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BRAMITOB is a brand name for Tobramycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Verbatim from this product's MHRA label. Tap a section to expand.
Bramitob is intended for inhalation only and not for parenteral use. Therapy should be initiated by a physician experienced in the management of cystic fibrosis. The recommended dose for adults and children above 6 years is one single-dose container (300mg) twice daily (morning and evening) for 28 days.
The dose interval should be as close as possible to 12 hours. After 28 days of therapy with Bramitob, patients should stop treatment for the next 28 days. Alternate cycles of 28-days of active therapy followed by 28 days without treatment should be maintained (a cycle of 28 days with therapy and 28 days without treatment).
Children under 6 years old The efficacy and safety of Bramitob have not been demonstrated in patients less than 6 years of age. 4). Patients with renal impairment Tobramycin should be used with caution in patients with known or suspected renal dysfunction.
4). Patients with hepatic insufficiency No changes in Bramitob dose are required in hepatic insufficiency. Dosage is not adjusted for body weight. All patients should be administered one single-dose container of Bramitob (300 mg of tobramycin) twice daily.
Treatment with tobramycin should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the inclusion of Bramitob in their treatment regimen. If clinical deterioration of pulmonary status is evident, additional anti-pseudomonal therapy should be considered.
Method of Administration:
The single-dose container should be opened just before use. Any unused solution that is not immediately used should be discarded and not stored for re-use. Administration of Bramitob should be carried out following general hygienic standards.
The apparatus used should be clean and working correctly; the nebuliser, that should be for personal use only, should be kept clean and regularly disinfected. For cleaning and disinfection of the nebuliser, refer to the instructions provided with the nebuliser.
Maximum tolerated daily dose:
The maximum tolerated daily dose of Bramitob has not been established. Instructions for opening the container: 1) Bend the single-dose container in both directions 2) Detach the single-dose container from the strip, firstly above then in the middle 3) Open the single-dose container by rotating the flap as indicated by the arrow 4) Exerting a moderate pressure on the single-dose container’s walls, let the medicinal product flow into the glass tube of the nebuliser.
In controlled clinical trials (4) and uncontrolled clinical trials (1) with Bramitob (565 patients treated), the most common reactions were those concerning the respiratory tract (cough and dysphonia). The adverse reactions reported in the clinical trials (see below) are classified as: common ( ≥1/100 and <1/10); uncommon ( ≥1/1,000 to <1/100); rare ( ≥1/10,000 and <1/1,000); very rare ( <1/10,000).
4) Uncommon Cough, dysphonia CommonRespiratory, thoracic and mediastinal disorders Forced expiratory volume decreased, dyspnoea, rales, haemoptysis, oropharyngeal pain, productive cough Uncommon Gastrointestinal disorders Salivary hypersecretion, glossitis, abdominal pain upper, nausea Uncommon Skin and subcutaneous tissue disorders Rash Uncommon General disorders and administration site conditions Asthenia, chest discomfort, mucosal dryness Uncommon Investigations Transaminases increased Uncommon tobramycin vs.
7% control) and (3% tobramycin vs. 0% control) respectively. These episodes of tinnitus were transient and resolved without discontinuation of tobramycin therapy, and were not associated with permanent loss of hearing on audiogram testing.
The risk of tinnitus did not increase with repeated cycles of exposure to tobramycin. Additional undesirable effects, some of which are common sequelae of the underlying disease, but where a causal relationship to tobramycin could not be excluded were: sputum discoloured, respiratory tract infection, myalgia, nasal polyps and otitis media.
4). 4 “Special warnings and precautions for use”). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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General Warnings Tobramycin should be used with caution in patients with known or suspected renal, auditory, vestibular or neuromuscular dysfunction, or with severe, active haemoptysis. Renal and eighth cranial nerve function should be closely monitored in patients with known or suspected renal impairment and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy.
Evidence of impairment in renal, vestibular and/or auditory function requires discontinuation of the drug or dosage adjustment. The serum concentration of tobramycin should only be monitored through venipuncture and not finger prick blood sampling which is a non validated dosing method.
It has been observed that contamination of the skin of the fingers from the preparation and nebulisation of tobramycin may lead to falsely increased serum levels of the drug. This contamination cannot be completely avoided by hand washing before testing.
