Tobramycin Solution for Inhalation

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KEY POINTS

• This medicine is inhaled by mouth to treat certain respiratory infections in people with cystic fibrosis. Use it exactly as directed.
• This medicine may cause hearing problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antibiotic

Generic and brand names: tobramycin solution for inhalation; Bethkis; Kitabis Pak; TOBI; TOBI Podhaler

What is this medicine used for?

This medicine is inhaled by mouth to treat certain respiratory infections in people with cystic fibrosis.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before you take this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• An organ transplant
• Dizziness
• Hearing problems
• Kidney problems
• Muscular disorders, such as myasthenia gravis, cerebral palsy, amyotrophic lateral sclerosis, or Parkinson's disease

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I use it?

Use this medicine exactly as your healthcare provider prescribes. Do not stop using this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under the age of 6.

• If you have the solution:

  An instruction guide comes with this medicine. Read it thoroughly, and follow all directions for cleaning and disinfecting the nebulizer.

  This medicine is a clear light yellow liquid. Do not use it if it is cloudy or contains particles.

  This medicine is inhaled from a nebulizer. Inhale the medicine while you are sitting or standing upright. Use the mouthpiece of the nebulizer to breathe the medicine in through your mouth. Nose clips may help you breathe through your mouth. Rinse your mouth after each treatment.

• If you have the TOBI Podhaler:

  Do not swallow the capsules. Take the capsules out of the blister pack right before use. They are only to be used in the Podhaler device. An instruction guide comes with this medicine. Read it thoroughly, and follow all directions.

After using this medicine for 28 days, you should stop using it and wait 28 days. After you have stopped using this medicine for 28 days, you should start using it 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

If you are using other inhaled medicines, ask your healthcare provider when you should take each medicine. If you do not understand how or when to use this medicine, ask your healthcare provider or pharmacist to explain.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is less than 6 hours before the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. Always wait at least 6 hours between doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

This medicine may affect your hearing. If you notice any hearing loss, contact your healthcare provider. You may need to have hearing tests regularly while taking this medicine. Do not drive or operate machinery if you are dizzy.

People who have cystic fibrosis can have many symptoms. Some symptoms may be caused by your medicine. If you have any new or worsening symptoms, tell your healthcare provider.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Ringing in your ears, hearing loss, dizziness, problems with balance or trouble walking, increased coughing or wheezing, cough that does not go away, fever, sore throat, increased sputum, chest pain, change in the amount or color of urine, unusual muscle weakness, trouble talking, coughing up blood.

Other: Mild cough, hoarseness, bad taste in your mouth, runny or stuffy nose, nausea, headache, loss of appetite.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Amphotericin b (Abelcet, AmBisome, Amphotec)
• Antibiotics such as amikacin, cefaclor, cefdinir (Omnicef), cefixime (Suprax), colistimethate (Coly-Mycin), gentamicin, kanamycin, neomycin (Neo-Fradin), piperacillin, streptomycin, ticarcillin/clavulanate (Timentin), tobramycin, and vancomycin (Vancocin)
• Botulinum injections such as abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox), and rimabotulinumtoxinB (Myobloc)
• Cancer medicines such as carboplatin and cisplatin
• Diuretics (water pills) such as bumetanide, ethacrynic acid (Edecrin), furosemide (Lasix), and torsemide (Demadex)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

If you have the solution, store it in the refrigerator in its original foil pouch. If you cannot store this medicine in a refrigerator, you may store the foil pouches at room temperature for up to 28 days, away from heat or bright light. This medicine is sensitive to light. Keep the medicine in its original foil pouch. Discard any unused medicine stored at room temperature after 28 days. Do not use any medicine that is cloudy or has particles in it.

If you have the Podhaler capsules, store them at room temperature in the original blister pack. Protect the medicine from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.