Brulamycin® (Brulamycin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTobramycinTobramycin
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    • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    1 ml of the preparation contains: active substance: tobramycin (in the form of amucin sulphate) 40.00 mg; remembergadgets: disodium edetate 0.10 mg, sodium disulphite 1.50 mg, sulfuric acid to pH 5.2, water for injection up to 1.00 ml.

    Description:
    Transparent, almost colorless solution.
    Pharmacotherapeutic group:Antibiotic - aminoglycoside
    ATX: & nbsp

    J.01.G.B   Other aminoglycosides

    J.01.G.B.01   Tobramycin

    Pharmacodynamics:
    A broad-spectrum antibiotic from the aminoglycoside group. It acts bacteriostatically (blocks the 30S subunit of the ribosome and breaks the synthesis of the protein).Highly active against gram-negative microorganisms (Pseudomonas aeruginosa, Acinetobacter spp., Esherichia coli, Klebsiella spp., Serratia spp., ProvidenCia spp., Enterobacter spp., Proteus spp., Salmonella spp., Shigella spp.), As well as some Gram-positive microorganisms: Staphylococcus spp. (including those resistant to penicillins, cephalosporins), some strains of Streptococcus spp.
    Aminoglycosides in combination with penicillins or some cephalosporins are effective for the treatment of infections caused by Pseudomonas aeruginosa or Enterococcus faecalis.
    Pharmacokinetics:
    After intramuscular injection, the drug is quickly distributed to organs and tissues. Penetrates through the placenta. The maximum serum concentration is detected 40-90 minutes after administration; when intramuscular injection of the drug at a dose of 1 mg / kg body weight of the patient maximum plasma concentration of 3-7 mg / l. The therapeutic concentration persists for 8 hours. The half-life (T1 / 2) with normal kidney function is 2 hours. 80-84% of the administered dose is excreted through the kidneys unchanged, 10-20% through the intestine.
    T1 / 2 in newborns - 5-8 hours, in older children - 2.5-4 hours. Final T1 / 2 - more than 100 hours (release from intracellular depot). In patients with renal insufficiency, T1 / 2 varies depending on the degree of insufficiency - up to 100 hours, and in patients with cystic fibrosis - 1-2 hours,in patients with burns and hyperthermia may be shorter compared with the average values ​​due to increased clearance. With hemodialysis, 25-70% of the dose administered is removed.
    Indications:
    Infectious diseases caused by sensitive microflora: infections of the bile ducts, bones and joints (including osteomyelitis), central nervous system (including meningitis), abdominal cavity (including peritonitis), respiratory organs (in including pneumonia, pleural empyema, lung abscess), skin and soft tissues (including infected burns), urinary tract (including pyelonephritis, pyelitis, cystitis), sepsis, postoperative infections.
    Contraindications:
    Hypersensitivity to tobramycin and other aminoglycoside antibiotics, auditory nerve neuritis, severe chronic renal failure (CRF), pregnancy, lactation.
    Carefully:
    With caution - renal failure, botulism, myasthenia gravis, parkinsonism, dehydration, old age, hearing impairment.
    Pregnancy and lactation:
    Application in pregnancy and lactation.
    If tobramycin is applied during pregnancy or pregnancy occurs during treatment with tobramycin,the patient should be informed of the possible dangers to the fetus, since the antibiotics of the aminoglycoside group penetrate the placenta and may cause the development of total irreversible bilateral deafness in newborns.
    If it is necessary to prescribe the drug during the lactation period, breastfeeding should be stopped for the duration of treatment.
    Dosing and Administration:PThe drug is used intramuscularly (in / m) and intravenously (intravenously) drip. For the / m introduction, the appropriate dose of the drug is extracted directly from the ampoules.

    For IV introduction, the solution is diluted in 100-200 ml of 0.9% solution of sodium chloride or 5% solution of dextrose, injected for 20-60 minutes.

    Single dose for adults and children over 1 year - 1 mg / kg, daily - 3 mg / kg / day; maximum dailyfor-5 mg / kg / day.

    Children from 1 week to 1 year: 6-7.5 mg / kg / day, divided into 3-4 identical doses (2-2.5 mg / kg every 8 hours or 1.5-1.89 mg / kg every 6 hours). Preterm or newborns before 1 week of life: up to 4 mg / kg / day, divided into 2 equal doses every 12 hours. The usual duration of treatment is 7-10 days. In severe and complicated infections, a longer course of therapy is possible (under the control of kidney function, hearing and vestibular apparatus,The appearance of neurotoxicity is most likely with a treatment duration of more than 10 days).

