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 * Full Prescribing Information


 * About
 * Savings
 * When and How to Use
 * FAQs
 * Teva's Commitment


TEVA OFFERS AN FDA-APPROVED GENERIC VERSION OF BETHKIS®* (TOBRAMYCIN INHALATION
SOLUTION).

For the management of cystic fibrosis with Pseudomonas aeruginosa.

Learn more Teva offers an FDA-approved generic version of Bethkis<sup>®*</sup>
(Tobramycin Inhalation Solution).


PAY AS LITTLE AS $0* FOR TEVA'S TOBRAMYCIN INHALATION SOLUTION

*Eligibility requirements apply.

Download Savings Card Pay as little as $0* for Teva's Tobramycin Inhalation
Solution


TEVA KNOWS GENERICS - IT'S WHAT WE DO.

Find out how Teva became a leading producer of generics.

Read more Teva knows generics - it's what we do.

 

 

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

Toggle Instructions

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

 * About
 * Savings
 * When & How to Use
 * FAQs
 * Teva's Commitment

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 * Full Prescribing Information
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*Bethkis®  is a registered trademark of Chiesi Farmaceutici S.p.A

© 2024 Teva Pharmaceuticals USA, Inc. TG-43604 February 2024



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