TOBI Podhaler is for people 6 years and older with cystic fibrosis (CF), Pseudomonas aeruginosa (Pa), and forced expiratory volume in 1 second (FEV1) 25% to 80% predicted and who do not have Burkholderia cepacia.

Dosing and helpful tips when using TOBI Podhaler

  • Your healthcare provider should show you or your caregiver how to use TOBI Podhaler before you use it for the first time

The recommended dosage of TOBI Podhaler

4 28-mg capsules for inhalation

2 times a day (AM and PM) in cycles of

28 days on and

28 days off

  • The powder from all 4 capsules must be inhaled to receive the full dose
  • Inhale 2 times from each capsule in order to empty it
  • Take each dose as close to 12 hours apart as possible and no less than 6 hours apart

Helpful tips

  • Practice with the TOBI Podhaler Inhalation Trainer
  • Do not press the button more than once, as the capsule may break into pieces
  • Tilt head back slightly when inhaling
  • Inhale with a single, deep breath. Practice may help to find the best speed for you
  • Sip water after administering each capsule

Important Dosing Considerations

  • TOBI Podhaler capsules must not be swallowed
  • Capsules are for use with the Podhaler device only
  • Capsules are for oral inhalation only
  • Each dose of 4 capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart
  • Capsules should always be stored in the blister card; each capsule should only be removed IMMEDIATELY BEFORE USE
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Watch a summary video on how to use TOBI Podhaler.

Please see full Prescribing Information, including Patient Information, and full Instructions for Use.



TOBI® Podhaler® (Tobramycin Inhalation Powder) 28 mg per capsule is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa.

It is not known if TOBI Podhaler is safe and effective in patients under 6 years of age, in those with lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia.


You should not use TOBI Podhaler if you are allergic to it or to any other aminoglycoside antibacterial.

Tell your doctor before starting treatment if you have or have had hearing, kidney, breathing, or muscle weakness problems or if you have dizziness, an organ transplant, or are pregnant or nursing.

Tell your doctor about all the drugs you take. Ask 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; or urea.

TOBI Podhaler can cause serious side effects, including hearing loss or ringing in the ears. Tell your doctor right away if you have hearing loss, noises in your ears such as ringing or hissing, vertigo, difficulty with balance, or dizziness.

TOBI Podhaler is in a class of drugs that may worsen kidney problems, especially in people with known or suspected kidney problems. Your healthcare provider may do a blood test to check how your kidneys are working while you are using TOBI Podhaler.

TOBI Podhaler is in a class of drugs that may worsen muscle weakness problems or harm an unborn baby.

TOBI Podhaler can cause severe breathing problems (bronchospasm). Tell your doctor right away if you get shortness of breath with wheezing, or coughing and chest tightness.

The most common side effects of TOBI Podhaler include cough, worsening of lung problems or cystic fibrosis, productive cough, shortness of breath, fever, sore throat, changes in your voice (hoarseness or loss of voice), coughing up blood, headache, and altered taste.

Let your doctor know if your symptoms worsen or if you have a side effect that bothers you enough to stop treatment or that does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.