Tobramycin Inhalation Solution: Uses, Side Effects and Dosage

What is TOBRAMYCIN INHALATION SOLUTION used for?

TOBRAMYCIN INHALATION SOLUTION is used to treat people (six years and older) with cystic fibrosis who have a bacterial lung infection with Pseudomonas aeruginosa (see “What is Pseudomonas aeruginosa?” section below).

Antibacterial drugs like TOBRAMYCIN INHALATION SOLUTION treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, TOBRAMYCIN INHALATION SOLUTION should be used exactly as directed. Misuse or overuse of TOBRAMYCIN INHALATION SOLUTION could lead to the growth of bacteria that will not be killed by TOBRAMYCIN INHALATION SOLUTION (resistance). This means that TOBRAMYCIN INHALATION SOLUTION may not work for you in the future. Do not share your medicine.

How does TOBRAMYCIN INHALATION SOLUTION work?

TOBRAMYCIN INHALATION SOLUTION contains a medicine called tobramycin. Tobramycin belongs to the aminoglycoside class of antibiotics. TOBRAMYCIN INHALATION SOLUTION is inhaled (breathe) directly into the lungs so that the antibiotic can kill the Pseudomonas aeruginosa bacteria causing the infection. This helps to fight lung infections and improve breathing in people with cystic fibrosis.

What is Pseudomonas aeruginosa?

It is a very common bacterium that infects the lung of 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 very young. It is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly fought, it will continue to damage your lungs causing further problems to your breathing.

What are the ingredients in TOBRAMYCIN INHALATION SOLUTION?

Medicinal ingredients: Tobramycin

Non-medicinal ingredients: Nitrogen, sodium chloride, sodium hydroxide, sulfuric acid and water for injection

TOBRAMYCIN INHALATION SOLUTION comes in the following dosage forms:

TOBRAMYCIN INHALATION SOLUTION comes in a single dose, ready to use ampoule containing 300 mg tobramycin. Each box of TOBRAMYCIN INHALATION SOLUTION contains a 28-day supply - 56 ampoules packaged in 14 foil pouches. Each foil pouch contains four ampoules, for two days of TOBRAMYCIN INHALATION SOLUTION therapy.

Do not use TOBRAMYCIN INHALATION SOLUTION if you are allergic:

• to tobramycin, or to any other aminoglycoside antibiotic such as amikacin, gentamycin, kanamycin, paromomycin, streptomycin,
• any of the other ingredients in TOBRAMYCIN INHALATION SOLUTION (see What are the ingredients in TOBRAMYCIN INHALATION SOLUTION?)

If this applies to you, tell your healthcare professional without taking TOBRAMYCIN INHALATION SOLUTION.

If you think you may be allergic, ask your healthcare professional for advice.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TOBRAMYCIN INHALATION SOLUTION. Talk about any health conditions or problems you may have, including if you:

• Have unusual difficulty in breathing with wheezing or coughing or chest tightness
• Have muscle weakness that lasts or becomes worse with time, a symptom mostly related to conditions such as myasthenia gravis or Parkinson’s disease
• Have ringing in the ears, dizziness, or any changes in hearing
• Have any history of kidney problems

• Want to become pregnant or are pregnant while on TOBRAMYCIN INHALATION SOLUTION. Talk with your healthcare professional about the possibility of TOBRAMYCIN INHALATION SOLUTION causing any harm. Treatment with TOBRAMYCIN INHALATION SOLUTION during pregnancy should be undertaken only if the benefits to the mother is greater than the risks to the fetus or baby.

• You are breastfeeding or planning to breastfeed.

Other warnings you should know about:

TOBRAMYCIN INHALATION SOLUTION is in a class of antibiotics that may cause hearing loss, dizziness, or kidney problems. While you are using TOBRAMYCIN INHALATION SOLUTION and if you have or are at risk of hearing or kidney problems, your healthcare professional may do bloodwork to check how your kidneys are working. You may also take a hearing test to check if TOBRAMYCIN INHALATION SOLUTION is not affecting your hearing.