Bronchospasm Bronchospasm can occur following inhalation of medicinal products and has been reported with nebulised tobramycin. The first dose of Bramitob should be given under medical supervision, using a pre-nebulisation bronchodilator if this is already part of the current treatment regimen for the patient.
FEV1 (forced expiratory volume) should be measured before and after nebulisation. If there is evidence of therapy-induced bronchospasm in a patient not receiving a bronchodilator, the test should be repeated on a separate occasion, using a bronchodilator.
Onset of bronchospasm in the presence of bronchodilator therapy may indicate an allergic reaction. Should an allergic reaction be suspected, Bramitob should be discontinued. Bronchospasm should be treated as clinically appropriate. Neuromuscular disorders Tobramycin should be used with great caution in patients with neuromuscular disorders, such as parkinsonism or other conditions characterised by myasthenia, including myasthenia gravis, as aminoglycosides may worsen muscular weakness due to a potential curare-like effect on the neuromuscular function.
1. It is also contraindicated in patients receiving potent diuretics, such as furosemide or ethacrynic acid, which have proved to be ototoxic.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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41μm) Bramitob is inhaled while the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebuliser. Nose clips may help the patient with breathing through the mouth. The patient should continue their standard regimen of chest physiotherapy.
The use of appropriate bronchodilators should continue as thought clinically necessary. In patients receiving several different respiratory therapies, it is recommended that they are taken in the following order: bronchodilator, respiratory physiotherapy, other inhaled medicinal products, and finally Bramitob.
Bramitob should not be mixed with other inhalation medicinal products.
Nephrotoxicity Although nephrotoxicity has been associated with parenteral aminoglycoside therapy, there was no evidence of nephrotoxicity during clinical trials with tobramycin. g. serum level assays after two or three doses should be performed, so that the dosage could be adjusted if necessary, and also at three to four day intervals during therapy.
In the event of changing renal function, more frequent serum levels should be obtained and the dosage or dosage intervals adjusted. e. 8 μmol/l) were not included in the clinical studies. Current clinical practice recommends that baseline renal function should be assessed.
Furthermore, the renal function should be periodically reassessed, by regularly monitoring urea and creatinine levels at least every 6 full cycles of therapy with tobramycin (180-day treatment with nebulised tobramycin). If there is evidence of nephrotoxicity, therapy with tobramycin should be discontinued until the drug minimum serum concentrations fall below 2 μg/ml.
Tobramycin therapy may then be resumed following medical advice. Patients receiving concomitant parenteral aminoglycoside therapy should be strictly monitored, due to the risk of cumulative toxicity. Monitoring of renal function is particular important in elderly patients who may have reduced renal function that may not be evident in the results of routine screening tests, such as blood urea or serum creatinine.
A creatinine clearance determination may be more useful. Urine should be examined for increased excretion of protein, cells and casts. Serum creatinine or creatinine clearance (preferred over blood urea) should be measured periodically.
Ototoxicity Ototoxicity, manifested as both auditory and vestibular toxicity has been reported with the parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness. During controlled clinical studies with tobramycin, modest hypoacusia and vertigo were observed, while with other nebulised tobramycin containing medicines auditory toxicity, as measured by complaints of hearing loss or by audiometric evaluations did not occur during controlled clinical studies.
In open label studies and post-marketing experience, some patients with a history of prolonged previous or concomitant use of intravenous aminoglycosides have experienced hearing loss. The physician should consider the possibility that aminoglycosides may cause vestibular and cochlear toxicity and should assess auditory function throughout the treatment period with Bramitob.
In patients with a predisposing risk due to previous prolonged systemic therapy with aminoglycosides, it may be necessary to consider audiological assessment before starting therapy with tobramycin. The occurrence of tinnitus warrants caution, since it represents an ototoxic symptom.
If the patient reports about tinnitus or hearing loss during the therapy with aminoglycosides, the physician should consider whether audiologic tests are necessary. When feasible, it is recommended that serial audiograms are performed in patients on continuous therapy, which are at particular high risk of ototoxicity.
Patients receiving concomitant parenteral therapy with aminoglycosides should be monitored as clinically appropriate, taking into account the risk of cumulative toxicity. Haemoptysis Inhalation of nebulised solutions may induce a cough reflex.
The use of nebulised Bramitob in patients with active, severe haemoptysis should be undertaken only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage. Microbial Resistance In clinical studies, some patients treated with nebulised tobramycin showed an […]