Active substanceGentamicinGentamicin
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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    1 ampoule of a solution for intravenous and intramuscular administration comprising:



    40 mg / 1ml

    80 mg / 2ml

    Active substance:



    Gentamicin Sulfate

    40.00 mg

    80.00 mg

    Excipients:



    Methylparahydroxybenzoate

    1.80 mg

    3.60 mg

    Propyl parahydroxybenzoate

    0.20 mg

    0.40 mg

    Disodium Edetate

    0.10 mg

    0.20 mg

    Sodium hydrosulfite

    3.20 mg

    6.40 mg

    Water for injections q.s. up to 1.00 ml.

    q.s up to 2.00 ml

    Description:The clear solution, colorless or slightly yellowish, practically does not contain mechanical impurities.
    Pharmacotherapeutic group:Antibiotic - aminoglycoside
    ATX: & nbsp

    J.01.G.B.03   Gentamicin

    Pharmacodynamics:

    A broad-spectrum antibiotic from the aminoglycoside group. It binds to the 30S subunit of the ribosomes and disrupts protein synthesis, preventing the formation of a complex of transport and information RNA, with an erroneous reading of the genetic code and the formation of non-functional proteins. The drug has a bactericidal activity against many gram-positive and gram-negative microorganisms, including

    Pseudomonas aeruginosa, Escherichia coli, Enterobacter spp., Proteus spp., Klebsiella spp., Serratia spp., Citrobacter spp., Providencia spp., Campylobacter pylori, Campylobacter jejuni, Salmonella spp., Shigella spp., Francisella tularensis, Acinetobacter cal. coaceticus, Aeromonas spp. et al. Affects strains of Staphylococcus spp., resistant to penicillin.Resistance of microorganisms develops slowly, however, strains resistant to neomycin and kanamycin are also resistant to gentamicin (cross-resistance). The drug does not affect the anaerobes, fungi, viruses, protozoa.

    Pharmacokinetics:

    Absorption. Gentamicin quickly absorbed after intramuscular injection. The maximum plasma concentration for intramuscular injection of 80 mg of gentamicin is 7 μg / ml after 0.5-2 hours. The optimal maximum plasma concentration is from 7 to 10 μg / ml. After intramuscular injection of the drug, the therapeutic concentration in the blood is maintained for 6-8 hours.

    Distribution. The association with plasma proteins is low (25%). In therapeutic concentrations in adult patients gentamicin with parenteral administration poorly penetrates the hemato-encephalic barrier; when meningitis, its concentration in the cerebrospinal fluid increases. Gentamicin is found in therapeutic concentrations in the tissues of the liver, kidneys, lungs, in exudates of the pleural and peritoneal cavities, ascites and lymphatic fluids, urine, in the separated wounds, pus, granulations. Penetrates through the placenta.

    Metabolism and excretion. Gentamicin is not metabolized, in a biologically active form is excreted mainly by the kidneys, in small amounts - with bile. The half-life is between 1.5 and 5.5 hours, and 1 hour in adolescents. Gentamicin clearance is normally 60 ml / min. Gentamicin excretion decreases with renal failure. It is excreted by hemodialysis - every 4-6 hours the concentration decreases by 50%. Peritoneal dialysis is less effective for 48-72 hours, 25% of the dose is excreted.

    With repeated administration cumulates, mainly in the lymphatic space of the inner ear and in the proximal sections of the renal tubules.

    Indications:

    Infectious-inflammatory diseases caused by sensitive Gram-negative aerobic bacteria:

    - sepsis, meningitis, peritonitis, endocarditis (usually in combination with beta-lactam antibiotics);

    - abdominal infections: abdominal abscesses, cholangitis (usually in combination with metronidazole or clindamycin);

    - urinary tract infections;

    - secondary infections with burns, injuries and surgical interventions;

    - Tularemia;

    - infections of the respiratory system (pneumonia, empyema of the pleura, abscess of the lung);

    - prevention of postoperative infections of the abdominal cavity, especially in cases of operations on the urinary tract and intestines.

    Contraindications:

    - Hypersensitivity to the drug, the components of the drug and to other antibiotics from the aminoglycoside group;

    - neuritis of the auditory nerve;

    myasthenia gravis;

    - severe renal failure with uremia and azotemia;

    - the period of newborns and prematurity of children (due to the high risk of development of ototoxic and nephrotoxic action);

    - pregnancy and lactation.

    Carefully:Myasthenic syndrome, Parkinson's disease, botulism (may cause a breakdown in neuromuscular conduction), hypokalemia, renal dysfunction, dehydration, old age, history of allergy or bronchial asthma.
    Pregnancy and lactation:During pregnancy, the drug is contraindicated. If necessary, use during lactation should stop breastfeeding.
    Dosing and Administration:

    The drug is administered intramuscularly and intravenously.

