks after the injection is not recommended. In case of prolonged contact with water or other aforementioned solutions
    the physical and colloidal properties of the drug vary, as a result of which the suspension becomes uneven and hardly passes through the needle of the syringe.
    Side effects:

    Allergic reactions: urticaria, angioedema, multiforme

    exudative erythema, rarely anaphylactic shock.

    Arthralgia, fever, exfoliative dermatitis; stomatitis, glossitis; anemia, thrombocytopenia, leukopenia, hypocoagulation.

    With long-term therapy - superinfection with resistant microorganisms and fungi.

    Overdose:

    There are no data on overdose.

    Interaction:

    Bactericidal antibiotics (including cephalosporins, vancomycin, rifampicin, aminoglycosides) have a synergistic effect; bacteriostatic (including macrolides, chloramphenicol, lincosamides, tetracyclines) - antagonistic. Reduces the effectiveness of oral contraceptives and ethinyl estradiol - the risk of bleeding "breakthrough".

    Diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs, reducing tubular secretion, increase the concentration of penicillins. Allopurinol increases the risk of allergic reactions (skin rashes).
    Special instructions:

    If any allergic reaction occurs, immediate cessation of treatment is required.

    Do not administer subcutaneously, intravenously, endolumbally, or in the body cavity. With a random intravascular injection, there may be a transient sense of depression, anxiety, and visual impairment (Ouenier syndrome). In order to avoid intravascular administration of the drug, it is recommended that aspiration be performed before the IM injection to detect a possible needle drop into the vessel. When treating venereal diseases, if there is a suspicion of syphilis, before the beginning of therapy and then for 4 months. it is necessary to conduct microscopic and serological studies.

    In connection with the possibility of developing fungal lesions, it is advisable to prescribe vitamins of group B and ascorbic acid, and, if necessary, nystatin and levorin, with signs of generalization of infection - fluconazole.

    It should be borne in mind that the use of the drug in insufficient doses or too early cessation of treatment often leads to the emergence of resistant strains of pathogens.

    In rare cases, anaphylactic shock can develop. With the appearance of the first signs of anaphylactic shock, urgent measures should be taken to remove the patient from this condition: the administration of norepinephrine, glucocorticosteroids, if necessary, artificial ventilation.

    Form release / dosage:

    Powder for the preparation of suspension for intramuscular injection 600,000 units, 1200000 units.

    Packaging:

    For 600,000 units and 1200,000 units in bottles with a capacity of 10 ml.

    1, 5 or 10 bottles together with instructions for use in a pack of cardboard.

    Storage conditions:
    At a temperature of 8 to 25 ° C.
    Keep out of the reach of children.
    Shelf life:

    3 years. Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000819 / 01
    Date of registration:07.11.2007
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.02.2017
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