Active substanceAmikacinAmikacin
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  • Dosage form: & nbspsolution for infusion and intramuscular injection
    Composition:

    In 1 ml of solution contains:

    active substance: amikacin sulfate (in terms of amikacin base) - 250 mg;

    Excipients: sodium citrate, sodium metabisulphite, sulfuric acid concentrated, water for injection.

    Description:Transparent colorless or slightly yellowish liquid.
    Pharmacotherapeutic group:Antibiotic-aminoglycoside
    ATX: & nbsp

    J.01.G.B.06   Amikacin

    Pharmacodynamics:

    Semisynthetic antibiotic of a wide spectrum of action, acts bactericidal. Communicating with 30S subunit of ribosomes, prevents the formation of a complex of transport and matrix RNA, blocks the synthesis of protein, and also destroys the cytoplasmic membranes of bacteria.

    Highly active against aerobic gram-negative microorganisms Pseudomonas aeruginosa, Escherichia coli, Klebsiella spp., Serratia spp., Providencia spp., Enterobacter spp., Salmonella spp., Shigella spp.; some Gram-positive microorganisms - Staphylococcus spp. (including those resistant to penicillin, some cephalosporins); moderately active against Streptococcus spp..

    When administered concomitantly with benzylpenicillin, it has a synergistic effect on strains Enterococcus faecalis.

    Does not affect anaerobic microorganisms.

    Amicacin does not lose activity under the action of enzymes that inactivate other aminoglycosides, and can remain active against strains Pseudomonas aeruginosa, resistant to tobramycin, gentamycin and netilmicin.

    Pharmacokinetics:

    After intramuscular injection (in / m) of the injection is absorbed quickly and completely. The maximum concentration (Cmah) with an IM injection of 7.5 mg / kg - 21 mcg / ml, after 30 min IV infusion 7.5 mg / kg - 38 mcg / ml. Time to reach the maximum concentration (Tcmah) - about 1.5 hours after the / m introduction. Connection with plasma proteins - 4-11%.

    It is well distributed in the extracellular fluid (the contents of abscesses, pleural effusion, ascitic, pericardial, synovial, lymphatic and peritoneal fluid); in high concentrations is found in urine; at low - at bile, breast milk, watery eye moisture, bronchial secretion, sputum and cerebrospinal fluid (CSF). It penetrates well into all tissues of the body, where it accumulates intracellularly; high concentrations are noted in organs with good blood supply: lungs, liver, myocardium, spleen, and especially in the kidneys where it accumulates in the cortex, lower concentrations - in muscles, adipose tissue and bones.

    At appointment in sredneverapepticheskih doses (in norm or rate) to adults amikacin does not penetrate the hemato-encephalic barrier (BBB), with inflammation of the meninges, the permeability slightly increases. In newborns, higher concentrations are achieved in CSF than in adults; passes through the placenta - is found in the fetal blood and amniotic fluid. The volume of distribution in adults is 0.26 l / kg, in children 0.2-0.4 l / kg,in newborns - less than 1 week old and weighing less than 1500 g - up to 0.68 l / kg, less than 1 week old and weighing more than 1500 grams - up to 0.58 l / kg, in cystic fibrosis patients - 0.3-0.39 l / kg. The average therapeutic concentration with IV or IM injection is maintained for 10-12 hours.

    It is not metabolized. The half-life period (T1 / 2) in adults is 2-4 hours, in newborns 5-8 hours, in older children 2.5-4 hours. The final value of T1 / 2 is more than 100 hours (release from intracellular depots).

    It is excreted by the kidneys by glomerular filtration (65-94%), mainly unchanged. Kidney clearance - 79-100 ml / min.

    T1 / 2 in adults with renal dysfunction varies depending on the degree of impairment - up to 100 h, in patients with cystic fibrosis - 1 -2 h, in patients with burns and hyperthermia T1 / 2 may be shorter in comparison with the average values ​​due to elevated clearance .

    It is excreted during hemodialysis (50% for 4-6 hours), peritoneal dialysis is less effective (25% for 48-72 hours).

    Indications:

    Infectious-inflammatory diseases caused by gram-negative microorganisms (resistant to gentamycin, sizomycin and kanamycin) or associations of gram-positive and gram-negative microorganisms: respiratory tract infections (bronchitis, pneumonia, pleural empyema, lung abscess), sepsis,septic endocarditis, CNS infections (including meningitis), abdominal infections (including peritonitis), urinary tract infections (pyelonephritis, cystitis, urethritis, prostatitis, gonorrhea), purulent infections of the skin and soft tissues (including those infected burns, infected ulcers and bedsores of various genesis), biliary tract infections, bones and joints (including osteomyelitis), wound infection, postoperative infections, otitis media, etc.

    Contraindications:

    Hypersensitivity (including to other aminoglycosides in the anamnesis), neuritis of the auditory nerve, severe chronic renal failure with azotemia and uremia, pregnancy.

    Carefully:Myasthenia gravis, parkinsonism, botulism (aminoglycosides can cause a violation of the neuromuscular transmission, which leads to further weakening of the skeletal muscles), dehydration, renal failure, the period of newborns, prematurity of children, advanced age, lactation.
    Dosing and Administration:

    In / m, in / in (struyno, for 2 min or drip), 5 mg / kg every 8 hours or 7.5 mg / kg every 12 hours; bacterial urinary tract infections (uncomplicated) - 250 mg every 12 hours; after the hemodialysis session, an additional dose of 3-5 mg / kg may be prescribed. The maximum dose for adults is up to 15 mg / kg / day, but not more than 1.5 g / day for 10 days.

