Tobramycin-Gobbi
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Tobramycin-Gobbi is an antibacterial drug used in the treatment of respiratory tract infections associated with cystic fibrosis.
Release form and composition
The dosage form of Tobramycin-Gobbi is a solution for inhalation: transparent, slightly yellowish or colorless (5 ml in polyethylene ampoules, 4 ampoules in aluminum foil bags, in a cardboard box 7 or 14 bags).
Composition of 1 ml solution:
- active substance: tobramycin - 60 mg;
- auxiliary components: sodium chloride, sodium hydroxide or sulfuric acid, water for injection.
Indications for use
Tobramycin-Gobbi is prescribed for the treatment of respiratory tract infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
Contraindications
Absolute:
- impaired renal function in severe course (with a creatinine content of more than 0.002 mg / ml);
- age up to 6 years;
- lactation period (the safety profile for this group of patients has not been studied, it is necessary to take into account the nephrotoxic and ototoxic effect of the drug);
- individual intolerance to the components of the drug, including hypersensitivity to other aminoglycosides.
Relative (diseases / conditions in which the use of Tobramycin-Gobbi requires caution):
- neuromuscular pathologies (parkinsonism or other diseases, the course of which is accompanied by muscle weakness, including severe pseudoparalytic myasthenia gravis - myasthenia gravis);
- hemoptysis (the appointment of Tobramycin-Gobbi is possible only in cases where the expected benefit is higher than the possible risk of pulmonary hemorrhage);
- kidney disease (diagnosed / suspected);
- dysfunction of the vestibular and / or hearing aids;
- pregnancy (the safety profile for this group of patients has not been studied; the appointment of Tobramycin-Gobbi is possible only in cases of vital indications, if the expected benefit is higher than the possible risk, including the likelihood of developing congenital deafness).
Method of administration and dosage
Tobramycin-Gobbi is applied by inhalation using a nebulizer.
The duration of the procedure is about 15 minutes. The patient must sit or stand.
Usually, Tobramycin-Gobbi is prescribed 2 times a day (the recommended duration of the interval is 12 hours, but not less than 6 hours), 300 mg for a course of 28 days. After a break of 28 days, the course is repeated.
The ampoule with the solution must be opened, its contents must be placed in the nebulizer chamber. Inhalation should be continued until the entire solution is consumed. To allow breathing through the mouth, the use of a nasal clothespin is recommended. The drug flow should be smooth and steady.
Side effects
The most common adverse events associated with therapy are tinnitus and voice changes. These violations are temporary and disappear after the cessation of the use of Tobramycin-Gobbi. Tinnitus is not associated with hearing impairments, and it does not increase with repeated courses of treatment.
Possible adverse reactions (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):
- hematopoietic system: rarely - lymphadenopathy;
- digestive system: rarely - oral ulcers, nausea, vomiting, loss of appetite; very rarely - diarrhea, candidiasis of the oral mucosa, abdominal pain;
- respiratory system: sometimes - increased cough, voice changes (including hoarseness), shortness of breath, aphonia, pharyngitis; rarely - hemoptysis, tightness in the sternum, bronchospasm, an increase in the amount of sputum, exacerbation of bronchial asthma, deterioration in respiratory function, laryngitis, rhinitis, nosebleeds; very rarely - hypoxia, hyperventilation, sinusitis;
- nervous system: rarely - dizziness; very rarely - drowsiness;
- sensory organs: possible ototoxicity (often - hum / ringing in the ears; very rarely - pain in the ears, isolated cases of complete / partial hearing loss), labyrinth / vestibular disorders (rarely - nausea, dizziness, vomiting, instability; very rarely - coordination disorders); rarely - taste distortion;
- dermatological reactions: rarely - rash;
- the body as a whole: rarely - chest pains, fever, asthenia, headache; very rarely - fungal infection, allergic reactions (including pruritus and hives), back pain, general malaise.
Symptoms such as respiratory tract infections, discoloration of sputum, myalgia, otitis media and nasal polyps are symptoms of cystic fibrosis, but the relationship between the use of Tobramycin-Gobbi and the development of these disorders cannot be ruled out.
