Active substanceAmpicillinAmpicillin
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  • Dosage form: & nbsppowder for solution for intravenous and intramuscular administration
    Composition:

    1 bottle contains:

    Active substances:

    Ampicillin 0.25 g 0.5 g 1 g

    (in the form of ampicillin sodium salt)

    Description:The powder is white or almost white, 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:

    Ampicillin is an antibacterial bactericide from the group of semisynthetic penicillins, a broad spectrum of action. Suppress synthesis cell wall of bacteria. Acid-resistant.

    Pharmacodynamics

    It is active against Gram-positive (alpha and beta-hemolytic streptococci, Streptococcus pneumoniae, Staphylococcus spp., Bacillus anthracis, Clostridium spp., moderately active against the majority Enterococcus spp., including Enterococcus faecalis), Listeria spp., and non-negative (Haemophilus influenzae, Neisseria gonorrhoae, Neisseria meningitidis, Proteus mirabilis, Yersinia multocida (formerly Pasteurella), many species Salmonella spp., Shigella spp., Escherichia coli) microorganisms, aerobic non-spore-forming bacteria. Not effective against penicillinase-producing strains Staphylococcus spp., all strains Pseudomonas aeruginosa, most strains Klebsiella spp. and Enterobacter spp.

    Pharmacokinetics:

    With parenteral administration, the concentration in the blood exceeds that produced when ingested.

    Evenly distributed in the organs and tissues of the body, it is found in therapeutic concentrations in the pleural, peritoneal, amniotic and synovial fluids, cerebrospinal fluid, contents of blisters, urine (high concentrations), intestinal mucosa, bones, gall bladder, lungs, female genital tract, bile, bronchial secretion (in the purulent bronchial secretion weak accumulation), paranasal sinuses middle ear (with its inflammation), saliva, the tissues of the fetus. 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 susceptible to ampicillin pathogens: respiratory tract and ENT organs (sinusitis,tonsillitis, pharyngitis, otitis media, bronchitis, pneumonia, lung abscess), kidney and urinary tract infections (pyelonephritis, pyelitis, cystitis, urethritis), gonorrhea, infections of the biliary system (cholangitis, cholecystitis), cervicitis, skin and soft tissue infections: erysipelas , impetigo, secondarily infected dermatoses; infections of the musculoskeletal system; pasteurellosis, listeriosis, gastrointestinal infections (typhoid and paratyphoid, dysentery, salmonellosis), abdominal infections (peritonitis), endocarditis (prevention and treatment), meningitis, sepsis.

    Contraindications:

    Hypersensitivity to ampicillin (including other penicillins, cephalosporins, carbapenems), infectious mononucleosis, lymphocytic leukemia, hepatic insufficiency, history of the gastrointestinal tract (especially colitis associated with the use of antibiotics), lactation period, children's age (up to 1 month).

    Carefully:Bronchial asthma, hay fever and other allergic diseases, renal failure, bleeding history, pregnancy.
    Pregnancy and lactation:

    The use of the drug during pregnancy is possible only in the event that,if the intended use for the mother exceeds the potential risk to the fetus.

    Ampicillin penetrates into breast milk in low concentrations. If necessary, the use of the drug during lactation should stop breastfeeding.

    Dosing and Administration:

    Intramuscularly, intravenously (struino or drip). Doses and dosing regimen are chosen individually depending on the severity of the course, the localization of the infection and the sensitivity of the pathogen. The average therapeutic dose for adults and children weighing more than 40 kg is 0.25-0.5 g, which is injected in / m or IV every 6 hours.

    In case of severe infection, the daily dose may be increased to 10 g.

    For the treatment of gonorrhea, 2 doses of 0.5 g are administered at intervals of 8 or 12 hours.

    For the treatment of bacterial meningitis and sepsis, the daily dose of the drug is 150 to 200 mg / kg, divided by 6-8 intravenously administrations with an interval of 3-4 hours. The maximum daily dose is 8-14 g.

    For the prevention of bacterial endocarditis in patients of high-risk group undergoing dental, endoscopic interventions, "small" surgeries on ENT organs, as well as operations on the organs of the gastrointestinal tract or bile ducts - 2 g IV or IM for 30 min before the procedure or operation; if necessary, after 6 hours, re-injected at a dose of 1 g.

    In children with a body weight of less than 40 kg, the daily dose of ampicillin for the treatment of respiratory, skin and soft tissue infections is 25-50 mg / kg; To treat infections of the abdominal cavity or urinary tract, 50-100 mg / kg per day is administered. The daily dose is divided into 4 injections with an interval of 6 hours.

    To treat septicemia or infections of the central nervous system (bacterial meningitis), the daily dose, equal to 100-200 mg / kg, is divided into 6-8 intravenous administrations with an interval between administrations of 3-4 hours.

