Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Tobramycin contains an antibiotic medicine called tobramycin. It belongs to a class of antibiotic medicines called aminoglycosides.
Tobramycin is used in patients aged 6 years and older who have cystic fibrosis to treat chest infections caused by a bacteria called Pseudomonas aeruginosa.
Tobramycin fights the infection caused by Pseudomonas bacteria in your lungs and helps to improve your breathing.
When you inhale Tobramycin, the antibiotic can get directly into your lungs to fight against the bacteria causing the infection. For the best results of this medicine, use it as this leaflet instructs you.
What is Pseudomonas aeruginosa? This is a very common bacteria that infects nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later on in their lives, while others get it while very young.
This is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly controlled, it will continue to damage your lungs causing further problems to your breathing.
Tobramycin kills the bacteria that cause infections in the lungs. The infection can be controlled successfully if the problem is tackled early.
Do NOT use Tobramycin • if you are allergic to tobramycin, to any type of aminoglycoside antibiotic or to any of the other ingredients of this medicine (listed in section 6).
If any of above applies to you, do not use this medicine and talk to your doctor.
If you think you may be allergic, ask your doctor for advice.
Warnings and precautions Talk to your doctor before using Tobramycin if you have or if you have ever had any of the following conditions:
• hearing problems (including ringing in your ears and dizziness)
• kidney problems
• unusual difficulty in breathing with wheezing or coughing, chest tightness
• blood in your sputum (the substance you cough up)
• muscle weakness that lasts or worsens with time, for example symptoms related to conditions such as myasthenia (muscle weakness) or Parkinson's disease.
• if you or your family members have a mitochondrial mutation disease (condition caused by variants in the genome of mitochondria, the parts of your cells which help make energy) or loss of hearing due to antibiotic medicines; certain mitochondrial mutations may increase your risk of hearing loss with this product.
If any of these apply to you, tell your doctor before you use Tobramycin.
Inhaling medicines can cause chest tightness and wheezing and this can happen with Tobramycin. Your doctor will supervise your first dose of Tobramycin and check your lung function before and after dosing. If you are not already doing so, your doctor may ask you to use a bronchodilator (e.g. salbutamol) before using Tobramycin.
If you are using Tobramycin, strains of Pseudomonas can become resistant to the treatment over time. This can mean the medicine may not work as well as it should over time. Talk to your doctor if you are concerned about this.
If you are receiving tobramycin by injection, it can sometimes cause hearing loss, dizziness and kidney damage, and can harm an unborn child.
Children and adolescents Tobramycin can be used by children and adolescents aged 6 years and older. Tobramycin should not be given to children less than 6 years old.
Elderly If you are aged 65 years and older, your doctor may perform additional tests to decide if Tobramycin is right for you.
Other medicines and Tobramycin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should NOT take the following medicines while you are using Tobramycin
• furosemide or ethacrynic acid, diuretics ('water tablets')
• other medicines which may affect kidney function such as urea or intravenous mannitol
• other medicines which may harm your nervous system, kidneys or hearing.
The following medicines can increase the chances of harmful effects occurring if they are given to you while you are receiving injections of tobramycin:
• amphotericin B, cefalotin, ciclosporin, polymyxins (used to treat microbial infections), tacrolimus (used to reduce the activity of immune system). These medicines may harm your kidneys
• platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer). These medicines may harm your kidneys or hearing
• anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin. These medicines may cause muscle weakness to appear or become worse.
If you are taking one or more of the above medicines, discuss this with your doctor before you use Tobramycin.
You should not mix or dilute Tobramycin with any other medicines in your nebuliser handset.
If you are taking several different treatments for cystic fibrosis, you should take them in the following order:
1. bronchodilator therapy, such as salbutamol
2. chest physiotherapy
3. other inhaled medicines
4. then Tobramycin.
Please check this order with your doctor as well.
Pregnancy and breast-feeding Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
It is not known whether inhaling this medicine when you are pregnant causes side effects. When given as an injection, tobramycin and other aminoglycoside antibiotics can cause harm to an unborn child, such as deafness.
Breast-feeding
If you are breast-feeding your child, you should talk to your doctor before using this medicine.
Driving and using machines Tobramycin should not affect your ability to drive and use machines.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The recommended dose is two ampoules each day (one in the morning and one in the evening) for 28 days.
