Tobramycin J 75 mg/ml 4 ml No. 56 ampoules
Content
Pharmacological action Indications of active Dosage regimen Side effects Contraindications for use With caution Use during pregnancy and breastfeeding Use for liver dysfunction Use for renal dysfunction Use in children Use in elderly patients Special instructions Drug interactions Storage conditions Shelf life
pharmachologic effect
An antibiotic of the aminoglycoside group, produced by fungi of the species Streptomyces tenebrarius. Inhibits protein synthesis in the microbial cell, which leads to disruption of the permeability of the cell membrane, its damage and death of the bacterial cell.
Active against a wide range of gram-negative microorganisms, including Pseudomonas aeruginosa. Bactericidal concentrations of tobramycin are equal to or slightly higher than the minimum inhibitory concentrations (MICs) for Pseudomonas aeruginosa.
When inhaled tobramycin was used in most patients with cystic fibrosis, sputum concentrations of tobramycin were 25 times higher than the MIC for Pseudomonas aeruginosa.
The group of microorganisms sensitive to tobramycin includes: Pseudomonas aeruginosa, Haemophilus influenzae, Staphylococcus aureus.
Insensitive are: Burkholderia cepacia, Stenotrophomonas maltophilia, Alcaligenes xylosoxidans.
Active readings
Long-term treatment of chronic pulmonary infection caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa) in patients with cystic fibrosis aged 6 years and older.
Dosage regimen
Intended only for inhalation use in adults and children over 6 years of age.
Use 300 mg 2 times a day for 28 days, regardless of the patient’s body weight. The interval between inhalations of the drug should be about 12 hours, but not less than 6 hours. After a 28-day course of therapy, the break in using the drug should be 28 days.
Side effect
- From the digestive system: rarely - nausea, loss of appetite, vomiting, oral ulcers; very rarely - diarrhea, abdominal pain and oral candidiasis.
- From the blood and lymphatic system: rarely - lymphadenopathy.
- From the nervous system: rarely - dizziness, taste disturbances, very rarely - drowsiness.
- From the respiratory system: uncommon - voice changes (including hoarseness), aphonia, shortness of breath, increased cough, pharyngitis; rarely - bronchospasm, tightness in the sternum, cough, breath holding, pulmonary disorders, increased amount of sputum, hemoptysis, decreased pulmonary function, laryngitis, nosebleeds, rhinitis, exacerbation of bronchial asthma; very rarely - hyperventilation, hypoxia, sinusitis; frequency unknown - pain in the oropharynx.
- From the organ of hearing and labyrinthine disorders: rarely - tinnitus, decreased/loss of hearing; very rarely - ear pain.
- From the skin and subcutaneous tissues: rarely - rash; frequency unknown - hypersensitivity, itching, urticaria.
- General reactions: rarely - chest pain, asthenia, fever, headache; very rarely - allergic reactions, including urticaria and skin itching, fungal infection, general malaise, back pain.
Contraindications for use
Hypersensitivity to tobramycin and other aminoglycosides; pregnancy, breastfeeding period; children under 6 years of age.
Carefully
In case of impaired function of the auditory or vestibular system, with established or suspected kidney disease, in patients with neuromuscular disorders such as parkinsonism or other diseases accompanied by muscle weakness, including myasthenia gravis.
Since inhalation with a nebulizer may activate the cough reflex, it is used in patients with hemoptysis only in cases where the expected benefit of therapy outweighs the potential risk of developing pulmonary hemorrhage.
Use during pregnancy and breastfeeding
Contraindicated for use during pregnancy and breastfeeding.
Use for liver dysfunction
Tobramycin is not metabolized by liver enzymes; therefore, changes in the systemic bioavailability of tobramycin in patients with hepatic impairment are unlikely.
Use for renal impairment
The drug should be prescribed with caution to patients with known or suspected kidney disease.
Use in children
The use of the drug in children under 6 years of age is contraindicated.
Use in elderly patients
The dosage regimen for patients over 65 years of age is established individually, taking into account the state of renal function.
special instructions
Therapy with the drug should only be carried out under the supervision of a physician experienced in the treatment of cystic fibrosis.
Treatment with alternating courses of therapy with breaks is carried out as long as the clinical effect is maintained. If the disease worsens during treatment, consideration should be given to prescribing additional antimicrobial therapy active against Pseudomonas aeruginosa.
Before and after inhalation, it is necessary to determine the function of external respiration - FEV1. If bronchospasm develops in patients not receiving bronchodilator therapy, the determination of FEV1 must be repeated, in some cases with the use of bronchodilators. If bronchospasm is not eliminated after using bronchodilators, then its development may be due to increased sensitivity to tobramycin. If an allergic reaction is suspected, inhaled tobramycin should be discontinued and appropriate bronchodilator therapy should be initiated.
Given the potential nephrotoxicity of aminoglycosides when used parenterally, renal function should be assessed before initiating therapy.
After every 6 complete cycles of therapy, the content of urea and creatinine in the blood plasma is re-determined.
Considering the potential ototoxicity of aminoglycosides, during treatment it is necessary to determine hearing acuity in patients with any hearing impairment (tinnitus, decreased hearing acuity), as well as at risk of such complications (especially in the presence of previous long-term systemic therapy with aminoglycosides or with concomitant parenteral therapy aminoglycoside antibiotics).
In patients who have previously received long-term systemic treatment with aminoglycosides, hearing acuity should be determined before using inhaled tobramycin.
