Active substanceTobramycinTobramycin
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  • Dosage form: & nbspinhalation solution
    Composition:
    1 ml of the preparation contains:
    Active substance:
    Tobramycin 75 mg
    Excipients:
    Sodium chloride 4.5 mg, sodium hydroxide 1M to pH 4.5-5.5, sulfuric acid 1M 0.4 ml, sulfuric acid 1M to pH 4.5-5.5, water for injection up to 1 ml.
    Description:
    From a light yellow to yellow transparent solution in a hermetically sealed plastic ampoule.
    Pharmacotherapeutic group:Antibiotic - aminoglycoside
    ATX: & nbsp

    J.01.G.B   Other aminoglycosides

    J.01.G.B.01   Tobramycin

    Pharmacodynamics:
    Tobramycin is an aminoglycoside antibiotic produced by microorganisms of the genus Streptomyces tenebrarius. The main mechanism of its action is a violation of protein synthesis, which leads to a change in the permeability of the cell membrane, increasing damage to the cell membrane and subsequent cell death. Tobramycin has a bactericidal action at concentrations equal to or slightly higher than the inhibitory concentrations.
    Tobramycin is active mainly in relation to gram-negative aerobic microorganisms, having a low activity against anaerobic microorganisms and most gram-positive bacteria.
    Tobramycin is more active than gentamicin, in a relationship Pseudomonas aeruginosa and some protease strains; about 50% of strains Pseudomonas aeruginosa, resistant to gentamicin, are sensitive to tobramycin.
    With inhalation administration, the minimum inhibitory concentration (MIC) of tobramycin in sputum in patients with cystic fibrosis is significantly higher than in parenteral administration.
    Pharmacokinetics:
    After the inhalation of 300 mg of BRAMITOB in patients with cystic fibrosis, a maximum concentration of about 1289 μg / g is reached in sputum in 30 minutes, while in plasma the maximum concentration is 758 ng / ml,is achieved in about 1.5 hours. The half-life period is 4.5 hours.
    Removal of the drug absorbed into the blood, occurs through the kidneys by glomerular filtration.
    Indications:
    Treatment of respiratory tract infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
    Contraindications:
    • Hypersensitivity to the drug;
    • children's age till 6 years.
    Carefully:
    Ischemic heart disease, chronic heart failure in the stage of decompensation, diabetes, pregnancy. Renal failure, hearing impairment, vestibular dysfunction or neuromuscular pathology such as parkinsonism or other conditions characterized by muscle weakness, including myasthenia gravis, acute hemoptysis.
    Pregnancy and lactation:
    The use of the drug during pregnancy is possible only if the expected benefit for the mother exceeds the possible risk to the fetus.
    If it is necessary to use the drug during lactation, it is necessary to stop breastfeeding.
    Dosing and Administration:
    Inhalation, using a nebulizer.
    Adults and children over 6 years of age:
    - One ampoule (300 mg) twice a day (morning and evening) for 28 days. The interval between inhalations should be about 12 hours, but not less than 6 hours.
    After applying BRAMITOB for 28 days, it is necessary to take a break for 28 days, after which, continue therapy for the next 28 days.
    The dosage regimen does not take into account the body weight. All patients should be prescribed one ampoule of Bramitob (300 mg tobramycin) twice a day.
    Directions for proper use.
    1. Bend the detachable ampoule from the strip in both directions.
    2. Separate the ampoule from the strip, first the upper part, then the middle one.
    3. Open the ampoule by turning its upper part relative to the body in the direction indicated by the arrow.
    4. Moderately pressing on the walls, pour the medicine into the glass neck of the nebulizer.
    The contents of one ampoule (300 mg) transfused into a nebulizer are injected by inhalation for 10-15 minutes using a reusable paralyzed PARI LC PLUS with compressors that, when connected to the PARI LC Plus nebulizer, provide 4-6 l / min and / or the back pressure is 110-217 kPa.
    Inhalations of Brahitob are performed in the position of the patient sitting or standing, with the usual breathing through the nebulizer mouthpiece.The nasal clamp can help the patient breathe through the mouth.
    Instructions for cleaning and disinfecting the nebulizer.
    After the end of the inhalation procedure, the nebulizer should be disassembled, separate parts of it (except the tube) thoroughly rinse with hot water and liquid detergent, rinse and dry with a clean dry rag leaving no fibers. For regular disinfection of the nebulizer, it is recommended to lower its individual parts (except the tube) cleaned in accordance with the instructions given above into a solution consisting of one part of 9% acetic acid and three parts of hot water for one hour, then rinse with hot water and wipe dry clean cloth.
    After disinfection, the used solution should be poured out immediately.
    Alternatively, the disinfection can be carried out by boiling for 10 minutes.
    Side effects:

    Rarely

    Rarely

    Infrequently

    <1/10000

    1/10000-1/1000

    1/1000-1/100


    From the musculoskeletal system:
    - very rarely: back pain.
    From the side of the blood and lymphatic system:
    - very rarely: lymphadenopathy;
    From the sense organs:
    - rarely: ringing in the ears, hearing loss;
    - very rarely: vestibular and labyrinthine disorders, pain in the ear.
    From the central and peripheral nervous system:
    - rarely: headache, dizziness;
    - Very rarely: drowsiness.
    From the gastrointestinal tract:
    - rarely: nausea, ulcerative stomatitis, vomiting, taste change;
    - very rarely: diarrhea.
    On the part of the respiratory system:
    - infrequently: change of voice, dyspnea, increased cough, pharyngitis;
    - rarely: bronchospasm, increased sputum production, hemoptysis, impaired lung function, laryngitis, epistaxis, rhinitis.
    - very rarely: hyperventilation, hypoxia, sinusitis.
    Local reactions:
    - very rarely: fungal infections, candidiasis of the oral cavity.
    Others:
    - rarely: skin rash, anorexia, pain in the chest, asthenia, fever.
    - very rarely: pain and discomfort in the abdomen.

