Tobramycin Oral Inhalation

Tobramycin inhalation is used to treat certain infections with bacteria in patients with cystic fibrosis (CF; genetic disorder that causes thick mucus production that causes problems in the lungs and digestive system).Tobramycin inhalation is in a class of medications called aminoglycoside antibiotics. It works by killing bacteria.

Tobramycin inhalation comes as a solution (liquid) to inhale by mouth using a special nebulizer and powder-filled capsule to inhale by mouth using a Podhaler device. Inhale two times a day for 28 days. Use tobramycin inhalation at around the same times every day, as close to every 12 hours as possible. Do not administer two doses within 6 hours. After 28 days of treatment, you will remain off of therapy for 28 days and then repeat the cycle.

Use tobramycin inhalation exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your healthcare provider will show you how to use tobramycin inhalation and the Podhaler or nebulizer you are prescribed. You will also be given instructions for use. Read these instructions carefully. Ask your doctor or pharmacist if you have any questions on how to use tobramycin inhalation.

If using the Podhaler, it is important to know the following:

• you must inhale all the powder for your prescribed dose. If you do not think you have inhaled all the powder or are unsure, it is important that you contact your doctor right away
• use a new Podhaler device every 7 days

If using the tobramycin inhalation solution for nebulizer, it is important to know the following:

• use only the nebulizer machine provided with tobramycin inhalation
• do not mix any other medications or solutions with tobramycin inhalation in the nebulizer
• it should take 15 minutes to give the full dose of tobramycin inhalation through the nebulizer
• use the nebulizer only while sitting or standing upright and breathing through the mouthpiece
• a noseclip may help you breathe better through the mouth during the treatment

If you are using other inhaled medications or taking other medications for CF, you should use or take those before tobramycin inhalation or as directed by your doctor.

Do not swallow the capsules or take the oral solution by mouth. If you accidentally swallow the capsule or solution, call your doctor right away.

Do not stop using tobramycin inhalation without talking to your doctor.

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

Before using tobramycin inhalation,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken or used with tobramycin inhalation. Other medications may cause dosing changes or extra monitoring when taken with tobramycin inhalation. Make sure you have discussed any medications you are currently taking or plan to take before starting tobramycin inhalation with your doctor and pharmacist. Before starting, stopping, or changing any medications while receiving tobramycin inhalation, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with tobramycin inhalation: nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using tobramycin inhalation. Do not start any of these medications while using tobramycin inhalation without discussing with your healthcare provider.
• tell your doctor if you have or have ever had hearing problems, hearing loss, or if your mother has suffered hearing problems after receiving an aminoglycoside antibiotic such as gentamicin, tobramycin, streptomycin; have or have ever had kidney disease, a neuromuscular disorder such as myasthenia gravis or Parkinson's disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving tobramycin inhalation, call your doctor immediately. Tobramycin inhalation may harm the fetus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using tobramycin inhalation.
• you should know that tobramycin inhalation has caused ototoxicity (inner ear damage). Call your doctor right away if you have any of the following symptoms: hearing loss, ringing in the ears, dizziness, difficulty with balance or coordination, or unsteady walking.

Unless your doctor tells you otherwise, continue your normal diet.

Inhale the missed dose as soon as you remember it. However, if it has been more than 6 hours since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not inhale a double dose to make up for a missed one.

Tobramycin inhalation may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• increased cough, coughing up blood or sputum, shortness of breath, difficulty breathing
• sore throat or hoarseness or changes in voice
• headache
• loss of taste

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• shortness of breath or wheezing, chest tightness and coughing
• rash; hives; swelling of face, lips or throat; difficulty breathing or shortness of breath
• swelling of legs or ankles or feet; fatigue or tiredness; blood in urine or urinating more frequently; poor appetite; muscle cramping

Tobramycin inhalation may cause worsening muscle weakness in patients with existing neuromuscular conditions like Parkinson's Disease or myasthenia gravis. Talk to your doctor about the risks of taking this medication if you have one of these conditions.

Tobramycin inhalation may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store capsules for Podhaler at room temperature and away from excess heat and moisture (not in the bathroom). Store solution for nebulizer in the refrigerator or at room temperature for 28 days away from direct light. The ampules of solution may be discolored if exposed to light but this doesn't mean it isn't still effective as long as it has been stored at the correct temperatures.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

If someone swallows tobramycin inhalation, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to tobramycin inhalation.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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