Tell your healthcare professional about all the medicines you take, or have taken recently, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with TOBRAMYCIN INHALATION SOLUTION:

You should not take the following medicines while you are taking TOBRAMYCIN INHALATION SOLUTION:

• Furosemide or ethacrynic acid, a diuretic (“water pills”)
• Urea or intravenous mannitol

You should not take the following medicines while you are taking TOBRAMYCIN INHALATION SOLUTION, or soon after finishing TOBRAMYCIN INHALATION SOLUTION treatment:

• Medicines (including tobramycin or another aminoglycoside antibiotic given by injection) that may harm your nervous system, kidneys or hearing. This interaction may cause hearing loss, dizziness, or kidney problems.

The following medicines can increase the chances of harmful effects occuring if they are given to you while receiving infusions of tobramycin or other aminoglycoside antibiotic. Talk to your healthcare professional if you are taking these medications:

• Amphotericin C, cefalotin, cyclosporine, tacrolimus, polymixins: these medicines may harm your kidneys.
• Platinum compounds (such as carboplastin and cisplatin): these medicines may harm your kidneys or hearing.
• Anticholinesterases (such as neostigmine and pyridostigmine) or botulinum toxin: these medicines may cause muscle weakness to appear or become worse.

Many other medications may also harm your nervous system, kidneys or hearing. Tell your healthcare professional about all the medications you are taking, even those that do not appear on this list.

How to take TOBRAMYCIN INHALATION SOLUTION:

• TOBRAMYCIN INHALATION SOLUTION is a solution specifically formulated for inhalation using a PARI LC PLUS™ reusable nebulizer and a DeVilbiss Pulmo-Aide® air compressor (see the step-by-step Instructions in the “How To Administer TOBRAMYCIN INHALATION SOLUTION” section below),
• Take TOBRAMYCIN INHALATION SOLUTION exactly as your healthcare professional tells you to. Ask your healthcare professional if you are not sure.
• Take TOBRAMYCIN INHALATION SOLUTION at the same time each day. This will help you remember when to take TOBRAMYCIN INHALATION SOLUTION.

• Usual dose of TOBRAMYCIN INHALATION SOLUTION in adults and children 6 years of age and older:

  • Inhale the content of one ampoule (with 300 milligrams (mg) of tobramycin) in the morning and one in the evening for 28 days using the nebulizer and a suitable compressor. Space the morning and evening doses as close as possible to 12 hours and not less than 6 hours apart.
• After taking TOBRAMYCIN INHALATION SOLUTION for 28 days, stop using it and wait 28 days before starting another 28-days treatment cycle again.
• It is important that you keep using TOBRAMYCIN INHALATION SOLUTION two times per day during your 28 days on treatment and that you keep to the 28-day on, 28-day off cycle (see picture below).

• Do NOT mix TOBRAMYCIN INHALATION SOLUTION with dornase alfa (PULMOZYME^®) in the nebulizer.

• Please check the order of medications with your doctor. If you are taking several medications and have other therapies for cystic fibrosis, take your medicines in the following order:

  • 1^st bronchodilator
  • 2^nd chest physiotherapy
  • 3^rd other inhaled medications
  • 4^th TOBRAMYCIN INHALATION SOLUTION
• Continue taking TOBRAMYCIN INHALATION SOLUTION as your healthcare professional tells you.
• If you have questions about how long to take TOBRAMYCIN INHALATION SOLUTION, talk to your doctor or your pharmacist.

Overdose:

Missed dose:

If you forget to take TOBRAMYCIN INHALATION SOLUTION and there are at least 6 hours to your next dose, take your dose as soon as you can. Otherwise, wait for your next dose. Do not double the dose to make up for the missed dose.

How to administer TOBRAMYCIN INHALATION SOLUTION:

This information is not intended to replace consultation with your healthcare professional, and cystic fibrosis care team about properly taking medication or using inhalation equipment.

TOBRAMYCIN INHALATION SOLUTION is specifically formulated for inhalation using a PARI LC PLUS™ reusable nebulizer and a DeVilbiss Pulmo-Aide® air compressor. You can take TOBRAMYCIN INHALATION SOLUTION at home, school, or at work. The following are instructions on how to use the DeVilbiss Pulmo-Aide® Compressor and PARI LC PLUSTM reusable nebulizer to administer TOBRAMYCIN INHALATION SOLUTION.

