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TOBRAMYCIN is a brand name for Tobramycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients 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.
Posology The recommended dose for adults and children is one ampoule twice daily for 28 days. The dose interval should be as close as possible to 12 hours and not less than 6 hours. After 28 days of therapy, patients should stop Tobramycin 300 mg/5 ml Nebuliser solution therapy for the next 28 days.
A cycle of 28 days of active therapy and 28 days of rest from treatment should be maintained. Dosage is not adjusted for weight. All patients should receive one ampoule of Tobramycin 300 mg/5 ml Nebuliser solution twice daily. Controlled clinical studies, conducted for a period of 6 months using the following Tobramycin 300 mg/5 ml Nebuliser solution dosage regimen, have shown that improvement in lung function was maintained above baseline during the 28 days rest periods.
TOBRAMYCIN DOSING RÉGIMEN IN CONTROLLED CLINICAL STUDIES Cycle 1 Cycle 2 Cycle 3 28 days 28 days 28 days 28 days 28 days 28 days Tobramycin 300 mg twice daily plus standard care Standard care Tobramycin 300 mg twice daily plus standard care Standard care Tobramycin 300 mg twice daily plus standard care Standard care Safety and efficacy for long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa have been assessed in controlled and open label studies for up to 96 weeks (12 cycles) but have not been studied in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonised with Burkholderia cepacia.
Therapy should be initiated by a physician experienced in the management of cystic fibrosis. Treatment with Tobramycin 300 mg/5 ml Nebuliser solution should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the inclusion of Tobramycin 300 mg/5 ml Nebuliser solution in their treatment regimen.
If clinical deterioration of pulmonary status is evident, additional anti-pseudomonal therapy should be considered. Clinical studies have shown that a microbiological report indicating in vitro drug resistance does not necessarily preclude a clinical benefit for the patient.
Special populations Elderly patients There are insufficient data in this population to support a recommendation for or against dose adjustment. Renal impairment There are no data in this population to support a recommendation for or against dose adjustment with Tobramycin 300 mg/5 ml Nebuliser solution.
Two parallel, 24-week, randomised, double-blind, placebo-controlled clinical studies were conducted with tobramycin in 520 cystic fibrosis patients ranging in age from 6 to 63 years. The most commonly (≥ 10%) reported adverse events in the placebo- controlled studies with tobramycin were cough, pharyngitis, productive cough, asthenia, rhinitis, dyspnoea, pyrexia, lung disorder, headache, chest pain, sputum discoloured, haemoptysis, anorexia, pulmonary function test decreased, asthma, vomiting, abdominal pain, dysphonia, nausea, and weight loss.
Most events were reported at similar or higher frequencies in patients receiving placebo. 8% tobramycin vs. 1% tobramycin vs. 0% placebo) 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.
4 Ototoxicity). Tabulated summary of adverse reactions In the 24-week placebo-controlled studies and their open-label extensions on active treatment, a total of 313, 264 and 120 patients completed treatment with tobramycin for 48, 72 and 96 weeks respectively.
Table 1 provides the incidence of treatment-emergent adverse drug reactions, according to the following criteria: reported with an incidence of ≥ 2% for patients receiving tobramycin, occurring at a higher rate in the tobramycin arm, and assessed as drug-related in ≥ 1% of patients.
Adverse drug reactions from clinical trials are listed according to system organ classes in MedDRA. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), including isolated reports.
General warnings For information on pregnancy and lactation see section
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2. Hepatic impairment No studies have been performed on patients with hepatic impairment. As tobramycin is not metabolized, an effect of hepatic impairment on the exposure to tobramycin is not expected. Patients after organ transplantation Adequate data do not exist for the use of Tobramycin 300 mg/5 ml Nebuliser solution in patients after organ transplantation.
Paediatric patients The safety and efficacy of Tobramycin 300 mg/5 ml Nebuliser solution in children aged less than 6 years have not yet been established. 1 but no recommendation on a posology can be made. Method of administration The contents of one ampoule should be emptied into the nebuliser and administered by inhalation over approximately a 15-minute period using a hand-held PARI LC PLUS reusable nebuliser with a suitable compressor.
Suitable compressors are those which, when attached to a PARI LC Plus nebuliser, deliver a flow rate of 4-6 L/min and/or a back pressure of 110-217 kPa. The manufacturers' instructions for the care and use of the nebuliser and compressor should be followed.
Tobramycin 300 mg/5 ml Nebuliser solution is inhaled whilst the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebuliser. Nose clips may help the patient breathe through the mouth. The patient should continue their standard regimen of chest physiotherapy.
The use of appropriate bronchodilators should continue as thought clinically necessary. Where patients are receiving several different respiratory therapies it is recommended that they are taken in the following order: bronchodilator, chest physiotherapy, other inhaled medicinal products, and finally Tobramycin 300 mg/5 ml Nebuliser solution.
Maximum tolerated daily dose The maximum tolerated daily dose of Tobramycin 300 mg/5 ml Nebuliser solution has not been established.
Table 1 Adverse reactions in clinical trials Adverse reactions Frequency category Respiratory, thoracic, and mediastinal disorders Lung disorder Very common Rhinitis Very common Dysphonia Very common Sputum discoloured Very common General disorders and administration site conditions Malaise Common Investigations Pulmonary function test decreased Very common Ear and labyrinth disorders Tinnitus Common Musculoskeletal and connective tissue disorders Myalgia Common Infections and infestations Laryngitis Common As the duration of exposure to tobramycin increased over the two open-label extension studies, the incidence of productive cough and pulmonary function test decreased appeared to increase; however, the incidence of dysphonia appeared to decline.
Overall, the incidence of adverse events related to the following MedDRA System Organ Class (SOC) decreased with increasing exposure to tobramycin: Respiratory, thoracic, and mediastinal disorders, Gastrointestinal disorders, and General disorders and administration site conditions.
Adverse reactions derived from spontaneous reports Spontaneously reported adverse reactions, presented below, are reported voluntarily and it is not always possible to reliably establish frequency or a causal relationship to drug exposure.
4). 4). 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
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