Store Tobramycin Inhalation Solution in the refrigerator between 36°F to 46°F (2°C to 8°C) until needed. The PARI LC PLUS does not need to be refrigerated.
Do not use Tobramycin Inhalation Solution if it has been stored at room temperature (up to 25ºC/77ºF) for more than 28 days.
Keep Tobramycin Inhalation Solution in the foil pouch and out of the light.
Do not use Tobramycin Inhalation Solution after the expiration date stamped on the ampule.
Do not use Tobramycin Inhalation Solution if it is cloudy, has particles in the solution, or if it has been stored at room temperature for more than 28 days. Throw the applicable ampule(s) away in the household trash and get a new ampule.
Unrefrigerated Tobramycin Inhalation Solution
When you don’t have a refrigerator available (for example, when you are traveling), you may store the Tobramycin Inhalation Solution pouches (opened or unopened) at room temperature (up to 25ºC/77ºF) for up to 28 days. Tobramycin Inhalation Solution is normally slightly yellow, but may get darker with age if unrefrigerated. The color change does not change how the medicine works.
Kitabis Pak (co-packaging of tobramycin inhalation solution and a PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
Important Safety Information
Do not take Kitabis Pak (Tobramycin Inhalation Solution) if you are allergic to tobramycin, or any of the ingredients in Kitabis Pak, or any aminoglycocide antibiotic.
Before taking Kitabis Pak, inform your health care provider if you have or have had any hearing problems including ringing or other noises in your ears, dizziness, kidney problems, muscle weakness such as myasthenia gravis or Parkinson’s disease, breathing problems such as wheezing, coughing or chest tightness, or have had an organ transplant. Before you inhale Kitabis Pak, inform your health care provider if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if Kitabis Pak will pass into breast milk.
Tell your health care provider about all the medicines you take. Taking Kitabis Pak with certain other medications can cause serious side effects. If you are taking Kitabis Pak, you should discuss with your health care provider if you should take other medicines that may harm your nervous system, kidneys or hearing, or diuretics (water pills) such as Edecrin® (ethacrynic acid), Lasix® (furosemide), mannitol, or urea.
Kitabis Pak can cause serious side effects including hearing loss or ringing in the ears (ototoxicity), worsening kidney problems (nephrotoxicity), worsening muscle weakness, harm to an unborn baby, and/or severe breathing problems (bronchospasm). Tell your health care provider right away of you have hearing loss or hear noises in your ears (such as ringing or hissing), develop vertigo, dizziness, difficulty with balance, shortness of breath with wheezing, or coughing or chest tightness. Your health care provider may do a blood test and urine test to check how your kidneys are working while you are taking Kitabis Pak.
The most common side effects of Kitabis Pak include cough, sore throat, productive cough, shortness of breath, coughing up blood, worsening of lung problems or cystic fibrosis, changes in your voice (hoarseness), altered taste, and rash. Tell your health care provider about any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.