No nephrotoxic effect was observed with the drug.
Hearing loss has been reported in patients who received prolonged prior aminoglycoside therapy, as well as in patients receiving concomitant intravenous aminoglycoside therapy.
Disorders such as nephrotoxicity and ototoxicity are associated with parenteral treatment with aminoglycosides.
special instructions
Treatment should only be carried out under the supervision of a specialist experienced in the treatment of cystic fibrosis.
Tobramycin-Gobbi should not be diluted or mixed with other drugs (including in a nebulizer container).
Unused solution must not be reused.
The courses can be repeated as long as the clinical effect persists.
In cases of worsening of the course of the disease during treatment, it is necessary to consider the appointment of additional antimicrobial therapy that is active against Pseudomonas aeruginosa.
During the period of application of Tobramycin-Gobbi, the standard regimen of physiotherapy procedures should not be interrupted. If necessary, the use of a bronchodilator can be continued. When carrying out complex therapy, inhalation is carried out last, after taking bronchodilators, physiotherapy procedures and inhalations with other drugs.
In rare cases, after inhalation of Tobramycin-Gobbi, the development of bronchospasm was noted, so the first dose should be inhaled under medical supervision. Bronchodilator therapy must be performed before the first inhalation of the drug.
Before and after inhalation of tobramycin, the function of external respiration should be determined - the volume of fixed expiration (FEV 1). If bronchospasm develops in patients who do not receive bronchodilator therapy, FEV 1 should be re-determined, sometimes with the use of bronchodilators. If, after using bronchodilators, bronchospasm is not eliminated, the cause of its appearance may be an increased sensitivity to the drug. If there is a suspicion of an allergic reaction, it is necessary to stop inhalation of Tobramycin-Gobbi and conduct appropriate bronchodilator therapy.
An assessment of renal function is required before prescribing the drug. Every 6 full cycles of treatment with Tobramycin-Gobbi, the content of urea and creatinine in the blood plasma is re-evaluated (1 full cycle is 56 days - 28 days of therapy and 28 days off).
If there are signs of nephrotoxicity, the use of the drug is interrupted until the plasma content of tobramycin in the blood falls below 0.002 mg / ml. After that, it is possible to resume therapy (at the discretion of the doctor). In patients with functional impairment of the kidneys, regular determination of the plasma concentration of tobramycin in the blood is required.
In patients who have previously received prolonged systemic treatment with aminoglycosides, hearing acuity must be determined before the appointment of Tobramycin-Gobbi.
Taking into account the risk of developing cumulative toxicity, it is necessary to ensure monitoring of patients who receive concomitant parenteral treatment with other aminoglycoside antibacterial drugs.
Aminoglycosides may increase muscle weakness and have a curariform effect on neuromuscular transmission.
There is a theoretical possibility that patients treated with inhaled tobramycin may develop resistance of Pseudomonas aeruginosa to intravenous tobramycin.
When driving vehicles, the risk of side effects such as dizziness and drowsiness must be taken into account.
Drug interactions
With the combined use of Tobramycin-Gobbi with some drugs / substances, the following effects may develop:
- non-depolarizing muscle relaxants: enhancing their action;
- anti-myasthenic drugs: reducing their effect;
- furosemide, urea, mannitol, drugs with oto- and nephrotoxicity: the combination must be avoided;
- amphotericin B, cyclosporin, cephalothin, polymyxins: increased nephrotoxic effect of the drug;
- some diuretics: the likelihood of increased toxicity of aminoglycosides (associated with a change in the concentration of the antibiotic in the tissues and blood plasma);
- botulinum neurotoxins, cholinesterase inhibitors: increasing the effect on neuromuscular conduction;
- platinum compounds: an increase in the potential toxicity of parenterally administered aminoglycosides (an increase in oto- and nephrotoxic effects is possible).
Analogs
Analogs of Tobramycin-Gobbi are: Toby Podhaler, Bramitob, Brulamycin, Tobi, Tobrex, Tobrex 2X, Tobropt, Tobrosopt, Tobriss.
Terms and conditions of storage
Store in a place protected from light at a temperature of 2-8 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
