Oxamp®-sodium (Oxamp®-sodium)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAmpicillin + OxacillinAmpicillin + Oxacillin
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    • Dosage form: & nbsppowder for solution for intravenous and intramuscular administration
    Composition:

    Active substances:

    Ampicillin sodium (in terms of ampicillin) 667.0 mg

    Oxacillin sodium (in terms of oxacillin) 333.0 mg

    Description:

    Powder white with a yellowish hue of color.

    Pharmacotherapeutic group:Antibiotic combined (semi-synthetic penicillins)
    ATX: & nbsp

    J.01.C.R.50   Combinations of penicillins

    Pharmacodynamics:

    Combined antibiotic uniting the spectrum effects of ampicillin and oxacillin.

    Ampicillin - semi-synthetic penicillin, acts bactericidal, acid-fast. Active against gram-positive, non-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, Actinomyces spp., Bacillus anthracis, Corynebacterium diphtheriae, anaerobic spore-forming sticks, incl. Clostridium spp.), gram-negative cocci; Escherichia coli, Proteus mirabilis, Haemophilus influenzae, Klebsiella pneumoniae, Actinomyces spp., Treponema spp.

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

    Pharmacokinetics:Time to reach the maximum concentration (TCmax) of both antibiotics in the blood - 0.5-1 h after intramuscular injection. Half-life is 1-2 hours. The drug penetrates well into various organs and tissues. With intravenous administration in the blood quickly (after 5-10 minutes), drug concentrations are created that exceed those for intramuscular injection. Both antibiotics are excreted by the kidneys, partly with bile. When repeated injections are not cumulated.
    Indications:

    Infectious-inflammatory diseases caused by sensitive 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 and others.

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

    Sepsis, endocarditis, meningitis, postpartum infection.

    Contraindications:

    Hypersensitivity, infectious mononucleosis / lymphocytic leukemia.

    Carefully:

    Children born to mothers with hypersensitivity to penicillins. Allergic reactions in history and / or bronchial asthma, renal failure, history of bleeding, enterocolitis on the background of antibiotics (in the anamnesis).

    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 (it is excreted in breast milk).

    Dosing and Administration:

    Intramuscularly and intravenously (struino or drip).

    Doses of the drug, 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, 1 g of the drug is equal to the sum of 667.0 mg of ampicillin + 333.0 mg of oxacillin).

    The daily dose for adults and children over 14 years old is 3-6 g; for newborns, prematurity and children under 1 year - 100-200 mg / kg / day; 1-6 years - 100 mg / kg / day; 7-14 years - 50 mg / kg / day. The daily dose is given in 3-4 injections, with an interval of 6-8 hours. If necessary, these doses can be increased by 1.5-2 times. The 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 injection, the contents of the vial are dissolved in 10 ml of water for injection.

    For intravenous fluid administration (within 2-3 min), a single dose is dissolved in 10-15 ml of water for injection or 0.9% solution of sodium chloride. For intravenous drip administration, a single dose is dissolved in 100-200 ml of a 0.9% solution of sodium chloride or 5% solution of dextrose (glucose) by adults and injected at a rate of 60-80 cap / min; Children as a solvent used 30-100 ml of a 5-10% solution of dextrose (glucose). Intravenously, the drug is administered for 5-7 days, with a subsequent transition to intramuscular injection.

    The solutions are used immediately after preparation.

    Side effects:

    Allergic reactions: itching and flaky skin, urticaria, skin hyperemia, rhinitis, conjunctivitis, angioedema, rarely - fever, arthralgia, eosinophilia, erythematous and maculopapular rash, exfoliative dermatitis, multiform exudative erythema (including Stevens-Johnson syndrome), reactions, similar to serum sickness, in isolated cases anaphylactic shock, non-allergic ampicillin rash, can disappear without drug withdrawal.

    From the gastrointestinal tract: dysbacteriosis, taste change, vomiting, nausea, diarrhea, moderate increase in the activity of "liver" transaminases, rarely - pseudomembranous colitis.

    Laboratory indicators: leukopenia, neutropenia, anemia, hematuria, proteinuria.

    Local reactions: pain at the injection site, phlebitis and periphlebitis (with intravenous administration); when intramuscular - at the injection site infiltration.

    Other: interstitial nephritis, nephropathy, superinfection (especially in patients with chronic diseases or reduced resistance of the body), vaginal candidiasis.

    Overdose:

    Symptoms:

    - manifestations of toxic effects on the central nervous system (especially in patients with renalinsufficiency): headache, tremor, convulsions;

    - nausea, vomiting, diarrhea, disturbance of the water-electrolyte balance.

    Treatment: symptomatic. It is excreted by hemodialysis.
    Interaction:

    Ampicillin. Pharmaceutically incompatible with aminoglycosides.

    Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, 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 estrogen-containing oral contraceptives, drugs, in the process of metabolism which produces paraaminobenzoic acid, ethinyl estradiol (in the latter case, the risk of bleeding "breakthrough" increases).

    Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion, increase the concentration of ampicillin in the plasma (due to a decrease in tubular secretion).

    Allopurinol increases the risk of skin rash.

    Reduces clearance and increases the toxicity of methotrexate.

    Oxacillin. Increases the toxicity of methotrexate (competition for tubular secretion); it may be necessary to increase the doses of calcium folinate (antidote of folic acid antagonists) and its longer use.

    It is necessary to avoid joint use with other drugs that have a hepatotoxic effect.

    It is not recommended to prescribe concomitantly with bacteriostatic antibiotics (decreased efficacy).

    Drugs that block tubular secretion, increase the concentration of oxacillin in the blood.

    Special instructions:

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

    When there are signs of anaphylactic shock, urgent measures should be taken to remove the patient from this condition: the introduction of epinephrine (adrenaline), glucocorticosteroids (hydrocortisone or prednisolone) and antihistamines, if necessary, carry out artificial ventilation of the lungs.

    The possibility of developing superinfection (due to the growth of microflora insensitive to the drug) 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 the preparation of solution for intravenous and intramuscular injection at 667.0 mg + 333.0 mg.

    Packaging:

    At 667.0 mg + 333.0 mg in bottles with a capacity of 10 ml or 20 ml, hermetically sealed with stoppers rubber, crimped aluminum caps, or caps combined aluminum with plastic caps.

    5 bottles are placed in a contour mesh package made of a polyvinyl chloride film.

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

    50 bottles with 5 instructions for use are placed in a carton box for delivery to hospitals.
    Storage conditions:

    List B. 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:LSR-004808/10
    Date of registration:27.05.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.05.2017
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