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Dosage form: & nbspPowder for solution for intramuscular injection
Composition:

Ampicillin sodium

(Ampicillin sodium salt is sterile)

(in terms of ampicillin)

133.4 mg

333.5 mg

Oxacillin sodium

(Oxacillin sodium salt is sterile)

(in terms of oxacillin)

66.6 mg

166.5 mg

Description:Powder white with a yellowish hue of color. Hygroscopic.
Pharmacotherapeutic group:Antibiotic combined (semi-synthetic penicillins)
ATX: & nbsp
  • Combinations of penicillins
  • Pharmacodynamics:

    Combined antibiotic, combining the spectrum of action of ampicillin and oxacillin.

    Ampicillin - semi-synthetic penicillin, it acts bactericidal, acid-fast. Active against gram-positive, non-retentive penicillinase (Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae) and gram-negative (Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Salmonella spp., Shigella spp., Proteus mirabilis, Haemophilus influenzae) microorganisms.

    Oxacillin - penicillin-resistant semisynthetic antibiotic from the penicillin group, acid-fast; has bactericidal action against gram-positive microorganisms (Staphylococcus spp., Streptococcus spp., in t.ch. Streptococcus pneumoniae, Actinimyces spp., Bacillus anthracis, Corynebacterium diphtheriae, anaerobic spore-forming sticks, incl. Clostridium), Gram-negative cocci (Neisseria gonorrhoeae, Neisseria meningitidis), E. coli, Pr.mirabilis, H.influenzae, K.pneumoniae, Actinomyces spp., Treponema spp.

    The action of the drug is stable Ps.aeruginosa and others non-fermenting gram-negative bacteria, most strains Pr.vulgaris, Providenda rettgeri, Morganella morganii.

    Pharmacokinetics:Time to reach the maximum concentration (TCmOh) of both antibiotics in the blood - 0.5-1 h after IM. Both antibiotics are excreted by the kidneys, partly with bile. When repeated injections are not cumulated.
    Indications:

    Bacterial infections caused by susceptible pathogens: sinusitis, tonsillitis, otitis media; bronchitis, pneumonia; cholangitis, cholecystitis; pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, cervicitis; infections of the skin and soft tissues: erysipelas, impetigo, secondarily infected dermatoses, etc.

    Prevention of postoperative complications during surgical interventions (including against the background of immunodeficiency), infections in newborns (infection of the amniotic fluid, impaired breathing of the newborn, requiring the use of resuscitative measures, the risk of aspiration pneumonia).

    Severely leaking infections (sepsis, endocarditis, meningitis, postpartum infection).

    Contraindications:

    Hypersensitivity, infectious mononucleosis, lymphocytic leukemia.

    Carefully:

    Children born to mothers with hypersensitivity to penicillins.

    Pregnancy and lactation:

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

    It is allocated with breast milk, therefore, if it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Intramuscularly.

    The doses indicated below are the sum of dosages of ampicillin and oxacillin (sodium salts) in their fixed ratio of 2: 1 (i.e., in the following dosages 0.5 g of the drug is equal to the sum of 333.5 ampicillin plus 166.5 mg of oxacillin) .

    Daily dose:

    - for adults and children over 14 years of age - 3-6 g;

    - for newborns and premature infants under 1 year of age - 100-200 mg / kg / day;

    - 1-6 years - 100 mg / kg / day;

    - 7-14 years - 100 mg / kg / day.

    The daily dose is administered in 3-4 divided doses, with an interval of 6-8 hours. If necessary, these doses can be increased by 1.5-2 times.

    Duration of treatment depends on the severity of the disease (from 5-10 days to 2-3 weeks, and in chronic processes - for several months)

    For intramuscular administration, the contents of the vial (133.4 mg + 66.6 mg or 333.5 mg + 166.5 mg) are dissolved, respectively, in 2 ml or 5 ml of water for injection.The solutions are used immediately after preparation.

    Side effects:

    Allergic reactions: urticaria, skin hyperemia, Quincke's edema, rhinitis, conjunctivitis; fever, arthralgia, eosinophilia, in rare cases anaphylactic shock; superinfection, dysbacteriosis, taste change, vomiting, nausea, diarrhea, rarely pseudomembranous enterocolitis, leukopenia, neutropenia, anemia.

    At the injection site, infiltration, soreness.

    When signs of anaphylactic shock appear, urgent measures must be taken to remove the patient from this condition: epinephrine, GCS (hydrocortisone or prednisolone) and antihistamines, if necessary, carry out artificial ventilation of the lungs.

    Interaction:

    Antacids, glucosamine, laxatives, food, aminoglycosides (for enteral administration) slow down and reduce absorption; ascorbic acid increases absorption.

    Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.

    Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index); reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which produces paraaminobenzoic acid, ethinyl estradiol - the risk of bleeding "breakthrough".

    Diuretics, allopurinol, tubular secretion blockers, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion, increase the concentration of the drug in the plasma, which increases the risk of developing toxic effects.

    Allopurinol increases the risk of skin rash.

    Special instructions:

    In course treatment it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys.

    The possibility of developing superinfection (due to the growth of insensitive microflora) requires a corresponding change in antibacterial therapy.

    In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.

    When used in high doses in patients with renal insufficiency, a toxic effect on the central nervous system is possible.

    Form release / dosage:Powder for solution for intramuscular injection, 133.4 mg + 66.6 mg, 333.5 mg + 166.5.
    Packaging:

    By 133.4 mg + 66.6 mg, 333.5 mg + 166.5 mg of the drug in vials of 10 ml or 20 ml.

    5 bottles are placed in a contour mesh package.

    1, 5 or 10 bottles or 1, 2 contour squares with instructions for use are placed in a pack of cardboard.

    50 bottles with 1-5 instructions for use are placed in a cardboard box for delivery to hospitals.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 20 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002576 / 02
    Date of registration:30.10.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp23.05.2017
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