You will need the following supplies:

• TOBRAMYCIN INHALATION SOLUTION plastic ampoule (vial)
• DeVilbiss Pulmo-Aide® Compressor
• PARI LC PLUSTM Reusable Nebulizer
• Tubing to connect the nebulizer and compressor
• Clean paper or cloth towels
• Nose clips (optional)

It is important that your nebulizer and compressor function properly before starting your TOBRAMYCIN INHALATION SOLUTION therapy.

Note: Please refer to the manufacturers’ care and use instructions for important information.

Preparing Your TOBRAMYCIN INHALATION SOLUTION For Inhalation:

1. 1. Wash your hands thoroughly with soap and water.

2a. TOBRAMYCIN INHALATION SOLUTION is packaged with four ampoules per foil pouch.

2b. Separate one ampoule by gently pulling apart at the bottom tabs. Store all remaining ampoules in the refrigerator as directed.

1. 3.

   Lay out the contents of a PARI LC PLUSTM Reusable Nebulizer package on a clean, dry paper or cloth towel. You should have the following parts: nebulizer top (a), nebulizer bottom (b), inspiratory valve cap (c), mouthpiece with valve (d)

   and tubing (e) on a clean, dry paper or cloth towel.

1. 4. Remove the Nebulizer Top from the Nebulizer Cup by twisting the Nebulizer Top counter-clockwise, and then lifting off. Place the Nebulizer Top on the clean paper or cloth towel. Stand the Nebulizer Cup upright on the towel.
2. 5. Connect one end of the tubing to the compressor air outlet. The tubing should fit snugly. Plug in your compressor to an electrical outlet.
3. 6. Open the TOBRAMYCIN INHALATION SOLUTION ampoule by holding the bottom tab with one hand and twisting off the top of the ampoule with the other hand. Be careful not to squeeze the ampoule until you are ready to empty its contents into the Nebulizer Cup.

1. 7. Squeeze all the contents of the ampoule into the Nebulizer Cup.

1. 8. Replace the Nebulizer Top (a). Note: In order to insert the Nebulizer Top into the Nebulizer Cup, the Semi-Circle halfway down the stem of the Nebulizer Top should face the Nebulizer Outlet (see illustration). Turn the Nebulizer Top clockwise until securely fastened to the Nebulizer Cup.
2. 9. Attach the Mouthpiece (d) to the Nebulizer Outlet. Then firmly push the Inspiratory Valve Cap (c) in place on the Nebulizer Top. Note: the Inspiratory Valve Cap will fit snugly.
3. 10. Connect the free end of the tubing (e) from the compressor to the Air Intake on the bottom of the nebulizer, making sure to keep the nebulizer upright. Press the tubing on the Air Intake firmly.

TOBRAMYCIN INHALATION SOLUTION Treatment:

1. 1. Turn on the compressor.
2. 2. Check for a steady mist from the Mouthpiece. If there is no mist, check all tubing connections and confirm that the compressor is working properly.
3. 3. Sit or stand in an upright position that will allow you to breathe normally.

1. 4. Place mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth. Nose clips may help you breathe through your mouth and not through your nose. Do not block airflow with your tongue.
2. 5. Continue treatment until all of your TOBRAMYCIN INHALATION SOLUTION is gone and there is no longer any mist being produced. You may hear a sputtering sound when the Nebulizer Cup is empty. The entire TOBRAMYCIN INHALATION SOLUTION treatment should take approximately 15 minutes to complete. Note: if you are interrupted, need to cough or rest during your TOBRAMYCIN INHALATION SOLUTION treatment, turn off the compressor to save your medication. Turn the compressor back on when you are ready to resume your therapy.
3. 6. Follow the nebulizer cleaning and disinfecting instructions after completing therapy.

Cleaning Your Nebulizer:

To reduce the risk of infection, illness or injury from contamination, you must thoroughly clean all parts of the nebulizer as instructed after each treatment. Never use a nebulizer with a clogged nozzle. If the nozzle is clogged, no aerosol mist is produced which will alter the effectiveness off the treatment. Replace the nebulizer if clogging occurs.

1. 1. Remove tubing from nebulizer and disassemble nebulizer parts.
2. 2. Wash all parts (except tubing) with warm water and liquid dish soap.
3. 3. Rinse thoroughly with warm water and shake out water.
4. 4. Air dry or hand dry nebulizer parts on a clean, lint-free cloth. Reassemble nebulizer when dry and store.
5. 5. You can also wash all parts of the nebulizer in a dishwasher (except tubing). Place the nebulizer parts in a dishwasher basket, then place on the top rack of the dishwasher. Remove and dry the parts when the cycle is complete.

