Active substanceAmpicillinAmpicillin
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  • Dosage form: & nbspPowder for solution for intramuscular injection
    Composition:Active substance - ampicillin sodium (in terms of ampicillin) - 0.25 g and 0.5 g.
    Description:The powder is white or white with a yellowish hue. Hygroscopic.
    Pharmacotherapeutic group:Antibiotic, penicillin semisynthetic
    ATX: & nbsp

    J.01.C.A   Penicillins of a wide spectrum of action

    J.01.C.A.01   Ampicillin

    Pharmacodynamics:

    Antibacterial bactericidal agent from the group of semisynthetic penicillins, obtained by acetylation of 6-aminopenicillanic acid with an aminophenylacetic acid residue, is acid-fast. Inhibits the polymerase of peptoglycan and transpeptidase, prevents the formation of peptide bonds and breaks the late stages of the synthesis of the cell wall of the fissile microorganism, which leads to a decrease in the osmotic resistance of the bacterial cell and causes its lysis.

    It is active against Gram-positive (alpha and beta-hemolytic streptokokki, Streptococcus pneumoniae, Staphylococcus spp., Bacillus anthracis, Clostridium spp., most enterococci, incl. Enterococcus faecalis) and gram-negative (Haemophilus influenzae, Neisseria meningitidis, Proteus mirabilis, Pasteurella multocida many species Salmonella spp., Shigella spp., Escherichia coli) microorganisms, aerobic non-spore-forming bacteria (Listeria spp.).

    He effective in the relationship of penicillinase-producing strains Staphylo­coccus spp., all strains Pseudomonas aeruginosa most strains Klebsiella spp.andEnterobacter spp.
    Pharmacokinetics:

    It is evenly distributed in the organs and tissues of the body, it is found in therapeutic concentrations in pleural, peritoneal, amniotic and synovial fluids, cerebrospinal fluid, contents of blisters, urine (high concentrations), intestinal mucosa, bones, gall bladder, tissues of the female genital organs, bile, in the bronchial secretion (in the purulent, bronchial secretion, the accumulation is weak), paranasal sinuses, middle ear fluid, saliva, fetal tissues. Poorly penetrates the blood-brain barrier (permeability increases with inflammation of the meninges).

    Excreted mainly by the kidneys (70-80%) in urine are very high concentrations of the unchanged antibiotic; partially - with bile, in nursing mothers - with milk. Do not cumulate.Removed during hemodialysis.
    Indications:

    Bacterial infections caused by the sensitive microflora of the respiratory tract and ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media, bronchitis, pneumonia, lung abscess), infections of the kidneys and urinary tract (pyelonephritis, pyelitis, cystitis, urethritis), infections of the biliary system (cholangitis , cholecystitis), gonorrhea, chlamydial infections in pregnant women (with intolerance of erythromycin), cervicitis, skin and soft tissue infections: erysipelas, impetigo, secondarily infected dermatoses; infections of the musculoskeletal system; pasteurellosis, listeriosis, gastrointestinal tract infections (typhoid and paratyphoid, dysentery, salmonellosis, salmonella, peritonitis), endocarditis (prevention and treatment), meningitis, bacterial septicemia.

    Contraindications:Hypersensitivity (including to other penicillins, cephalosporins, carbapenems, infectious mononucleosis, lymphocytic leukemia, hepatic insufficiency, a history of gastrointestinal disease (especially colitis associated with the use of antibiotics), lactation period; children's age (up to 1 month).
    Carefully:Bronchial asthma, hay fever, etc.allergic diseases, renal insufficiency, bleeding in the anamnesis, pregnancy.
    Pregnancy and lactation:

    It is possible to use ampicillin during pregnancy if the benefit to the mother exceeds the potential risk to the fetus.

    Ampicillin is excreted in breast milk in low concentrations. If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

    Dosing and Administration:

    Intramuscularly.

    For infections of moderate-to-moderate course, adults are injected in / m 0.25-0.5 g every 6-8 hours; at a serious current of infections - 1-2 g 3-4 times a day.

    Listeriosis - in / m or IV in 50 mg / kg every 6 h.