    The duration of treatment with iv introduction is 3-7 days, with a / m - 7-10 days.

    Preterm neonates with an initial dose of 10 mg / kg, then 7.5 mg / kg every 18-24 hours; newborns the initial dose is 10 mg / kg, then 7.5 mg / kg every 12 hours for 7-10 days.

    Patients with renal failure require a correction of the dosing regimen.

    Patients with burns may require a dose of 5-7.5 mg / kg every 4-6 hours due to a shorter T1 / 2 (1-1.5 h) in these patients.

    For IV introduction, the same solutions as for IM are used, previously diluted with 200 ml of a 5% solution of dextrose or 0.9% solution NaCl. The concentration of amikacin in the solution for intravenous administration should not exceed 5 mg / ml.

    Side effects:

    On the part of the digestive system: nausea, vomiting, impaired liver function (increased activity of "liver" transaminases, hyperbilirubinemia).

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

    From the side of the nervous system: headache, drowsiness, neurotoxic effect (muscle twitching, numbness, tingling, epileptic seizures), violation of neuromuscular transmission (respiratory arrest).

    From the sense organs: ototoxicity (hearing loss, vestibular and labyrinthine disorders, irreversible deafness), toxic effect on the vestibular apparatus (discoordination of movements, dizziness, nausea, vomiting).

    From the urinary system: nephrotoxicity - a violation of kidney function (oliguria, proteinuria, microhematuria).

    Allergic reactions: skin rash, itching, skin hyperemia, fever, angioedema.

    Overdose:

    Symptoms: toxic reactions (hearing loss, ataxia, dizziness, urination disorders, thirst, loss of appetite, nausea, vomiting, ringing or feeling in the ears, respiratory failure). Treatment: to remove the blockade of the neuromuscular transmission and its consequences - hemodialysis or peritoneal dialysis; anticholinesterase drugs, Ca2 + salts, artificial lung ventilation, other symptomatic and maintenance therapy.

    Interaction:

    Pharmaceutically incompatible with penicillins, heparin, cephalosporins, capreomycin, amphotericin B, hydrochlorothiazide, erythromycin, nitrofurantoin, vitamins of group B and C, potassium chloride.

    It exhibits synergism in the interaction with carbenicillin, benzylpenicillin,cephalosporins (in patients with severe chronic renal failure when combined with beta-lactam antibiotics, a decrease in the efficacy of aminoglycosides is possible).

    Nalidixic acid, polymyxin AT, cisplatin and vancomycin increase the risk of oto and nephrotoxicity.

    Diuretics (especially furosemide), cephalosporins, penicillins, sulfonamides and non-steroidal anti-inflammatory drugs, competing for active secretion in the nephron tubules, block the elimination of aminoglycosides, increase their serum concentration, enhancing nephro- and neurotoxicity.

    Strengthens the muscle relaxant effect of curare-like drugs.

    Methoxyflurane, polymyxins for parenteral administration capreomycin and other drugs that block neuromuscular transmission (halogenated hydrocarbons as drugs for inhalation anesthesia, opioid analgesics), transfusion of large amounts of blood with citrated preservatives increase the risk of stopping breathing (especially with intraperitoneal administration of amikacin).

    Parenteral administration of indomethacin increases the risk of toxic actions of aminoglycosides (an increase in the periodelimination half-life and reduced clearance).

    Reduces the effect of antimiasthenic drugs.

    Special instructions:

    Before use, the sensitivity of the isolated pathogens is determined using discs containing 30 μg of amikacin. With a diameter of a growth free zone of 17 mm or more, the microorganism is considered sensitive, from 15 to 16 mm - moderately sensitive, less than 14 mm - resistant.

    The concentration of amikacin in plasma should not exceed 25 mcg / ml (the therapeutic concentration is 15-25 mcg / ml).

    During the treatment period, it is necessary to monitor the function of the kidneys, the auditory nerve and the vestibular apparatus at least once a week.

    The probability of nephrotoxicity was higher in patients with impaired kidney function, and also at high doses and for a long time (in this category of patients may require daily monitoring of renal function).

    When unsatisfactory audiometric tests, the dose of the drug is reduced or terminate treatment.

    If life indications are available, it can be used in pregnant and lactating women (aminoglycosides penetrate breast milk in small amounts. poorly absorbed from the gastrointestinal tract, and complications associated with them in infants were not recorded).

    Patients with infectious and inflammatory diseases of the urinary tract is recommended to take an increased amount of liquid.

    In the absence of positive clinical dynamics should be remembered the possibility of developing resistant microorganisms. In such cases, it is necessary to cancel treatment and begin appropriate therapy.

    The sodium bisulfite contained in the ampoules of sodium can cause the development of allergic complications in patients (up to anaphylactic reactions), especially in patients with allergic anamnesis.

    Effect on the ability to drive transp. cf. and fur:
    Form release / dosage:

    Solution for injection 500 mg / 2 ml in vials.

    Packaging:Bottles of 100 pieces together with instructions for use are placed in a cardboard pack.
    Storage conditions:

    List B. In a place protected from light, inaccessible to children, at a temperature of no higher than 25 ° C.

    Shelf life:

    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N011383 / 01
    Date of registration:10.06.2010
    The owner of the registration certificate:Medocemi Co., Ltd.Medocemi Co., Ltd. Cyprus
    Manufacturer: & nbsp
    Representation: & nbspMEDOKEMI LTD. MEDOKEMI LTD. Cyprus
    Information update date: & nbsp30.08.2015
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