Tobramycin inhalation belongs to a group of medications called antibiotics, and more specifically to the group called aminoglycosides. It is used for people with cystic fibrosis to treat chronic lung infections caused by certain bacteria. It works by killing the bacteria causing the infection.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

For the ampules, the usual dose for adults and children 6 years of age and older is one ampule (300 mg) inhaled twice a day for 28 days. The doses should be used as close to 12 hours apart as possible, and no less than 6 hours apart. After 28 days, this medication should be stopped for the next 28 days and then restarted for the next 28 days.

Each dose should be given with the hand-held reusable nebulizer provided to you. Do not dilute or mix this medication with other medications in the nebulizer. If you are using other medications that require a nebulizer, use them first, then use this medication.

For the capsules, the usual dose for adults and children 6 years of age and older is the contents of 4 capsules inhaled twice a day for 28 days. The doses should be used as close to 12 hours apart as possible, and no less than 6 hours apart. After 28 days, this medication should be stopped for the next 28 days and then restarted for the next 28 days.

The contents of the capsules should only be inhaled with the device that is provided and should not be swallowed. If you are using other inhaled medications, this medication should be used last. If you are using a short-acting bronchodilator (e.g., salbutamol), use it 15 to 90 minutes before inhaling this medication. Always allow the device and capsules to reach room temperature before using. Children, especially those who are 10 years of age or younger, should be provided assistance for using this medication until they are able to use the device properly without help.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

The effectiveness of the medication depends on the proper use of the device that delivers the tobramycin. The powder contents of the capsule are intended to be inhaled. Do not swallow the capsules.  Have your doctor or pharmacist instruct you in the correct procedure for using the devices used to administer the medication, depending on which form of inhaled tobramycin you are using.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose and there is at least 6 hours until the next dose, take it as soon as possible and continue with your regular schedule. Otherwise, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store the ampules in the refrigerator at 2°C to 8°C, protect them from light, and keep them out of the reach of children. If a refrigerator is not available, you can store the pouches (opened or unopened) at room temperature (up to 25°C) for up to 28 days.

The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions. Do not use this medication if it appears cloudy or there are particles in the solution.

Store the capsules at room temperature in the original package to protect from them moisture, and keep them out of the reach of children. Only remove the capsules from their packaging immediately before use.

Each clear, colorless hypromellose inhalation powder capsule with "NVR AVCI" in blue radial imprint on one part of the capsule and the Novartis logo in blue radial imprint on the other part of the capsule contains tobramycin 28 mg. Nonmedicinal ingredients: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), blue ink, calcium chloride, carnauba wax, carrageenan, hypromellose, potassium chloride, and sulfuric acid (for pH adjustment). The delivered dose (the dose that leaves the mouthpiece of the inhalation device) is tobramycin 25.5 mg.

Do not use this medication if you:

• are allergic to tobramycin or any ingredients of this medication
• are allergic to other aminoglycosides (e.g., gentamicin)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• change in sputum colour
• coughing
• dry mouth
• feeling unwell
• loss of voice
• muscle aches
• runny nose
• sore throat or mouth
• taste changes
• trouble speaking
• voice changes or loss of voice

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• coughing up blood
• ringing in the ears or hearing changes
• skin rash
• wheezing, shortness of breath, or chest tightness
• worsening difficulty breathing

Stop taking the medication and seek immediate medical attention if any of the following occur:

• severe watery or bloody diarrhea
• symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; swelling of the face, mouth, throat, or tongue)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Antibiotic-related diarrhea: As with other antibiotics, tobramycin inhalation can cause a severe form of diarrhea associated with a condition known as pseudomembranous colitis. If you develop severe diarrhea while taking (or within a few weeks of taking) this medication, contact your doctor.

Breathing problems: Occasionally, inhaled medications may cause the airways to spasm and close up, making breathing even more difficult (bronchospasm) and can be life-threatening. If you experience increased difficulty breathing after using a dose of inhaled tobramycin, seek immediate medical attention.

Ear problems: This medication may cause ear problems that appear as decreased hearing, ringing in the ears, dizziness, spinning sensations, or lack of coordination. If you experience any of these symptoms, contact your doctor.

Kidney function:  If you have reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Neuromuscular problems: Tobramycin may make symptoms of muscle weakness worse for people with neuromuscular problems. If you have myasthenia gravis, Parkinson’s disease, or similar health problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Resistance: There is a chance that bacteria can become resistant to this medication. If you are not getting better despite using this medication, contact your doctor.

Pregnancy: Like other medications in this class, tobramycin may cause harm to an unborn baby if it is used by the mother during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Tobramycin given by the intravenous (into a vein) route passes into breast milk. It is not known if tobramycin inhalation passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 6 years of age.

Seniors: The safety and effectiveness of using this medication have not been established for seniors.

There may be an interaction between tobramycin inhalation and any of the following:

• aminoglycosides given by injection (e.g., tobramycin, gentamicin)
• amphotericin B
• BCG vaccine
• bisphosphonates (e.g., alendronate, etidronate)
• botulinum toxins
• cisplatin
• carboplatin
• cyclosporine
• foscarnet
• loop diuretics (e.g., ethacrynic acid, furosemide)
• mannitol
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
• tacrolimus
• urea
• vancomycin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.