    In chronic renal failure and in elderly patients, the dose should be reduced and the intervals between administrations should be increased. Calculation of the dose is as follows: the interval between administrations in hours is equal to the concentration of creatinine in the serum multiplied by 8; doses remain the same as with normal kidney function; the initial single dose of the drug is similar to the dose administered to patients with normal renal function and is 1 mg / kg.

    Side effects:
    On the part of the digestive system: nausea, vomiting, diarrhea, impaired liver function (increased activity of "liver" transaminases, lactate dehydrogenase, hyperbilirubinemia).
    From the hematopoiesis: anemia, leukopenia, granulocytopenia, thrombocytopenia, leukocytosis.
    From the side of the nervous system: headache, neurotoxic action (muscle twitching, paresthesia, epileptic seizures); rarely - neuromuscular blockade (difficulty breathing, drowsiness, weakness).
    From the sense organs: ototoxicity (partial or complete bilateral deafness, ringing,hum or sensation of "stuffiness" in the ears), vestibular and labyrinthine disturbances (discoordination, dizziness, nausea, vomiting, instability).
    From the urinary system: nephrotoxicity (oliguria, cylindruria, proteinuria, a significant increase or decrease in the frequency of urination, polyuria, the appearance of signs of renal insufficiency - increased concentrations of creatinine and urea nitrogen, thirst, decreased appetite, nausea, vomiting).
    Allergic reactions: skin itching, skin hyperemia, rash, fever, angioedema, eosinophilia.
    Laboratory indicators: hypocalcemia, hyponatremia, hypomagnesemia.
    Overdose:
    Overdose.
    Symptoms: toxic reactions (hearing loss, ataxia, dizziness, urination disorders, thirst, decreased appetite, nausea, vomiting, ringing or feeling in the ears, nephronecrosis - increased urea concentration, hypercreatinemia, proteinuria, oliguria), respiratory muscle paralysis. Treatment: patients with normal renal function are given a fluid infusion and forced diuresis; patients with impaired renal function - hemodialysis or peritoneal dialysis.With neuromuscular blockade - anticholinesterase drugs, calcium salts; when breathing is stopped - artificial ventilation (IVL), other symptomatic and supportive therapy.
    Interaction:
    Tobramycin enhances the effect of nondepolarizing muscle relaxants.
    Reduces the effect of antimiasthenic drugs.
    Aminoglycosides, cephalosporins, vancomycin, polymyxin, diuretics increase the risk of oto- and nephrotoxicity.
    Beta-lactam antibiotics weaken the effect.
    Intravenous administration of indomethacin reduces the renal clearance of tobramycin, increasing the concentration in the blood and increasing the half-life (T1 / 2) (correction of the dosing regimen may be required).
    Methoxyflurane increases the risk of side effects.
    Medicines for inhalation of general anesthesia (halogenated hydrocarbons), narcotic analgesics, transfusion of large amounts of blood with nitrate preservatives as anticoagulants, drugs that block neuromuscular transmission, enhance neuromuscular blockade.
    Special instructions:
    During the treatment it is necessary to monitor the kidney, liver, vestibular apparatus and hearing (at least once a week), monitor the concentration of tobramycin in the serum, which should not exceed 8 μg / ml.
    When unsatisfactory audiometric tests, the dose of the drug is reduced or discontinued.
    The risk of oto- and nephrotoxicity significantly increases with long-lasting plasma concentrations of more than 12 μg / ml.
    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).
    Aminoglycosides penetrate breast milk in small amounts (because they are poorly absorbed from the gastrointestinal tract, complications associated with them in infants were not recorded).
    In the process of therapy, superinfection may develop.
    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.
    With an increase in the distribution of the drug (burns, peritonitis, retroperitoneal infection), the dose should be increased in order to achieve an effective concentration, and in the case of critical conditions in young patients with high circulatory volume (IOC) and glomerular filtration rate, increase the rate of administration.
    Form release / dosage:
    Solution for intravenous and intramuscular injection 40 mg / ml.
    Packaging:
    Solution in ampoules with a point of 1 ml (40 mg / ml) or 2 ml (80 mg / 2 ml).
    5 ampoules per PVC / Alu blister. Two blisters in a cardboard box along with instructions for medical use.
    Storage conditions:
    Store at a temperature of no higher than 25 ° C in a dark place.
    Keep out of the reach of children.
    Shelf life:5 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014197 / 01
    Date of registration:18.11.2008 / 28.11.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Information update date: & nbsp09.03.2017
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