Disinfecting Your Nebulizer:

Your nebulizer is for your use only - Do not share your nebulizer with other people. You must regularly disinfect the nebulizer. Failure to do so could lead to serious or fatal illness.

Clean the nebulizer as described above. Every other treatment day, disinfect the nebulizer parts (except tubing) by boiling them in water for a full 10 minutes.

Dry parts on a clean, lint-free cloth.

Care And Use Of Your Pulmo-Aide Compressor:

Follow the manufacturer’s instructions for care and use of your compressor.

Filter Change:

1. 1. DeVilbiss Compressor filters should be changed every six months or sooner if filter turns completely grey in colour.

Compressor Cleaning:

1. 1. With power switch in the “Off” position, unplug power cord from wall outlet.
2. 2. Wipe outside of the compressor cabinet with a clean, damp cloth every few days to keep dust free.

Caution: Do not submerge in water; doing so will result in compressor damage.

What are possible side effects from using TOBRAMYCIN INHALATION

SOLUTION?

These are not all the possible side effects you may feel when taking TOBRAMYCIN INHALATION SOLUTION. If you experience any side effects not listed here, contact your healthcare professional.

Some side effects are very common (these side effects may affect more than 1 in 10 patients):

• Runny or stuffy nose, sneezing
• Changes in your voice (hoarseness)
• Discoloration of the substance you cough up (sputum)
• Decreased results for the tests of lung function

If any of these affects you severely, tell your doctor.

Some side effects are common (these side effects may affect between 1 and 10 in every 100 patients):

• Generally feeling unwell
• Muscle pain
• Voice alteration with sore throat and difficulty swallowing (laryngitis)

If any of these affects you severely, tell your doctor.

The frequency of some side effects is not known (the frequency cannot be estimated from the available data):

• Increased quantity of the substance you cough up (sputum)
• Chest pain
• Reduced appetite
• Itching
• Itchy rash
• Rash
• Loss of voice
• Disturbed sense of taste
• Sore throat

If any of these affects you severely, tell your doctor.

If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking TOBRAMYCIN INHALATION SOLUTION and contact your healthcare professional immediately.

Talk to your doctor if the following occurs while taking TOBRAMYCIN INHALATION SOLUTION:

• If you are not getting better. Strains of Pseudomonas can become resistant to treatment with the antibiotic over time. This can mean TOBRAMYCIN INHALATION SOLUTION may not work as well over time.

If you notice any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• TOBRAMYCIN INHALATION SOLUTION ampoules are for single use only. Once opened, use immediately. Discard any unused solution.
• Store TOBRAMYCIN INHALATION SOLUTION ampoules in a refrigerator (2-8°C or 36 - 46°F).
• If you can't keep TOBRAMYCIN INHALATION SOLUTION ampoules in the refrigerator store them in the foil pouches (opened or unopened) at room temperature (up to 25°C/77°F) for up to 28 days.
• Store TOBRAMYCIN INHALATION SOLUTION ampoules in the original package away from heat or direct light.
• The solution in TOBRAMYCIN INHALATION SOLUTION ampoule is normally slightly yellow. However unrefrigerated TOBRAMYCIN INHALATION SOLUTION solution may darken with time. The colour change of unrefrigerated TOBRAMYCIN INHALATION SOLUTION solution does not mean a change in the quality of TOBRAMYCIN INHALATION SOLUTION provided that the foil pouches (opened or unopened) are stored at room temperature (up to 25°C/77°F) for a maximum of 28 days.
• Do not use the unrefrigerated TOBRAMYCIN INHALATION SOLUTION after 28 days.

• Do not use TOBRAMYCIN INHALATION SOLUTION :

  • if the soluion is cloudy or if there are particles in the solution,
  • beyond the expiration date stamped on the ampoule.
• Keep out of reach and sight of children.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sandoz Canada Inc., at:

1-800-361-3062

or by written request at:

145 Jules-Léger

Boucherville QC

J4B 7K8

Or by e-mail at:

medinfo@sandoz.com

Last revised: October 27, 2017