If there are signs of nephrotoxicity or ototoxicity, treatment should be discontinued until plasma tobramycin levels are below 2 mcg/ml. After this, at the discretion of the doctor, treatment can be resumed. In patients with normal renal function, 1 hour after inhalation of tobramycin, the serum concentration of the drug is approximately 1 mcg/ml.
In patients with impaired hearing and/or renal function, as well as those receiving concomitant parenteral therapy with aminoglycosides, it is necessary to regularly determine the concentration of tobramycin in the blood plasma.
Given the risk of cumulative toxicity, patients receiving concomitant parenteral therapy with other aminoglycoside antibiotics should be monitored.
Aminoglycosides may have a curare-like effect on neuromuscular transmission and increase muscle weakness.
There is a theoretical risk that patients treated with inhaled tobramycin may develop Pseudomonas aeruginosa resistance to IV tobramycin.
Impact on the ability to drive vehicles and machinery
Due to the possible occurrence of dizziness or drowsiness, patients should be careful when driving vehicles or operating machinery.
Drug interactions
Avoid simultaneous and/or sequential use of inhaled tobramycin with drugs known to be nephrotoxic or ototoxic.
Some diuretics may enhance aminoglycoside toxicity by altering plasma and tissue concentrations of the antibiotic. Tobramycin inhalation should not be used together with ethacrynic acid, furosemide, urea or mannitol.
The following drugs may also increase the potential toxicity of parenterally administered aminoglycosides: amphotericin B, cephalothin, cyclosporine, polymyxins (possible increased nephrotoxic effect); platinum compounds (possible increased nephrotoxic and ototoxic effects); anticholinesterase drugs, botulinum toxin (effects on the neuromuscular system).
Storage conditions
In a place protected from light at a temperature of 2 to 8 ° C.
Keep out of the reach of children.
Best before date
3 years.
Do not use after the expiration date.
Pharmacological properties of the drug Tobramycin
broad-spectrum bactericidal antibiotic of the aminoglycoside group. Active against both reproducing microorganisms and those in the dormant stage. Inhibits protein synthesis in microbial cells. Highly active against gram-negative bacteria: Escherichia coli, Proteus spp., Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., Salmonella spp., Shigella spp., as well as some gram-positive microorganisms: staphylococci (including those resistant to penicillin, methicillin, some cephalosporins), some strains of streptococci. Has synergistic action with β-lactam antibiotics against Streptococcus spp. After parenteral administration, maximum serum concentrations are achieved within 30–60 minutes. With normal renal function, the half-life of tobramycin in adults is 2–4 hours, and with impaired renal function it increases significantly. In newborns, the half-life is 2-3 times longer than in adults. A small amount of tobramycin (up to 10%) is bound to plasma proteins. Tobramycin penetrates well into tissues and biological fluids of the body. When distributed, it accumulates in the extracellular space. High concentrations of tobramycin were found in urine, ovaries, ascitic, pleural and synovial fluids; lower concentrations were determined in bile, bronchial secretions, and cerebrospinal fluid. Penetrates through the placenta and accumulates in significant quantities in the kidneys of the fetus. With intact meninges, it practically does not penetrate the BBB. Up to 93% of tobramycin is excreted unchanged in the urine within 24 hours. Tobramycin is removed by hemodialysis or peritoneal dialysis.
Overdose of the drug Tobramycin, symptoms and treatment
Acute poisoning with tobramycin can develop if the administered daily dose exceeds 5 mg/kg in adults and 7.5 mg/kg in children. Signs of poisoning: auditory and vestibular disorders, neuromuscular blockade up to the development of paralysis of the respiratory muscles (especially in patients with myasthenia gravis and epilepsy), kidney damage. Treatment of poisoning includes the administration of calcium salts for neuromuscular blockade, ensuring effective ventilation of the lungs, and with the development of acute renal failure - hemodialysis.
List of pharmacies where you can buy Tobramycin:
- Moscow
- Saint Petersburg
Special instructions for the use of the drug Tobramycin
Tobramycin should be prescribed with caution to patients with severe impairment of the liver, kidneys, vestibular apparatus, as well as elderly patients with reduced renal function. If surgical intervention is necessary, you must inform the anesthesiologist that the patient is taking tobramycin. If signs of intoxication appear, the dose should be reduced or discontinued. The use of tobramycin during pregnancy is indicated only in cases where the expected effect on the expectant mother exceeds the possible negative effect on the fetus. The safety of tobramycin during breastfeeding has not been established.
Drug interactions Tobramycin
With the simultaneous use of tobramycin with nephro- and ototoxic drugs, the severity of its side effects increases. If such combinations are necessary, the concentration of drugs in the blood plasma should be monitored. The specific toxic effects of tobramycin may be increased when taking loop diuretics (furosemide, ethacrynic acid). Inhibition of neuromuscular transmission increases with simultaneous use with neuromuscular blockers, general anesthetics, polymyxin, as well as with massive transfusion. Tobramycin may enhance the inhibition of respiratory center function by narcotic analgesics.
Side effects of the drug Tobramycin
With long-term use of tobramycin in high doses, its nephro- and ototoxic effects may occur; less often - increased levels of serum bilirubin, liver enzyme activity, damage to the optic nerves, inhibition of neuromuscular transmission, changes in hematological tests (anemia, leukopenia, leukocytosis, granulocytopenia, thrombocytopenia), neurotoxic phenomena; Allergic reactions are possible - itching, rash, urticaria, Quincke's edema, anaphylactic shock. When using eye drops, rarely - transient hyperemia of the conjunctiva, a burning or tingling sensation after instillation of the drug; very rarely - hypersensitivity reactions.