• the recommended dose is the same for all persons aged 6 years and older
• inhale by mouth the full contents of one ampoule in the morning and one ampoule in the evening using the nebuliser handset
• it is best to have an interval as close as possible to 12 hours between the doses, but this interval must be at least 6 hours
• after you have used your medicine for 28 days, you then have a 28-day break, during which you do not inhale any Tobramycin. You then start another course after the break (as illustrated)
• it is important that you keep using the medicine twice each day during your 28 days on treatment and that you keep to the 28-day on, 28-day off cycle
On Tobramycin Off Tobramycin
Use Tobramycin twice a day, every day for 28 days Do not use any Tobramycin for the next 28 days
Repeat cycle
Continue using Tobramycin on this cyclical basis for as long as your doctor tells you. If you have questions about how long to use Tobramycin, talk to your doctor or pharmacist.
Instructions for use of Tobramycin This part of the leaflet explains how to use, care and handle Tobramycin. Please read carefully and follow these instructions.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
The equipment you need for inhaling Tobramycin Tobramycin should be used with a clean and dry reusable nebuliser.
The LC PLUS nebuliser (manufactured by PARI GmbH) is suitable for use with Tobramycin.
Your doctor or physiotherapist can advise you on the proper use of Tobramycin and the equipment you need. You may need different nebulisers for your other inhaled medicines for cystic fibrosis.
Preparing to inhale Tobramycin • wash your hands thoroughly with soap and water
• each foil pouch contains 4 ampoules. Cut or tear open the pouch. Remove one ampoule of Tobramycin from the aluminium pouch. Keep the rest of the medicine refrigerated in the original carton
• lay out all the pieces of your nebuliser on a clean, dry paper or cloth towel
• make sure you have a suitable compressor and tubing to connect the nebuliser to the compressor
• be careful to follow the appropriate instructions for use for your type of nebuliser, you must read the leaflet provided by the manufacturer. Check that your nebuliser and compressor are working properly according to the manufacturer's instructions before you start to take your medicine.
Use of Tobramycin with LC PLUS (PARI GmbH) For more detailed instructions on the use and care of the nebuliser, please read the leaflet provided with the PARI LC PLUS.
1. Remove the nebuliser top from the nebuliser by twisting the top anticlockwise and then lifting it. Place the top on the towel and stand the nebuliser chamber upright on the towel
2. Connect one end of the tubing to the compressor air outlet. Make sure that the tubing fits snugly. Plug the compressor into the electrical outlet
3. Open the Tobramycin ampoule by holding the bottom tab with one hand and twisting off the top with your other hand. Squeeze all the contents of the ampoule into the nebuliser chamber
4. Replace the nebuliser top, put the mouthpiece and the inspiratory valve cap in place on the nebuliser, and connect the compressor as indicated in your PARI LC PLUS nebuliser leaflet
5. Turn on the compressor. Check that there is steady mist coming from the mouthpiece. If there is no mist, check all tubing connections and that the compressor is working properly
6. Sit or stand in an upright position so that you can breathe normally
7. Place the mouthpiece between your teeth and on top of your tongue. Breathe normally, but only through your mouth (you may use a nose clip if your doctor agrees). Try not to block the airflow with your tongue
8. Continue until all of the Tobramycin is gone and there is no longer any mist being produced. It should take about 15 minutes to take all the treatment. You may hear a spluttering sound when the nebuliser cup is empty.
9. Please remember to clean and disinfect your nebuliser after treatment according to the manufacturer's instructions. You should never use a dirty or clogged nebuliser. You should not share your nebuliser with other people.
If you are interrupted, or need to cough or rest during your treatment, turn off the compressor to save your medicine.
Turn the compressor on again when you are ready to restart your treatment. Leave out this dose if your next dose is due in less than 6 hours.
If you use more Tobramycin than you should If you inhale too much Tobramycin you may get a very hoarse voice. Make sure you tell your doctor as soon as possible. If Tobramycin is swallowed, tell your doctor as soon as possible.
If you forget to use Tobramycin If you forget to use Tobramycin and there are at least 6 hours to your next dose, use your dose as soon as you can. Otherwise, wait for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop using Tobramycin Do not stop using Tobramycin unless your doctor tells you to do so, as your lung infection may not be controlled sufficiently and may become worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects Stop using Tobramycin and tell your doctor immediately about any of the following serious side effects:
• unusual difficulty in breathing with wheezing or coughing and chest tightness
• allergic reactions including hives and itching
Tell your doctor immediately about any of the following serious side effects:
• loss of hearing (ringing in the ears is a potential warning sign of hearing loss), noises (such as hissing) in the ears
Your underlying lung disease may worsen while you are using Tobramycin. This may be due to a lack of effect. Tell your doctor straight away if this happens.