    For the prevention of bacterial endocarditis - 50 mg / kg IV or IM for 30 minutes before the procedure or operation; if necessary, after 6 hours, re-injected at a dose of 25 mg / kg.

    The duration of the / m introduction is 7-14 days. The duration of IV application is 5-7 days, with the subsequent transition (if necessary) to the / m introduction. It is recommended to continue the introduction of ampicillin another 48-72 h after disappearance of clinical signs of the disease.

    Solution for intramuscular injection is prepared extepore, adding to the contents of the vial (0.25 g, 0.5 g and 1 g) 2 ml of water for injection.

    For intravenous administration, a single dose of the drug (not more than 2 g) is dissolved in 5-10 ml of water for injection or isotonic sodium chloride solution and injected slowly for 3-5 minutes (1-2 g for 10-15 minutes).With a single dose exceeding 2 g the drug is administered intravenously drip. For intravenous drip, a single dose of the drug (2-4 g) is dissolved in a small amount of water for injection, 7.5-15 ml, respectively, then the resulting antibiotic solution is added to 125-250 ml of isotonic sodium chloride solution or 5-10% solution of dextrose and injected at a rate of 60-80 drops per minute. With the drop introduction to children, a 5-10% dextrose solution (30-50 ml, depending on the age) is used as a solvent. Solutions used immediately after preparation, it is unacceptable to add other medicines to them.

    Side effects:

    Allergic reactions: peeling skin, itching, hives, rhinitis, conjunctivitis, Quincke's edema, fever, arthralgia, eosinophilia, erythematous and maculopapular rash, exfoliative dermatitis, multiforme exudative erythema, malignant exudative erythema (Stevens-Johnson syndrome), reactions similar to serum sickness, anaphylactic shock, non-allergic ampicillin rash, may disappear without withdrawal preparation.

    From the gastrointestinal tract: dysbiosis, stomatitis, gastritis,dryness of the oral mucosa, taste change, abdominal pain, vomiting, nausea, diarrhea, glossitis, increased activity of "liver" transaminases, pseudomembranous colitis.

    From the central nervous system: agitation, aggressiveness, anxiety, confusion, behavior change, depression, headache pain, tremor, cramps are possible (with high-dose therapy).

    From the hematopoiesis: leukopenia, neutropenia, thrombocytopenia, agranulocytosis, anemia.

    Local reactions: pain at the site of injection, infiltrates in places with intramuscular injection, phlebitis with intravenous administration in large quantities.

    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: medicines to maintain the water-electrolyte balance, symptomatic therapy.In severe cases, it is excreted by hemodialysis.

    Interaction:

    Pharmaceutically incompatible with aminoglycosides.

    Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic medicinal products (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 (it is necessary to use additional methods of contraception), drugs, in the process of metabolism of which parahaminobenzoic acid is formed, ethinyl estradiol (in the latter case, the risk of bleeding "breakthrough" is increased).

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

    Allopurinol increases the risk of skin rash. Ampicillin reduces the clearance and increases the toxicity of methotrexate. Increases the absorption of digoxin.

    Compatible with antibiotics streptomycin, kanamycin.

    Special instructions:

    Before using the drug, you should consult your doctor.

    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.

    With the appointment of patients with sepsis, the development of a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible.

    In patients who have increased sensitivity to penicillins, there may be cross-allergic reactions with other beta-lactam antibiotics.

    In the treatment of mild diarrhea, arising against the background of course treatment should avoid antidiarrhoeal drugs that reduce peristalsis of the intestine; You can use kaolin- or attapulgite-containing antidiarrhoeal drugs, the withdrawal of the drug is indicated. With severe diarrhea, you should see a doctor.

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

    Effect on the ability to drive transp. cf. and fur:During treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:

    Powder for the preparation of solution for intravenous and intramuscular injection 0.25 g, 0.5 g, or 1 g.

    Packaging:

    For 0.25 g, 0.5 g or 1 g of active substance (ampicillin) in 10 ml vials hermetically sealed with stoppers made of rubber compound, crimped with aluminum caps.

    1 bottle together with instructions for use are placed in a pack of cardboard or cardboard chromium-ersatz coated.

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

    5 vials with the drug are placed in a contour mesh box made of a polyvinylchloride film and aluminum foil.

    1 or 2 contour mesh packages with instructions for use are placed in a pack of cardboard.

    5 or 10 bottles together with the instruction for use are placed in a pack.

    Packing for hospitals

    For 10, 20, 30, 40, 50 contour squares with instructions for use are placed in a cardboard box.
    Storage conditions:

    In a dry, dark place at a temperature of no higher than 25 ° C

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002238
    Date of registration:28.03.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.08.2017
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