    Overdose:
    Symptom of overdose can be pronounced hoarseness of the voice.
    In case of accidental ingestion of BRAMITOB, a toxic effect is unlikely, because tobramycin poorly absorbed from the gastrointestinal tract.
    With occasional intravenous administration of BRAMITOB, symptoms and signs of tobramycin overdose such as dizziness, hearing loss, ringing in the ears, vertigo, respiratory distress syndrome, blockade of neuromuscular conduction and impaired renal function may develop.
    In case of signs of overdose, Braamytob should be immediately discontinued and an examination of renal function indicators should be carried out. To control overdose it may be useful to determine the concentrations of tobramycin in the blood serum.
    Interaction:
    There was no significant drug interaction of BRAMITOB in combination with mucolytics, p2-adrenomimetics, inhaled corticosteroids and other oral and parenteral antibiotics with antipseudomonas activity.
    Simultaneous or sequential use of inhaled tobramycin and other potentially nephro- or ototoxic drugs should be avoided. Some diuretics can increase the toxicity of aminoglycosides by changing the concentrations of antibiotic in serum and tissues. Inhalation tobramycin should not be administered concomitantly with ethacrynic acid, furosemide, urea or mannitol.
    The toxicity of aminoglycosides may increase with parenteral administration of the following drugs: amphotericin B, cephalothin, cyclosporine, tacrolimus, polymyxins (risk of increased nephrotoxicity),Platinum preparations (risk of increased nephrotoxicity and ototoxicity) as well as inhibitors of cholinesterase and botulinum toxin (neuromuscular effects).
    Special instructions:
    Treatment with Brahitibom should appoint a doctor who has experience in managing patients with cystic fibrosis. The duration of the course treatment is determined by the doctor, based on the clinical picture of the disease. In case of confirmed impairment of pulmonary function, additional antibiotic therapy should be prescribed.
    When inhaled, BRAMITOB can develop bronchospasm. The first dose of BRAMITOB should be administered under the supervision of a doctor, appointing a bronchodilator before inhalation, if it is already part of the patient's treatment regimen. Before and after the procedure, measure FEV1 (volume of forced expiration). When there are signs of iatrogenic bronchospasm in a patient who does not receive a bronchodilator, the use of the drug should be repeated separately, using a bronchodilator. The appearance of bronchospasm on the background of the use of a bronchodilator may indicate an allergic reaction. If you suspect a allergic reaction, use of BRAMITOB should be discontinued.For relief of bronchospasm should be appropriate pathogenetic therapy.
    During treatment with Brahitobom, the patient should continue with standard chest physiotherapy. The use of bronchodilators should continue according to clinical indications. When using several methods of treatment of respiratory disorders, the following order is recommended: bronchodilator, respiratory physiotherapy, other inhaled medications and in the end - Bramitob.
    Bramitob should not be mixed with other inhaled medications.
    Braamytob should be used with great caution in patients with Parkinsonism or other conditions characterized by muscle weakness, including myasthenia gravis, since aminoglycosides can exacerbate muscle weakness due to a possible curare-like effect on neuromuscular conductivity.
    The drug should be used with caution in patients with proven or suspected renal failure, provided monitoring of tobramycin concentrations in serum.
    It is necessary to periodically assess the indicators of kidney function (the level of urea and creatinine at least once during 6 courses of therapy with Brahitibom.When signs of nephrotoxicity appear, treatment with tobramycin should be discontinued until the minimum serum concentrations in the serum are reduced to less than 2 μg / ml. Then, treatment with BRAMITBOM can be resumed for medical reasons. Patients simultaneously receiving parenteral therapy with other aminoglycosides should be carefully monitored because of the possibility of developing cumulative toxicity.
    When using aminoglycosides, it is possible to develop ototoxicity (hypoacusia, systemic and non-systemic dizziness, ataxia).
    The physician should consider the possibility that aminoglycosides may have vestibular and cochlear toxicity and, in the course of therapy, BRAMITIBOM should evaluate the function of the hearing. Patients who have previously received aminoglycosides for a long time are advised to undergo audiometric tests prior to the initiation of therapy with BRAMITBOM. In the treatment of vertigo, it should be taken into account that it is a manifestation of ototoxicity. If there is dizziness or hearing loss during therapy with Brahitybom, an audiological examination is necessary.
    When inhaled, a cough reflex may appear.The use of inhaled tobramycin in patients with acute hemoptysis should only be carried out if the benefit of treatment exceeds the risk of provoking further bleeding.
    In some patients who received tobramycin, there is an increase in the MIC of aminoglycosides with respect to the studied isolated strains
    R. aeruginosa. Possible development of resistance of strains of P. aeruginosa, to intravenously injected tobramycin.
    Form release / dosage:
    Solution for inhalation 300 mg / 4 ml.
    Packaging:
    For 4 ml in a hermetically sealed plastic ampoule. A strip of 4 ampoules is placed in an aluminum strip. For 4, 7 or 14 strips with instructions for use are placed in a cardboard box.
    Storage conditions:
    At a temperature of + 2-8 ° C, in the original packaging to protect from light, away from heating appliances. Do not freeze.
    Keep out of the reach of children.
    Shelf life:
    2 years.
    Do not use after the date shown on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003882/08
    Date of registration:21.05.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Kiesi Pharmaceuticals SpAKiesi Pharmaceuticals SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspChiesi Pharmaceuticals Ltd.Chiesi Pharmaceuticals Ltd.
    Information update date: & nbsp21.02.2017
    Illustrated instructions
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