Other side effects Tell your doctor as soon as possible about any of the following side effects:
Very common (may affect more than 1 in 10 users)
• runny or stuffy nose, sneezing
• voice alteration (hoarseness)
• discoloration of the substance you cough up (sputum)
• worsening of lung function test results
Common (may affect up to 1 in 10 users)
• generally feeling unwell
• muscle pain
• voice alteration with sore throat and difficulty swallowing (laryngitis)
Other side effects • itching
• itchy rash
• rash
• loss of the voice
• disturbed sense of taste
• sore throat
Not known (frequence cannot be estimated from the available data)
• increased quantity of the substance you cough up (sputum)
• chest pain
• reduced appetite.
If you use Tobramycin at the same time as or following repeated courses of tobramycin or another aminoglycoside antibiotic by injection, hearing loss has been reported as a side effect.
Injections of tobramycin or other aminoglycosides can cause allergic reactions, hearing problems and kidney problems.
People with cystic fibrosis have many symptoms of the disease. These may still happen while using Tobramycin, but should not be any more frequent or seem worse than before.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or the pouch or carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C -8°C). If you don't have a refrigerator available (such as when you are transporting your medicine) you can store the carton with the medicines (pouches opened or unopened) below 25°C for up to 28 days. Do not use Tobramycin ampoules which have been stored at room temperature for more than 28 days.
Store your ampoules in the original package in order to protect from light. This medicine is normally colourless to light yellow but this can vary and sometimes it can be a darker yellow. This does not change the way this medicine works provided that the storage instructions have been followed.
Do not use this medicine if you notice that it has gone cloudy, or if there are bits in the solution.
Never store an opened ampoule. Once opened an ampoule should be used immediately and any remaining product should be discarded.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Tobramycin contains • The active substance is tobramycin. Each ampoule of 5 ml contains 300 mg tobramycin, corresponding to 60 mg/ml.
• The other ingredients are: sodium chloride, water for injection, nitrogen (E941), sulfuric acid (E513) (for pH adjustment) and/or sodium hydroxide (E524) (for pH adjustment).
What Tobramycin looks like and contents of the pack Tobramycin nebuliser solution is a clear, colourless to light yellow solution free from visible particulate matter.
Tobramycin is provided in a ready-to-use ampoule. Ampoules are packed in foil pouches, one foil pouch contains 4 ampoules which corresponds to 2 days of treatment.
Tobramycin is available in packs of 56, 112 or 168 ampoules, which is enough to last one, two or three cycles of treatment, respectively.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Rumania
This medicinal product is authorised in the Member States of the EEA under the following names
Germany: Tobramycin SUN 300 mg Lösung für einen Vernebler
Denmark: Tobramycin SUN 300 mg/ 5 ml inhalationsvæske til nebulisator, opløsning
Spain: Tobramicina SUN 300 mg/ 5 ml solución para inhalación por nebulizador
France: Tobramycine SUN 300 mg/ 5 ml solution pour inhalation par nébuliseur
Italy: Tobramicina SUN 300 mg/ 5 ml soluzione per nebulizzatore
Netherlands: Tobramycine SUN 300 mg/ 5 ml verneveloplossing
Poland: Tobramycyna SUN 300 mg/ 5 ml roztwór do nebulizacji
Romania: Tobramicină SUN 300 mg/ 5 ml soluţie pentru nebulizator
United Kingdom (NI): Tobramycin 300 mg/ 5 ml nebuliser solution
This leaflet was last revised in 09/2021
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Tobramycin 300 mg/ 5 ml nebuliser solution comes as inhaler containing 300mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Tobramycin 300 mg/ 5 ml nebuliser solution is tobramycin.
