Teva's Tobramycin Inhalation Solution

IMPORTANT SAFETY INFORMATION

Do not take tobramycin inhalation solution if you are allergic to tobramycin, any of the ingredients in tobramycin inhalation solution, or to any other aminoglycoside antibacterial.

See the end of the Patient Information Leaflet found in the Prescribing Information for a complete list of ingredients in tobramycin inhalation solution.

Before you take tobramycin inhalation solution, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had hearing problems (including noises in your ears such as ringing or hissing) hearing loss, or your mother has had hearing problems after taking an aminoglycoside.
• have been told you have certain gene variants (a change in the gene) related to hearing abnormalities inherited from your mother.
• 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
• are pregnant or plan to become pregnant. Tobramycin inhalation solution is in a class of medicines that can harm your unborn baby and may be connected with complete deafness in babies at birth. The deafness affects both ears and cannot be changed.
• are breastfeeding or plan to breastfeed. It is not known if tobramycin passes into your breast milk. Tobramycin, the medicine in tobramycin inhalation solution may cause the following symptoms in your breastfed baby:
   
  • loose or bloody stools
  •  yeast infection in the mouth or throat (thrush)
  • diaper rash
     

Call your baby’s healthcare provider if your breastfed baby has any of these problems. Talk to your healthcare provider about the best way to feed your baby during treatment with tobramycin inhalation solution.

• are receiving aminoglycoside therapy by injection or through a vein (intravenous) while taking tobramycin inhalation solution. Your blood levels of tobramycin will be checked.
   

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

 What are the possible side effects of tobramycin inhalation solution?

 Tobramycin inhalation solution can cause serious side effects, including:

• hearing loss or ringing in the ears (ototoxicity). Some people who were treated with tobramycin, the medicine in tobramycin inhalation solution had hearing loss or ringing in the ears. Tell your healthcare provider right away if you have hearing loss or hear noises in your ears (such as ringing or hissing), or if you develop vertigo, dizziness, or difficulty with balance.
• worsening kidney problems (nephrotoxicity). Your healthcare provider may do a blood test and urine test to check how your kidneys are working while you are taking tobramycin inhalation solution.
• worsening muscle weakness (neuromuscular disorder). Tobramycin inhalation solution 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 while taking tobramycin inhalation solution:

• • shortness of breath with wheezing
  • coughing and chest tightness
     

The most common side effects of tobramycin inhalation solution include:

• worsening of lung problems or cystic fibrosis
• noisy breathing (rales)
• abnormal red blood cell activity
• changes in your voice (hoarseness)
   

These are not all of the possible side effects of tobramycin inhalation solution.

Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 Please read the Patient Leaflet in the full Prescribing Information.

 What is tobramycin inhalation solution?

Tobramycin inhalation solution is a prescription medicine that is used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. Tobramycin inhalation solution contains an antibacterial medicine called tobramycin (an aminoglycoside).

It is not known if tobramycin inhalation solution is safe and effective:

• in children under 6 years of age
• in people who have decreased lung volume or a forced expiratory volume in one second (FEV1) less than 40% or greater than 80% predicted
• in people who are colonized with a bacterium called Burkholderia cepacia