The First FDA Approved Convenience Kit with Nebulized Tobramycin
Kitabis® Pak (Ki TAH biss Pak) is a co-packaging of Tobramycin Inhalation Solution (drug) and PARI LC PLUS® Reusable Nebulizer (device) in a patient convenience kit. Kitabis Pak is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa.
Kitabis Pak also includes a PARI LC PLUS, the nebulizer handset used exclusively in clinical trials for Tobramycin Inhalation Solution. It is the only nebulizer approved by the FDA to safely and effectively deliver Tobramycin Inhalation Solution. One prescription, one stop. Drug. Device. Delivered.*
See the world in 3D with Kitabis Pak.
Drug. Device. Delivered.
Taking nebulized tobramycin requires the drug and a nebulizer to deliver the drug. Kitabis Pak includes both the Tobramycin Inhalation Solution and a PARI LC PLUS Nebulizer – making it the first FDA approved convenience kit with nebulized tobramycin. Simpler, smarter, and easier than ever to get the treatments you need.
Your Kitabis Pak Convenience Kit includes:
Drug: 56 Single-Use Ampules (28-Day Supply)
(14 foil pouches – each with 4 Single-Use Ampules)
Device: One PARI LC PLUS Reusable Nebulizer
Delivered together in one convenient Pak.
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.
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