Medicines with the same active substance, strength and form include: Munuza 300 mg/5 ml nebuliser solution, Tobi 300 mg/5 ml Nebuliser Solution, Tymbrineb (tobramycin) 300 mg/5 mL Nebuliser Solution. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Tobramycin 300 mg/ 5 ml nebuliser solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
Tobramycin is supplied for use via inhalation and is not for parenteral use. 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 therapy with tobramycin 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 of tobramycin) twice daily. Controlled clinical studies, conducted for a period of 6 months using the following tobramycin dosage regimen, have shown that improvement in lung function was maintained above baseline during the 28 day rest periods. Tobramycin Dosing Regimen 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 (FEV 1 ) <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 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 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. Please also refer to nephrotoxicity information in section 4.4 and excretion information in section 5.2. 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. After organ transplantation Adequate data do not exist for the use of tobramycin in patients after organ transplantation. Paediatric population The safety and efficacy of tobramycin in children aged less than 6 years have not yet been established. Currently available data are described in section 5.1 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-minuted period using a hand-held PARI LC PLUS reusable nebuliser with a suitable compressor (drug delivery rate 7.2 mg/min; total drug delivery 115 mg; mass median aerodynamic diameter: 4.3; droplet size distribution: D 10 1.7 µm, D 50</sub
Administration of tobramycin is contraindicated in any patient with known hypersensitivity to any aminoglycoside or any of the excipients listed in section 6.1. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
General Warnings For information on pregnancy and lactation see section 4.6. Tobramycin should be used with caution in patients with known or suspected renal, auditory, vestibular or neuromuscular dysfunction, or with severe, active haemoptysis. Monitoring of serum tobramycin concentrations Serum tobramycin concentrations should be monitored in patients with known or suspected auditory or renal dysfunction. If oto- or nephrotoxicity occurs in a patient receiving Tobramycin, tobramycin therapy should be discontinued until serum concentration falls below 2 μg/ml. Serum concentrations of tobramycin should be monitored in patients receiving concomitant parenteral aminoglycoside therapy (or other medications that can affect renal excretion). These patients should be monitored as clinically appropriate. The serum concentration of tobramycin should only be monitored through venipuncture and not finger prick blood sampling. Contamination of the skin of the fingers with tobramycin may lead to falsely increased measurements of serum levels of the drug. This contamination cannot be completely avoided by hand washing before testing. Bronchospasm Bronchospasm can occur with inhalation of medicinal products and has been reported with nebulised tobramycin. The first dose of tobramycin should be given under supervision, using a pre-nebulisation bronchodilator if this is part of the current regimen for the patient. FEV 1 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. Evidence of bronchospasm in the presence of bronchodilator therapy may indicate an allergic response. If an allergic response is suspected tobramycin should be discontinued. Bronchospasm should be treated as medically appropriate. Neuromuscular disorders Tobramycin should be used with great caution in patients with known or suspected neuromuscular disorders such as parkinsonism or other conditions characterised by myasthenia, including myasthenia gravis, as aminoglycosides may aggravate muscle weakness due to a potential curare-like effect on neuromuscular function. Nephrotoxicity Although nephrotoxicity has been associated with parenteral aminoglycoside therapy, there was no evidence of nephrotoxicity during clinical trials with tobramycin. The product should be used with caution in patients with known or suspected renal dysfunction and serum concentrations of tobramycin should be monitored. Patients with severe renal impairment, i.e. serum creatinine >2 mg/dl (176.8 μmol/l), were not included in the clinical studies. Current clinical practice suggests baseline renal function should be assessed. Urea and creatinine levels should be reassessed after every 6 complete cycles of tobramycin therapy (180 days of nebulised aminoglycoside therapy). See also “Monitoring of serum tobramycin concentrations” above. Ototoxicity Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness. Ototoxicity, as measured by complaints of hearing loss or by audiometric evaluations, did not occur with tobramycin therapy 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. Patients with hearing loss frequently reported tinnitus. Physicians should consider the potential for aminoglycosides to cause vestibular and cochlear toxicity and carry out appropriate assessments of auditory function during tobramycin therapy. In patients with a predisposing risk due to previous prolonged, systemic aminoglycoside therapy it may be necessary to consider audiological assessment before initiating tobramycin therapy. The onset of tinnitus warrants caution as it is a sentinel symptom of ototoxicity. Caution should be exercised when prescribing tobramycin to patients with known or suspected auditory or vestibular dysfunction. Physicians should consider an audiological assessment for patients who show any evidence of auditory dysfunction, or who are at increased risk for auditory dysfunction. If a patient reports tinnitus or hearing loss during aminoglycoside therapy the physician should consider referring them for audiological assessment. See