Teva’s Tobramycin Inhalation Solution

Learn how to use Teva’s Tobramycin Inhalation Solution

Tobramycin Inhalation Solution: for the management of cystic fibrosis patients with Pseudomonas aeruginosa

Follow the instructions below for taking Tobramycin Inhalation Solution. If you have any questions, ask your healthcare provider or pharmacist.

Supplies you will need to take Tobramycin Inhalation Solution (See Figure A):

1 ampule of Tobramycin Inhalation Solution
PARI LC PLUS reusable Nebulizer
PARI Vios compressor
tubing to connect the nebulizer and compressor
clean paper or cloth towels
nose clips (optional)

Figure A

Tobramycin inhalation solution is used only in a PARI LC PLUS re-usable Nebulizer connected to a PARI LC PLUS Vios air compressor. Make sure you know how to use your nebulizer machine before you use it to breathe in tobramycin inhalation solution.

Do not mix tobramycin inhalation solution with other medicines in your nebulizer.

Tobramycin inhalation solution comes in a sealed foil pouch. Do not open a sealed pouch until you are ready to use a dose of tobramycin inhalation solution. After opening the pouch, unused ready-to-use ampules should be returned to, and stored in, the pouch.

Getting ready:

Put your PARI LC PLUS Reusable Nebulizer Top and Bottom (Nebulizer Cup) Assembly, Inspiratory Valve Cap, Mouthpiece with Valve, and Tubing on a clean and dry surface.
Wash your hands with soap and water.

Preparing your Tobramycin Inhalation Solution dose

Open foil pouch.

Figure B

Separate 1 ampule by gently pulling apart at the bottom tabs (See Figure C) and use it right away.

Figure C

Hold the bottom tab on the Tobramycin Inhalation Solution ampule with 1 hand (See Figure D). With your other hand, hold the top of the ampule and twist off the top of the ampule (See Figure D).

Do not squeeze the ampule until you are ready to squeeze all the medicine into the Nebulizer Cup.

Figure D

Hold the Nebulizer Cup and twist off the Nebulizer Cup Top in a counter-clockwise direction (See Figure E). Set the Top aside on a clean, dry surface.

Figure E

Squeeze all of the medicine from the ampule into the Nebulizer Cup (See Figure F).

Figure F

Line up the semi-circle on the Nebulizer Cup Top with the Nebulizer Cup Outlet and twist on the Nebulizer Cup Top in a clock-wise direction until it is tight (See Figure G).

Figure G

Push the mouthpiece straight onto the Nebulizer Cup Outlet (See Figure H).

Figure H

Firmly push the Inspiratory Valve Cap straight down onto the Nebulizer Cup Top (See Figure I). The Inspiratory Valve Cap should fit tightly.

Figure I

Connect 1 end of the tubing to the compressor air outlet. The tubing should fit tightly (See Figure J).

Figure J

Plug your compressor plug into an electrical (See Figure K).

Figure K

Hold the Nebulizer Cup upright and firmly push the free end of the tubing straight up onto the Air Intake on the bottom of the Nebulizer Cup (See Figure L).

Make sure to keep the Nebulizer Cup upright.

Figure L

Giving your tobramycin inhalation solution dose

Turn on the compressor (Figure M) and check the Mouthpiece. You should see a steady mist coming from the Mouthpiece (Figure N).

If you do not see a steady mist coming from the mouthpiece, check all tubing connections and make sure that the compressor is working the right way.

Figure M

Figure N

Sit or stand in a comfortable, upright position that will let you breathe normally. Place the Mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth (See Figure O).

Nose clips may help you breathe only through your mouth and not through your nose.

Figure O

Keep breathing in your Tobramycin Inhalation Solution dose for at least 15 minutes. You will know that you have received your full dose of medicine when you hear a “spitting noise” coming from the Mouthpiece for at least 1 minute and the Nebulizer Cup is empty.

After your tobramycin inhalation solution dose

Clean and disinfect your nebulizer (see manufacturer’s instructions).

Care and Use of Your PARI Vios® Compressor

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

More Show More Close

IMPORTANT SAFETY INFORMATION

Do not take tobramycin inhalation solution if you are allergic to tobramycin, any of the ingredients in tobramycin inhalation solution, or to any other aminoglycoside antibacterial.

See the end of the Patient Information Leaflet found in the Prescribing Information for a complete list of ingredients in tobramycin inhalation solution.

Before you take tobramycin inhalation solution, tell your healthcare provider about all of your medical conditions, including if you:

have or have had hearing problems (including noises in your ears such as ringing or hissing)
have dizziness
have or have had kidney problems
have or have had problems with muscle weakness such as myasthenia gravis or Parkinson’s disease
have or have had breathing problems such as wheezing, coughing, or chest tightness
are pregnant or plan to become pregnant. Tobramycin inhalation solution is in a class of medicines that can harm your unborn baby and may be connected with complete deafness in babies at birth. The deafness affects both ears and cannot be changed.
are breastfeeding or plan to breastfeed. It is not known if tobramycin passes into your breast milk. Tobramycin, the medicine in tobramycin inhalation solution may cause the following symptoms in your breastfed baby:
- loose or bloody stools
- yeast infection in the mouth or throat (thrush)
- diaper rash

Call your baby’s healthcare provider if your breastfed baby has any of these problems. Talk to your healthcare provider about the best way to feed your baby during treatment with tobramycin inhalation solution.

are receiving aminoglycoside therapy by injection or through a vein (intravenous) while taking tobramycin inhalation solution. Your blood levels of tobramycin will be checked.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of tobramycin inhalation solution?

Tobramycin inhalation solution can cause serious side effects, including:

hearing loss or ringing in the ears (ototoxicity). Some people who were treated with tobramycin, the medicine in tobramycin inhalation solution had hearing loss or ringing in the ears. Tell your healthcare provider right away if you have hearing loss or hear noises in your ears (such as ringing or hissing), or if you develop vertigo, dizziness, or difficulty with balance.
worsening kidney problems (nephrotoxicity). Your healthcare provider may do a blood test and urine test to check how your kidneys are working while you are taking tobramycin inhalation solution.
worsening muscle weakness (neuromuscular disorder). Tobramycin inhalation solution can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis or Parkinson’s disease).
severe breathing problems (bronchospasm). Tell your healthcare provider right away if you get any of these symptoms of bronchospasm while taking tobramycin inhalation solution:
- shortness of breath with wheezing
- coughing and chest tightness

The most common side effects of tobramycin inhalation solution include:

worsening of lung problems or cystic fibrosis
noisy breathing (rales)
abnormal red blood cell activity
changes in your voice (hoarseness)

These are not all of the possible side effects of tobramycin inhalation solution.

Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the Medication Guide in the full Prescribing Information.

What is tobramycin inhalation solution?

Tobramycin inhalation solution is a prescription medicine that is used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. Tobramycin inhalation solution contains an antibacterial medicine called tobramycin (an aminoglycoside).

It is not known if tobramycin inhalation solution is safe and effective:

in children under 6 years of age
in people who have decreased lung volume or a forced expiratory volume in one second (FEV₁) less than 40% or greater than 80% predicted
in people who are colonized with a bacterium called Burkholderia cepacian

How to use Tobramycin Inhalation Solution