When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to tobramycin or similar medicines, or if you are pregnant.

How to Use This Medicine:
Capsule, Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You may need to use other medicine or receive therapy before this medicine. Carefully follow your doctor's instructions about how to use your medicines, because they work best when used in the right order. Tobramycin is usually used last.
• This medicine is usually used for 28 days in a row, and then you stop using it for 28 days. This 28 days-on/28 days-off cycle may be repeated.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions. You should receive an information sheet that will tell you how to take care of the equipment that you use with the medicine.
• Inhalation solution (liquid):
  
  • The medicine should look clear. Do not use it if the liquid is cloudy or you see particles in it. The color of the medicine might get darker if you store it at room temperature, and you can still use the medicine if this happens.
  • You will use this medicine with an inhaler device called a nebulizer. The nebulizer turns the medicine into a fine mist that you breathe in through your mouth and to your lungs. Your caregiver will show you how to use your nebulizer. Use only the nebulizer that your doctor prescribes.
  • Do not mix other medicine with tobramycin unless your doctor tells you to.
  • Set up your nebulizer by following the manufacturer's instructions.
  • Stand or sit upright. Breathe in the medicine through the mouthpiece. This usually takes about 15 minutes. Do not inhale through your nose.
  • Clean all the parts of the nebulizer after each use.
• Inhalation capsule:
  
  • Do not swallow the capsule.
  • This medicine must be used with the Podhaler™ device. Use a new Podhaler™ every 7 days.
  • Do not take a capsule out of the blister pack until you are ready to use it. Insert the capsule into the Podhaler™ as your health caregiver taught you to do.
  • To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece in your mouth with the device upright.
  • Breathe in slowly and deeply. Hold your breath for about 5 seconds, and then breathe out slowly. Repeat this cycle.
  • Check to see if the capsule is empty. Repeat the breathe in/breath out cycle until the capsule is empty. If you were told to use more than one capsule, repeat this process.
  • Wipe the mouthpiece with a clean, dry cloth. Keep the Podhaler™ dry at all times.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not use 2 doses within 6 hours
• Inhalation solution: Store in the refrigerator. Do not use the medicine after the expiration date. If you cannot keep the medicine in the refrigerator, you may store it at room temperature for only 28 days. Dispose of any medicine that has been at room temperature for longer than 28 days. Store it in the foil pouch, away from heat or direct light.
• Inhalation capsules: Store at room temperature in a dry place, away from heat and direct light. Do not store the capsules inside the Podhaler™.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how tobramycin works. Tell your doctor if you are using a diuretic (water pill, including ethacrynic acid, furosemide, mannitol, urea).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding or if you have kidney problems. Also tell your doctor if you have myasthenia gravis, Parkinson disease, or a similar nerve or muscle problem.
• This medicine may cause hearing or balance problems. Make sure your doctor knows if you already have trouble with hearing, balance, ringing in your ears, or dizziness.
• Never swallow the capsule or liquid medicine. It works only if you breathe it into your lungs.
• Talk to your doctor right away if any of your medicines do not seem to be working as well as usual. Do not change your dose or stop using your medicines without asking your doctor.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Feeling of constant movement, problems with balance, dizziness, clumsiness
• Trouble hearing, ringing in your ears
• Worse trouble breathing, chest tightness or pain, cough

If you notice these less serious side effects, talk with your doctor:

• Change in sense of taste
• Headache
• Hoarseness, voice changes, sore throat

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088