ruginosa. TOBI Podhaler contains an antibacterial medicine called tobramycin (an aminoglycoside).
It is not known if TOBI Podhaler is safe and effective:
in children under 6 years of age
in people who have an FEV1 less than 25% predicted
in people who are colonized with a bacterium called Burkholderia cepacia
when used for more than 3 cycles
Who should not use TOBI Podhaler?
Do not use TOBI Podhaler if you are allergic to tobramycin, any of the ingredients in TOBI Podhaler, or to any other aminoglycoside antibacterial.
What should I tell my healthcare provider before using TOBI Podhaler?
Before you use TOBI Podhaler, tell your healthcare provider 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
have had an organ transplant
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed. It is not known if TOBI Podhaler passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Using TOBI Podhaler with certain other medicines can cause serious side effects.
If you are using TOBI Podhaler, you should discuss with your healthcare provider if you should take:
other medicines that may harm your nervous system, kidneys, or hearing
“water pills” (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or mannitol
urea
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use TOBI Podhaler?
See the step-by-step Instructions for Use at the end of this Patient Information leaflet about the right way to use TOBI Podhaler. Do not use TOBI Podhaler unless your healthcare provider has taught you how to use it the right way. Ask your healthcare provider or pharmacist if you are not sure.
Always use TOBI Podhaler exactly as your healthcare provider tells you to use it. Ask your healthcare provider or pharmacist if you are not sure.
The usual dose for adults and children over 6 years of age is:
The content of 4 TOBI Podhaler capsules inhaled by mouth in the morning using your Podhaler device and the content of 4 TOBI Podhaler capsules inhaled by mouth in the evening using your Podhaler device.
Check to see that each capsule is empty after inhaling. If powder remains in the capsule, repeat inhalation until the capsule is empty.
Each dose of 4 TOBI Podhaler capsules should be taken as close to 12 hours as possible.
You should not take your dose of 4 TOBI Podhaler capsules less than 6 hours apart.
If you forget to take TOBI Podhaler 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.
After using TOBI Podhaler for 28 days, you should stop using it and wait 28 days. After you have stopped using TOBI Podhaler for 28 days, you should start using TOBI Podhaler again for 28 days. Complete the full 28 day course even if you are feeling better. It is important that you keep to the 28-day on, 28-day off cycle (S