also “Monitoring of serum tobramycin concentrations” above. Patients with mitochondrial DNA mutations, particularly the nucleotide 1555 A to G substitution in the 12S rRNA gene may be at higher risk for ototoxicity, even if the patient's aminoglycoside serum levels were within the recommended range. In case of family history of aminoglycoside-induced deafness or known mitochondrial DNA mutations in the 12S rRNA gene, alternative treatments other than aminoglycosides may need to be considered. Haemoptysis Inhalation of nebulised solutions may induce a cough reflex. The use of tobramycin 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 on tobramycin therapy showed an increase in aminoglycoside Minimum Inhibitory Concentrations for P. aeruginosa isolates tested. There is a theoretical risk that patients being treated with nebulised tobramycin may develop P. aeruginosa isolates resistant to intravenous tobramycin (see 5.1). <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
No interaction studies have been performed with tobramycin. In clinical studies, patients taking tobramycin concomitantly with dornase alfa, β-agonists, inhaled corticosteroids, and other oral or parenteral anti-pseudomonal antibiotics, demonstrated adverse experience profiles which were similar to those of the control group. Concurrent and/or sequential use of tobramycin with other medicinal products with neurotoxic, nephrotoxic or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Tobramycin should not be administered concomitantly with ethacrynic acid, furosemide, urea or intravenous mannitol. Other medicinal products that have been reported to increase the potential toxicity of parenterally administered aminoglycosides include: - Amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity); - Platinum compounds (risk of increased nephrotoxicity and ototoxicity); - Anticholinesterases, botulinum toxin (neuromuscular effects). <summary id="PREGNANCY" data-evt="smpcSectionOpen"
Tobramycin should not be used during pregnancy or lactation unless the benefits to the mother outweigh the risks to the foetus or baby.
Pregnancy
There are no adequate data from the use of tobramycin administered by inhalation in pregnant women. Animal studies do not indicate a teratogenic effect of tobramycin (see 5.3 Preclinical data). However, aminoglycosides can cause foetal harm (e.g., congenital deafness) when high systemic concentrations are achieved in a pregnant woman. If tobramycin is used during pregnancy, or if the patient becomes pregnant while taking tobramycin, she should be informed of the potential hazard to the foetus.
Breast-feeding
Systemic tobramycin is excreted in breast milk. It is not known if administration of tobramycin will result in serum concentrations high enough for tobramycin to be detected in breast milk. Because of the potential for ototoxicity and nephrotoxicity with tobramycin in infants, a decision should be made whether to terminate nursing or discontinue tobramycin therapy.
Fertility
No effect on male or female fertility was observed in animal studies after subcutaneous administration (see section 5.3).
On the basis of reported adverse drug reactions, tobramycin is presumed to be unlikely to produce an effect on the ability to drive and use machinery.
Summary of the safety profile 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. Dysphonia and tinnitus were the only undesirable effects reported in significantly more patients treated with tobramycin; (12.8% tobramycin vs. 6.5% placebo) and (3.1% 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. The risk of tinnitus did not increase with repeated cycles of exposure to tobramycin (see section 4.4 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 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. Table 1 Adverse reactions in clinical trials Adverse reactions Frequency category Infections and infestations Laryngitis Common Ear and labyrinth disorders Tinnitus Common Respiratory, thoracic, and mediastinal disorders Lung disorder Very common Rhinitis Very common Dysphonia Very common Sputum discoloured Very common Musculoskeletal and connective tissue disorders Myalgia Common General disorders and administration site conditions Malaise Common Investigations Pulmonary function test decreased Very 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. Nervous system disorders Aphonia, dysgeusia Ear and labyrinth disorders Hearing loss Respiratory, thoracic, and mediastinal disorders Bronchospasm, oropharyngeal pain, sputum increased, chest pain Skin and subcutaneous tissue disorders Hypersensitivity, pruritus, urticaria, rash General disorders and administration site conditions Decreased appetite 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 (see 4.4). Parenteral aminoglycosides have been associated with hypersensitivity, ototoxicity and nephrotoxicity (see 4.3, 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
Administration by inhalation results in low systemic bioavailability of tobramycin. Symptoms of aerosol overdose may include severe hoarseness.
In the event of accidental ingestion of tobramycin, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract.
In the event of inadvertent administration of tobramycin by the intravenous route, signs and symptoms of parenteral tobramycin overdose may occur that include dizziness, tinnitus, vertigo, loss of hearing acuity, respiratory distress and/or neuromuscular blockade and renal impairment.
Acute toxicity should be treated with immediate withdrawal of tobramycin, and baseline tests of renal function should be undertaken. Tobramycin serum concentrations may be helpful in monitoring overdose. In the case of any overdosage, the possibility of drug interactions with alterations in the elimination of tobramycin or other medicinal products should be considered.
Ask anything about Tobramycin 300 mg/ 5 ml nebuliser solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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