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Tobi Podhaler powder

Generic Name: tobramycin (TOE-bra-MYE-sin)
Brand Name: Tobi Podhaler

Tobi Podhaler powder is used for:

Treating patients with cystic fibrosis and certain infections (Pseudomonas aeruginosa). It may also be used for other conditions as determined by your doctor.

Tobi Podhaler powder is an aminoglycoside antibiotic. It works by killing sensitive bacteria.

Do NOT use Tobi Podhaler powder if:

  • you are allergic to any ingredient in Tobi Podhaler powder or another aminoglycoside antibiotic (eg, gentamicin)
  • you are taking ethacrynic acid, furosemide, mannitol, or urea
  • you are taking any medicine that may harm your kidneys, nervous system, or hearing. Ask your doctor or pharmacist if you are unsure if any of your medicines might cause these problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tobi Podhaler powder:

Some medical conditions may interact with Tobi Podhaler powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have dizziness or a history of breathing problems (eg, wheezing, coughing, chest tightness), hearing problems, kidney problems, or problems with muscle weakness (eg, myasthenia gravis, Parkinson disease)
  • if you have had an organ transplant

Some MEDICINES MAY INTERACT with Tobi Podhaler powder. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Aminoglycosides (eg, gentamicin), loop diuretics (eg, ethacrynic acid, furosemide), mannitol, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), urea, or vancomycin because they may increase the risk of Tobi Podhaler powder's side effects, including increased risk of kidney or hearing loss

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tobi Podhaler powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tobi Podhaler powder:

Use Tobi Podhaler powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Tobi Podhaler powder. It also comes with detailed instructions for use. Read them carefully. Talk to your pharmacist if you have questions about this information.
  • Do not swallow the capsules. The capsules are used with the provided special inhaler. If you swallow a capsule on accident, tell your doctor right away.
  • Tobi Podhaler powder is usually used in cycles of 28 days on the medicine, followed by 28 days off the medicine. Carefully follow the dosing schedule given to you by your doctor.
  • Do not remove a capsule from the packaging until you are ready to use it.
  • If you are taking several inhaled medicines or other therapies for cystic fibrosis (eg, chest physiotherapy), talk to your doctor about the best order for taking your medicines or other therapies.
  • Use a new inhaler device every 7 days. Clean the device as needed according to the instructions in the patient leaflet.
  • Use your doses as close to 12 hours apart as possible.
  • Very small pieces of the capsules may get into your mouth, and you may feel them on your tongue. It will not hurt you if you swallow or inhale them.
  • Ask your doctor or pharmacist if you are unclear about how to use this device or inhale the medicine.
  • Using Tobi Podhaler powder at the same times each day will help you remember to use it.
  • Use Tobi Podhaler powder on a regular schedule to get the most benefit from it.
  • If you miss a dose of Tobi Podhaler powder, use it as soon as possible. If it is less than 6 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tobi Podhaler powder.

Important safety information:

  • Tobi Podhaler powder is for oral inhalation only. Do not get it in your eyes. If you get it in your eyes, rinse right away with cool water.
  • Tobi Podhaler powder only works against bacteria; it does not treat viral infections (eg, the common cold).
  • Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor.
  • Be sure to use Tobi Podhaler powder for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Long-term or repeated use of Tobi Podhaler powder may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
  • Tobi Podhaler powder may sometimes cause severe breathing problems (eg, shortness of breath with wheezing, coughing and chest tightness) right after you use a dose. Contact your doctor or seek other medical care at once.
  • If your symptoms do not get better or if they get worse, check with your doctor.
  • Tell your doctor or dentist that you take Tobi Podhaler powder before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including kidney function, hearing tests, and tobramycin levels, may be performed while you use Tobi Podhaler powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Tobi Podhaler powder should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Tobi Podhaler powder has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tobi Podhaler powder while you are pregnant. It is not known if this medicine is found in breast milk after inhalation. Do not breast-feed while taking Tobi Podhaler powder.

Possible side effects of Tobi Podhaler powder:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; headache; mouth or throat irritation; nausea; stuffy nose; taste changes; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; coughing up blood; decreased coordination; decreased hearing or other hearing changes (eg, hearing loss, ringing or roaring in the ears); decreased urination; dizziness or light-headedness; feeling of a whirling motion; fever, chills, or persistent cough or sore throat; hoarseness; muscle weakness; new or worsening breathing problems (eg, shortness of breath, wheezing); numbness or tingling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Tobi Podhaler powder:

Store Tobi Podhaler powder between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tobi Podhaler powder out of the reach of children and away from pets.

General information:

  • If you have any questions about Tobi Podhaler powder, please talk with your doctor, pharmacist, or other health care provider.
  • Tobi Podhaler powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Tobi Podhaler powder or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tobi Podhaler powder. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tobi Podhaler powder. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Tobi Podhaler powder.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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