    Dosing for patients with normal renal function:

    Usually the daily dose in adults with diseases of moderate severity is Zmg / kg, the frequency of administration is 2-3 times a day. In severe disease, the daily dose is 5 mg / kg, the frequency of administration 3-4 times a day; after improving the condition, the dose is reduced to 3 mg / kg / day. The maximum daily dose is 5 mg / kg.

    Patients with infectious and inflammatory diseases of the urinary tract and normal kidney function are prescribed once a day at a dose of 120-160 mg for 7-10 days; with gonorrhea - 240-280 mg once. With a single intravenous injection of a daily dose of gentamicin, the administration time should be 30-60 minutes. When 2-3 times the introduction of gentamicin: its concentration in the serum before the next administration should not exceed 2 μg / ml, with a single administration - not more than 1 μg / ml. The average duration of treatment is 7-10 days.

    Children from 1 month to 12 years administered intramuscularly or intravenously at a dose of 6 mg / kg / day in 1-3 doses.

    Children over 12 years of age: intramuscularly or intravenously - 2-5 mg / kg / day in 1-3 administration. Prevention of postoperative infections of the abdominal cavity: with surgical intervention on the intestine, a single dose of gentamicin is administered in combination with metronidazole or clindamycin.

    Dosage of gentamicin in patients with impaired renal function.

    In renal failure, the gentamicin administration regimen is adjusted by reducing the dose or extending the intervals between administrations. In this case, a single dose of the drug for patients with a body weight above 60 kg is 1 mg / kg, less than 60 kg - 0.8 mg / kg.

    To calculate the intervals between the administration of the drug to a patient with a violation of the excretory function of the kidneys, the following formula can be recommended: interval between administrations (in hours) = serum creatinine concentration (mg / 100 ml) x 8.

    Urea

    Clearance

    creatinine

    Whey

    creatinine

    Doses and intervals between doses

    mg / 100 ml

    mmol / l

    ml / min

    ml / s

    mg / 100 ml

    tsmol / l


    <40

    <6.8

    >70

    >1.16

    <1.4

    <124

    80 mg * every 8 hours

    40-100

    6.8-17

    30-70

    0.5-1.16

    1.4-1.9

    124-168

    80 mg * every 12 hours

    1.9-2.8

    168-248

    80 mg * every 18 hours

    100-200

    17-34

    10-30

    0.16-0.5

    2.8-3.7

    248-327

    80 mg * every 24 hours

    3.7-5.3

    327-469

    80 mg * every 36 hours

    >200

    >34

    5-10

    0.08-0.16

    5.3-7.2

    469-636

    80 mg * every 48 hours

    * 60 mg, gentamicin, if the body weight is less than 60 kg.

    Elderly patients, as well as with severe burn disease, need to determine the concentration of gentamicin in plasma for an adequate choice of dosing regimen.

    In severe infections, the recommended use of smaller single doses with a higher multiplicity; the reduction in the single dose should be a multiple of the ratio of the interval calculated according to the above formula to the value of the normal interval between administrations (8 h).The dose should be selected so that Cmax does not exceed 12 μg / ml (reduced risk of developing nephro-, oto- and neurotoxicity).

    With edema, ascites, obesity, the dose is determined by the "ideal" or "dry" mass of the body. In case of kidney failure and hemodialysis, the recommended dose after the adult session is -1-1.7 mg / kg (depending on the severity of the infection), children - 2-2.5 mg / kg. When intravenously administered gentamicin: the contents of the ampoule (1 or 2 ml solution for injection) should be dissolved in 100 ml or 200 ml of sterile saline or sterile 5% glucose solution. Concentration of gentamicin in the solution should not exceed 1 mg / ml. Enter intravenously drip for 30-60 minutes.

    Side effects:

    From the urinary system: nephrotoxic action (proteinuria, microhematuria, azotemia and rarely oliguria). This effect of the drug is observed more often in patients with impaired renal function. In rare cases, renal tubular necrosis.

    From the sense organs: ototoxic effect: vestibular and labyrinthine disorders, hearing loss, tinnitus, irreversible deafness. In rare cases, visual impairment is possible.

    From the nervous system: headache, paresthesia, muscle twitching, numbness sensation, epileptic seizures, drowsiness; a rare complication is the blockade of neuromuscular conduction and respiratory depression; in children, psychosis.

    From the digestive system: nausea, vomiting, hyperbilirubinemia, increased activity of "hepatic" transaminases of blood, diarrhea (pseudomembranous colitis).

    From the cardiovascular system: palpitation.

