Tobi Podhaler

TOBI Podhaler is a prescription medication used for people with cystic fibrosis with long-lasting lung infections caused by certain bacteria. Tobramycin, the active ingredient in TOBI Podhaler, belongs to a group of medicines called aminoglycoside antibiotics. It works by killing the bacteria causing the infections.

This medication comes in the form of a dry powder to be inhaled into the lungs using a special handheld inhaler device called a Podhaler. It is inhaled twice daily, usually twelve hours between doses. After 28 days the medication is stopped for 28 days, and then restarted.

Common side effects of TOBI Podhaler include cough, coughing up blood, and shortness of breath.

TOBI Podhaler is a prescription medication used for people with cystic fibrosis with long-lasting lung infections caused by certain bacteria.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported with TOBI Podhaler. See “Drug Precautions” section.

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)
• coughing up blood
• headache
• altered taste

This is not a complete list of TOBI Podhaler side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines that may harm your nervous system, kidneys, or hearing
• “water pills” (diuretics) such as hydrochlorothiazide (Microzide) or furosemide (Lasix)

This is not a complete list of TOBI Podhaler drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with TOBI Podhaler including:

• hearing loss or ringing in the ears (ototoxicity). Tell your healthcare provider right away if you have some or all of the following symptoms:
  • hearing loss
  • hearing noises in your ears such as ringing or hissing
  • vertigo, difficulty with balance or dizziness
• worsening kidney problems (nephrotoxicity). TOBI Podhaler is in a class of drugs which may cause worsening 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.
• worsening muscle weakness. TOBI Podhaler is in a class of drugs which 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:
  • shortness of breath with wheezing
  • coughing and chest tightness
• TOBI Podhaler is in a class of drugs which may cause harm to an unborn baby

Do not take TOBI Podhaler if you:

• are allergic to tobramycin, any of the ingredients in TOBI Podhaler, or to any other aminoglycoside antibacterial

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of TOBI Podhaler, there are no specific foods that you must exclude from your diet when receiving TOBI Podhaler.

Before taking TOBI Podhaler, tell your doctor about all of your medical conditions. Especially tell your doctor 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 are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

TOBI Podhaler falls into category D. There is evidence of risk to the unborn baby based on studies in humans or adverse reaction data, but this medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby. TOBI Podhaler may harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if TOBI Podhaler is excreted in human breast milk or if it will harm your nursing baby.

Take TOBI Podhaler exactly as prescribed.

This medication comes in the form of a dry powder to be inhaled into the lungs using a special handheld inhaler device called a Podhaler. It is inhaled twice daily, usually twelve hours between doses. After 28 days the medication is stopped for 28 days, and then restarted.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of TOBI Podhaler at the same time.

Take TOBI Podhaler exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The usual dose for adults and children over 6 years of age is:

• The content of 4 capsules inhaled by mouth in the morning using your Podhaler device and the content of 4 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.
• You should not take your dose of 4 capsules less than 6 hours apart.

If you take too much TOBI Podhaler, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store TOBI Podhaler at room temperature.

Keep the TOBI Podhaler capsules and Podhaler device in a dry place.

Store the Podhaler device tightly closed in its case when you are not using it.

Keep TOBI Podhaler capsules, Podhaler device, and all medicines out of the reach of children.