What is Teva’s Tobramycin Inhalation Solution?

What does “therapeutically equivalent” to Bethkis® mean?

Teva’s Tobramycin Inhalation Solution has the same active ingredient as Bethkis®. It works in the body the same way as Bethkis® does to help improve lung function.

Teva offers Tobramycin Inhalation Solution, a generic version of Bethkis® (Tobramycin Inhalation Solution).

 

Teva’s Tobramycin Inhalation Solution is an inhaled antibacterial solution prescribed for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Tobramycin Inhalation Solution contains an antibacterial medicine called tobramycin (an aminoglycoside).

Tobramycin Inhalation Solution is available as a 28-day supply containing 56 ampules including 14 foil pouches and as a 14-day supply containing 28 ampules including 7 foil pouches. Each foil pouch contains 4 Tobramycin Inhalation Solution ampules.

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.

If you are taking several other medicines or treatments to treat your cystic fibrosis, you should take your medicines or other treatments before inhaling Tobramycin Inhalation Solution or as directed by your healthcare provider.

Tobramycin Inhalation Solution can cause serious side effects, including: 

  • hearing loss or ringing in the ears (ototoxicity)

  • worsening kidney problems (nephrotoxicity)

  • worsening muscle weakness (neuromuscular disorder)

  • severe breathing problems (bronchospasm)

          - 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 may report side effects to FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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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)
  • 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 Medication Guide 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 cepacian