    On the part of the hematopoiesis system: granulocytopenia, neutropenia, leukopenia, thrombocytopenia, anemia.

    Other laboratory indicators: hypokalemia, hypocalcemia, hypomagnesemia, proteinuria, increased levels of urea, creatinine.

    Allergic reactions: skin rashes, itching, angioedema, eosinophilia, bronchospasm, anaphylactic reaction.

    Other: an increase in body temperature, weakness, the development of superinfection, in a few cases, a transient imbalance may develop.

    Overdose:

    Symptoms: decrease in neuromuscular conduction (respiratory arrest).

    Treatment: adults in / in injected anticholinesterase drugs (proserin),as well as calcium preparations (10% calcium chloride solution 5-10 ml, calcium gluconate 10% 5-10 ml). Before the introduction of proserine, previously in / in injected atropine in a dose of 0.5-0.7 mg, the pulse is expected to accelerate, and after 1.5-2 minutes, 1.5 mg (3 ml of a 0.05% solution) of prozerin are injected / in. If the effect of this dose was insufficient, enter the same dose of proserine again (with the appearance of bradycardia, an additional injection of atropine).

    Children are given calcium preparations. In severe cases of respiratory depression, artificial ventilation is necessary. Can be excreted by hemodialysis (more effective) and peritoneal dialysis.

    Interaction:

    It is pharmaceutically incompatible with other drugs (including other aminoglycosides, amphotericin B, heparin, ampicillin, benzylpenicillin, cloxacillin, carbenicillin, capreomycin).

    In connection with a wide range of actions gentamicin often prescribed for mixed infection, as well as in cases where the pathogen is not established (usually in combination with semisynthetic penicillins - ampicillin, carbenicillin, etc.)

    With simultaneous or sequential use with other oto-and nephrotoxic drugs (with other aminoglycosides), loop diuretics and indomethacin, cyclosporine, cisplatinum, clindamycin, piperacillin, methoxyflurane, foscarnet and intravenous forms of radiocontrast agents, the risk of developing kidney, hearing and vestibular damage increases apparatus.

    Polymyxins for parenteral administration and other drugs that block neuromuscular transmission (halogenated hydrocarbons as a medicine for inhalation anesthesia, narcotic analgesics, transfusion of large amounts of blood with citrate preservatives) increase the risk of nephrotoxic action and respiratory arrest (as a result of nerve enhancement muscular blockade).

    The effect of antimiasthenic drugs decreases.

    Special instructions:

    Gentamicin K contains parahydroxybenzoate, sodium bisulfite, which, especially if there is a history of allergy or bronchial asthma, can cause reactions of a delayed type (contact dermatitis, etc.), in rare cases - hives, anaphylaxis, bronchospasm. When they occur, the drug is canceled.

    Patients with infectious and inflammatory diseases of the urinary tract is recommended to take the increased amount of fluid at adequate diuresis. During treatment with aminoglycosides it is necessary to determine the concentration of the drug in the serum, and also to monitor the clearance of creatinine, especially in the elderly.

    The likelihood of developing nephrotoxicity is higher in patients with impaired renal function, and also when administering high doses for a long time, therefore, kidney function should be monitored regularly (1 or 2 times a week), and in patients treated more than 10 days daily.

    In order to avoid the development of hearing disorders, it is recommended to conduct regular (1 or 2 times a week) studies of vestibular function and hearing, monitor kidney function, and determine the concentration of gentamicin in the blood. In case of symptoms of hearing loss, the dose of the drug is reduced or discontinued.

    Against the backdrop of prolonged therapy may develop resistance of microorganisms, in this case, it is necessary to cancel the drug.

    The use of a single daily dose is not recommended for patients: with neutropenia, with severe renal damage,with cystic fibrosis, with abscesses, infective endocarditis, massive burns (more than 20% of the skin surface).

    Effect on the ability to drive transp. cf. and fur:There was no effect on psychophysical activity. In some cases, a transient imbalance may develop. This condition can continue even after the drug is discontinued, and the patient should be warned about it.
    Form release / dosage:Solution for intravenous and intramuscular administration, 40 mg / 1 ml and 80 mg / 2 ml.
    Packaging:Ampoules of 1 ml or 2 ml of neutral glass. The ampoule has a colored dot on the fault site and a color coding ring. 5 ampoules in the blister pack. 10 ampoules in together with instructions for use in a cardboard pack.
    Storage conditions:

    Store at a temperature not exceeding 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use the drug after the expiry date. <

    Terms of leave from pharmacies:On prescription
    Registration number:П N013913 / 01
    Date of registration:04.04.2008 / 14.10.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Manufacturer: & nbsp
    KRKA, d.d. Slovenia
    Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Information update date: & nbsp23.03.2017
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