    With meningitis - 14 g / day; multiplicity of administration - 6-8 time.

    With gonococcal urethritis - inside 3.5 g once, or in / m 0.5 g 2 times for one day; with gonorrheal uncomplicated urethritis - once 0.5 g.

    Children with severe and moderate infections - in / m at 25-50 mg / kg 4 times a day; when meningitis daily dose - 100-200 mg / kg for 6-8 introductions.

    With a mild infection in children, oral administration in the form of a suspension is preferable.

    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).

    Side effects:

    Allergic reactions: itching and flaky skin, hives, rhinitis, conjunctivitis, Quincke's edema, rarely - fever, arthralgia, eosinophilia, erythematous and maculopapular rash, exfoliative dermatitis, multiform exudative erythema, Stevens-Johnson syndrome; reactions similar to serum sickness, in isolated cases - anaphylactic shock.

    From the digestive system: dysbacteriosis, stomatitis, gastritis, dry mouth, taste change, abdominal pain, vomiting, nausea, diarrhea, stomatitis, glossitis, impaired liver function, moderate increase in activity of "liver" transaminases, pseudomembranous enterocolitis.

    From the central nervous system: agitation or aggression; anxiety, confusion, behavior change, depression, convulsions (with high-dose therapy).

    Laboratory indicators: leukopenia, neutropenia, thrombocytopenia, agranulocytosis, anemia.

    Local Reactions: pain at the injection site; infiltrates with the / m introduction.

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

    Overdose:

    Symptoms: manifestations of toxic effects on the central nervous system (especially in patients with renal insufficiency); nausea, vomiting, diarrhea, violation of water-electrolyte balance (as a consequence of vomiting and diarrhea).

    Treatment: gastric lavage, Activated carbon, salt laxatives, preparations for maintaining water-electrolyte balance and symptomatic.

    It is excreted by hemodialysis.
    Interaction:

    Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) - synergistic action, 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 the effectiveness of estrogen-containing oral contraceptives (additional methods of contraception must be used), drugs that metabolize para- aminobenzoic 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 concentration (by lowering tubular secretion). Allopurinol increases the risk of skin rash.

    Reduces clearance and increases the toxicity of methotrexate.

    Increases the absorption of digoxin.

    Special instructions:

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

    It is possible to develop superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapy.

    In the treatment of patients with bacteremia (sepsis), the development of a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible.

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

    In the treatment of mild diarrhea against the background of course treatment, antidiarrheal drugs should be avoided, which reduce intestinal peristalsis; it is possible to use kaolin- or attapulgite-containing antidiarrhoeic agents. With severe diarrhea, you should see a doctor.

    Treatment should necessarily continue for another 48-72 hours after the disappearance of clinical signs of the disease.

    When using estrogen-containing oral contraceptives at the same time, other or additional methods of contraception should be used whenever possible.

    Effect on the ability to drive transp. cf. and fur:Care must be taken when driving a vehicle or potentially dangerous machinery.
    Form release / dosage:Powder for solution for intramuscular injection 0.25 g and 0.5 g.
    Packaging:

    In bottles of a glass tube for medicines with a capacity of 10 ml.

    eleven; 5 or 10 bottles are placed in individual packs of cardboard together with instructions for use.

    2. Packing complete with a solvent-water for injection. The kit includes:

    a) 1 vial of the drug and 1 ampoule with water for injection for 5 ml.

    b) 5 vials of the drug and 5 ampoules of water for injection for 5 ml.

    c) 10 vials of the drug and 10 ampoules of water for injection for 5 ml.

    The kit is placed in individual packs, along with instructions for medical use, with a ampoule or ampoule knife.

    When using ampoules with incisions, rupture rings or break points, the ampoule knife or the ampoule scapegrator is not inserted.

    3. 50 vials are placed in boxes of cardboard with an investment of 3 to 5 instructions for the use of the drug (for hospitals).

    Storage conditions:In dry, protected from light and out of reach of children at a temperature of no higher than 25 ° C.
    Shelf life:2 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-002699
    Date of registration:25.10.2011 / 30.06.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.08.2017
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